{
"description": "Description of the packaged authorized medicinal product(s) associated to this ePI document.",
"_filename": "StructureDefinition-MedicinalProductDefinition-uv-epi.json",
"package_name": "hl7.fhir.uv.emedicinal-product-info",
"date": "2023-07-26T13:32:34+00:00",
"derivation": "constraint",
"publisher": "HL7 International - Biomedical Research & Regulation Work Group",
"fhirVersion": "5.0.0",
"jurisdiction": [ {
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"display": "World"
} ]
} ],
"name": "MedicinalProductDefinitionUvEpi",
"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": "MedicinalProductDefinition",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "MedicinalProductDefinition (ePI)",
"package_version": "1.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 2
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use"
} ],
"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()"
} ],
"path": "MedicinalProductDefinition",
"min": 0,
"definition": "A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).",
"isModifier": false,
"short": "Detailed definition of a medicinal product",
"mapping": [ {
"map": "Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']",
"identity": "rim"
}, {
"map": "administrative.medication",
"identity": "w5"
}, {
"map": "Medicinal Product and Investigational Medicinal Product",
"identity": "idmp"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition"
},
"isSummary": false
}, {
"path": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.meta",
"base": {
"max": "1",
"min": 0,
"path": "Resource.meta"
},
"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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "1",
"id": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.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": "MedicinalProductDefinition.identifier",
"min": 1,
"definition": "Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.",
"isModifier": false,
"short": "Business identifier for this product. Could be an MPID",
"mapping": [ {
"map": "FiveWs.class",
"identity": "w5"
}, {
"map": "Medicinal Product.MPID, Investigational Medicinal Product.IMPID",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code",
"identity": "rim"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": false,
"alias": [ "MPID" ],
"max": "*",
"id": "MedicinalProductDefinition.identifier",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.identifier"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.identifier.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": "MedicinalProductDefinition.identifier.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": "MedicinalProductDefinition.identifier.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": "MedicinalProductDefinition.identifier.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": "MedicinalProductDefinition.identifier.use",
"requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
"min": 0,
"definition": "The purpose of this identifier.",
"isModifier": true,
"short": "usual | official | temp | secondary | old (If known)",
"mapping": [ {
"map": "N/A",
"identity": "v2"
}, {
"map": "Role.code or implied by context",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/identifier-use|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/binding-definition",
"valueMarkdown": "Identifies the purpose for this identifier, if known ."
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "IdentifierUse"
} ],
"description": "Identifies the purpose for this identifier, if known ."
},
"max": "1",
"id": "MedicinalProductDefinition.identifier.use",
"comment": "Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.use"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one.",
"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": "MedicinalProductDefinition.identifier.type",
"requirements": "Allows users to make use of identifiers when the identifier system is not known.",
"min": 0,
"definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
"isModifier": false,
"short": "Description of identifier",
"mapping": [ {
"map": "CX.5",
"identity": "v2"
}, {
"map": "Role.code or implied by context",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/identifier-type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/binding-definition",
"valueMarkdown": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "IdentifierType"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."
