{
"description": "The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.",
"_filename": "StructureDefinition-pqcmc-product-part.json",
"package_name": "hl7.fhir.us.pq-cmc-fda",
"date": "2024-04-08T17:51:06+00:00",
"derivation": "constraint",
"publisher": "HL7 International / Biomedical Research and Regulation",
"fhirVersion": "5.0.0",
"jurisdiction": [ {
"coding": [ {
"code": "US",
"system": "urn:iso:std:iso:3166",
"display": "United States of America"
} ]
} ],
"name": "FinishedProduct",
"mapping": [ {
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping",
"identity": "w5"
}, {
"uri": "https://www.iso.org/obp/ui/#iso:std:iso:11615",
"name": "IDMP Mapping",
"identity": "idmp"
}, {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
} ],
"abstract": false,
"type": "ManufacturedItemDefinition",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "Manufactured Drug Product",
"package_version": "1.0.0-ballot",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
} ],
"snapshot": {
"element": [ {
"constraint": [ {
"key": "dom-2",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.contained.empty()"
}, {
"key": "dom-3",
"human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"
}, {
"key": "dom-4",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"
}, {
"key": "dom-5",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.security.empty()"
}, {
"key": "dom-6",
"human": "A resource should have narrative for robust management",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "warning",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
} ],
"expression": "text.`div`.exists()"
}, {
"key": "cmc-capsule-count-required",
"human": "Capsule constituent count is required when the dosage form is 'Capsule'",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433')\nimplies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists()"
}, {
"key": "cmc-arbitrary-unit-text-required",
"human": "BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "property.where(\n type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (\n code = 'TotWgtNum' or \n code = 'TotWgtDen'\n )\n ) and\n value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765')\n).exists() implies property.where(\n type.coding.exists(\n code = 'TotWgtTxt' and\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'\n )\n).exists()"
}, {
"key": "cmc-coating-indication-required",
"human": "Coating indication is required when the dosage form is a tablet, lozenge or capsule",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (\n code = 'C154605' or\n code = 'C154433' or\n code = 'C154554'\n))\nimplies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists()"
}, {
"key": "cmc-tablet-layer-count-required",
"human": "Tablet layer count is required when the dosage form is a tablet",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'C154605'\n) implies property.where(\n type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'TabLayCnt'\n )\n).exists()"
}, {
"key": "cmc-tablet-bead-count-required",
"human": "Tablet bead count is required when the dosage form is a tablet",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'C154605'\n) implies property.where(\n type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'BeaTypCnt'\n )\n).exists()"
}, {
"key": "cmc-capsule-classification-required",
"human": "when the the dosage form is 'capsule' and a 'capsule shell' part\nexists, a capsule shell part classification is mandatory",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'C154433'\n) and component.type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'C203897'\n) implies property.where(\n type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'CapClass'\n )\n).exists()"
} ],
"path": "ManufacturedItemDefinition",
"min": 0,
"definition": "The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.",
"isModifier": false,
"short": "The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product",
"mapping": [ {
"map": "Entity, Role, or Act",
"identity": "rim"
}, {
"map": "administrative.medication",
"identity": "w5"
}, {
"map": "Manufactured Item",
"identity": "idmp"
} ],
"mustSupport": false,
"max": "*",
"id": "ManufacturedItemDefinition",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition"
},
"isSummary": false
}, {
"path": "ManufacturedItemDefinition.id",
"min": 0,
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"isModifier": false,
"short": "Logical id of this artifact",
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.id",
"comment": "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.id"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.meta",
"min": 0,
"definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"isModifier": false,
"short": "Metadata about the resource",
"type": [ {
"code": "Meta"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.meta",
"base": {
"max": "1",
"min": 0,
"path": "Resource.meta"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.meta.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.meta.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.meta.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.meta.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.meta.versionId",
"min": 0,
"definition": "The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.",
"isModifier": false,
"short": "Version specific identifier",
"type": [ {
"code": "id"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.meta.versionId",
"comment": "The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.",
"base": {
"max": "1",
"min": 0,
"path": "Meta.versionId"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.meta.lastUpdated",
"min": 0,
"definition": "When the resource last changed - e.g. when the version changed.",
"isModifier": false,
"short": "When the resource version last changed",
"type": [ {
"code": "instant"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.meta.lastUpdated",
"comment": "This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http://hl7.org/fhir/R5/http.html#read) interaction.",
"base": {
"max": "1",
"min": 0,
"path": "Meta.lastUpdated"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.meta.source",
"min": 0,
"definition": "A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.",
"isModifier": false,
"short": "Identifies where the resource comes from",
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.meta.source",
"comment": "The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference. \n\nThis element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.",
"base": {
"max": "1",
"min": 0,
"path": "Meta.source"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.meta.profile",
"min": 1,
"definition": "A list of profiles (references to [StructureDefinition](structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url).",
"isModifier": false,
"short": "Profiles this resource claims to conform to",
"type": [ {
"code": "canonical",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/StructureDefinition" ]
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.meta.profile",
"comment": "It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.",
"base": {
"max": "*",
"min": 0,
"path": "Meta.profile"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.meta.security",
"min": 0,
"definition": "Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.",
"isModifier": false,
"short": "Security Labels applied to this resource",
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/security-labels",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SecurityLabels"
} ],
"description": "Security Labels from the Healthcare Privacy and Security Classification System."
},
"max": "*",
"id": "ManufacturedItemDefinition.meta.security",
"comment": "The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.",
"base": {
"max": "*",
"min": 0,
"path": "Meta.security"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.meta.tag",
"min": 0,
"definition": "Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.",
"isModifier": false,
"short": "Tags applied to this resource",
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/common-tags",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Tags"
} ],
"description": "Codes that represent various types of tags, commonly workflow-related; e.g. \"Needs review by Dr. Jones\"."
