{
"description": "This MedicinalProductDefinition profile represents information that identifies the drug product.",
"_filename": "StructureDefinition-MedicinalProductDefinition-drug-product-pq.json",
"package_name": "hl7.fhir.uv.pharm-quality",
"date": "2024-05-08T13:23:45+00:00",
"derivation": "constraint",
"meta": {
"source": "#9DaoKzOUalt0bLJS",
"versionId": "13",
"lastUpdated": "2023-01-02T14:45:07.672+00:00"
},
"publisher": "HL7 International / Biomedical Research and Regulation",
"fhirVersion": "5.0.0",
"jurisdiction": [ {
"text": "World",
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"display": "World"
} ]
} ],
"name": "MedicinalProductDefinitionDrugProductPq",
"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 - Drug Product PQ",
"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": "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"
} ],
"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": 0,
"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": true,
"alias": [ "MPID" ],
"max": "*",
"id": "MedicinalProductDefinition.identifier",
"base": {
"max": "*",
"min": 0,
"path": "MedicinalProductDefinition.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": "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",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "MedicinalProductType"
} ],
"description": "Applicable domain for this product (e.g. human, veterinary)."
},
"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"
} ],
"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 the given 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 this product",
"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": true,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform",
"description": "EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes."
},
"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": "preferred",
"valueSet": "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration",
"description": "EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes."
},
"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": "Description of indication(s) for this product, used when structured indications are not required",
"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 use in children",
"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",
"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/ValueSet/medicinal-product-classification",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ProductClassification"
} ],
"description": "This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set."
},
"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
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR 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 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": "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": true,
"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, BAN, Proprietary, Non-Proprietary",
"mapping": [ {
"map": "n/a",
"identity": "idmp"
}, {
"map": "ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq"
},
"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": "Identifying 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 code for 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"
} ],
"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 code for 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"
} ],
"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 code 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"
} ],
"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": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "*",
"id": "MedicinalProductDefinition.characteristic.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "MedicinalProductDefinition.characteristic.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "substance-property-range",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq" ]
} ],
"mustSupport": true,
"sliceName": "substance-property-range",
"max": "1",
"id": "MedicinalProductDefinition.characteristic.extension:substance-property-range",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "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/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type",
"description": "Example codes for MedicinalProduct.characteristic.type"
},
"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"
} ],
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"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
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR 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": "Quantity"
} ],
"mustSupport": false,
"sliceName": "valueQuantity",
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity",
"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
}, {
"path": "MedicinalProductDefinition.characteristic.value[x].id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.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.value[x].extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.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.characteristic.value[x].value",
"requirements": "Precision is handled implicitly in almost all cases of measurement.",
"min": 0,
"definition": "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
"isModifier": false,
"short": "Numerical value (with implicit precision)",
"mapping": [ {
"map": "SN.2 / CQ - N/A",
"identity": "v2"
}, {
"map": "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value",
"identity": "rim"
} ],
"type": [ {
"code": "decimal"
} ],
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.value",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "MedicinalProductDefinition.characteristic.value[x].comparator",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min": 0,
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"isModifier": true,
"short": "< | <= | >= | > | ad - how to understand the value",
"mapping": [ {
"map": "SN.1 / CQ.1",
"identity": "v2"
}, {
"map": "IVL properties",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"meaningWhenMissing": "If there is no comparator, then there is no modification of the value",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "QuantityComparator"
} ],
"description": "How the Quantity should be understood and represented."
},
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.comparator"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "MedicinalProductDefinition.characteristic.value[x].unit",
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min": 0,
"definition": "A human-readable form of the unit.",
"isModifier": false,
"short": "Unit representation",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.unit",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.unit",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.unit"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "MedicinalProductDefinition.characteristic.value[x].system",
"requirements": "Need to know the system that defines the coded form of the unit.",
"min": 0,
"definition": "The identification of the system that provides the coded form of the unit.",
"isModifier": false,
"short": "System that defines coded unit form",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "CO.codeSystem, PQ.translation.codeSystem",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.system",
"condition": [ "qty-3" ],
"base": {
"max": "1",
"min": 0,
"path": "Quantity.system"
},
"patternUri": "http://unitsofmeasure.org",
"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].code",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min": 0,
"definition": "A computer processable form of the unit in some unit representation system.",
"isModifier": false,
"short": "Coded form of the unit",
"mapping": [ {
"map": "(see OBX.6 etc.) / CQ.2",
"identity": "v2"
}, {
"map": "PQ.code, MO.currency, PQ.translation.code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive",
"description": "UCUM codes for unit"
},
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code",
"condition": [ "qty-3" ],
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"base": {
"max": "1",
"min": 0,
"path": "Quantity.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "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"
} ],
"mustSupport": false,
"sliceName": "valueCodeableConcept",
"max": "1",
"id": "MedicinalProductDefinition.characteristic.value[x]:valueCodeableConcept",
"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": "ce2cecdd-9878-499b-875e-0ce7d23a6167",
"kind": "resource",
"url": "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.41.42.30",
"system": "urn:ietf:rfc:3986"
} ],
"version": "1.0.0",
"differential": {
"element": [ {
"id": "MedicinalProductDefinition",
"path": "MedicinalProductDefinition"
}, {
"id": "MedicinalProductDefinition.identifier",
"path": "MedicinalProductDefinition.identifier",
"mustSupport": true
}, {
"id": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm",
"path": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm",
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform",
"description": "EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes."
},
"mustSupport": true
}, {
"id": "MedicinalProductDefinition.route",
"path": "MedicinalProductDefinition.route",
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration",
"description": "EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes."
}
}, {
"id": "MedicinalProductDefinition.name",
"path": "MedicinalProductDefinition.name",
"mustSupport": true
}, {
"id": "MedicinalProductDefinition.name.type",
"path": "MedicinalProductDefinition.name.type",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq"
},
"mustSupport": true
}, {
"id": "MedicinalProductDefinition.characteristic",
"path": "MedicinalProductDefinition.characteristic"
}, {
"id": "MedicinalProductDefinition.characteristic.extension",
"path": "MedicinalProductDefinition.characteristic.extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
}
}, {
"id": "MedicinalProductDefinition.characteristic.extension:substance-property-range",
"max": "1",
"min": 0,
"path": "MedicinalProductDefinition.characteristic.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq" ]
} ],
"short": "substance-property-range",
"sliceName": "substance-property-range",
"mustSupport": true
}, {
"id": "MedicinalProductDefinition.characteristic.type",
"path": "MedicinalProductDefinition.characteristic.type",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type",
"description": "Example codes for MedicinalProduct.characteristic.type"
}
}, {
"id": "MedicinalProductDefinition.characteristic.value[x]",
"path": "MedicinalProductDefinition.characteristic.value[x]",
"slicing": {
"rules": "closed",
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity",
"path": "MedicinalProductDefinition.characteristic.value[x]",
"type": [ {
"code": "Quantity"
} ],
"sliceName": "valueQuantity"
}, {
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.system",
"path": "MedicinalProductDefinition.characteristic.value[x].system",
"patternUri": "http://unitsofmeasure.org"
}, {
"id": "MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code",
"path": "MedicinalProductDefinition.characteristic.value[x].code",
"binding": {
"strength": "required",
"valueSet": "http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive",
"description": "UCUM codes for unit"
}
}, {
"id": "MedicinalProductDefinition.characteristic.value[x]:valueCodeableConcept",
"path": "MedicinalProductDefinition.characteristic.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"sliceName": "valueCodeableConcept"
} ]
},
"contact": [ {
"name": "HL7 International - Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"
}