{
"description": "Container Closure for drug product referred to in Drug Product Description.",
"_filename": "StructureDefinition-ContainerClosure.json",
"package_name": "hl7.fhir.us.pq-cmc-fda",
"date": "2024-12-11T13:47:08+00:00",
"derivation": "constraint",
"publisher": "HL7 International / Biomedical Research and Regulation",
"fhirVersion": "5.0.0",
"jurisdiction": [ {
"coding": [ {
"code": "US",
"system": "urn:iso:std:iso:3166",
"display": "United States of America"
} ]
} ],
"name": "ContainerClosure",
"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": "PackagedProductDefinition",
"experimental": null,
"resourceType": "StructureDefinition",
"title": null,
"package_version": "1.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
} ],
"snapshot": {
"element": [ {
"constraint": [ {
"key": "dom-2",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.contained.empty()"
}, {
"key": "dom-3",
"human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"
}, {
"key": "dom-4",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"
}, {
"key": "dom-5",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.security.empty()"
}, {
"key": "dom-6",
"human": "A resource should have narrative for robust management",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "warning",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
} ],
"expression": "text.`div`.exists()"
} ],
"path": "PackagedProductDefinition",
"min": 0,
"definition": "A medically related item or items, in a container or package.",
"isModifier": false,
"short": "A medically related item or items, in a container or package",
"mapping": [ {
"map": "Entity, Role, or Act",
"identity": "rim"
}, {
"map": "administrative.medication",
"identity": "w5"
}, {
"map": "Packaged Medicinal Product",
"identity": "idmp"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition"
},
"isSummary": false
}, {
"path": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.language",
"min": 0,
"definition": "The base language in which the resource is written.",
"isModifier": false,
"short": "Language of the resource content",
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "1",
"id": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.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": "PackagedProductDefinition.identifier",
"min": 0,
"definition": "A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.",
"isModifier": false,
"short": "A unique identifier for this package as whole - not for the content of the package",
"mapping": [ {
"map": "FiveWs.class",
"identity": "w5"
}, {
"map": "Packaged Medicinal Product.PCID",
"identity": "idmp"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.identifier",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.name",
"min": 0,
"definition": "A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.",
"isModifier": false,
"short": "A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "PackagedProductDefinition.name",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.type",
"min": 0,
"definition": "A high level category e.g. medicinal product, raw material, shipping/transport container, etc.",
"isModifier": false,
"short": "A high level category e.g. medicinal product, raw material, shipping container etc",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/package-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PackageType"
} ],
"description": "A high level categorisation of a package."
},
"max": "1",
"id": "PackagedProductDefinition.type",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.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": "PackagedProductDefinition.packageFor",
"min": 1,
"definition": "The product this package model relates to, not the contents of the package (for which see package.containedItem).",
"isModifier": false,
"short": "The product that this is a pack for",
"mapping": [ {
"map": "(the link from Packaged Medicinal Product to Medicinal Product)",
"identity": "idmp"
} ],
"type": [ {
"code": "Reference",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference" ],
"aggregation": [ "bundled" ],
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description" ]
} ],
"mustSupport": true,
"max": "1",
"id": "PackagedProductDefinition.packageFor",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packageFor"
},
"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": "PackagedProductDefinition.status",
"min": 0,
"definition": "The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.",
"isModifier": true,
"short": "The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"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"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "PackagedProductDefinition.status",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.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": "PackagedProductDefinition.statusDate",
"min": 0,
"definition": "The date at which the given status became applicable.",
"isModifier": false,
"short": "The date at which the given status became applicable",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "PackagedProductDefinition.statusDate",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.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": "PackagedProductDefinition.containedItemQuantity",
"min": 0,
"definition": "A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource.",
"isModifier": false,
"short": "A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.containedItemQuantity",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.containedItemQuantity"
},
"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": "PackagedProductDefinition.description",
"min": 1,
"definition": "Any textual comments that describe the sum of container closure system (CCS) components that together contain and protect the dosage form or drug substance. [Source: Adapted from Q1A(R2)-ICH Glossary]\nExample: White opaque, round 50 mL HDPE bottle with a fitted 33 mm child resistant black polypropylene threaded cap closure, aluminum sealed, and containing molecular sieve canister 2 gm (CAN TRISORB 2G) as desiccant.\nNote: This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug substance or the drug product. A packaging system is equivalent to a container closure system. [Source: Adapted from Q1A(R2)-ICH Glossary]",
"isModifier": false,
"short": "Container Closure System Description",
"mapping": [ {
"map": "Packaged Medicinal Product.description",
"identity": "idmp"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": true,
"max": "1",
"id": "PackagedProductDefinition.description",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.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": "PackagedProductDefinition.legalStatusOfSupply",
