Generated Narrative: StructureDefinition profile-MedicinalProductDefinition Name Flags Card. Type Description & Constraints Basic 0..* Basic Resource for non-supported content #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:type 0..1 CodeableConcept R5: Regulatory type, e.g. Investigational or Authorized (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.type Binding: R5MedicinalProductTypeForR3 (0.1.0) (example): Overall defining type of this medicinal product. #xD; extension:domain 0..1 CodeableConcept R5: If this medicine applies to human or veterinary uses (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.domain Binding: R5MedicinalProductDomainForR3 (0.1.0) (example): Applicable domain for this product (e.g. human, veterinary). #xD; extension:version 0..1 string R5: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version #xD; extension:statusDate 0..1 dateTime R5: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate #xD; extension:description 0..1 markdown R5: General description of this product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description #xD; extension:combinedPharmaceuticalDoseForm 0..1 CodeableConcept R5: The dose form for a single part product, or combined form of a multiple part product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.combinedPharmaceuticalDoseForm Binding: R5CombinedDoseFormForR3 (0.1.0) (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing #xD; extension:route 0..* CodeableConcept R5: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route #xD; extension:indication 0..1 markdown R5: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication #xD; extension:legalStatusOfSupply 0..1 CodeableConcept R5: The legal status of supply of the medicinal product as classified by the regulator (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.legalStatusOfSupply Binding: R5LegalStatusOfSupplyForR3 (0.1.0) (example): The prescription supply types appropriate to a medicinal product #xD; extension:additionalMonitoringIndicator 0..1 CodeableConcept R5: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.additionalMonitoringIndicator Binding: R5MedicinalProductAdditionalMonitoringForR3 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). #xD; extension:specialMeasures 0..* CodeableConcept R5: Whether the Medicinal Product is subject to special measures for regulatory reasons (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures Binding: R5MedicinalProductSpecialMeasuresForR3 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. #xD; extension:pediatricUseIndicator 0..1 CodeableConcept R5: If authorised for use in children (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R5MedicinalProductPediatricUseForR3 (0.1.0) (example): Suitability for age groups, in particular children. #xD; extension:classification 0..* CodeableConcept R5: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification #xD; extension:marketingStatus 0..* (Complex) R5: Marketing status of the medicinal product, in contrast to marketing authorization (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.marketingStatus #xD; extension:packagedMedicinalProduct 0..* CodeableConcept R5: Package type for the product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct Binding: R5MedicinalProductPackageTypeForR3 (0.1.0) (example): Types of medicinal product packs #xD; extension:comprisedOf 0..* Reference(Cross-version Profile for R5.ManufacturedItemDefinition for use in FHIR STU3(0.1.0) | Basic | Cross-version Profile for R5.DeviceDefinition for use in FHIR STU3(0.1.0) | Basic) R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf #xD; extension:ingredient 0..* CodeableConcept R5: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient #xD; extension:impurity 0..* (Complex) R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity #xD; extension:attachedDocument 0..* Reference(Cross-version Profile for R5.DocumentReference for use in FHIR STU3(0.1.0) | Media) R5: Additional documentation about the medicinal product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.attachedDocument #xD; extension:masterFile 0..* Reference(Cross-version Profile for R5.DocumentReference for use in FHIR STU3(0.1.0) | Media) R5: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.masterFile #xD; extension:contact 0..* (Complex) R5: A product specific contact, person (in a role), or an organization (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact #xD; extension:clinicalTrial 0..* Reference(Cross-version Profile for R5.ResearchStudy for use in FHIR STU3(0.1.0) | ResearchStudy) R5: Clinical trials or studies that this product is involved in (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.clinicalTrial #xD; extension:code 0..* Coding R5: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code #xD; extension:name 1..* (Complex) R5: The product's name, including full name and possibly coded parts (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name #xD; extension:crossReference 0..* (Complex) R5: Reference to another product, e.g. for linking authorised to investigational product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference #xD; extension:operation 0..* (Complex) R5: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation #xD; extension:characteristic 0..* (Complex) R5: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic #xD; Slices for modifierExtension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; modifierExtension:status 0..1 CodeableConcept R5: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. #xD; Documentation for this format
Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR STU3
This cross-version profile allows R5 MedicinalProductDefinition content to be represented via FHIR STU3 Basic resources.