},
"max": "*",
"id": "ManufacturedItemDefinition.meta.tag",
"comment": "The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.",
"base": {
"max": "*",
"min": 0,
"path": "Meta.tag"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.implicitRules",
"min": 0,
"definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"isModifier": true,
"short": "A set of rules under which this content was created",
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.implicitRules",
"comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.implicitRules"
},
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.language",
"min": 0,
"definition": "The base language in which the resource is written.",
"isModifier": false,
"short": "Language of the resource content",
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "1",
"id": "ManufacturedItemDefinition.language",
"comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"base": {
"max": "1",
"min": 0,
"path": "Resource.language"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.text",
"min": 0,
"definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"isModifier": false,
"short": "Text summary of the resource, for human interpretation",
"mapping": [ {
"map": "Act.text?",
"identity": "rim"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"alias": [ "narrative", "html", "xhtml", "display" ],
"max": "1",
"id": "ManufacturedItemDefinition.text",
"condition": [ "dom-6" ],
"comment": "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"base": {
"max": "1",
"min": 0,
"path": "DomainResource.text"
},
"isSummary": false
}, {
"path": "ManufacturedItemDefinition.contained",
"min": 0,
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"isModifier": false,
"short": "Contained, inline Resources",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Resource"
} ],
"mustSupport": false,
"alias": [ "inline resources", "anonymous resources", "contained resources" ],
"max": "*",
"id": "ManufacturedItemDefinition.contained",
"condition": [ "dom-2", "dom-4", "dom-3", "dom-5" ],
"comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.contained"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"mustSupport": false,
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"mustSupport": false,
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.identifier",
"min": 0,
"definition": "Unique identifier.",
"isModifier": false,
"short": "Unique identifier",
"mapping": [ {
"map": "FiveWs.class",
"identity": "w5"
}, {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.identifier",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.status",
"min": 1,
"definition": "The status of this item. Enables tracking the life-cycle of the content.",
"isModifier": true,
"short": "draft | active | retired | unknown",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "code"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "ManufacturedItemDefinition.status",
"comment": "Allows filtering of manufactured items that are appropriate for use versus not.",
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.status"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because applications should not use a retired {{title}} without due consideration",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.name",
"min": 0,
"definition": "Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. \nExample: Tylenol\n\nProduct Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]",
"isModifier": false,
"short": "Product Proprietary Name | Product Non-proprietary Name",
"mapping": [ {
"map": "FiveWs.class",
"identity": "w5"
}, {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.name",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.manufacturedDoseForm",
"min": 1,
"definition": "Dose form as manufactured and before any transformation into the pharmaceutical product.",
"isModifier": false,
"short": "Dose form as manufactured (before any necessary transformation)",
"mapping": [ {
"map": "Manufactured Item.Manufactured Dose Form",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/manufactured-dose-form",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ManufacturedDoseForm"
} ],
"description": "Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary."
},
"max": "1",
"id": "ManufacturedItemDefinition.manufacturedDoseForm",
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.manufacturedDoseForm"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.manufacturedDoseForm.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.manufacturedDoseForm.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.manufacturedDoseForm.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.manufacturedDoseForm.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.manufacturedDoseForm.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology"
},
"max": "*",
"id": "ManufacturedItemDefinition.manufacturedDoseForm.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.manufacturedDoseForm.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.manufacturedDoseForm.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.unitOfPresentation",
"min": 0,
"definition": "The “real-world” units in which the quantity of the manufactured item is described.",
"isModifier": false,
"short": "The “real-world” units in which the quantity of the item is described",
"mapping": [ {
"map": "Manufactured Item.Unit of Presentation",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/unit-of-presentation",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "UnitOfPresentation"
} ],
"description": "The presentation type in which an administrable medicinal product is given to a patient."
},
"max": "1",
"id": "ManufacturedItemDefinition.unitOfPresentation",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.unitOfPresentation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.manufacturer",
"min": 0,
"definition": "Manufacturer of the item, one of several possible.",
"isModifier": false,
"short": "Manufacturer of the item, one of several possible",
"mapping": [ {
"map": "Manufactured Item.Manufacturer / Establishment (Organisation)",
"identity": "idmp"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "ManufacturedItemDefinition.manufacturer",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.manufacturer"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.marketingStatus",
"min": 0,
"definition": "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.",
"isModifier": false,
"short": "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "MarketingStatus"
} ],
"mustSupport": false,
"max": "*",
"id": "ManufacturedItemDefinition.marketingStatus",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.marketingStatus"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.ingredient",
"min": 0,
"definition": "The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource.",
"isModifier": false,
"short": "The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource",
"mapping": [ {
"map": "Manufactured Item.Ingredient (see also FHIR Ingredient resource)",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTSubstanceCodes"
} ],
"description": "This value set includes all substance codes from SNOMED CT - provided as an exemplar value set."
},
"max": "*",
"id": "ManufacturedItemDefinition.ingredient",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.ingredient"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 5,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"description": "Slice based on value",
"discriminator": [ {
"path": "type",
"type": "value"
} ]
},
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "ManufacturedItemDefinition.property",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.property.type",
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 0,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
}, {
"code": "Quantity"
}, {
"code": "date"
}, {
"code": "boolean"
}, {
"code": "markdown"
}, {
"code": "Attachment"
}, {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Binary" ]
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 1,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "OvrRelsProf",
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsProf",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.type",
"patternCodeableConcept": {
"coding": [ {
"code": "OvrRelsProf",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Overall Release Profile"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids).\nFor example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the \"product overall release profile\" is \"ER\". [Source: SME Defined]",
"isModifier": false,
"short": "Product Overall Release Profile",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile"
},
"max": "*",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "OvrRelsMech",
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsMech",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.type",
"patternCodeableConcept": {
"coding": [ {
"code": "OvrRelsMech",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Overall Release Mechanism"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "TThe dosage form design used to achieve an ER release profile. Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]",
"isModifier": false,
"short": "Product Overall Release Mechanism",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism"
},
"max": "*",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "CoatInd",
"max": "1",
"id": "ManufacturedItemDefinition.property:CoatInd",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CoatInd.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:CoatInd.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:CoatInd.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:CoatInd.type",
"patternCodeableConcept": {
"coding": [ {
"code": "CoatInd",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Coating Indicator"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"type": [ {
"code": "boolean"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property:CoatInd.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A property that identifies whether the drug product contains any coatings. [Source: SME Defined]",
"isModifier": false,
"short": "Product Coating Indicator",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "boolean"
} ],
"mustSupport": true,
"sliceName": "valueBoolean",
"max": "1",
"id": "ManufacturedItemDefinition.property:CoatInd.value[x]:valueBoolean",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "LayCnt",
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:LayCnt.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:LayCnt.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.type",
"patternCodeableConcept": {
"coding": [ {
"code": "TabLayCnt",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Tablet Layer Count"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].value",
"requirements": "Precision is handled implicitly in almost all cases of measurement.",
"min": 0,
"definition": "The total number of layers in the tablet. [Source: SME Defined]\nNote: Non-layered tablets will be considered as one layer tablets.",
"isModifier": false,
"short": "Product Tablet Layer Count",
"mapping": [ {
"map": "SN.2 / CQ - N/A",
"identity": "v2"
}, {
"map": "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value",
"identity": "rim"
} ],
"type": [ {
"code": "decimal"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].value",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].comparator",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min": 0,
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"isModifier": true,
"short": "< | <= | >= | > | ad - how to understand the value",
"mapping": [ {
"map": "SN.1 / CQ.1",
"identity": "v2"
}, {
"map": "IVL properties",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"meaningWhenMissing": "If there is no comparator, then there is no modification of the value",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "QuantityComparator"
} ],
"description": "How the Quantity should be understood and represented."