},
"max": "1",
"id": "MedicinalProductDefinition.identifier.type",
"comment": "This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.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": "MedicinalProductDefinition.identifier.system",
"requirements": "There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
"min": 1,
"definition": "Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.",
"isModifier": false,
"short": "The namespace for the identifier value",
"mapping": [ {
"map": "CX.4 / EI-2-4",
"identity": "v2"
}, {
"map": "II.root or Role.id.root",
"identity": "rim"
}, {
"map": "./IdentifierType",
"identity": "servd"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "MedicinalProductDefinition.identifier.system",
"comment": "Identifier.system is always case sensitive.",
"example": [ {
"label": "General",
"valueUri": "http://www.acme.com/identifiers/patient"
} ],
"base": {
"max": "1",
"min": 0,
"path": "Identifier.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": "MedicinalProductDefinition.identifier.value",
"min": 1,
"definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
"isModifier": false,
"short": "The value that is unique",
"mapping": [ {
"map": "CX.1 / EI.1",
"identity": "v2"
}, {
"map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
"identity": "rim"
}, {
"map": "./Value",
"identity": "servd"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "MedicinalProductDefinition.identifier.value",
"condition": [ "ident-1" ],
"comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.",
"example": [ {
"label": "General",
"valueString": "123456"
} ],
"base": {
"max": "1",
"min": 0,
"path": "Identifier.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": "MedicinalProductDefinition.identifier.period",
"min": 0,
"definition": "Time period during which identifier is/was valid for use.",
"isModifier": false,
"short": "Time period when id is/was valid for use",
"mapping": [ {
"map": "CX.7 + CX.8",
"identity": "v2"
}, {
"map": "Role.effectiveTime or implied by context",
"identity": "rim"
}, {
"map": "./StartDate and ./EndDate",
"identity": "servd"
} ],
"type": [ {
"code": "Period"
} ],
"max": "1",
"id": "MedicinalProductDefinition.identifier.period",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.period"
},
"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": "MedicinalProductDefinition.identifier.assigner",
"min": 0,
"definition": "Organization that issued/manages the identifier.",
"isModifier": false,
"short": "Organization that issued id (may be just text)",
"mapping": [ {
"map": "CX.4 / (CX.4,CX.9,CX.10)",
"identity": "v2"
}, {
"map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper",
"identity": "rim"
}, {
"map": "./IdentifierIssuingAuthority",
"identity": "servd"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"max": "1",
"id": "MedicinalProductDefinition.identifier.assigner",
"comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.assigner"
},
"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": "MedicinalProductDefinition.type",
"min": 0,
"definition": "Regulatory type, e.g. Investigational or Authorized.",
"isModifier": false,
"short": "Regulatory type, e.g. Investigational or Authorized.",
"mapping": [ {
"map": "(indicates if this is Medicinal Product or an Investigational Medicinal Product)",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "MedicinalProductType"
} ],
"description": "Overall defining type of this medicinal product."
},
"max": "1",
"id": "MedicinalProductDefinition.type",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.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": "MedicinalProductDefinition.domain",
"min": 0,
"definition": "If this medicine applies to human or veterinary uses.",
"isModifier": false,
"short": "If this medicine applies to human or veterinary uses.",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-domain"
},
"max": "1",
"id": "MedicinalProductDefinition.domain",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.domain"
},
"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": "MedicinalProductDefinition.version",
"min": 0,
"definition": "A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.",
"isModifier": false,
"short": "A business identifier relating to a specific version of the product.",
"mapping": [ {
"map": "Medicinal Product.Header.Version Number",
"identity": "idmp"
}, {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.version",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.version"
},
"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": "MedicinalProductDefinition.status",
"min": 0,
"definition": "The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.",
"isModifier": true,
"short": "The status within the lifecycle of this product record.",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "MedicinalProductDefinition.status",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.status"
},
"isModifierReason": "This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid",
"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": "MedicinalProductDefinition.statusDate",
"min": 0,
"definition": "The date at which the given status became applicable.",
"isModifier": false,
"short": "The date at which this status became applicable.",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.statusDate",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.statusDate"
},
"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": "MedicinalProductDefinition.description",
"min": 0,
"definition": "General description of this product.",
"isModifier": false,
"short": "General description of the medicinal product referred by the ePI",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc",
"identity": "rim"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.description",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.description"
},
"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": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm",
"min": 0,
"definition": "The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).",
"isModifier": false,
"short": "The dose form for a single part product, or combined form of a multiple part product",
"mapping": [ {
"map": "Medicinal Product.Combined Pharmaceutical Dose Form",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm"
},
"max": "1",
"id": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm"
},
"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": "MedicinalProductDefinition.route",
"min": 0,
"definition": "The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.",
"isModifier": false,
"short": "The path by which the product is taken into or makes contact with the body",
"mapping": [ {
"map": "Pharmaceutical Product.Route of Administration",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration"
},
"max": "*",
"id": "MedicinalProductDefinition.route",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.route"
},
"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": "MedicinalProductDefinition.indication",
"min": 0,
"definition": "Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.",
"isModifier": false,
"short": "Narrative text of the authorized indication(s) for this product.",
"mapping": [ {
"map": "(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value",
"identity": "rim"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.indication",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.indication"
},
"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": "MedicinalProductDefinition.legalStatusOfSupply",
"min": 0,
"definition": "The legal status of supply of the medicinal product as classified by the regulator.",
"isModifier": false,
"short": "The legal status of supply of the medicinal product as classified by the regulator.",
"mapping": [ {
"map": "Marketing Authorisation.Legal Status of Supply (moved here for practicality)",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/legal-status-of-supply",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "LegalStatusOfSupply"
} ],
"description": "The prescription supply types appropriate to a medicinal product"
},
"max": "1",
"id": "MedicinalProductDefinition.legalStatusOfSupply",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.legalStatusOfSupply"
},
"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": "MedicinalProductDefinition.additionalMonitoringIndicator",
"min": 0,
"definition": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.",
"isModifier": false,
"short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.",
"mapping": [ {
"map": "Medicinal Product.Additional Monitoring Indicator",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.policy.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdditionalMonitoring"
} ],
"description": "Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring)."