"min": 0,
"definition": "The legal status of supply of the packaged item as classified by the regulator.",
"isModifier": false,
"short": "The legal status of supply of the packaged item as classified by the regulator",
"mapping": [ {
"map": "Marketing Authorization.Legal Status of Supply (for a package)",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.legalStatusOfSupply",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.legalStatusOfSupply"
},
"isSummary": true
}, {
"path": "PackagedProductDefinition.legalStatusOfSupply.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": "PackagedProductDefinition.legalStatusOfSupply.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": "PackagedProductDefinition.legalStatusOfSupply.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": "PackagedProductDefinition.legalStatusOfSupply.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": "PackagedProductDefinition.legalStatusOfSupply.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": "PackagedProductDefinition.legalStatusOfSupply.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": "PackagedProductDefinition.legalStatusOfSupply.code",
"min": 0,
"definition": "The actual status of supply. Conveys in what situation this package type may be supplied for use.",
"isModifier": false,
"short": "The actual status of supply. In what situation this package type may be supplied for use",
"mapping": [ {
"map": "Marketing Authorization.Legal Status of Supply (for a package)",
"identity": "idmp"
} ],
"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": "PackagedProductDefinition.legalStatusOfSupply.code",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.legalStatusOfSupply.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": "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"min": 0,
"definition": "The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.",
"isModifier": false,
"short": "The place where the legal status of supply applies",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"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"
} ],
"description": "Jurisdiction codes"
},
"max": "1",
"id": "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.legalStatusOfSupply.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": "PackagedProductDefinition.marketingStatus",
"min": 0,
"definition": "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.",
"isModifier": false,
"short": "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated",
"mapping": [ {
"map": "Packaged Medicinal Product.Marketing Status",
"identity": "idmp"
} ],
"type": [ {
"code": "MarketingStatus"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.marketingStatus",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.marketingStatus"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.copackagedIndicator",
"min": 0,
"definition": "Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant.",
"isModifier": false,
"short": "Identifies if the drug product is supplied with another item such as a diluent or adjuvant",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "boolean"
} ],
"mustSupport": false,
"meaningWhenMissing": "If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made",
"max": "1",
"id": "PackagedProductDefinition.copackagedIndicator",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.copackagedIndicator"
},
"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": "PackagedProductDefinition.manufacturer",
"min": 0,
"definition": "Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.",
"isModifier": false,
"short": "Manufacturer of this package type (multiple means these are all possible manufacturers)",
"mapping": [ {
"map": "Packaged Medicinal Product.Manufacturer / Establishment (Organisation)",
"identity": "idmp"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.manufacturer",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.manufacturer"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.attachedDocument",
"min": 0,
"definition": "Diagram of cContainer Closure System or any of its parts noted in the Container Closure System Description",
"isModifier": false,
"short": "Container Closure System Depiction",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"type": [ {
"code": "Reference",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference" ],
"aggregation": [ "bundled" ],
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference" ]
} ],
"mustSupport": true,
"max": "*",
"id": "PackagedProductDefinition.attachedDocument",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.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": "PackagedProductDefinition.packaging",
"min": 1,
"definition": "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).",
"isModifier": false,
"short": "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap",
"mapping": [ {
"map": "Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "1",
"id": "PackagedProductDefinition.packaging",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.packaging"
},
"isSummary": true
}, {
"path": "PackagedProductDefinition.packaging.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": "PackagedProductDefinition.packaging.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": "PackagedProductDefinition.packaging.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": "PackagedProductDefinition.packaging.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": "PackagedProductDefinition.packaging.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": "PackagedProductDefinition.packaging.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": "PackagedProductDefinition.packaging.identifier",
"min": 0,
"definition": "A business identifier that is specific to this particular part of the packaging, often assigned by the manufacturer. Including possibly Data Carrier Identifier (a GS1 barcode).",
"isModifier": false,
"short": "An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier",
"mapping": [ {
"map": "Package Item (Container).Data Carrier Identifier",
"identity": "idmp"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.packaging.identifier",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packaging.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.type",
"min": 1,
"definition": "The physical type of the container of the items.",
"isModifier": false,
"short": "The physical type of the container of the items",
"mapping": [ {
"map": "Package Item (Container).Package Item (Container) Type",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/packaging-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PackagingType"
} ],
"description": "A high level categorisation of a package."