},
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].comparator",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.comparator"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].unit",
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min": 0,
"definition": "A human-readable form of the unit.",
"isModifier": false,
"short": "Unit representation",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.unit",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].unit",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.unit"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].system",
"requirements": "Need to know the system that defines the coded form of the unit.",
"min": 0,
"definition": "The identification of the system that provides the coded form of the unit.",
"isModifier": false,
"short": "System that defines coded unit form",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "CO.codeSystem, PQ.translation.codeSystem",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].system",
"condition": [ "qty-3" ],
"base": {
"max": "1",
"min": 0,
"path": "Quantity.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].code",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min": 0,
"definition": "A computer processable form of the unit in some unit representation system.",
"isModifier": false,
"short": "Coded form of the unit",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.code, MO.currency, PQ.translation.code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"patternCode": "C66832",
"max": "1",
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].code",
"condition": [ "qty-3" ],
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "BeaTypCnt",
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.type",
"patternCodeableConcept": {
"coding": [ {
"code": "BeaTypCnt",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Tablet Bead Type Count"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].value",
"requirements": "Precision is handled implicitly in almost all cases of measurement.",
"min": 0,
"definition": "TThe total number of type of beads present in a tablet [Source: SME Defined]\nExample: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.",
"isModifier": false,
"short": "Tablet Bead Type Count",
"mapping": [ {
"map": "SN.2 / CQ - N/A",
"identity": "v2"
}, {
"map": "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value",
"identity": "rim"
} ],
"type": [ {
"code": "decimal"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].value",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].comparator",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min": 0,
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"isModifier": true,
"short": "< | <= | >= | > | ad - how to understand the value",
"mapping": [ {
"map": "SN.1 / CQ.1",
"identity": "v2"
}, {
"map": "IVL properties",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"meaningWhenMissing": "If there is no comparator, then there is no modification of the value",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "QuantityComparator"
} ],
"description": "How the Quantity should be understood and represented."
},
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.comparator"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].unit",
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min": 0,
"definition": "A human-readable form of the unit.",
"isModifier": false,
"short": "Unit representation",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.unit",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].unit",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.unit"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].system",
"requirements": "Need to know the system that defines the coded form of the unit.",
"min": 0,
"definition": "The identification of the system that provides the coded form of the unit.",
"isModifier": false,
"short": "System that defines coded unit form",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "CO.codeSystem, PQ.translation.codeSystem",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].system",
"condition": [ "qty-3" ],
"base": {
"max": "1",
"min": 0,
"path": "Quantity.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].code",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min": 0,
"definition": "A computer processable form of the unit in some unit representation system.",
"isModifier": false,
"short": "Coded form of the unit",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.code, MO.currency, PQ.translation.code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"patternCode": "C66832",
"max": "1",
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].code",
"condition": [ "qty-3" ],
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "CapClass",
"max": "1",
"id": "ManufacturedItemDefinition.property:CapClass",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CapClass.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:CapClass.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:CapClass.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:CapClass.type",
"patternCodeableConcept": {
"coding": [ {
"code": "CapClass",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Capsule Classification Category"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property:CapClass.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "Categorization of the capsule shell based on factors such as the shell’s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]",
"isModifier": false,
"short": "Capsule Shell Part Classification Category",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category"
},
"max": "*",
"id": "ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "CapConCnt",
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:CapConCnt.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:CapConCnt.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.type",
"patternCodeableConcept": {
"coding": [ {
"code": "CapConCnt",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Capsule Constituent Count"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].value",
"requirements": "Precision is handled implicitly in almost all cases of measurement.",
"min": 0,
"definition": "The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined]\nExample: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.",
"isModifier": false,
"short": "Product Capsule Constituent Count",
"mapping": [ {
"map": "SN.2 / CQ - N/A",
"identity": "v2"
}, {
"map": "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value",
"identity": "rim"
} ],
"type": [ {
"code": "decimal"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].value",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].comparator",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min": 0,
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"isModifier": true,
"short": "< | <= | >= | > | ad - how to understand the value",
"mapping": [ {
"map": "SN.1 / CQ.1",
"identity": "v2"
}, {
"map": "IVL properties",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"meaningWhenMissing": "If there is no comparator, then there is no modification of the value",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "QuantityComparator"
} ],
"description": "How the Quantity should be understood and represented."
},
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].comparator",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.comparator"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].unit",
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min": 0,
"definition": "A human-readable form of the unit.",
"isModifier": false,
"short": "Unit representation",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.unit",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].unit",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.unit"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].system",
"requirements": "Need to know the system that defines the coded form of the unit.",
"min": 0,
"definition": "The identification of the system that provides the coded form of the unit.",
"isModifier": false,
"short": "System that defines coded unit form",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "CO.codeSystem, PQ.translation.codeSystem",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].system",
"condition": [ "qty-3" ],
"base": {
"max": "1",
"min": 0,
"path": "Quantity.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].code",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min": 0,
"definition": "A computer processable form of the unit in some unit representation system.",
"isModifier": false,
"short": "Coded form of the unit",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.code, MO.currency, PQ.translation.code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"patternCode": "C66832",
"max": "1",
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].code",
"condition": [ "qty-3" ],
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 1,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "Schematic",
"max": "*",
"id": "ManufacturedItemDefinition.property:Schematic",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:Schematic.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:Schematic.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:Schematic.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:Schematic.type",
"patternCodeableConcept": {
"coding": [ {
"code": "Schematic",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Schematic"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"type": [ {
"code": "Attachment"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property:Schematic.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "The pictorial representation of the drug product. [Source: SME Defined]",
"isModifier": false,
"short": "Product Schematic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "Attachment"
} ],
"mustSupport": true,
"sliceName": "valueAttachment",
"max": "1",
"id": "ManufacturedItemDefinition.property:Schematic.value[x]:valueAttachment",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 1,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "WgtTyp",
"max": "1",
"id": "ManufacturedItemDefinition.property:WgtTyp",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:WgtTyp.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:WgtTyp.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:WgtTyp.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:WgtTyp.type",
"patternCodeableConcept": {
"coding": [ {
"code": "WgtTyp",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Weight Type"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined]\nExample: Mass, Activity",
"isModifier": false,
"short": "Product Weight Type",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology"
},
"max": "*",
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 1,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "TotWgtNum",
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtNum.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtNum.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.type",
"patternCodeableConcept": {
"coding": [ {
"code": "TotWgtNum",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Total Weight Numeric Numerator"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].value",
"requirements": "Precision is handled implicitly in almost all cases of measurement.",
"min": 0,
"definition": "Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a tablet or a capsule",
"isModifier": false,
"short": "Product Total Weight Numeric Numerator",
"mapping": [ {
"map": "SN.2 / CQ - N/A",
"identity": "v2"
}, {
"map": "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value",
"identity": "rim"
} ],
"type": [ {
"code": "decimal"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].value",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].comparator",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min": 0,
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"isModifier": true,
"short": "< | <= | >= | > | ad - how to understand the value",
"mapping": [ {
"map": "SN.1 / CQ.1",
"identity": "v2"
}, {
"map": "IVL properties",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"meaningWhenMissing": "If there is no comparator, then there is no modification of the value",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "QuantityComparator"
} ],
"description": "How the Quantity should be understood and represented."