},
"max": "1",
"id": "MedicinalProductDefinition.additionalMonitoringIndicator",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.additionalMonitoringIndicator"
},
"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": "MedicinalProductDefinition.specialMeasures",
"min": 0,
"definition": "Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.",
"isModifier": false,
"short": "Whether the Medicinal Product is subject to special measures for regulatory reasons.",
"mapping": [ {
"map": "Medicinal Product.Special Measures",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-special-measures",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SpecialMeasures"
} ],
"description": "Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies."
},
"max": "*",
"id": "MedicinalProductDefinition.specialMeasures",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.specialMeasures"
},
"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": "MedicinalProductDefinition.pediatricUseIndicator",
"min": 0,
"definition": "If authorised for use in children, or infants, neonates etc.",
"isModifier": false,
"short": "If authorised for pediatric use",
"mapping": [ {
"map": "Medicinal Product.Pediatric Use Indicator",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.policy.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PediatricUse"
} ],
"description": "Suitability for age groups, in particular children."
},
"max": "1",
"id": "MedicinalProductDefinition.pediatricUseIndicator",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.pediatricUseIndicator"
},
"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": "MedicinalProductDefinition.classification",
"min": 0,
"definition": "Allows the product to be classified by various systems, commonly WHO ATC.",
"isModifier": false,
"short": "Allows the product to be classified by various systems (e.g. ATC)",
"mapping": [ {
"map": "Product Classification.Value",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification"
},
"max": "*",
"id": "MedicinalProductDefinition.classification",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.classification"
},
"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": "MedicinalProductDefinition.marketingStatus",
"min": 0,
"definition": "Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).",
"isModifier": false,
"short": "Marketing status of the medicinal product, in contrast to marketing authorization",
"mapping": [ {
"map": "Marketing Status",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode",
"identity": "rim"
} ],
"type": [ {
"code": "MarketingStatus"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.marketingStatus",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.marketingStatus"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.marketingStatus.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": "MedicinalProductDefinition.marketingStatus.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": "MedicinalProductDefinition.marketingStatus.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": "MedicinalProductDefinition.marketingStatus.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": "MedicinalProductDefinition.marketingStatus.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": "MedicinalProductDefinition.marketingStatus.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": "BackboneType.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": "MedicinalProductDefinition.marketingStatus.country",
"min": 0,
"definition": "The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.",
"isModifier": false,
"short": "The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements",
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country"
},
"max": "1",
"id": "MedicinalProductDefinition.marketingStatus.country",
"base": {
"max": "1",
"min": 0,
"path": "MarketingStatus.country"
},
"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": "MedicinalProductDefinition.marketingStatus.jurisdiction",
"min": 0,
"definition": "Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.",
"isModifier": false,
"short": "Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified",
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "MedicinalProductDefinition.marketingStatus.jurisdiction",
"base": {
"max": "1",
"min": 0,
"path": "MarketingStatus.jurisdiction"
},
"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": "MedicinalProductDefinition.marketingStatus.status",
"min": 1,
"definition": "This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.",
"isModifier": false,
"short": "Status of the marketing of the medicinal product.",
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "MedicinalProductDefinition.marketingStatus.status",
"base": {
"max": "1",
"min": 1,
"path": "MarketingStatus.status"
},
"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": "MedicinalProductDefinition.marketingStatus.dateRange",
"min": 0,
"definition": "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.",
"isModifier": false,
"short": "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder",
"type": [ {
"code": "Period"
} ],
"max": "1",
"id": "MedicinalProductDefinition.marketingStatus.dateRange",
"base": {
"max": "1",
"min": 0,
"path": "MarketingStatus.dateRange"
},
