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 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

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: MedicinalProductDefinition - Drug Product

This MedicinalProductDefinition profile represents information that identifies the drug product.

Usage:

• Use this Resource Profile: Bundle – Analytical Procedure PQ, Bundle – Batch Analysis PQ, Bundle – Batch Formula PQ, Bundle – Container Closure System PQ... Show 11 more, Bundle – drug Product Batch Information PQ, Bundle - Drug Product Compatibility PQ, Bundle – Drug Product Composition PQ, Bundle – Drug Product Excipients PQ, Bundle – Drug Product Microbiological Attributes PQ, Bundle - Drug Product PQ, Bundle – Drug Product Specification PQ, Bundle – Drug Stability PQ, Bundle - Product Impurities PQ, Bundle - Product Manufacturing PQ and Bundle - Product Process Validation PQ
• Refer to this Resource Profile: Composition - Drug PQ and Extension - Medication Definition PQ
• Examples for this Resource Profile: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from MedicinalProductDefinition

Name	Flags	Card.	Type	Description & Constraints
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.
name	S	1..*	BackboneElement	The product's name, including full name and possibly coded parts
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform from this IG
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration from this IG
MedicinalProductDefinition.name.type	example	VsProductNameTypePQ (a valid code from Product Name Type - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq from this IG
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Name	Flags	Card.	Type	Description & Constraints
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
identifier	SΣ	0..*	Identifier	Business identifier for this product. Could be an MPID
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform from this IG
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration from this IG
MedicinalProductDefinition.name.type	example	VsProductNameTypePQ (a valid code from Product Name Type - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq from this IG
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : 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-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
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 Bindings Purpose 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 Bindings Purpose 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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.type	example	MedicinalProductType http://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard
MedicinalProductDefinition.domain	example	MedicinalProductDomain http://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform from this IG
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration from this IG
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring from the FHIR Standard
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures http://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard
MedicinalProductDefinition.classification	example	ProductClassification http://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType http://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
MedicinalProductDefinition.impurity	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
MedicinalProductDefinition.contact.type	example	ProductContactType http://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes http://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard
MedicinalProductDefinition.name.type	example	VsProductNameTypePQ (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.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : 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-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must 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:

• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq

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

Name	Flags	Card.	Type	Description & Constraints
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.
name	S	1..*	BackboneElement	The product's name, including full name and possibly coded parts
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform from this IG
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration from this IG
MedicinalProductDefinition.name.type	example	VsProductNameTypePQ (a valid code from Product Name Type - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq from this IG
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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
identifier	SΣ	0..*	Identifier	Business identifier for this product. Could be an MPID
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform from this IG
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration from this IG
MedicinalProductDefinition.name.type	example	VsProductNameTypePQ (a valid code from Product Name Type - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq from this IG
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : 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-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
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 Bindings Purpose 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 Bindings Purpose 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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.type	example	MedicinalProductType http://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard
MedicinalProductDefinition.domain	example	MedicinalProductDomain http://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform from this IG
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration from this IG
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring from the FHIR Standard
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures http://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard
MedicinalProductDefinition.classification	example	ProductClassification http://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType http://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
MedicinalProductDefinition.impurity	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
MedicinalProductDefinition.contact.type	example	ProductContactType http://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes http://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard
MedicinalProductDefinition.name.type	example	VsProductNameTypePQ (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.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : 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-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must 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:

• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq

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