Union of http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq and http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq

This is the set of resources that conform to either of the profiles MedicinalProductDefinition - Drug Product PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq) and MedicinalProductDefinition - Drug Product PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq). E.g. what you have to deal with if you get resources conforming to one of them

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*Detailed definition of a medicinal product
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: 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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... meta Σ0..1MetaMetadata about the resource
ele-1: All FHIR elements must have a @value or children
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... language 0..1codeLanguage of the resource content
Binding: ?? (required): IETF language tag for a human language


ele-1: All FHIR elements must have a @value or children
... text 0..1NarrativeText summary of the resource, for human interpretation
ele-1: All FHIR elements must have a @value or children
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... identifier SΣ0..*IdentifierBusiness identifier for this product. Could be an MPID
ele-1: All FHIR elements must have a @value or children
... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
Binding: ?? (example): Overall defining type of this medicinal product.


ele-1: All FHIR elements must have a @value or children
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).


ele-1: All FHIR elements must have a @value or children
... version Σ0..1stringA business identifier relating to a specific version of the product
ele-1: All FHIR elements must have a @value or children
... status ?!Σ0..1CodeableConceptThe status within the lifecycle of this product record
Binding: ?? (preferred): The lifecycle status of an artifact.


ele-1: All FHIR elements must have a @value or children
... statusDate Σ0..1dateTimeThe date at which the given status became applicable
ele-1: All FHIR elements must have a @value or children
... description Σ0..1markdownGeneral description of this product
ele-1: All FHIR elements must have a @value or children
... combinedPharmaceuticalDoseForm SΣ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
Binding: ?? (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.


ele-1: All FHIR elements must have a @value or children
... route Σ0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
Binding: ?? (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.


ele-1: All FHIR elements must have a @value or children
... indication Σ0..1markdownDescription of indication(s) for this product, used when structured indications are not required
ele-1: All FHIR elements must have a @value or children
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
Binding: ?? (example): The prescription supply types appropriate to a medicinal product


ele-1: All FHIR elements must have a @value or children
... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).


ele-1: All FHIR elements must have a @value or children
... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
Binding: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


ele-1: All FHIR elements must have a @value or children
... pediatricUseIndicator Σ0..1CodeableConceptIf authorised for use in children
Binding: ?? (example): Suitability for age groups, in particular children.


ele-1: All FHIR elements must have a @value or children
... classification Σ0..*CodeableConceptAllows the product to be classified by various systems
Binding: ?? (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization
ele-1: All FHIR elements must have a @value or children
... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for the product
Binding: ?? (example): Types of medicinal product packs


ele-1: All FHIR elements must have a @value or children
... comprisedOf Σ0..*Reference(ManufacturedItemDefinition | DeviceDefinition)Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ele-1: All FHIR elements must have a @value or children
... ingredient Σ0..*CodeableConceptThe ingredients of this medicinal product - when not detailed in other resources
Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
... impurity Σ0..*CodeableReference(SubstanceDefinition)Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
... attachedDocument Σ0..*Reference(DocumentReference)Additional documentation about the medicinal product
ele-1: All FHIR elements must have a @value or children
... masterFile Σ0..*Reference(DocumentReference)A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
ele-1: All FHIR elements must have a @value or children
... contact Σ0..*BackboneElementA product specific contact, person (in a role), or an organization
ele-1: All FHIR elements must have a @value or children
.... extension 0..*ExtensionAdditional content defined by implementations
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type Σ0..1CodeableConceptAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.


ele-1: All FHIR elements must have a @value or children
.... contact Σ1..1Reference(Organization | PractitionerRole)A product specific contact, person (in a role), or an organization
ele-1: All FHIR elements must have a @value or children
... clinicalTrial Σ0..*Reference(ResearchStudy)Clinical trials or studies that this product is involved in
ele-1: All FHIR elements must have a @value or children
... code Σ0..*CodingA code that this product is known by, within some formal terminology
Binding: ?? (example): A coded concept that defines the type of a medication.


ele-1: All FHIR elements must have a @value or children
... name SΣ1..*BackboneElementThe product's name, including full name and possibly coded parts
ele-1: All FHIR elements must have a @value or children
.... extension 0..*ExtensionAdditional content defined by implementations
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... productName Σ1..1stringThe full product name
ele-1: All FHIR elements must have a @value or children
.... type SΣ0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ?? (example): Type of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
.... part Σ0..*BackboneElementCoding words or phrases of the name
ele-1: All FHIR elements must have a @value or children
..... extension 0..*ExtensionAdditional content defined by implementations
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... part Σ1..1stringA fragment of a product name
ele-1: All FHIR elements must have a @value or children
..... type Σ1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
Binding: ?? (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
.... usage Σ0..*BackboneElementCountry and jurisdiction where the name applies
ele-1: All FHIR elements must have a @value or children
..... extension 0..*ExtensionAdditional content defined by implementations
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... country Σ1..1CodeableConceptCountry code for where this name applies
Binding: ?? (example): Jurisdiction codes


ele-1: All FHIR elements must have a @value or children
..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
Binding: ?? (example): Jurisdiction codes


ele-1: All FHIR elements must have a @value or children
..... language Σ1..1CodeableConceptLanguage code for this name
Binding: ?? (required): IETF language tag for a human language


ele-1: All FHIR elements must have a @value or children
... crossReference Σ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product
ele-1: All FHIR elements must have a @value or children
.... extension 0..*ExtensionAdditional content defined by implementations
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... product Σ1..1CodeableReference(MedicinalProductDefinition)Reference to another product, e.g. for linking authorised to investigational product
ele-1: All FHIR elements must have a @value or children
.... type Σ0..1CodeableConceptThe type of relationship, for instance branded to generic or virtual to actual product
Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.


ele-1: All FHIR elements must have a @value or children
... operation Σ0..*BackboneElementA manufacturing or administrative process for the medicinal product
ele-1: All FHIR elements must have a @value or children
.... extension 0..*ExtensionAdditional content defined by implementations
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type Σ0..1CodeableReference(ActivityDefinition | PlanDefinition)The type of manufacturing operation e.g. manufacturing itself, re-packaging
ele-1: All FHIR elements must have a @value or children
.... effectiveDate Σ0..1PeriodDate range of applicability
ele-1: All FHIR elements must have a @value or children
.... organization Σ0..*Reference(Organization)The organization responsible for the particular process, e.g. the manufacturer or importer
ele-1: All FHIR elements must have a @value or children
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this process is considered proprietary or confidential
Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"
ele-1: All FHIR elements must have a @value or children
.... extension 0..*Extensionleft: Additional content defined by implementations; right: Extension
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
Binding: ?? (example): Example codes for MedicinalProduct.characteristic.type


ele-1: All FHIR elements must have a @value or children
.... value[x] Σ0..1A value for the characteristic
ele-1: All FHIR elements must have a @value or children
..... valueCodeableConceptCodeableConcept
..... valueMarkdownmarkdown
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format