"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": "MedicinalProductDefinition.marketingStatus.restoreDate",
"min": 0,
"definition": "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.",
"isModifier": false,
"short": "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain",
"type": [ {
"code": "dateTime"
} ],
"max": "1",
"id": "MedicinalProductDefinition.marketingStatus.restoreDate",
"base": {
"max": "1",
"min": 0,
"path": "MarketingStatus.restoreDate"
},
"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": "MedicinalProductDefinition.packagedMedicinalProduct",
"min": 0,
"definition": "Package type for the product. See also the PackagedProductDefinition resource.",
"isModifier": false,
"short": "Package type for the product.",
"mapping": [ {
"map": "Packaged Medicinal Product",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-package-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "MedicinalProductPackageType"
} ],
"description": "Types of medicinal product packs"
},
"max": "*",
"id": "MedicinalProductDefinition.packagedMedicinalProduct",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.packagedMedicinalProduct"
},
"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": "MedicinalProductDefinition.comprisedOf",
"min": 0,
"definition": "Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).",
"isModifier": false,
"short": "Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes",
"mapping": [ {
"map": "Manufactured Item",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition", "http://hl7.org/fhir/StructureDefinition/DeviceDefinition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.comprisedOf",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.comprisedOf"
},
"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": "MedicinalProductDefinition.ingredient",
"min": 0,
"definition": "The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.",
"isModifier": false,
"short": "The ingredients of this medicinal product - when not detailed in other resources",
"mapping": [ {
"map": "Medicinal Product.Ingredient (see also FHIR Ingredient resource)",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code",
"identity": "rim"
} ],
"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": "MedicinalProductDefinition.ingredient",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.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": "MedicinalProductDefinition.impurity",
"min": 0,
"definition": "Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.",
"isModifier": false,
"short": "Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "(to do)",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition" ]
} ],
"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": "MedicinalProductDefinition.impurity",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.impurity"
},
"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": "MedicinalProductDefinition.attachedDocument",
"min": 0,
"definition": "Additional information or supporting documentation about the medicinal product.",
"isModifier": false,
"short": "Additional documentation about the medicinal product",
"mapping": [ {
"map": "Attached Document",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.document",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.attachedDocument",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.attachedDocument"
},
"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": "MedicinalProductDefinition.masterFile",
"min": 0,
"definition": "A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.",
"isModifier": false,
"short": "A master file for the medicinal product (e.g. Pharmacovigilance System Master File)",
"mapping": [ {
"map": "Master File",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.document",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.masterFile",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.masterFile"
},
"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": "MedicinalProductDefinition.contact",
"min": 0,
"definition": "A product specific contact, person (in a role), or an organization.",
"isModifier": false,
"short": "A product specific contact, person (in a role), or an organization",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.contact",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.contact"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.contact.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": "MedicinalProductDefinition.contact.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": "MedicinalProductDefinition.contact.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": "MedicinalProductDefinition.contact.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": "MedicinalProductDefinition.contact.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": "MedicinalProductDefinition.contact.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": "MedicinalProductDefinition.contact.type",
"min": 0,
"definition": "Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.",
"isModifier": false,
"short": "Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-contact-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ProductContactType"
} ],
"description": "Extra measures defined for a Medicinal Product, such as heightened reporting requirements."
