R4 Draft for Comment
MedicationsThis page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Ballot Status: Informative | Compartments: Not linked to any defined compartments |
StructureDefinition for medicinalproduct
{
"resourceType": "StructureDefinition",
"id": "MedicinalProduct",
"meta": {
"lastUpdated": "2017-12-20T15:52:34.818+11:00"
},
"text": {
"status": "generated",
"div": "<div>!-- Snipped for Brevity --></div>"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 0
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
}
],
"url": "http://hl7.org/fhir/StructureDefinition/MedicinalProduct",
"name": "MedicinalProduct",
"status": "draft",
"date": "2017-12-20T15:52:34+11:00",
"publisher": "Health Level Seven International (Biomedical Research and Regulation)",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "http://hl7.org/fhir"
}
]
},
{
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim/index.cfm"
}
]
}
],
"description": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).",
"fhirVersion": "3.2.0",
"mapping": [
{
"identity": "w5",
"uri": "http://hl7.org/fhir/w5",
"name": "W5 Mapping"
},
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "MedicinalProduct",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation": "specialization",
"snapshot": {
"element": [
{
"id": "MedicinalProduct",
"path": "MedicinalProduct",
"short": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)",
"definition": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).",
"min": 0,
"max": "*",
"constraint": [
{
"key": "dom-2",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression": "contained.contained.empty()",
"xpath": "not(parent::f:contained and f:contained)",
"source": "DomainResource"
},
{
"key": "dom-1",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain any narrative",
"expression": "contained.text.empty()",
"xpath": "not(parent::f:contained and f:text)",
"source": "DomainResource"
},
{
"key": "dom-4",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source": "DomainResource"
},
{
"key": "dom-3",
"severity": "error",
"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",
"expression": "contained.all(('#'+id in %resource.descendants().reference) or descendants().where(reference = '#').exists())",
"xpath": "not(exists(for $contained in f:contained return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::reference[@value='#'])]))",
"source": "DomainResource"
}
],
"mapping": [
{
"identity": "rim",
"map": "Entity. Role, or Act"
},
{
"identity": "w5",
"map": "clinical.medication"
}
]
},
{
"id": "MedicinalProduct.id",
"path": "MedicinalProduct.id",
"short": "Logical id of this artifact",
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "id"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.meta",
"path": "MedicinalProduct.meta",
"short": "Metadata about the resource",
"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.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.meta",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Meta"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.implicitRules",
"path": "MedicinalProduct.implicitRules",
"short": "A set of rules under which this content was created",
"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.",
"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. \n\nThis element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.implicitRules",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"isModifier": true,
"isSummary": true
},
{
"id": "MedicinalProduct.language",
"path": "MedicinalProduct.language",
"short": "Language of the resource content",
"definition": "The base language in which the resource is written.",
"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).",
"min": 0,
"max": "1",
"base": {
"path": "Resource.language",
"min": 0,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueReference": {
"reference": "http://hl7.org/fhir/ValueSet/all-languages"
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
}
],
"strength": "extensible",
"description": "A human language.",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/languages"
}
}
},
{
"id": "MedicinalProduct.text",
"path": "MedicinalProduct.text",
"short": "Text summary of the resource, for human interpretation",
"definition": "A human-readable narrative that contains a summary of the resource, and may 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.",
"comment": "Contained resources do not have 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 in formation is added later.",
"alias": [
"narrative",
"html",
"xhtml",
"display"
],
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Narrative"
}
],
"condition": [
"dom-1"
],
"mapping": [
{
"identity": "rim",
"map": "Act.text?"
