EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: EMA Write API MedicinalProductDefinition Restrictions

Defines the restrictive rules a MedicinalProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application

Usages:

• Derived from this Profile: EMA Write API MedicinalProductDefinition

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
name	Σ	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
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition			MedicinalProductDefinition
implicitRules		0..0		A set of rules under which this content was created
language		0..0		Language of the resource content
text		0..0		Text summary of the resource, for human interpretation
contained		0..0		Contained, inline Resources
modifierExtension		0..0		Extension
version		0..0		A business identifier relating to a specific version of the product
statusDate		0..0		The date at which the given status became applicable
description		0..0		General description of this product
route		0..0		The path by which the product is taken into or makes contact with the body
specialMeasures		0..0		Whether the Medicinal Product is subject to special measures for regulatory reasons
marketingStatus		0..0		Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct		0..0		Package type for the product
ingredient		0..0		The ingredients of this medicinal product - when not detailed in other resources
impurity		0..0		Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
code		0..0		A code that this product is known by, within some formal terminology
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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
extension		0..*	Extension	Additional content defined by implementations
identifier	Σ	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).
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
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).
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.
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
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
name	Σ	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
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: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueMarkdown			markdown
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​type	Base	example	Medicinal Product Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​domain	Base	example	Medicinal Product Domain	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm	Base	example	Combined Dose Form	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply	Base	example	Legal Status Of Supply	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​additionalMonitoringIndicator	Base	example	Additional Monitoring	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​pediatricUseIndicator	Base	example	Pediatric Use	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact.type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.type	Base	example	Product Name Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.country	Base	example	Country ValueSet	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.jurisdiction	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.language	Base	required	All Languages	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​crossReference.type	Base	example	Product Cross Reference Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​operation.confidentialityIndicator	Base	example	Product Confidentiality	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​characteristic.type	Base	example	Product Characteristic	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
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

Prohibited: 15 elements

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
name	Σ	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
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
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()

Differential View

This structure is derived from MedicinalProductDefinition

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition			MedicinalProductDefinition
implicitRules		0..0		A set of rules under which this content was created
language		0..0		Language of the resource content
text		0..0		Text summary of the resource, for human interpretation
contained		0..0		Contained, inline Resources
modifierExtension		0..0		Extension
version		0..0		A business identifier relating to a specific version of the product
statusDate		0..0		The date at which the given status became applicable
description		0..0		General description of this product
route		0..0		The path by which the product is taken into or makes contact with the body
specialMeasures		0..0		Whether the Medicinal Product is subject to special measures for regulatory reasons
marketingStatus		0..0		Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct		0..0		Package type for the product
ingredient		0..0		The ingredients of this medicinal product - when not detailed in other resources
impurity		0..0		Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
code		0..0		A code that this product is known by, within some formal terminology
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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
extension		0..*	Extension	Additional content defined by implementations
identifier	Σ	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).
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
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).
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.
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
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
name	Σ	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
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: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueMarkdown			markdown
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​type	Base	example	Medicinal Product Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​domain	Base	example	Medicinal Product Domain	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm	Base	example	Combined Dose Form	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply	Base	example	Legal Status Of Supply	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​additionalMonitoringIndicator	Base	example	Additional Monitoring	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​pediatricUseIndicator	Base	example	Pediatric Use	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact.type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.type	Base	example	Product Name Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.country	Base	example	Country ValueSet	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.jurisdiction	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.language	Base	required	All Languages	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​crossReference.type	Base	example	Product Cross Reference Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​operation.confidentialityIndicator	Base	example	Product Confidentiality	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​characteristic.type	Base	example	Product Characteristic	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
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

Prohibited: 15 elements

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