},
"max": "1",
"id": "MedicinalProductDefinition.contact.type",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.contact.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": "MedicinalProductDefinition.contact.contact",
"min": 1,
"definition": "A product specific contact, person (in a role), or an organization.",
"isModifier": false,
"short": "A specific contact, person (in a role), or an organization for this product",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization", "http://hl7.org/fhir/StructureDefinition/PractitionerRole" ]
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.contact.contact",
"base": {
"max": "1",
"min": 1,
"path": "MedicinalProductDefinition.contact.contact"
},
"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": "MedicinalProductDefinition.clinicalTrial",
"min": 0,
"definition": "Clinical trials or studies that this product is involved in.",
"isModifier": false,
"short": "Clinical trials or studies that this product is involved in",
"mapping": [ {
"map": "Investigational Medicinal Product.Clinical Trial Status",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ]
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.clinicalTrial",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.clinicalTrial"
},
"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": "MedicinalProductDefinition.code",
"min": 0,
"definition": "A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.",
"isModifier": false,
"short": "A code that this product is known by, within some formal terminology",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code",
"identity": "rim"
} ],
"type": [ {
"code": "Coding"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medication-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "MedicationFormalRepresentation"
} ],
"description": "A coded concept that defines the type of a medication."
},
"max": "*",
"id": "MedicinalProductDefinition.code",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.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": "MedicinalProductDefinition.name",
"min": 1,
"definition": "The product's name, including full name and possibly coded parts.",
"isModifier": false,
"short": "The product's name, including full name and possibly coded parts",
"mapping": [ {
"map": "Medicinal Product Name",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.name",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.name",
"base": {
"max": "*",
"min": 1,
"path": "MedicinalProductDefinition.name"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.name.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": "MedicinalProductDefinition.name.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": "MedicinalProductDefinition.name.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": "MedicinalProductDefinition.name.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": "MedicinalProductDefinition.name.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": "MedicinalProductDefinition.name.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": "MedicinalProductDefinition.name.productName",
"min": 1,
"definition": "The full product name.",
"isModifier": false,
"short": "The full product name.",
"mapping": [ {
"map": "Medicinal Product Name.Full Name",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.name",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.name.productName",
"base": {
"max": "1",
"min": 1,
"path": "MedicinalProductDefinition.name.productName"
},
"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": "MedicinalProductDefinition.name.type",
"min": 0,
"definition": "Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.",
"isModifier": false,
"short": "Type of product name, such as rINN, Proprietary, Non-Proprietary",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-name-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ProductNameType"
} ],
"description": "Type of a name for a Medicinal Product."
},
"max": "1",
"id": "MedicinalProductDefinition.name.type",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.name.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": "MedicinalProductDefinition.name.part",
"min": 0,
"definition": "Coding words or phrases of the name.",
"isModifier": false,
"short": "Coding words or phrases of the name",
"mapping": [ {
"map": "(any and all of the name parts e.g. Medicinal Product Name.Formulation Part)",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.name.part",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.name.part"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.name.part.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": "MedicinalProductDefinition.name.part.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": "MedicinalProductDefinition.name.part.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": "MedicinalProductDefinition.name.part.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": "MedicinalProductDefinition.name.part.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": "MedicinalProductDefinition.name.part.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": "MedicinalProductDefinition.name.part.part",
"min": 1,
"definition": "A fragment of a product name.",
"isModifier": false,
"short": "A fragment of a product name.",
"mapping": [ {
"map": "(text of any of the name parts e.g. Medicinal Product Name.Formulation Part)",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.name.part.part",
"base": {
"max": "1",
"min": 1,
"path": "MedicinalProductDefinition.name.part.part"
},
"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": "MedicinalProductDefinition.name.part.type",
"min": 1,
"definition": "Identifying type for this part of the name (e.g. strength part).",
"isModifier": false,
"short": "Type for this part of the name (e.g. strength part)",
"mapping": [ {
"map": "(which of the name parts this is e.g. Formulation Part)",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ProductNamePartType"
} ],
"description": "Type of part of a name for a Medicinal Product."
