Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, 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
Active as of 2024-05-08 Computable Name: MedicinalProductDefinitionDrugProductPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.30

This MedicinalProductDefinition profile represents information that identifies the drug product.

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..* MedicinalProductDefinition Detailed definition of a medicinal product
... identifier S 0..* Identifier Business identifier for this product. Could be an MPID
... combinedPharmaceuticalDoseForm S 0..1 CodeableConcept The 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..* CodeableConcept The 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.

.... type S 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Product Name Type (example)
... characteristic 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..1 Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... type 1..1 CodeableConcept A code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

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

..... value[x]:valueCodeableConcept 0..1 CodeableConcept A value for the characteristic

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.combinedPharmaceuticalDoseFormpreferredMedicineDoseFormEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration
from this IG
MedicinalProductDefinition.name.typeexampleVsProductNameTypePQ (a valid code from Product Name Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq
from this IG
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-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..* MedicinalProductDefinition Detailed definition of a medicinal product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... combinedPharmaceuticalDoseForm SΣ 0..1 CodeableConcept The 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 Σ 0..* CodeableConcept The 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 SΣ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name
.... type SΣ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Product Name Type (example)
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..1 Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] Σ 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
..... value[x]:valueQuantity Σ 0..1 Quantity A value for the characteristic
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... system ΣC 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

..... value[x]:valueCodeableConcept Σ 0..1 CodeableConcept A value for the characteristic

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/vs-medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration
from this IG
MedicinalProductDefinition.name.typeexampleVsProductNameTypePQ (a valid code from Product Name Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq
from this IG
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-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..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..* Identifier Business identifier for this product. Could be an MPID
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.

... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm SΣ 0..1 CodeableConcept The 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 Σ 0..* CodeableConcept The 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 Σ 0..1 markdown Description of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ 0..1 CodeableConcept The 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 Σ 0..1 CodeableConcept Whether 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 Σ 0..* CodeableConcept Whether 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 Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.

... classification Σ 0..* CodeableConcept Allows 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 Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The 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 Σ 0..* 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 Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableConcept Allows 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 Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A 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 SΣ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name
.... type SΣ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Product Name Type (example)
.... part Σ 0..* BackboneElement Coding words or phrases of the name
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... part Σ 1..1 string A fragment of a product name
..... type Σ 1..1 CodeableConcept Identifying 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 Σ 0..* BackboneElement Country and jurisdiction where the name applies
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The 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 Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..1 Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] Σ 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
..... value[x]:valueQuantity Σ 0..1 Quantity A value for the characteristic
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ 0..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ 0..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

..... value[x]:valueCodeableConcept Σ 0..1 CodeableConcept A value for the characteristic

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/vs-medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-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.typeexampleVsProductNameTypePQ (a valid code from Product Name Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq
from this IG
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/vs-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: 5 elements

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.characteristic.value[x] (Closed)

Differential View

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... identifier S 0..* Identifier Business identifier for this product. Could be an MPID
... combinedPharmaceuticalDoseForm S 0..1 CodeableConcept The 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..* CodeableConcept The 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.

.... type S 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Product Name Type (example)
... characteristic 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..1 Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... type 1..1 CodeableConcept A code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

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

..... value[x]:valueCodeableConcept 0..1 CodeableConcept A value for the characteristic

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.combinedPharmaceuticalDoseFormpreferredMedicineDoseFormEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration
from this IG
MedicinalProductDefinition.name.typeexampleVsProductNameTypePQ (a valid code from Product Name Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq
from this IG
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-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..* MedicinalProductDefinition Detailed definition of a medicinal product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... combinedPharmaceuticalDoseForm SΣ 0..1 CodeableConcept The 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 Σ 0..* CodeableConcept The 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 SΣ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name
.... type SΣ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Product Name Type (example)
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..1 Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] Σ 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
..... value[x]:valueQuantity Σ 0..1 Quantity A value for the characteristic
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... system ΣC 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

..... value[x]:valueCodeableConcept Σ 0..1 CodeableConcept A value for the characteristic

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/vs-medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration
from this IG
MedicinalProductDefinition.name.typeexampleVsProductNameTypePQ (a valid code from Product Name Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq
from this IG
MedicinalProductDefinition.characteristic.typeexampleMedicinalProductCharacteristicType
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-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..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..* Identifier Business identifier for this product. Could be an MPID
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.

... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm SΣ 0..1 CodeableConcept The 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 Σ 0..* CodeableConcept The 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 Σ 0..1 markdown Description of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ 0..1 CodeableConcept The 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 Σ 0..1 CodeableConcept Whether 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 Σ 0..* CodeableConcept Whether 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 Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.

... classification Σ 0..* CodeableConcept Allows 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 Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The 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 Σ 0..* 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 Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableConcept Allows 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 Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A 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 SΣ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name
.... type SΣ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Product Name Type (example)
.... part Σ 0..* BackboneElement Coding words or phrases of the name
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... part Σ 1..1 string A fragment of a product name
..... type Σ 1..1 CodeableConcept Identifying 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 Σ 0..* BackboneElement Country and jurisdiction where the name applies
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The 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 Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... substance-property-range S 0..1 Range substance-property-range
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type

.... Slices for value[x] Σ 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
..... value[x]:valueQuantity Σ 0..1 Quantity A value for the characteristic
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ 0..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ 0..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

..... value[x]:valueCodeableConcept Σ 0..1 CodeableConcept A value for the characteristic

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/vs-medicine-doseform
from this IG
MedicinalProductDefinition.routepreferredMedicineRouteOfAdministrationEDQM
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-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.typeexampleVsProductNameTypePQ (a valid code from Product Name Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq
from this IG
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/vs-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: 5 elements

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.characteristic.value[x] (Closed)

 

Other representations of profile: CSV, Excel, Schematron