Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Resource Profile: MedicinalProductDefinition - Drug Product

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq Version: 1.0.0-ballot
Active as of 2024-02-21 Computable Name: MedicinalProductDefinitionDrugProductPq

Section 1.1 - Drug Product Identification

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product
... identifier S0..*IdentifierBusiness identifier for this product. Could be an MPID
... combinedPharmaceuticalDoseForm S0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.

... route 0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.

... characteristic 0..*BackboneElementKey product features such as "sugar free", "modified release"
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... substance-property-range S0..1Rangesubstance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... type 1..1CodeableConceptA code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] 0..1CodeableConcept, markdown, Quantity, integer, date, boolean, AttachmentA value for the characteristic
Slice: Unordered, Closed by type:$this
..... value[x]:valueQuantity 0..1QuantityA value for the characteristic
...... system 0..1uriSystem that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code 0..1codeCoded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit


doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.combinedPharmaceuticalDoseFormpreferredMedicineDoseFormEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-route-of-administration
from this IG
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicinalproduct-characteristic-type
from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... status ?!Σ0..1CodeableConceptThe status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... combinedPharmaceuticalDoseForm SΣ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.

... route Σ0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.


... name SΣ1..*BackboneElementThe product's name, including full name and possibly coded parts
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... productName Σ1..1stringThe full product name
... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... substance-property-range S0..1Rangesubstance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] Σ0..1A value for the characteristic
Slice: Unordered, Open by type:$this
..... valueCodeableConceptCodeableConcept
..... valueMarkdownmarkdown
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
..... value[x]:valueQuantity Σ0..1QuantityA value for the characteristic
...... comparator ?!Σ0..1code< | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... system ΣC0..1uriSystem that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC0..1codeCoded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormpreferredMedicineDoseFormEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-route-of-administration
from this IG
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicinalproduct-characteristic-type
from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: 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()
dom-4errorMedicinalProductDefinitionIf 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()
dom-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguagesStarter Set
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..*IdentifierBusiness identifier for this product. Could be an MPID
... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.

... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... version Σ0..1stringA business identifier relating to a specific version of the product
... status ?!Σ0..1CodeableConceptThe status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ0..1dateTimeThe date at which the given status became applicable
... description Σ0..1markdownGeneral description of this product
... combinedPharmaceuticalDoseForm SΣ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.

... route Σ0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.


... indication Σ0..1markdownDescription of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ0..1CodeableConceptIf authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.

... classification Σ0..*CodeableConceptAllows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


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


... 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: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... attachedDocument Σ0..*Reference(DocumentReference)Additional documentation about the medicinal product
... masterFile Σ0..*Reference(DocumentReference)A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ0..*BackboneElementA product specific contact, person (in a role), or an organization
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableConceptAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

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


... name SΣ1..*BackboneElementThe product's name, including full name and possibly coded parts
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... productName Σ1..1stringThe full product name
.... type Σ0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.

.... part Σ0..*BackboneElementCoding words or phrases of the name
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... part Σ1..1stringA fragment of a product name
..... type Σ1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

.... usage Σ0..*BackboneElementCountry and jurisdiction where the name applies
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... country Σ1..1CodeableConceptCountry code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... language Σ1..1CodeableConceptLanguage code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguagesStarter Set
... crossReference Σ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... product Σ1..1CodeableReference(MedicinalProductDefinition)Reference to another product, e.g. for linking authorised to investigational product
.... type Σ0..1CodeableConceptThe type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

... operation Σ0..*BackboneElementA manufacturing or administrative process for the medicinal product
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableReference(ActivityDefinition | PlanDefinition)The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ0..1PeriodDate range of applicability
.... organization Σ0..*Reference(Organization)The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... substance-property-range S0..1Rangesubstance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] Σ0..1A value for the characteristic
Slice: Unordered, Open by type:$this
..... valueCodeableConceptCodeableConcept
..... valueMarkdownmarkdown
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
..... value[x]:valueQuantity Σ0..1QuantityA value for the characteristic
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ0..1decimalNumerical value (with implicit precision)
...... comparator ?!Σ0..1code< | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ0..1stringUnit representation
...... system ΣC0..1uriSystem that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC0..1codeCoded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormpreferredMedicineDoseFormEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-route-of-administration
from this IG
MedicinalProductDefinition.legalStatusOfSupplyexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.typeexampleProductCrossReferenceType
http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicatorexampleProductConfidentiality
http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
from the FHIR Standard
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicinalproduct-characteristic-type
from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: 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()
dom-4errorMedicinalProductDefinitionIf 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()
dom-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from MedicinalProductDefinition

Summary

Must-Support: 4 elements

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element MedicinalProductDefinition.characteristic.value[x] is sliced based on the value of type:$this (Closed)

Differential View

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product
... identifier S0..*IdentifierBusiness identifier for this product. Could be an MPID
... combinedPharmaceuticalDoseForm S0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.