},
"max": "1",
"id": "MedicinalProductDefinition.name.part.type",
"base": {
"max": "1",
"min": 1,
"path": "MedicinalProductDefinition.name.part.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": "MedicinalProductDefinition.name.usage",
"min": 0,
"definition": "Country and jurisdiction where the name applies, and associated language.",
"isModifier": false,
"short": "Country and jurisdiction where the name applies",
"mapping": [ {
"map": "Country / Language",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.name.usage",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.name.usage"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.name.usage.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": "MedicinalProductDefinition.name.usage.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": "MedicinalProductDefinition.name.usage.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": "MedicinalProductDefinition.name.usage.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": "MedicinalProductDefinition.name.usage.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": "MedicinalProductDefinition.name.usage.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": "MedicinalProductDefinition.name.usage.country",
"min": 1,
"definition": "Country code for where this name applies.",
"isModifier": false,
"short": "Country where this name applies",
"mapping": [ {
"map": "Country / Language.Country",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/country",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Country"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"description": "Jurisdiction codes"
},
"max": "1",
"id": "MedicinalProductDefinition.name.usage.country",
"base": {
"max": "1",
"min": 1,
"path": "MedicinalProductDefinition.name.usage.country"
},
"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": "MedicinalProductDefinition.name.usage.jurisdiction",
"min": 0,
"definition": "Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).",
"isModifier": false,
"short": "Jurisdiction where this name applies",
"mapping": [ {
"map": "Country / Language.Jurisdiction",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Jurisdiction"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"description": "Jurisdiction codes"
},
"max": "1",
"id": "MedicinalProductDefinition.name.usage.jurisdiction",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.name.usage.jurisdiction"
},
"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": "MedicinalProductDefinition.name.usage.language",
"min": 1,
"definition": "Language code for this name.",
"isModifier": false,
"short": "Language for this name",
"mapping": [ {
"map": "Country / Language.Language",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"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"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "1",
"id": "MedicinalProductDefinition.name.usage.language",
"base": {
"max": "1",
"min": 1,
"path": "MedicinalProductDefinition.name.usage.language"
},
"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": "MedicinalProductDefinition.crossReference",
"min": 0,
"definition": "Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.",
"isModifier": false,
"short": "Reference to another product, e.g. for linking authorised to investigational product",
"mapping": [ {
"map": "Product Cross-Reference",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.crossReference",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.crossReference"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.crossReference.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": "MedicinalProductDefinition.crossReference.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": "MedicinalProductDefinition.crossReference.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": "MedicinalProductDefinition.crossReference.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": "MedicinalProductDefinition.crossReference.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": "MedicinalProductDefinition.crossReference.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": "MedicinalProductDefinition.crossReference.product",
"min": 1,
"definition": "Reference to another product, e.g. for linking authorised to investigational product.",
"isModifier": false,
"short": "Reference to another product, e.g. for linking authorised to investigational product",
"mapping": [ {
"map": "Product Cross-Reference",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition" ]
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.crossReference.product",
"base": {
"max": "1",
"min": 1,
"path": "MedicinalProductDefinition.crossReference.product"
},
"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": "MedicinalProductDefinition.crossReference.type",
"min": 0,
"definition": "The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.",
"isModifier": false,
"short": "The type of relationship, for instance branded to generic or virtual to actual product",
"mapping": [ {
"map": "Product Cross-Reference",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ProductCrossReferenceType"
} ],
"description": "Extra measures defined for a Medicinal Product, such as heightened reporting requirements."