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.comparator"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].unit",
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min": 0,
"definition": "A human-readable form of the unit.",
"isModifier": false,
"short": "Unit representation",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.unit",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].unit",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.unit"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].system",
"requirements": "Need to know the system that defines the coded form of the unit.",
"min": 0,
"definition": "The identification of the system that provides the coded form of the unit.",
"isModifier": false,
"short": "System that defines coded unit form",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "CO.codeSystem, PQ.translation.codeSystem",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].system",
"condition": [ "qty-3" ],
"base": {
"max": "1",
"min": 0,
"path": "Quantity.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].code",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min": 0,
"definition": "A computer processable form of the unit in some unit representation system.",
"isModifier": false,
"short": "Coded form of the unit",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.code, MO.currency, PQ.translation.code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].code",
"condition": [ "qty-3" ],
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "TotWgtDen",
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtDen.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtDen.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.type",
"patternCodeableConcept": {
"coding": [ {
"code": "TotWgtDen",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Total Weight Numeric Denominator"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].value",
"requirements": "Precision is handled implicitly in almost all cases of measurement.",
"min": 0,
"definition": "Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined]\nNote: For solid oral dose forms, by definition this is 1",
"isModifier": false,
"short": "Product Total Weight Numeric Denominator",
"mapping": [ {
"map": "SN.2 / CQ - N/A",
"identity": "v2"
}, {
"map": "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value",
"identity": "rim"
} ],
"type": [ {
"code": "decimal"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].value",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].comparator",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min": 0,
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"isModifier": true,
"short": "< | <= | >= | > | ad - how to understand the value",
"mapping": [ {
"map": "SN.1 / CQ.1",
"identity": "v2"
}, {
"map": "IVL properties",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"meaningWhenMissing": "If there is no comparator, then there is no modification of the value",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "QuantityComparator"
} ],
"description": "How the Quantity should be understood and represented."
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].comparator",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.comparator"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].unit",
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min": 0,
"definition": "A human-readable form of the unit.",
"isModifier": false,
"short": "Unit representation",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.unit",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].unit",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.unit"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].system",
"requirements": "Need to know the system that defines the coded form of the unit.",
"min": 0,
"definition": "The identification of the system that provides the coded form of the unit.",
"isModifier": false,
"short": "System that defines coded unit form",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "CO.codeSystem, PQ.translation.codeSystem",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].system",
"condition": [ "qty-3" ],
"base": {
"max": "1",
"min": 0,
"path": "Quantity.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x].code",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min": 0,
"definition": "A computer processable form of the unit in some unit representation system.",
"isModifier": false,
"short": "Coded form of the unit",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.code, MO.currency, PQ.translation.code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].code",
"condition": [ "qty-3" ],
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "TotWgtTxt",
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtTxt",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtTxt.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtTxt.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtTxt.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtTxt.type",
"patternCodeableConcept": {
"coding": [ {
"code": "TotWgtTxt",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Total Weight Textual"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtTxt.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.value[x].id",
"min": 0,
"definition": "unique id for the element within a resource (for internal references)",
"isModifier": false,
"short": "xml:id (or equivalent in JSON)",
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtTxt.value[x].id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtTxt.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "ManufacturedItemDefinition.property.value[x].value",
"min": 0,
"definition": "A written description of the weight of the drug product. [Source: SME Defined]\nNote: This is typically applicable to biologics\nExample: International Units for Enzymes",
"isModifier": false,
"short": "Product Total Weight Textual",
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "markdown"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/regex",
"valueString": "^[\\s\\S]+$"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtTxt.value[x].value",
"base": {
"max": "1",
"min": 0,
"path": "string.value"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "TotWgtOper",
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtOper",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtOper.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtOper.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:TotWgtOper.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtOper.type",
"patternCodeableConcept": {
"coding": [ {
"code": "TotWgtOper",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Total Weight Operator"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtOper.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT.\nNote: This is typically applicable to biologics.",
"isModifier": false,
"short": "Product Total Weight Operator",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property",
"min": 1,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "QualStd",
"max": "*",
"id": "ManufacturedItemDefinition.property:QualStd",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.property:QualStd.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:QualStd.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.property:QualStd.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:QualStd.type",
"patternCodeableConcept": {
"coding": [ {
"code": "QualStd",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Quality Standard"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.property:QualStd.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard",
"isModifier": false,
"short": "Product Quality Standard",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "cmc-ppidref-required",
"human": "A PPiDref is required when the PPiD is designated a child.",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "property.where(\n type.coding.exists(system = '' and code = 'PPiD') and \n value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child')\n ).exists()\n implies \n property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists()"
} ],
"path": "ManufacturedItemDefinition.component",
"min": 1,
"definition": "Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup.",
"isModifier": false,
"short": "Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup",
"mapping": [ {
"map": "Manufactured Item.Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "ManufacturedItemDefinition.component",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.type",
"min": 1,
"definition": "Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined]\nExample: Layer, Bead, Minitablet, Capsule Shell, Coating",
"isModifier": false,
"short": "Product Part Type",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.type",
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.type"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.type.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.type.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.type.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.type.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.type.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type"
},
"max": "*",
"id": "ManufacturedItemDefinition.component.type.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.type.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.type.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.function",
"min": 0,
"definition": "The function of this component within the item e.g. delivers active ingredient, masks taste.",
"isModifier": false,
"short": "The function of this component within the item e.g. delivers active ingredient, masks taste",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "*",
"id": "ManufacturedItemDefinition.component.function",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.function"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.function.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.function.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.function.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.function.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.function.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "ManufacturedItemDefinition.component.function.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.function.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "The main purpose for the part in the dosage form. [Source: SME Defined]\nExample: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2",
"isModifier": false,
"short": "Product Part Function Description",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.function.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.amount",
"min": 0,
"definition": "The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).",
"isModifier": false,
"short": "The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)",
"type": [ {
"code": "Quantity"
} ],
"mustSupport": false,
"max": "*",
"id": "ManufacturedItemDefinition.component.amount",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.amount"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.amount.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.amount.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.amount.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.amount.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.amount.extension",
"min": 0,
"definition": "Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined]\nExample: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1",
"isModifier": false,
"short": "Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator" ]
} ],
"mustSupport": true,
"sliceName": "WghtlDenom",
"max": "1",
"id": "ManufacturedItemDefinition.component.amount.extension:WghtlDenom",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.amount.value",
"requirements": "Precision is handled implicitly in almost all cases of measurement.",
"min": 1,
"definition": "Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule",
"isModifier": false,
"short": "Product Part Total Weight Numeric Numerator",
"mapping": [ {
"map": "SN.2 / CQ - N/A",
"identity": "v2"
}, {
"map": "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value",
"identity": "rim"
} ],
"type": [ {
"code": "decimal"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.amount.value",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.amount.comparator",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min": 0,
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"isModifier": true,
"short": "< | <= | >= | > | ad - how to understand the value",
"mapping": [ {
"map": "SN.1 / CQ.1",
"identity": "v2"
}, {
"map": "IVL properties",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"meaningWhenMissing": "If there is no comparator, then there is no modification of the value",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "QuantityComparator"
} ],
"description": "How the Quantity should be understood and represented."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.amount.comparator",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.comparator"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.amount.unit",
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min": 1,
"definition": "The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055]\nExample: mg",
"isModifier": false,
"short": "Product Part Total Weight Numeric Numerator UOM",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.unit",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.amount.unit",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.unit"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.amount.system",
"requirements": "Need to know the system that defines the coded form of the unit.",