},
"max": "1",
"id": "PackagedProductDefinition.packaging.type",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.packaging.type"
},
"isSummary": true
}, {
"path": "PackagedProductDefinition.packaging.type.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "PackagedProductDefinition.packaging.type.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "PackagedProductDefinition.packaging.type.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "PackagedProductDefinition.packaging.type.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.type.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 2,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"slicing": {
"rules": "closed",
"discriminator": [ {
"path": "$this",
"type": "value"
} ]
},
"type": [ {
"code": "Coding"
} ],
"mustSupport": true,
"max": "2",
"id": "PackagedProductDefinition.packaging.type.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.type.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 1,
"definition": "The kind of container that drug substances and finished dosage forms are contained in, which could include both the immediate (or primary) and secondary containers [Source: Adapted from NCI Thesaurus C4164]",
"isModifier": false,
"short": "Container Type",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"mustSupport": true,
"sliceName": "ContainerType",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology"
},
"max": "1",
"id": "PackagedProductDefinition.packaging.type.coding:ContainerType",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.type.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 1,
"definition": "The kind of closures used for the container in which the drug substances and finished dosage forms are stored. [Source: SME Defined]",
"isModifier": false,
"short": "Closure Type",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"mustSupport": true,
"sliceName": "ClosureType",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology"
},
"max": "1",
"id": "PackagedProductDefinition.packaging.type.coding:ClosureType",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.type.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "PackagedProductDefinition.packaging.type.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.componentPart",
"min": 0,
"definition": "Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial). The latter type are designed be a container, but the former are not.",
"isModifier": false,
"short": "Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)",
"mapping": [ {
"map": "Whether this packaging item corresponds to an Package Item (Container), if false, or a Package (Component), when true",
"identity": "idmp"
} ],
"type": [ {
"code": "boolean"
} ],
"mustSupport": false,
"meaningWhenMissing": "If absent, it cannot be assumed that the item is packaging (a container) or a part of the packaging - it is just 'packaging'. Systems can sometimes infer this from the packaging.type (e.g. bottles are containers, bottle caps are not), or from the fact that a container will usually have other items within it (though it is possible that these exist but are not mentioned). Often the distinction is not critical - and can easily be understood by humans - but if that is necessary for machine processing it is recommended that this attribute is given a value.",
"max": "1",
"id": "PackagedProductDefinition.packaging.componentPart",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.packaging.componentPart"
},
"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": "PackagedProductDefinition.packaging.quantity",
"min": 0,
"definition": "The quantity of packaging items contained at this layer of the package. This does not relate to the number of contained items but relates solely to the number of packaging items. When looking at the outermost layer it is always 1. If there are two boxes within, at the next layer it would be 2.",
"isModifier": false,
"short": "The quantity of this level of packaging in the package that contains it (with the outermost level being 1)",
"mapping": [ {
"map": "Package Item (Container).Package Item (Container) Quantity",
"identity": "idmp"
} ],
"type": [ {
"code": "integer"
} ],
"mustSupport": true,
"max": "1",
"id": "PackagedProductDefinition.packaging.quantity",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.packaging.quantity"
},
"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": "PackagedProductDefinition.packaging.material",
"min": 0,
"definition": "Material type of the package item.",
"isModifier": false,
"short": "Material type of the package item",
"mapping": [ {
"map": "Package Item (Container).Material",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/package-material",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PackageMaterial"
} ],
"description": "A material used in the construction of packages and their components."
},
"max": "*",
"id": "PackagedProductDefinition.packaging.material",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packaging.material"
},
"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": "PackagedProductDefinition.packaging.alternateMaterial",
"min": 0,
"definition": "A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve).",
"isModifier": false,
"short": "A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material",
"mapping": [ {
"map": "Package Item (Container).Alternate Material",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/package-material",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PackageMaterial"
} ],
"description": "A material used in the construction of packages and their components."