}
]
},
{
"id": "MedicinalProduct.contained",
"path": "MedicinalProduct.contained",
"short": "Contained, inline Resources",
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"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.",
"alias": [
"inline resources",
"anonymous resources",
"contained resources"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.contained",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Resource"
}
],
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProduct.extension",
"path": "MedicinalProduct.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProduct.modifierExtension",
"path": "MedicinalProduct.modifierExtension",
"short": "Extensions that cannot be ignored",
"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. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProduct.identifier",
"path": "MedicinalProduct.identifier",
"short": "Business idenfifier for this product. Could be an MPID",
"definition": "Business idenfifier for this product. Could be an MPID.",
"alias": [
"MPID"
],
"min": 1,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.type",
"path": "MedicinalProduct.type",
"short": "Regulatory type, e.g Investigational or Authorized",
"definition": "Regulatory type, e.g Investigational or Authorized.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.combinedPharmaceuticalDoseForm",
"path": "MedicinalProduct.combinedPharmaceuticalDoseForm",
"short": "The dose form for a single part product, or combined form of a multiple part product",
"definition": "The dose form for a single part product, or combined form of a multiple part product.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.additionalMonitoringIndicator",
"path": "MedicinalProduct.additionalMonitoringIndicator",
"short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons",
"definition": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.specialMeasures",
"path": "MedicinalProduct.specialMeasures",
"short": "Whether the Medicinal Product is subject to special measures for regulatory reasons",
"definition": "Whether the Medicinal Product is subject to special measures for regulatory reasons.",
"min": 0,
"max": "*",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.paediatricUseIndicator",
"path": "MedicinalProduct.paediatricUseIndicator",
"short": "If authorised for use in children",
"definition": "If authorised for use in children.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.orphanDesignationStatus",
"path": "MedicinalProduct.orphanDesignationStatus",
"short": "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease",
"definition": "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.productClassification",
"path": "MedicinalProduct.productClassification",
"short": "Allows the product to be classified by various systems",
"definition": "Allows the product to be classified by various systems.",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.marketingAuthorization",
"path": "MedicinalProduct.marketingAuthorization",
"short": "Product regulatory authorization",
"definition": "Product regulatory authorization.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicinalProductAuthorization"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.packagedMedicinalProduct",
"path": "MedicinalProduct.packagedMedicinalProduct",
"short": "Package representation for the product",
"definition": "Package representation for the product.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.pharmaceuticalProduct",
"path": "MedicinalProduct.pharmaceuticalProduct",
"short": "Pharmaceutical aspects of product",
"definition": "Pharmaceutical aspects of product.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.clinicalParticulars",
"path": "MedicinalProduct.clinicalParticulars",
"short": "Clinical particulars, indications etc",
"definition": "Clinical particulars, indications etc.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicinalProductClinicals"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.attachedDocument",
"path": "MedicinalProduct.attachedDocument",
"short": "Supporting documentation, typically for regulatory submission",
"definition": "Supporting documentation, typically for regulatory submission.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/DocumentReference"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.masterFile",
"path": "MedicinalProduct.masterFile",
"short": "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)",
"definition": "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/DocumentReference"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name",
"path": "MedicinalProduct.name",
"short": "The product's name, including full name and possibly coded parts",
"definition": "The product's name, including full name and possibly coded parts.",
"min": 1,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.id",
"path": "MedicinalProduct.name.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProduct.name.extension",
"path": "MedicinalProduct.name.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProduct.name.modifierExtension",
"path": "MedicinalProduct.name.modifierExtension",
"short": "Extensions that cannot be ignored",
"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 that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProduct.name.fullName",
"path": "MedicinalProduct.name.fullName",
"short": "The full product name",
"definition": "The full product name.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.namePart",
"path": "MedicinalProduct.name.namePart",
"short": "Coding words or phrases of the name",
"definition": "Coding words or phrases of the name.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.namePart.id",
"path": "MedicinalProduct.name.namePart.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProduct.name.namePart.extension",
"path": "MedicinalProduct.name.namePart.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProduct.name.namePart.modifierExtension",
"path": "MedicinalProduct.name.namePart.modifierExtension",
"short": "Extensions that cannot be ignored",
"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 that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProduct.name.namePart.part",
"path": "MedicinalProduct.name.namePart.part",
"short": "A fragment of a product name",
"definition": "A fragment of a product name.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.namePart.type",
"path": "MedicinalProduct.name.namePart.type",
"short": "Idenifying type for this part of the name (e.g. strength part)",