"min": 0,
"definition": "The identification of the system that provides the coded form of the unit.",
"isModifier": false,
"short": "System that defines coded unit form",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "CO.codeSystem, PQ.translation.codeSystem",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.amount.system",
"condition": [ "qty-3" ],
"base": {
"max": "1",
"min": 0,
"path": "Quantity.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.amount.code",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min": 1,
"definition": "A computer processable form of the unit in some unit representation system.",
"isModifier": false,
"short": "Coded form of the unit",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.code, MO.currency, PQ.translation.code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology"
},
"max": "1",
"id": "ManufacturedItemDefinition.component.amount.code",
"condition": [ "qty-3" ],
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "cmc-ingredient-functions",
"human": "If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable.\nIf Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2"
} ],
"path": "ManufacturedItemDefinition.component.constituent",
"min": 1,
"definition": "A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient).",
"isModifier": false,
"short": "A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.constituent.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.extension",
"min": 1,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.extension",
"min": 1,
"definition": "The percentage of the constituent in the component. [Source: SME Defined]\nExample: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08",
"isModifier": false,
"short": "Constituent Content Percent",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent" ]
} ],
"mustSupport": true,
"sliceName": "ConstituentPercent",
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.extension:ConstituentPercent",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.amount",
"min": 1,
"definition": "The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).",
"isModifier": false,
"short": "The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)",
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.amount",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent.amount"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.constituent.amount.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.amount.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.amount.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.amount.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.amount.extension",
"min": 0,
"definition": "Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined]\nExample: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1",
"isModifier": false,
"short": "Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator" ]
} ],
"mustSupport": true,
"sliceName": "OptionalDenom",
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.amount.extension:OptionalDenom",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.amount.value",
"requirements": "Precision is handled implicitly in almost all cases of measurement.",
"min": 1,
"definition": "Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined]\nNote: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule\nNote: Amount can also be referred to as potency in biologics and other products.",
"isModifier": false,
"short": "Product Part Ingredient Amount Numeric Numerator",
"mapping": [ {
"map": "SN.2 / CQ - N/A",
"identity": "v2"
}, {
"map": "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value",
"identity": "rim"
} ],
"type": [ {
"code": "decimal"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.amount.value",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.amount.comparator",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min": 0,
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"isModifier": true,
"short": "< | <= | >= | > | ad - how to understand the value",
"mapping": [ {
"map": "SN.1 / CQ.1",
"identity": "v2"
}, {
"map": "IVL properties",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"meaningWhenMissing": "If there is no comparator, then there is no modification of the value",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "QuantityComparator"
} ],
"description": "How the Quantity should be understood and represented."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.amount.comparator",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.comparator"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.amount.unit",
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min": 1,
"definition": "The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]",
"isModifier": false,
"short": "Product Part Ingredient Amount Numeric Numerator UOM",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.unit",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.amount.unit",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.unit"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.amount.system",
"requirements": "Need to know the system that defines the coded form of the unit.",
"min": 0,
"definition": "The identification of the system that provides the coded form of the unit.",
"isModifier": false,
"short": "System that defines coded unit form",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "CO.codeSystem, PQ.translation.codeSystem",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.amount.system",
"condition": [ "qty-3" ],
"base": {
"max": "1",
"min": 0,
"path": "Quantity.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.amount.code",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min": 1,
"definition": "A computer processable form of the unit in some unit representation system.",
"isModifier": false,
"short": "Coded form of the unit",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.code, MO.currency, PQ.translation.code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology"
},
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.amount.code",
"condition": [ "qty-3" ],
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.location",
"min": 0,
"definition": "Identifies where the ingredient physically resides within the product part. [Source: SME Defined]\nExamples: Intragranular, Extra granular, Blend",
"isModifier": false,
"short": "Product Part Ingredient Physical Location",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.location",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent.location"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.constituent.location.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.location.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.location.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.location.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.location.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 1,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location"
},
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.location.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.location.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.location.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function",
"min": 1,
"definition": "The function of this constituent within the component e.g. binder.",
"isModifier": false,
"short": "The function of this constituent within the component e.g. binder",
"slicing": {
"rules": "closed",
"description": "Slice on the function coding",
"discriminator": [ {
"path": "coding",
"type": "value"
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "2",
"id": "ManufacturedItemDefinition.component.constituent.function",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent.function"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.constituent.function.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.function.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 1,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function",
"min": 1,
"definition": "A classification that identifies the higher level purpose of that material. [Source: SME Defined]\nExample: Active Ingredient, Inactive Ingredient, Adjuvant.",
"isModifier": false,
"short": "Product Part Ingredient Component Function Category",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "Category",
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function:Category",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent.function"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.constituent.function.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function:Category.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.function:Category.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology"
},
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.function:Category.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function:Category.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function",
"min": 0,
"definition": "A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined]\nExamples: Filler, Surfactant",
"isModifier": false,
"short": "Product Part Ingredient Function",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "Function",
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function:Function",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent.function"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.constituent.function.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function:Function.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.function:Function.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology"
},
"max": "*",
"id": "ManufacturedItemDefinition.component.constituent.function:Function.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.function.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.function:Function.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.constituent.hasIngredient",
"min": 1,
"definition": "The ingredient that is the constituent of the given component.",
"isModifier": false,
"short": "The ingredient that is the constituent of the given component",
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component" ]
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.constituent.hasIngredient",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent.hasIngredient"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 3,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"contentReference": "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.property",
"slicing": {
"rules": "closed",
"description": "Slice based on value",
"discriminator": [ {
"path": "type",
"type": "value"
} ]
},
"mustSupport": true,
"max": "*",
"id": "ManufacturedItemDefinition.component.property",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 1,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "PPiD",
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiD",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiD.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:PPiD.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:PPiD.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiD.type",
"patternCodeableConcept": {
"coding": [ {
"code": "PPiD",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Identifier"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiD.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiD.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:PPiD.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "If the Product does not have parts the Product Part Role is 'Primary'.\nIf the Product does have parts and the Product Part does not have a Product Part Identifier Reference then the component is a 'Parent'. \nIf the Product does have parts and there is a Product Part Identifier Reference the component is a 'Child'.",
"isModifier": false,
"short": "Product Part Role",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs"
},
"max": "*",
"id": "ManufacturedItemDefinition.component.property:PPiD.value[x].coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined]\nExamples: 1, A1, Red bead, Blue minitablet",
"isModifier": false,
"short": "Product Part Identifier",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiD.value[x].text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 0,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "PPiDref",
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiDref",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiDref.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:PPiDref.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:PPiDref.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiDref.type",
"patternCodeableConcept": {
"coding": [ {
"code": "PPiDref",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Identifier Reference"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiDref.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiDref.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:PPiDref.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:PPiDref.value[x].coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": " Identifies the parent or outer-level product part. [Source: SME Defined]\nExample: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.",
"isModifier": false,
"short": "Product Part Identifier Reference",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:PPiDref.value[x].text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 1,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "RelsProf",
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsProf",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsProf.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:RelsProf.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:RelsProf.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsProf.type",