Basic is used for handling concepts not yet defined in FHIR, narrative-only resources that don't map to an existing resource, and custom resources not appropriate for inclusion in the FHIR specification.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
If the resource is contained in another resource, it SHALL NOT contain any narrative
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
contained.where(('#'+id in %resource.descendants().reference).not()).empty()
not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.
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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
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.
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.
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.
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.
R5: Regulatory type, e.g. Investigational or Authorized (new)
R5: `MedicinalProductDefinition.type` (new:CodeableConcept)
Element `MedicinalProductDefinition.type` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.type` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
All FHIR elements must have a @value or children
hasValue() | (children().count() > id.count())
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
R5: If this medicine applies to human or veterinary uses (new)
R5: `MedicinalProductDefinition.domain` (new:CodeableConcept)
Element `MedicinalProductDefinition.domain` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.domain` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: A business identifier relating to a specific version of the product (new)
R5: `MedicinalProductDefinition.version` (new:string)
Element `MedicinalProductDefinition.version` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.version` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: The date at which the given status became applicable (new)
R5: `MedicinalProductDefinition.statusDate` (new:dateTime)
Element `MedicinalProductDefinition.statusDate` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.statusDate` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: General description of this product (new)
R5: `MedicinalProductDefinition.description` (new:markdown)
Element `MedicinalProductDefinition.description` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.description` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: The dose form for a single part product, or combined form of a multiple part product (new)
R5: `MedicinalProductDefinition.combinedPharmaceuticalDoseForm` (new:CodeableConcept)
Element `MedicinalProductDefinition.combinedPharmaceuticalDoseForm` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.combinedPharmaceuticalDoseForm` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: The path by which the product is taken into or makes contact with the body (new)
R5: `MedicinalProductDefinition.route` (new:CodeableConcept)
Element `MedicinalProductDefinition.route` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.route` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Description of indication(s) for this product, used when structured indications are not required (new)
R5: `MedicinalProductDefinition.indication` (new:markdown)
Element `MedicinalProductDefinition.indication` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.indication` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: The legal status of supply of the medicinal product as classified by the regulator (new)
R5: `MedicinalProductDefinition.legalStatusOfSupply` (new:CodeableConcept)
Element `MedicinalProductDefinition.legalStatusOfSupply` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.legalStatusOfSupply` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons (new)
R5: `MedicinalProductDefinition.additionalMonitoringIndicator` (new:CodeableConcept)
Element `MedicinalProductDefinition.additionalMonitoringIndicator` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.additionalMonitoringIndicator` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Whether the Medicinal Product is subject to special measures for regulatory reasons (new)
R5: `MedicinalProductDefinition.specialMeasures` (new:CodeableConcept)
Element `MedicinalProductDefinition.specialMeasures` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.specialMeasures` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: If authorised for use in children (new)
R5: `MedicinalProductDefinition.pediatricUseIndicator` (new:CodeableConcept)
Element `MedicinalProductDefinition.pediatricUseIndicator` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.pediatricUseIndicator` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Allows the product to be classified by various systems (new)
R5: `MedicinalProductDefinition.classification` (new:CodeableConcept)
Element `MedicinalProductDefinition.classification` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.classification` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Marketing status of the medicinal product, in contrast to marketing authorization (new)
R5: `MedicinalProductDefinition.marketingStatus` (new:MarketingStatus)
Element `MedicinalProductDefinition.marketingStatus` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.marketingStatus` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: `MedicinalProductDefinition.packagedMedicinalProduct` (new:CodeableConcept)