"definition": "Idenifying type for this part of the name (e.g. strength part).",
"min": 1,
"max": "1",
"type": [
{
"code": "Coding"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.countryLanguage",
"path": "MedicinalProduct.name.countryLanguage",
"short": "Country where the name applies",
"definition": "Country where the name applies.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.countryLanguage.id",
"path": "MedicinalProduct.name.countryLanguage.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProduct.name.countryLanguage.extension",
"path": "MedicinalProduct.name.countryLanguage.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProduct.name.countryLanguage.modifierExtension",
"path": "MedicinalProduct.name.countryLanguage.modifierExtension",
"short": "Extensions that cannot be ignored",
"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 that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProduct.name.countryLanguage.country",
"path": "MedicinalProduct.name.countryLanguage.country",
"short": "Country code for where this name applies",
"definition": "Country code for where this name applies.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.countryLanguage.jurisdiction",
"path": "MedicinalProduct.name.countryLanguage.jurisdiction",
"short": "Jurisdiction code for where this name applies",
"definition": "Jurisdiction code for where this name applies.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.countryLanguage.language",
"path": "MedicinalProduct.name.countryLanguage.language",
"short": "Language code for this name",
"definition": "Language code for this name.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.crossReference",
"path": "MedicinalProduct.crossReference",
"short": "Reference to another product, e.g. for linking authorised to investigational product",
"definition": "Reference to another product, e.g. for linking authorised to investigational product.",
"min": 0,
"max": "*",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation",
"path": "MedicinalProduct.manufacturingBusinessOperation",
"short": "An operation applied to the product, for manufacturing or adminsitrative purpose",
"definition": "An operation applied to the product, for manufacturing or adminsitrative purpose.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.id",
"path": "MedicinalProduct.manufacturingBusinessOperation.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.extension",
"path": "MedicinalProduct.manufacturingBusinessOperation.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.modifierExtension",
"path": "MedicinalProduct.manufacturingBusinessOperation.modifierExtension",
"short": "Extensions that cannot be ignored",
"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 that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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.",
"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.",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.operationType",
"path": "MedicinalProduct.manufacturingBusinessOperation.operationType",
"short": "The type of manufacturing operation",
"definition": "The type of manufacturing operation.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"path": "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"short": "Regulatory authorization reference number",
"definition": "Regulatory authorization reference number.",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"path": "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"short": "Regulatory authorization date",
"definition": "Regulatory authorization date.",
"min": 0,
"max": "1",
"type": [
{
"code": "dateTime"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"path": "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"short": "To indicate if this proces is commercially confidential",
"definition": "To indicate if this proces is commercially confidential.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"path": "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"short": "The manufacturer or establishment associated with the process",
"definition": "The manufacturer or establishment associated with the process.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.regulator",
"path": "MedicinalProduct.manufacturingBusinessOperation.regulator",
"short": "A regulator which oversees the operation",
"definition": "A regulator which oversees the operation.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
}
],
"isSummary": true
}
]
},
"differential": {
"element": [
{
"id": "MedicinalProduct",
"path": "MedicinalProduct",
"short": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)",
"definition": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).",
"min": 0,
"max": "*",
"mapping": [
{
"identity": "w5",
"map": "clinical.medication"
}
]
},
{
"id": "MedicinalProduct.identifier",
"path": "MedicinalProduct.identifier",
"short": "Business idenfifier for this product. Could be an MPID",
"definition": "Business idenfifier for this product. Could be an MPID.",
"alias": [
"MPID"
],
"min": 1,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.type",
"path": "MedicinalProduct.type",
"short": "Regulatory type, e.g Investigational or Authorized",
"definition": "Regulatory type, e.g Investigational or Authorized.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.combinedPharmaceuticalDoseForm",
"path": "MedicinalProduct.combinedPharmaceuticalDoseForm",
"short": "The dose form for a single part product, or combined form of a multiple part product",
"definition": "The dose form for a single part product, or combined form of a multiple part product.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.additionalMonitoringIndicator",
"path": "MedicinalProduct.additionalMonitoringIndicator",
"short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons",
"definition": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.specialMeasures",
"path": "MedicinalProduct.specialMeasures",
"short": "Whether the Medicinal Product is subject to special measures for regulatory reasons",
"definition": "Whether the Medicinal Product is subject to special measures for regulatory reasons.",
"min": 0,
"max": "*",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.paediatricUseIndicator",
"path": "MedicinalProduct.paediatricUseIndicator",
"short": "If authorised for use in children",
"definition": "If authorised for use in children.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.orphanDesignationStatus",
"path": "MedicinalProduct.orphanDesignationStatus",
"short": "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease",