"patternCodeableConcept": {
"coding": [ {
"code": "RelsProf",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Release Profile"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x]",
"min": 1,
"definition": "The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]",
"isModifier": false,
"short": "Product Part Release Profile",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsProf.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsProf.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:RelsProf.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile"
},
"max": "*",
"id": "ManufacturedItemDefinition.component.property:RelsProf.value[x].coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsProf.value[x].text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 0,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "RelsMech",
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsMech",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsMech.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:RelsMech.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:RelsMech.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsMech.type",
"patternCodeableConcept": {
"coding": [ {
"code": "RelsMech",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Release Mechanism"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x]",
"min": 1,
"definition": "The method employed to realize the specified part release profile. [Source: SME Defined] Example: matrix or reservoir",
"isModifier": false,
"short": "Product Part Release Mechanism",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsMech.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsMech.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:RelsMech.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism"
},
"max": "*",
"id": "ManufacturedItemDefinition.component.property:RelsMech.value[x].coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:RelsMech.value[x].text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 0,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "CoatPurpose",
"max": "*",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.type",
"patternCodeableConcept": {
"coding": [ {
"code": "CoatPurpose",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Coating Product Part Purpose"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x]",
"min": 1,
"definition": "The reason the coating or covering was added. [Source: SME Defined]\nExamples: rate-controlling, color, release type, protective, taste masking.",
"isModifier": false,
"short": "Coating Product Part Purpose",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose"
},
"max": "*",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.value[x].text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 0,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "Color",
"max": "1",
"id": "ManufacturedItemDefinition.component.property:Color",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:Color.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:Color.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:Color.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.property:Color.type",
"patternCodeableConcept": {
"coding": [ {
"code": "Color",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Color Description"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x]",
"min": 1,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.property:Color.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:Color.value[x].id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:Color.value[x].extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:Color.value[x].coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "The hue or the tint of the drug product part. [Source: SME Defined]\nExamples: yellow, pink, blue, pale yellow.",
"isModifier": false,
"short": "Product Part Color Description",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:Color.value[x].text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 1,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "ContPercent",
"max": "1",
"id": "ManufacturedItemDefinition.component.property:ContPercent",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:ContPercent.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:ContPercent.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:ContPercent.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.property:ContPercent.type",
"patternCodeableConcept": {
"coding": [ {
"code": "ContPercent",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Content Percent"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x]",
"min": 1,
"definition": "The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined]\nExample: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5",
"isModifier": false,
"short": "Product Part Content Percent",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true,
"max": "1",
"id": "ManufacturedItemDefinition.component.property:ContPercent.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property",
"min": 0,
"definition": "General characteristics of this component.",
"isModifier": false,
"short": "General characteristics of this component",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "AddInfo",
"max": "1",
"id": "ManufacturedItemDefinition.component.property:AddInfo",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property"
},
"isSummary": true
}, {
"path": "ManufacturedItemDefinition.component.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ManufacturedItemDefinition.component.property:AddInfo.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:AddInfo.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ManufacturedItemDefinition.component.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ManufacturedItemDefinition.component.property:AddInfo.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "ManufacturedItemDefinition.component.property:AddInfo.type",
"patternCodeableConcept": {
"coding": [ {
"code": "AddInfo",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Additional Information"
} ]
},
"base": {
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.property.value[x]",
"min": 0,
"definition": "A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.\nImplementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.",
"isModifier": false,
"short": "Product Part Additional Information",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": false,
"max": "1",
"id": "ManufacturedItemDefinition.component.property:AddInfo.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ManufacturedItemDefinition.component.component",
"min": 0,
"definition": "A component that this component contains or is made from.",
"isModifier": false,
"short": "A component that this component contains or is made from",
"contentReference": "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.component",
"mustSupport": true,
"max": "*",
"id": "ManufacturedItemDefinition.component.component",
"base": {
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.component"
},
"isSummary": true
} ]
},
"status": "active",
"id": "457db6ab-e5b5-4c38-9f04-5970994df162",
"kind": "resource",
"url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.36.42.29",
"system": "urn:ietf:rfc:3986"
} ],
"version": "1.0.0-ballot",
"differential": {
"element": [ {
"id": "ManufacturedItemDefinition",
"path": "ManufacturedItemDefinition",
"constraint": [ {
"key": "cmc-capsule-count-required",
"human": "Capsule constituent count is required when the dosage form is 'Capsule'",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433')\nimplies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists()"
}, {
"key": "cmc-arbitrary-unit-text-required",
"human": "BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "property.where(\n type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (\n code = 'TotWgtNum' or \n code = 'TotWgtDen'\n )\n ) and\n value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765')\n).exists() implies property.where(\n type.coding.exists(\n code = 'TotWgtTxt' and\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'\n )\n).exists()"
}, {
"key": "cmc-coating-indication-required",
"human": "Coating indication is required when the dosage form is a tablet, lozenge or capsule",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (\n code = 'C154605' or\n code = 'C154433' or\n code = 'C154554'\n))\nimplies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists()"
}, {
"key": "cmc-tablet-layer-count-required",
"human": "Tablet layer count is required when the dosage form is a tablet",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'C154605'\n) implies property.where(\n type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'TabLayCnt'\n )\n).exists()"
}, {
"key": "cmc-tablet-bead-count-required",
"human": "Tablet bead count is required when the dosage form is a tablet",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'C154605'\n) implies property.where(\n type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'BeaTypCnt'\n )\n).exists()"
}, {
"key": "cmc-capsule-classification-required",
"human": "when the the dosage form is 'capsule' and a 'capsule shell' part\nexists, a capsule shell part classification is mandatory",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "manufacturedDoseForm.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'C154433'\n) and component.type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'C203897'\n) implies property.where(\n type.coding.exists(\n system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n code = 'CapClass'\n )\n).exists()"
} ]
}, {
"id": "ManufacturedItemDefinition.meta.profile",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.meta.profile",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.identifier",
"max": "1",
"path": "ManufacturedItemDefinition.identifier",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.status",
"path": "ManufacturedItemDefinition.status",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.name",
"path": "ManufacturedItemDefinition.name",
"short": "Product Proprietary Name | Product Non-proprietary Name",
"definition": "Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. \nExample: Tylenol\n\nProduct Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.manufacturedDoseForm.coding",
"path": "ManufacturedItemDefinition.manufacturedDoseForm.coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology"
}
}, {
"id": "ManufacturedItemDefinition.property",
"min": 5,
"path": "ManufacturedItemDefinition.property",
"slicing": {
"rules": "closed",
"description": "Slice based on value",
"discriminator": [ {
"path": "type",
"type": "value"
} ]
},
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:OvrRelsProf",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property",
"sliceName": "OvrRelsProf",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:OvrRelsProf.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "OvrRelsProf",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Overall Release Profile"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids).\nFor example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the \"product overall release profile\" is \"ER\". [Source: SME Defined]",
"short": "Product Overall Release Profile",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept"
}, {
"id": "ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding",
"path": "ManufacturedItemDefinition.property.value[x].coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile"
}
}, {
"id": "ManufacturedItemDefinition.property:OvrRelsMech",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "OvrRelsMech",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:OvrRelsMech.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "OvrRelsMech",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Overall Release Mechanism"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "TThe dosage form design used to achieve an ER release profile. Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]",
"short": "Product Overall Release Mechanism",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept"
}, {
"id": "ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding",
"path": "ManufacturedItemDefinition.property.value[x].coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism"
}
}, {
"id": "ManufacturedItemDefinition.property:CoatInd",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "CoatInd",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:CoatInd.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "CoatInd",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Coating Indicator"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:CoatInd.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A property that identifies whether the drug product contains any coatings. [Source: SME Defined]",
"short": "Product Coating Indicator",
"type": [ {
"code": "boolean"
} ],
"mustSupport": true,
"sliceName": "valueBoolean",
"max": "1",
"id": "ManufacturedItemDefinition.property:CoatInd.value[x]:valueBoolean"
}, {
"id": "ManufacturedItemDefinition.property:LayCnt",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "LayCnt",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:LayCnt.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "TabLayCnt",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Tablet Layer Count"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:LayCnt.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].value",
"path": "ManufacturedItemDefinition.property.value[x].value",
"short": "Product Tablet Layer Count",
"definition": "The total number of layers in the tablet. [Source: SME Defined]\nNote: Non-layered tablets will be considered as one layer tablets."