... route 0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.

... characteristic 0..*BackboneElementKey product features such as "sugar free", "modified release"
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... substance-property-range S0..1Rangesubstance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... type 1..1CodeableConceptA code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] 0..1CodeableConcept, markdown, Quantity, integer, date, boolean, AttachmentA value for the characteristic
Slice: Unordered, Closed by type:$this
..... value[x]:valueQuantity 0..1QuantityA value for the characteristic
...... system 0..1uriSystem that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code 0..1codeCoded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit


doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.combinedPharmaceuticalDoseFormpreferredMedicineDoseFormEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-route-of-administration
from this IG
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicinalproduct-characteristic-type
from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... status ?!Σ0..1CodeableConceptThe status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... combinedPharmaceuticalDoseForm SΣ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.

... route Σ0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.


... name SΣ1..*BackboneElementThe product's name, including full name and possibly coded parts
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... productName Σ1..1stringThe full product name
... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... substance-property-range S0..1Rangesubstance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] Σ0..1A value for the characteristic
Slice: Unordered, Open by type:$this
..... valueCodeableConceptCodeableConcept
..... valueMarkdownmarkdown
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
..... value[x]:valueQuantity Σ0..1QuantityA value for the characteristic
...... comparator ?!Σ0..1code< | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... system ΣC0..1uriSystem that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC0..1codeCoded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormpreferredMedicineDoseFormEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-route-of-administration
from this IG
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicinalproduct-characteristic-type
from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: 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()
dom-4errorMedicinalProductDefinitionIf 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()
dom-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguagesStarter Set
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..*IdentifierBusiness identifier for this product. Could be an MPID
... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.

... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... version Σ0..1stringA business identifier relating to a specific version of the product
... status ?!Σ0..1CodeableConceptThe status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ0..1dateTimeThe date at which the given status became applicable
... description Σ0..1markdownGeneral description of this product
... combinedPharmaceuticalDoseForm SΣ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.

... route Σ0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.


... indication Σ0..1markdownDescription of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ0..1CodeableConceptIf authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.

... classification Σ0..*CodeableConceptAllows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


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


... 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: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... attachedDocument Σ0..*Reference(DocumentReference)Additional documentation about the medicinal product
... masterFile Σ0..*Reference(DocumentReference)A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ0..*BackboneElementA product specific contact, person (in a role), or an organization
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableConceptAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

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


... name SΣ1..*BackboneElementThe product's name, including full name and possibly coded parts
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... productName Σ1..1stringThe full product name
.... type Σ0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.

.... part Σ0..*BackboneElementCoding words or phrases of the name
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... part Σ1..1stringA fragment of a product name
..... type Σ1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

.... usage Σ0..*BackboneElementCountry and jurisdiction where the name applies
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... country Σ1..1CodeableConceptCountry code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... language Σ1..1CodeableConceptLanguage code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguagesStarter Set
... crossReference Σ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... product Σ1..1CodeableReference(MedicinalProductDefinition)Reference to another product, e.g. for linking authorised to investigational product
.... type Σ0..1CodeableConceptThe type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

... operation Σ0..*BackboneElementA manufacturing or administrative process for the medicinal product
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableReference(ActivityDefinition | PlanDefinition)The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ0..1PeriodDate range of applicability
.... organization Σ0..*Reference(Organization)The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... substance-property-range S0..1Rangesubstance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] Σ0..1A value for the characteristic
Slice: Unordered, Open by type:$this
..... valueCodeableConceptCodeableConcept
..... valueMarkdownmarkdown
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
..... value[x]:valueQuantity Σ0..1QuantityA value for the characteristic
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ0..1decimalNumerical value (with implicit precision)
...... comparator ?!Σ0..1code< | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ0..1stringUnit representation
...... system ΣC0..1uriSystem that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC0..1codeCoded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormpreferredMedicineDoseFormEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicine-route-of-administration
from this IG
MedicinalProductDefinition.legalStatusOfSupplyexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.typeexampleProductCrossReferenceType
http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicatorexampleProductConfidentiality
http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
from the FHIR Standard
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/medicinalproduct-characteristic-type
from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: 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()
dom-4errorMedicinalProductDefinitionIf 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()
dom-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from MedicinalProductDefinition

Summary

Must-Support: 4 elements

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element MedicinalProductDefinition.characteristic.value[x] is sliced based on the value of type:$this (Closed)

 

Other representations of profile: CSV, Excel, Schematron