"definition": "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.productClassification",
"path": "MedicinalProduct.productClassification",
"short": "Allows the product to be classified by various systems",
"definition": "Allows the product to be classified by various systems.",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.marketingAuthorization",
"path": "MedicinalProduct.marketingAuthorization",
"short": "Product regulatory authorization",
"definition": "Product regulatory authorization.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicinalProductAuthorization"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.packagedMedicinalProduct",
"path": "MedicinalProduct.packagedMedicinalProduct",
"short": "Package representation for the product",
"definition": "Package representation for the product.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.pharmaceuticalProduct",
"path": "MedicinalProduct.pharmaceuticalProduct",
"short": "Pharmaceutical aspects of product",
"definition": "Pharmaceutical aspects of product.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.clinicalParticulars",
"path": "MedicinalProduct.clinicalParticulars",
"short": "Clinical particulars, indications etc",
"definition": "Clinical particulars, indications etc.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicinalProductClinicals"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.attachedDocument",
"path": "MedicinalProduct.attachedDocument",
"short": "Supporting documentation, typically for regulatory submission",
"definition": "Supporting documentation, typically for regulatory submission.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/DocumentReference"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.masterFile",
"path": "MedicinalProduct.masterFile",
"short": "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)",
"definition": "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/DocumentReference"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name",
"path": "MedicinalProduct.name",
"short": "The product's name, including full name and possibly coded parts",
"definition": "The product's name, including full name and possibly coded parts.",
"min": 1,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.fullName",
"path": "MedicinalProduct.name.fullName",
"short": "The full product name",
"definition": "The full product name.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.namePart",
"path": "MedicinalProduct.name.namePart",
"short": "Coding words or phrases of the name",
"definition": "Coding words or phrases of the name.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.namePart.part",
"path": "MedicinalProduct.name.namePart.part",
"short": "A fragment of a product name",
"definition": "A fragment of a product name.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.namePart.type",
"path": "MedicinalProduct.name.namePart.type",
"short": "Idenifying type for this part of the name (e.g. strength part)",
"definition": "Idenifying type for this part of the name (e.g. strength part).",
"min": 1,
"max": "1",
"type": [
{
"code": "Coding"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.countryLanguage",
"path": "MedicinalProduct.name.countryLanguage",
"short": "Country where the name applies",
"definition": "Country where the name applies.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.countryLanguage.country",
"path": "MedicinalProduct.name.countryLanguage.country",
"short": "Country code for where this name applies",
"definition": "Country code for where this name applies.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.countryLanguage.jurisdiction",
"path": "MedicinalProduct.name.countryLanguage.jurisdiction",
"short": "Jurisdiction code for where this name applies",
"definition": "Jurisdiction code for where this name applies.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.name.countryLanguage.language",
"path": "MedicinalProduct.name.countryLanguage.language",
"short": "Language code for this name",
"definition": "Language code for this name.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.crossReference",
"path": "MedicinalProduct.crossReference",
"short": "Reference to another product, e.g. for linking authorised to investigational product",
"definition": "Reference to another product, e.g. for linking authorised to investigational product.",
"min": 0,
"max": "*",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation",
"path": "MedicinalProduct.manufacturingBusinessOperation",
"short": "An operation applied to the product, for manufacturing or adminsitrative purpose",
"definition": "An operation applied to the product, for manufacturing or adminsitrative purpose.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.operationType",
"path": "MedicinalProduct.manufacturingBusinessOperation.operationType",
"short": "The type of manufacturing operation",
"definition": "The type of manufacturing operation.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"path": "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"short": "Regulatory authorization reference number",
"definition": "Regulatory authorization reference number.",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"path": "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"short": "Regulatory authorization date",
"definition": "Regulatory authorization date.",
"min": 0,
"max": "1",
"type": [
{
"code": "dateTime"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"path": "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"short": "To indicate if this proces is commercially confidential",
"definition": "To indicate if this proces is commercially confidential.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"path": "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"short": "The manufacturer or establishment associated with the process",
"definition": "The manufacturer or establishment associated with the process.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
}
],
"isSummary": true
},
{
"id": "MedicinalProduct.manufacturingBusinessOperation.regulator",
"path": "MedicinalProduct.manufacturingBusinessOperation.regulator",
"short": "A regulator which oversees the operation",
"definition": "A regulator which oversees the operation.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
}
],
"isSummary": true
}
]
}
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
®© HL7.org 2011+. FHIR Release 4 Draft for Comment (Jan-2018 v3.2.0-12885) generated on Wed, Dec 20, 2017 15:57+1100. QA Page
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