}, {
"id": "ManufacturedItemDefinition.property:LayCnt.value[x].code",
"path": "ManufacturedItemDefinition.property.value[x].code",
"patternCode": "C66832"
}, {
"id": "ManufacturedItemDefinition.property:BeaTypCnt",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "BeaTypCnt",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:BeaTypCnt.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "BeaTypCnt",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Tablet Bead Type Count"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].value",
"path": "ManufacturedItemDefinition.property.value[x].value",
"short": "Tablet Bead Type Count",
"definition": "TThe total number of type of beads present in a tablet [Source: SME Defined]\nExample: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2."
}, {
"id": "ManufacturedItemDefinition.property:BeaTypCnt.value[x].code",
"path": "ManufacturedItemDefinition.property.value[x].code",
"patternCode": "C66832"
}, {
"id": "ManufacturedItemDefinition.property:CapClass",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "CapClass",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:CapClass.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "CapClass",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Capsule Classification Category"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:CapClass.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "Categorization of the capsule shell based on factors such as the shell’s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]",
"short": "Capsule Shell Part Classification Category",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept"
}, {
"id": "ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding",
"path": "ManufacturedItemDefinition.property.value[x].coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category"
}
}, {
"id": "ManufacturedItemDefinition.property:CapConCnt",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "CapConCnt",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:CapConCnt.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "CapConCnt",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Capsule Constituent Count"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].value",
"path": "ManufacturedItemDefinition.property.value[x].value",
"short": "Product Capsule Constituent Count",
"definition": "The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined]\nExample: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2."
}, {
"id": "ManufacturedItemDefinition.property:CapConCnt.value[x].code",
"path": "ManufacturedItemDefinition.property.value[x].code",
"patternCode": "C66832"
}, {
"id": "ManufacturedItemDefinition.property:Schematic",
"max": "*",
"min": 1,
"path": "ManufacturedItemDefinition.property",
"sliceName": "Schematic",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:Schematic.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "Schematic",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Schematic"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:Schematic.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "The pictorial representation of the drug product. [Source: SME Defined]",
"short": "Product Schematic",
"type": [ {
"code": "Attachment"
} ],
"mustSupport": true,
"sliceName": "valueAttachment",
"max": "1",
"id": "ManufacturedItemDefinition.property:Schematic.value[x]:valueAttachment"
}, {
"id": "ManufacturedItemDefinition.property:WgtTyp",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property",
"sliceName": "WgtTyp",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:WgtTyp.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "WgtTyp",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Weight Type"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined]\nExample: Mass, Activity",
"short": "Product Weight Type",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept"
}, {
"id": "ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding",
"path": "ManufacturedItemDefinition.property.value[x].coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology"
}
}, {
"id": "ManufacturedItemDefinition.property:TotWgtNum",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.property",
"sliceName": "TotWgtNum",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:TotWgtNum.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "TotWgtNum",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Total Weight Numeric Numerator"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].value",
"path": "ManufacturedItemDefinition.property.value[x].value",
"short": "Product Total Weight Numeric Numerator",
"definition": "Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a tablet or a capsule"
}, {
"id": "ManufacturedItemDefinition.property:TotWgtNum.value[x].code",
"path": "ManufacturedItemDefinition.property.value[x].code",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology"
}
}, {
"id": "ManufacturedItemDefinition.property:TotWgtDen",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "TotWgtDen",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:TotWgtDen.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "TotWgtDen",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Total Weight Numeric Denominator"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"type": [ {
"code": "Quantity"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].value",
"path": "ManufacturedItemDefinition.property.value[x].value",
"short": "Product Total Weight Numeric Denominator",
"definition": "Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined]\nNote: For solid oral dose forms, by definition this is 1"
}, {
"id": "ManufacturedItemDefinition.property:TotWgtDen.value[x].code",
"path": "ManufacturedItemDefinition.property.value[x].code",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology"
}
}, {
"id": "ManufacturedItemDefinition.property:TotWgtTxt",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "TotWgtTxt",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:TotWgtTxt.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "TotWgtTxt",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Total Weight Textual"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:TotWgtTxt.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"type": [ {
"code": "markdown"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:TotWgtTxt.value[x].value",
"path": "ManufacturedItemDefinition.property.value[x].value",
"short": "Product Total Weight Textual",
"definition": "A written description of the weight of the drug product. [Source: SME Defined]\nNote: This is typically applicable to biologics\nExample: International Units for Enzymes"
}, {
"id": "ManufacturedItemDefinition.property:TotWgtOper",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.property",
"sliceName": "TotWgtOper",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:TotWgtOper.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "TotWgtOper",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Total Weight Operator"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:TotWgtOper.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT.\nNote: This is typically applicable to biologics.",
"short": "Product Total Weight Operator",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept"
}, {
"id": "ManufacturedItemDefinition.property:QualStd",
"max": "*",
"min": 1,
"path": "ManufacturedItemDefinition.property",
"sliceName": "QualStd",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.property:QualStd.type",
"path": "ManufacturedItemDefinition.property.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"
},
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "QualStd",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Quality Standard"
} ]
}
}, {
"id": "ManufacturedItemDefinition.property:QualStd.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.property.value[x]",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"path": "ManufacturedItemDefinition.property.value[x]",
"min": 1,
"definition": "The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard",
"short": "Product Quality Standard",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "valueCodeableConcept",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology"
},
"max": "1",
"id": "ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept"
}, {
"id": "ManufacturedItemDefinition.component",
"min": 1,
"path": "ManufacturedItemDefinition.component",
"constraint": [ {
"key": "cmc-ppidref-required",
"human": "A PPiDref is required when the PPiD is designated a child.",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "property.where(\n type.coding.exists(system = '' and code = 'PPiD') and \n value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child')\n ).exists()\n implies \n property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists()"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.type",
"path": "ManufacturedItemDefinition.component.type",
"short": "Product Part Type",
"definition": "Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined]\nExample: Layer, Bead, Minitablet, Capsule Shell, Coating",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.type.coding",
"path": "ManufacturedItemDefinition.component.type.coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type"
}
}, {
"id": "ManufacturedItemDefinition.component.function.text",
"path": "ManufacturedItemDefinition.component.function.text",
"short": "Product Part Function Description",
"definition": "The main purpose for the part in the dosage form. [Source: SME Defined]\nExample: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.amount.extension:WghtlDenom",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.component.amount.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator" ]
} ],
"sliceName": "WghtlDenom",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.amount.value",
"min": 1,
"path": "ManufacturedItemDefinition.component.amount.value",
"short": "Product Part Total Weight Numeric Numerator",
"definition": "Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.amount.unit",
"min": 1,
"path": "ManufacturedItemDefinition.component.amount.unit",
"short": "Product Part Total Weight Numeric Numerator UOM",
"definition": "The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055]\nExample: mg",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.amount.code",
"min": 1,
"path": "ManufacturedItemDefinition.component.amount.code",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology"
},
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent",
"constraint": [ {
"key": "cmc-ingredient-functions",
"human": "If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable.\nIf Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part",
"severity": "error",
"expression": "function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.extension",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.constituent.extension:ConstituentPercent",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent" ]
} ],
"sliceName": "ConstituentPercent",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.amount",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.amount",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.amount.extension:OptionalDenom",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent.amount.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator" ]