},
"max": "*",
"id": "PackagedProductDefinition.packaging.alternateMaterial",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packaging.alternateMaterial"
},
"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": "PackagedProductDefinition.packaging.shelfLifeStorage",
"min": 0,
"definition": "Shelf Life and storage information.",
"isModifier": false,
"short": "Shelf Life and storage information",
"mapping": [ {
"map": "Package Item (Container).Shelf Life / Storage",
"identity": "idmp"
} ],
"type": [ {
"code": "ProductShelfLife"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.packaging.shelfLifeStorage",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packaging.shelfLifeStorage"
},
"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": "PackagedProductDefinition.packaging.manufacturer",
"min": 0,
"definition": "Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item.",
"isModifier": false,
"short": "Manufacturer of this packaging item (multiple means these are all potential manufacturers)",
"mapping": [ {
"map": "Package Item (Container).Manufacturer / Establishment (Organisation)",
"identity": "idmp"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.packaging.manufacturer",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packaging.manufacturer"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.property",
"min": 0,
"definition": "General characteristics of this item.",
"isModifier": false,
"short": "General characteristics of this item",
"mapping": [ {
"map": "Package Item (Container).Physical Characteristics",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.packaging.property",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packaging.property"
},
"isSummary": true
}, {
"path": "PackagedProductDefinition.packaging.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "PackagedProductDefinition.packaging.property.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "PackagedProductDefinition.packaging.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "PackagedProductDefinition.packaging.property.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "PackagedProductDefinition.packaging.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "PackagedProductDefinition.packaging.property.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.property.type",
"min": 1,
"definition": "A code expressing the type of characteristic.",
"isModifier": false,
"short": "A code expressing the type of characteristic",
"mapping": [ {
"map": "Physical Characteristics, all attributes",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ProductCharacteristic"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "PackagedProductDefinition.packaging.property.type",
"base": {
"max": "1",
"min": 1,
"path": "PackagedProductDefinition.packaging.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.property.value[x]",
"min": 0,
"definition": "A value for the characteristic.",
"isModifier": false,
"short": "A value for the characteristic",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableConcept"
}, {
"code": "Quantity"
}, {
"code": "date"
}, {
"code": "boolean"
}, {
"code": "Attachment"
} ],
"mustSupport": false,
"max": "1",
"id": "PackagedProductDefinition.packaging.property.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.packaging.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "PackagedProductDefinition.packaging.containedItem",
"min": 0,
"definition": "The item(s) within the packaging.",
"isModifier": false,
"short": "The item(s) within the packaging",
"mapping": [ {
"map": "Package Item (Container).Manufactured Item, Package Item (Container).Device",
"identity": "idmp"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.packaging.containedItem",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packaging.containedItem"
},
"isSummary": true
}, {
"path": "PackagedProductDefinition.packaging.containedItem.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": "PackagedProductDefinition.packaging.containedItem.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": "PackagedProductDefinition.packaging.containedItem.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": "PackagedProductDefinition.packaging.containedItem.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": "PackagedProductDefinition.packaging.containedItem.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": "PackagedProductDefinition.packaging.containedItem.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": "PackagedProductDefinition.packaging.containedItem.item",
"min": 1,
"definition": "The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.packaging.packaging).",
"isModifier": false,
"short": "The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package",
"mapping": [ {
"map": "(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device",
"identity": "idmp"
} ],
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition", "http://hl7.org/fhir/StructureDefinition/DeviceDefinition", "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition", "http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct", "http://hl7.org/fhir/StructureDefinition/NutritionProduct" ]
} ],
"mustSupport": false,
"max": "1",
"id": "PackagedProductDefinition.packaging.containedItem.item",
"base": {
"max": "1",
"min": 1,
"path": "PackagedProductDefinition.packaging.containedItem.item"
},
"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": "PackagedProductDefinition.packaging.containedItem.amount",
"min": 0,
"definition": "The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition).",