},
"max": "1",
"id": "MedicinalProductDefinition.crossReference.type",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.crossReference.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": "MedicinalProductDefinition.operation",
"min": 0,
"definition": "A manufacturing or administrative process or step associated with (or performed on) the medicinal product.",
"isModifier": false,
"short": "A manufacturing or administrative process for the medicinal product",
"mapping": [ {
"map": "Manufacturing / Business Operation",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.action",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.operation",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.operation"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.operation.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": "MedicinalProductDefinition.operation.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": "MedicinalProductDefinition.operation.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": "MedicinalProductDefinition.operation.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": "MedicinalProductDefinition.operation.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": "MedicinalProductDefinition.operation.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": "MedicinalProductDefinition.operation.type",
"min": 0,
"definition": "The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.",
"isModifier": false,
"short": "The type of manufacturing operation e.g. manufacturing itself, re-packaging",
"mapping": [ {
"map": "Manufacturing / Business Operation.Operation Type",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.action.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ActivityDefinition", "http://hl7.org/fhir/StructureDefinition/PlanDefinition" ]
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.operation.type",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.operation.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": "MedicinalProductDefinition.operation.effectiveDate",
"min": 0,
"definition": "Date range of applicability.",
"isModifier": false,
"short": "Date range of applicability",
"mapping": [ {
"map": "Manufacturing / Business Operation.Effective Date",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime",
"identity": "rim"
} ],
"type": [ {
"code": "Period"
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.operation.effectiveDate",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.operation.effectiveDate"
},
"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": "MedicinalProductDefinition.operation.organization",
"min": 0,
"definition": "The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.",
"isModifier": false,
"short": "The organization responsible for the particular process, e.g. the manufacturer or importer",
"mapping": [ {
"map": "Manufacturer / Establishment (Organisation)",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.operation.organization",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.operation.organization"
},
"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": "MedicinalProductDefinition.operation.confidentialityIndicator",
"min": 0,
"definition": "Specifies whether this particular business or manufacturing process is considered proprietary or confidential.",
"isModifier": false,
"short": "Specifies whether this process is considered proprietary or confidential",
"mapping": [ {
"map": "Manufacturing / Business Operation.Confidentiality Indicator",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ProductConfidentiality"
} ],
"description": "Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product."
},
"max": "1",
"id": "MedicinalProductDefinition.operation.confidentialityIndicator",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.operation.confidentialityIndicator"
},
"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": "MedicinalProductDefinition.characteristic",
"min": 0,
"definition": "Allows the key product features to be recorded, such as \"sugar free\", \"modified release\", \"parallel import\".",
"isModifier": false,
"short": "Key product features such as \"sugar free\", \"modified release\"",
"mapping": [ {
"map": "Package Item (Container).Physical Characteristics",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.characteristic",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "MedicinalProductDefinition.characteristic",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.characteristic"
},
"isSummary": true
}, {
"path": "MedicinalProductDefinition.characteristic.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": "MedicinalProductDefinition.characteristic.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": "MedicinalProductDefinition.characteristic.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": "MedicinalProductDefinition.characteristic.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": "MedicinalProductDefinition.characteristic.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": "MedicinalProductDefinition.characteristic.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": "MedicinalProductDefinition.characteristic.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"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']",
"identity": "rim"
} ],
"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": "ProductCharacteristic"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "MedicinalProductDefinition.characteristic.type",
"base": {
"max": "1",
"min": 1,
"path": "MedicinalProductDefinition.characteristic.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": "MedicinalProductDefinition.characteristic.value[x]",
"min": 0,
"definition": "A value for the characteristic.text.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
}, {
"code": "markdown"
}, {
"code": "Quantity"
}, {
"code": "integer"
}, {
"code": "date"
}, {
"code": "boolean"
}, {
"code": "Attachment"
} ],
"mustSupport": false,
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]",
"comment": "Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text.",
"base": {
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.characteristic.value[x]"
},
"isSummary": true
} ]
},
"status": "active",
"id": "1d3e587e-11db-4c9c-8fb0-21d03cec1565",
"kind": "resource",
"url": "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi",
"version": "1.0.0",
"differential": {
"element": [ {
"id": "MedicinalProductDefinition",
"path": "MedicinalProductDefinition"
}, {
"id": "MedicinalProductDefinition.identifier",
"min": 1,
"path": "MedicinalProductDefinition.identifier"
}, {
"id": "MedicinalProductDefinition.identifier.system",
"min": 1,
"path": "MedicinalProductDefinition.identifier.system"
}, {
"id": "MedicinalProductDefinition.identifier.value",
"min": 1,
"path": "MedicinalProductDefinition.identifier.value"
}, {
"id": "MedicinalProductDefinition.type",
"path": "MedicinalProductDefinition.type",
"short": "Regulatory type, e.g. Investigational or Authorized."
}, {
"id": "MedicinalProductDefinition.domain",
"path": "MedicinalProductDefinition.domain",
"short": "If this medicine applies to human or veterinary uses.",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-domain"
}
}, {
"id": "MedicinalProductDefinition.version",
"path": "MedicinalProductDefinition.version",
"short": "A business identifier relating to a specific version of the product."
}, {
"id": "MedicinalProductDefinition.status",
"path": "MedicinalProductDefinition.status",
"short": "The status within the lifecycle of this product record."