} ],
"sliceName": "OptionalDenom",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.amount.value",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.amount.value",
"short": "Product Part Ingredient Amount Numeric Numerator",
"definition": "Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined]\nNote: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule\nNote: Amount can also be referred to as potency in biologics and other products.",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.amount.unit",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.amount.unit",
"short": "Product Part Ingredient Amount Numeric Numerator UOM",
"definition": "The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.amount.code",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.amount.code",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology"
},
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.location",
"path": "ManufacturedItemDefinition.component.constituent.location",
"short": "Product Part Ingredient Physical Location",
"definition": "Identifies where the ingredient physically resides within the product part. [Source: SME Defined]\nExamples: Intragranular, Extra granular, Blend",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.location.coding",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.location.coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location"
},
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.location.text",
"path": "ManufacturedItemDefinition.component.constituent.location.text",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.function",
"max": "2",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.function",
"slicing": {
"rules": "closed",
"description": "Slice on the function coding",
"discriminator": [ {
"path": "coding",
"type": "value"
} ]
},
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.function.coding",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.function.coding",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.function:Category",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.function",
"short": "Product Part Ingredient Component Function Category",
"sliceName": "Category",
"definition": "A classification that identifies the higher level purpose of that material. [Source: SME Defined]\nExample: Active Ingredient, Inactive Ingredient, Adjuvant.",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.function:Category.coding",
"path": "ManufacturedItemDefinition.component.constituent.function.coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology"
}
}, {
"id": "ManufacturedItemDefinition.component.constituent.function:Function",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.component.constituent.function",
"short": "Product Part Ingredient Function",
"sliceName": "Function",
"definition": "A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined]\nExamples: Filler, Surfactant",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.constituent.function:Function.coding",
"path": "ManufacturedItemDefinition.component.constituent.function.coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology"
}
}, {
"id": "ManufacturedItemDefinition.component.constituent.hasIngredient",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.constituent.hasIngredient",
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component" ]
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property",
"min": 3,
"path": "ManufacturedItemDefinition.component.property",
"slicing": {
"rules": "closed",
"description": "Slice based on value",
"discriminator": [ {
"path": "type",
"type": "value"
} ]
},
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:PPiD",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.property",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "PPiD",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:PPiD.type",
"path": "ManufacturedItemDefinition.component.property.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "PPiD",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Identifier"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.property:PPiD.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:PPiD.value[x].coding",
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"short": "Product Part Role",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs"
},
"definition": "If the Product does not have parts the Product Part Role is 'Primary'.\nIf the Product does have parts and the Product Part does not have a Product Part Identifier Reference then the component is a 'Parent'. \nIf the Product does have parts and there is a Product Part Identifier Reference the component is a 'Child'."
}, {
"id": "ManufacturedItemDefinition.component.property:PPiD.value[x].text",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"short": "Product Part Identifier",
"definition": "A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined]\nExamples: 1, A1, Red bead, Blue minitablet",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:PPiDref",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.component.property",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "PPiDref",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:PPiDref.type",
"path": "ManufacturedItemDefinition.component.property.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "PPiDref",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Identifier Reference"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.property:PPiDref.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:PPiDref.value[x].text",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"short": "Product Part Identifier Reference",
"definition": " Identifies the parent or outer-level product part. [Source: SME Defined]\nExample: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:RelsProf",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.property",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "RelsProf",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:RelsProf.type",
"path": "ManufacturedItemDefinition.component.property.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "RelsProf",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Release Profile"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.property:RelsProf.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"short": "Product Part Release Profile",
"definition": "The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:RelsProf.value[x].coding",
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile"
}
}, {
"id": "ManufacturedItemDefinition.component.property:RelsMech",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.component.property",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "RelsMech",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:RelsMech.type",
"path": "ManufacturedItemDefinition.component.property.type",
"patternCodeableConcept": {
"coding": [ {
"code": "RelsMech",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Release Mechanism"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.property:RelsMech.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"short": "Product Part Release Mechanism",
"definition": "The method employed to realize the specified part release profile. [Source: SME Defined] Example: matrix or reservoir",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:RelsMech.value[x].coding",
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism"
}
}, {
"id": "ManufacturedItemDefinition.component.property:CoatPurpose",
"max": "*",
"min": 0,
"path": "ManufacturedItemDefinition.component.property",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "CoatPurpose",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.type",
"path": "ManufacturedItemDefinition.component.property.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "CoatPurpose",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Coating Product Part Purpose"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"short": "Coating Product Part Purpose",
"definition": "The reason the coating or covering was added. [Source: SME Defined]\nExamples: rate-controlling, color, release type, protective, taste masking.",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding",
"path": "ManufacturedItemDefinition.component.property.value[x].coding",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose"
}
}, {
"id": "ManufacturedItemDefinition.component.property:Color",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.component.property",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "Color",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:Color.type",
"path": "ManufacturedItemDefinition.component.property.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "Color",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Color Description"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.property:Color.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:Color.value[x].text",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x].text",
"short": "Product Part Color Description",
"definition": "The hue or the tint of the drug product part. [Source: SME Defined]\nExamples: yellow, pink, blue, pale yellow.",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:ContPercent",
"max": "1",
"min": 1,
"path": "ManufacturedItemDefinition.component.property",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "ContPercent",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:ContPercent.type",
"path": "ManufacturedItemDefinition.component.property.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "ContPercent",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Content Percent"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.property:ContPercent.value[x]",
"min": 1,
"path": "ManufacturedItemDefinition.component.property.value[x]",
"type": [ {
"code": "Quantity"
} ],
"short": "Product Part Content Percent",
"definition": "The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined]\nExample: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:AddInfo",
"max": "1",
"min": 0,
"path": "ManufacturedItemDefinition.component.property",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "AddInfo",
"mustSupport": true
}, {
"id": "ManufacturedItemDefinition.component.property:AddInfo.type",
"path": "ManufacturedItemDefinition.component.property.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "AddInfo",
"system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"display": "Product Part Additional Information"
} ]
}
}, {
"id": "ManufacturedItemDefinition.component.property:AddInfo.value[x]",
"path": "ManufacturedItemDefinition.component.property.value[x]",
"type": [ {
"code": "markdown"
} ],
"short": "Product Part Additional Information",
"definition": "A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.\nImplementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes."
}, {
"id": "ManufacturedItemDefinition.component.component",
"path": "ManufacturedItemDefinition.component.component",
"mustSupport": true
} ]
},
"contact": [ {
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
}, {
"value": "brr@lists.HL7.org",
"system": "email"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"
}