Element `MedicinalProductDefinition.packagedMedicinalProduct` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.packagedMedicinalProduct` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new)
R5: `MedicinalProductDefinition.comprisedOf` (new:Reference(ManufacturedItemDefinition,DeviceDefinition))
Element `MedicinalProductDefinition.comprisedOf` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.comprisedOf` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: The ingredients of this medicinal product - when not detailed in other resources (new)
R5: `MedicinalProductDefinition.ingredient` (new:CodeableConcept)
Element `MedicinalProductDefinition.ingredient` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.ingredient` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new)
R5: `MedicinalProductDefinition.impurity` (new:CodeableReference(SubstanceDefinition))
Element `MedicinalProductDefinition.impurity` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.impurity` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Additional documentation about the medicinal product (new)
R5: `MedicinalProductDefinition.attachedDocument` (new:Reference(DocumentReference))
Element `MedicinalProductDefinition.attachedDocument` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.attachedDocument` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) (new)
R5: `MedicinalProductDefinition.masterFile` (new:Reference(DocumentReference))
Element `MedicinalProductDefinition.masterFile` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.masterFile` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: A product specific contact, person (in a role), or an organization (new)
R5: `MedicinalProductDefinition.contact` (new:BackboneElement)
Element `MedicinalProductDefinition.contact` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.contact` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Clinical trials or studies that this product is involved in (new)
R5: `MedicinalProductDefinition.clinicalTrial` (new:Reference(ResearchStudy))
Element `MedicinalProductDefinition.clinicalTrial` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.clinicalTrial` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: A code that this product is known by, within some formal terminology (new)
R5: `MedicinalProductDefinition.code` (new:Coding)
Element `MedicinalProductDefinition.code` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.code` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: The product's name, including full name and possibly coded parts (new)
R5: `MedicinalProductDefinition.name` (new:BackboneElement)
Element `MedicinalProductDefinition.name` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.name` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Reference to another product, e.g. for linking authorised to investigational product (new)
R5: `MedicinalProductDefinition.crossReference` (new:BackboneElement)
Element `MedicinalProductDefinition.crossReference` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.crossReference` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: A manufacturing or administrative process for the medicinal product (new)
R5: `MedicinalProductDefinition.operation` (new:BackboneElement)
Element `MedicinalProductDefinition.operation` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.operation` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Key product features such as "sugar free", "modified release" (new)
R5: `MedicinalProductDefinition.characteristic` (new:BackboneElement)
Element `MedicinalProductDefinition.characteristic` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.characteristic` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: The status within the lifecycle of this product record (new)
R5: `MedicinalProductDefinition.status` (new:CodeableConcept)
Element `MedicinalProductDefinition.status` is not mapped to FHIR STU3, since FHIR R5 `MedicinalProductDefinition` is not mapped. Element `MedicinalProductDefinition.status` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
Identifier assigned to the resource for business purposes, outside the context of FHIR.
Identifies the 'type' of resource - equivalent to the resource name for other resources.
Because resource references will only be able to indicate 'Basic', the type of reference will need to be specified in a Profile identified as part of the resource. Refer to the resource notes section for information on appropriate terminologies for this code. This element is labeled as a modifier because the it defines the meaning of the resource and cannot be ignored.
Must be able to distinguish different types of Basic resources.
Codes for identifying types of resources not yet defined by FHIR
Identifies the patient, practitioner, device or any other resource that is the "focus" of this resource.
Optional as not all potential resources will have subjects. Resources associated with multiple subjects can handle this via extension.
Needed for partitioning the resource by Patient.
./participation[typeCode='SBJ'] (possibly through a ControlAct and Role)
Identifies when the resource was first created.
Allows ordering resource instances by time.
./participation[typeCode='AUT']/time (possibly through a ControlAct and Role)
Indicates who was responsible for creating the resource instance.
./participation[typeCode='SUB'] (possibly through a ControlAct and Role)