}, {
"id": "MedicinalProductDefinition.statusDate",
"path": "MedicinalProductDefinition.statusDate",
"short": "The date at which this status became applicable."
}, {
"id": "MedicinalProductDefinition.description",
"path": "MedicinalProductDefinition.description",
"short": "General description of the medicinal product referred by the ePI"
}, {
"id": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm",
"path": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm"
}
}, {
"id": "MedicinalProductDefinition.route",
"path": "MedicinalProductDefinition.route",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration"
}
}, {
"id": "MedicinalProductDefinition.indication",
"path": "MedicinalProductDefinition.indication",
"short": "Narrative text of the authorized indication(s) for this product."
}, {
"id": "MedicinalProductDefinition.legalStatusOfSupply",
"path": "MedicinalProductDefinition.legalStatusOfSupply",
"short": "The legal status of supply of the medicinal product as classified by the regulator."
}, {
"id": "MedicinalProductDefinition.additionalMonitoringIndicator",
"path": "MedicinalProductDefinition.additionalMonitoringIndicator",
"short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons."
}, {
"id": "MedicinalProductDefinition.specialMeasures",
"path": "MedicinalProductDefinition.specialMeasures",
"short": "Whether the Medicinal Product is subject to special measures for regulatory reasons."
}, {
"id": "MedicinalProductDefinition.pediatricUseIndicator",
"path": "MedicinalProductDefinition.pediatricUseIndicator",
"short": "If authorised for pediatric use"
}, {
"id": "MedicinalProductDefinition.classification",
"path": "MedicinalProductDefinition.classification",
"short": "Allows the product to be classified by various systems (e.g. ATC)",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification"
}
}, {
"id": "MedicinalProductDefinition.marketingStatus.country",
"path": "MedicinalProductDefinition.marketingStatus.country",
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country"
}
}, {
"id": "MedicinalProductDefinition.marketingStatus.status",
"path": "MedicinalProductDefinition.marketingStatus.status",
"short": "Status of the marketing of the medicinal product."
}, {
"id": "MedicinalProductDefinition.marketingStatus.dateRange",
"path": "MedicinalProductDefinition.marketingStatus.dateRange",
"short": "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder"
}, {
"id": "MedicinalProductDefinition.packagedMedicinalProduct",
"path": "MedicinalProductDefinition.packagedMedicinalProduct",
"short": "Package type for the product."
}, {
"id": "MedicinalProductDefinition.contact.type",
"path": "MedicinalProductDefinition.contact.type",
"short": "Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information."
}, {
"id": "MedicinalProductDefinition.contact.contact",
"path": "MedicinalProductDefinition.contact.contact",
"short": "A specific contact, person (in a role), or an organization for this product"
}, {
"id": "MedicinalProductDefinition.name.productName",
"path": "MedicinalProductDefinition.name.productName",
"short": "The full product name."
}, {
"id": "MedicinalProductDefinition.name.type",
"path": "MedicinalProductDefinition.name.type",
"short": "Type of product name, such as rINN, Proprietary, Non-Proprietary"
}, {
"id": "MedicinalProductDefinition.name.part.part",
"path": "MedicinalProductDefinition.name.part.part",
"short": "A fragment of a product name."
}, {
"id": "MedicinalProductDefinition.name.part.type",
"path": "MedicinalProductDefinition.name.part.type",
"short": "Type for this part of the name (e.g. strength part)"
}, {
"id": "MedicinalProductDefinition.name.usage.country",
"path": "MedicinalProductDefinition.name.usage.country",
"short": "Country where this name applies"
}, {
"id": "MedicinalProductDefinition.name.usage.jurisdiction",
"path": "MedicinalProductDefinition.name.usage.jurisdiction",
"short": "Jurisdiction where this name applies"
}, {
"id": "MedicinalProductDefinition.name.usage.language",
"path": "MedicinalProductDefinition.name.usage.language",
"short": "Language for this name"
} ]
},
"contact": [ {
"name": "HL7 International - Biomedical Research & Regulation Work Group",
"telecom": [ {
"value": "http://hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"
}