"isModifier": false,
"short": "The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)",
"mapping": [ {
"map": "Manufactured Item.Manufactured Item Quantity",
"identity": "idmp"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": false,
"max": "1",
"id": "PackagedProductDefinition.packaging.containedItem.amount",
"base": {
"max": "1",
"min": 0,
"path": "PackagedProductDefinition.packaging.containedItem.amount"
},
"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": "PackagedProductDefinition.packaging.packaging",
"min": 0,
"definition": "Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).",
"isModifier": false,
"short": "Allows containers (and parts of containers) within containers, still as a part of single packaged product",
"mapping": [ {
"map": "(link from Package Item (Container) to itself)",
"identity": "idmp"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging",
"mustSupport": true,
"max": "*",
"id": "PackagedProductDefinition.packaging.packaging",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.packaging.packaging"
},
"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": "PackagedProductDefinition.characteristic",
"min": 0,
"definition": "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\", \"calendar pack\".",
"isModifier": false,
"short": "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\"",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging.property",
"mustSupport": false,
"max": "*",
"id": "PackagedProductDefinition.characteristic",
"base": {
"max": "*",
"min": 0,
"path": "PackagedProductDefinition.characteristic"
},
"isSummary": true
} ]
},
"status": "active",
"id": "8e51387d-32df-472c-91e8-cf7bce27681a",
"kind": "resource",
"url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.36.42.52",
"system": "urn:ietf:rfc:3986"
} ],
"version": "1.0.0",
"differential": {
"element": [ {
"id": "PackagedProductDefinition",
"path": "PackagedProductDefinition"
}, {
"id": "PackagedProductDefinition.packageFor",
"max": "1",
"min": 1,
"path": "PackagedProductDefinition.packageFor",
"type": [ {
"code": "Reference",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference" ],
"aggregation": [ "bundled" ],
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description" ]
} ],
"mustSupport": true
}, {
"id": "PackagedProductDefinition.description",
"min": 1,
"path": "PackagedProductDefinition.description",
"short": "Container Closure System Description",
"definition": "Any textual comments that describe the sum of container closure system (CCS) components that together contain and protect the dosage form or drug substance. [Source: Adapted from Q1A(R2)-ICH Glossary]\nExample: White opaque, round 50 mL HDPE bottle with a fitted 33 mm child resistant black polypropylene threaded cap closure, aluminum sealed, and containing molecular sieve canister 2 gm (CAN TRISORB 2G) as desiccant.\nNote: This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug substance or the drug product. A packaging system is equivalent to a container closure system. [Source: Adapted from Q1A(R2)-ICH Glossary]",
"mustSupport": true
}, {
"id": "PackagedProductDefinition.attachedDocument",
"path": "PackagedProductDefinition.attachedDocument",
"type": [ {
"code": "Reference",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference" ],
"aggregation": [ "bundled" ],
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference" ]
} ],
"short": "Container Closure System Depiction",
"definition": "Diagram of cContainer Closure System or any of its parts noted in the Container Closure System Description",
"mustSupport": true
}, {
"id": "PackagedProductDefinition.packaging",
"min": 1,
"path": "PackagedProductDefinition.packaging",
"mustSupport": true
}, {
"id": "PackagedProductDefinition.packaging.type",
"min": 1,
"path": "PackagedProductDefinition.packaging.type",
"mustSupport": true
}, {
"id": "PackagedProductDefinition.packaging.type.coding",
"max": "2",
"min": 2,
"path": "PackagedProductDefinition.packaging.type.coding",
"slicing": {
"rules": "closed",
"discriminator": [ {
"path": "$this",
"type": "value"
} ]
},
"mustSupport": true
}, {
"path": "PackagedProductDefinition.packaging.type.coding",
"min": 1,
"definition": "The kind of container that drug substances and finished dosage forms are contained in, which could include both the immediate (or primary) and secondary containers [Source: Adapted from NCI Thesaurus C4164]",
"short": "Container Type",
"mustSupport": true,
"sliceName": "ContainerType",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology"
},
"max": "1",
"id": "PackagedProductDefinition.packaging.type.coding:ContainerType"
}, {
"path": "PackagedProductDefinition.packaging.type.coding",
"min": 1,
"definition": "The kind of closures used for the container in which the drug substances and finished dosage forms are stored. [Source: SME Defined]",
"short": "Closure Type",
"mustSupport": true,
"sliceName": "ClosureType",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology"
},
"max": "1",
"id": "PackagedProductDefinition.packaging.type.coding:ClosureType"
}, {
"id": "PackagedProductDefinition.packaging.quantity",
"path": "PackagedProductDefinition.packaging.quantity",
"mustSupport": true
}, {
"id": "PackagedProductDefinition.packaging.packaging",
"path": "PackagedProductDefinition.packaging.packaging",
"mustSupport": true
} ]
},
"contact": [ {
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
}, {
"value": "brr@lists.HL7.org",
"system": "email"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition"
}