This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples

Resource Profile: MedicinalProductDefinition - Drug Product

Section 1.1 - Drug Product Identification

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: 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
characteristic		0..*	BackboneElement	Key product features such as "sugar free", "modified release"
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM)

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
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
MedicinalProductDefinition.status	preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator	required	QuantityComparator
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM)

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	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
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
extension		0..*	Extension	Additional content defined by implementations
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
MedicinalProductDefinition.language	required	AllLanguages
MedicinalProductDefinition.type	example	MedicinalProductType
MedicinalProductDefinition.domain	example	MedicinalProductDomain
MedicinalProductDefinition.status	preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse
MedicinalProductDefinition.classification	example	ProductClassification
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes
MedicinalProductDefinition.impurity	example	SNOMEDCTSubstanceCodes
MedicinalProductDefinition.contact.type	example	ProductContactType
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes
MedicinalProductDefinition.name.type	example	ProductNameType
MedicinalProductDefinition.name.part.type	example	ProductNamePartType
MedicinalProductDefinition.name.usage.country	example	CountryValueSet
MedicinalProductDefinition.name.usage.jurisdiction	example	JurisdictionValueSet
MedicinalProductDefinition.name.usage.language	required	AllLanguages
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator	required	QuantityComparator
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM)

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: 3 elements

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from MedicinalProductDefinition

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
characteristic		0..*	BackboneElement	Key product features such as "sugar free", "modified release"
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM)

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
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
MedicinalProductDefinition.status	preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator	required	QuantityComparator
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM)

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	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
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
extension		0..*	Extension	Additional content defined by implementations
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
MedicinalProductDefinition.language	required	AllLanguages
MedicinalProductDefinition.type	example	MedicinalProductType
MedicinalProductDefinition.domain	example	MedicinalProductDomain
MedicinalProductDefinition.status	preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	preferred	MedicineDoseFormEDQM
MedicinalProductDefinition.route	preferred	MedicineRouteOfAdministrationEDQM
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse
MedicinalProductDefinition.classification	example	ProductClassification
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes
MedicinalProductDefinition.impurity	example	SNOMEDCTSubstanceCodes
MedicinalProductDefinition.contact.type	example	ProductContactType
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes
MedicinalProductDefinition.name.type	example	ProductNameType
MedicinalProductDefinition.name.part.type	example	ProductNamePartType
MedicinalProductDefinition.name.usage.country	example	CountryValueSet
MedicinalProductDefinition.name.usage.jurisdiction	example	JurisdictionValueSet
MedicinalProductDefinition.name.usage.language	required	AllLanguages
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality
MedicinalProductDefinition.characteristic.type	example	MedicinalProductCharacteristicType
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator	required	QuantityComparator
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM)

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: 3 elements

Slices

This structure defines the following Slices:

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

Other representations of profile: CSV, Excel, Schematron