Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition			MedicinalProductDefinition
Slices for identifier		0..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid		0..1	Identifier	MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:pmsid		0..1	Identifier	PMS ID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
domain		0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
status		0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current'
combinedPharmaceuticalDoseForm		0..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
legalStatusOfSupply		0..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
Slices for classification		0..*	CodeableConcept	ATC or other classification Slice: Unordered, Open by pattern:coding.system
classification:atc		0..*	CodeableConcept	Allows the product to be classified by various systems
Slices for coding		0..*	Coding	ATC classification Slice: Unordered, Open by pattern:system
coding:ema		0..1	Coding	ATC classification as EMA SPOR code
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
coding:who		0..1	Coding	ATC classification as WHO ATC code
system		1..1	uri	Identity of the terminology system Required Pattern: http://www.whocc.no/atc
name		1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName		1..1	string	The full product name
usage		0..*	BackboneElement	Country and jurisdiction where the name applies
country
Slices for coding		0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
coding:iso		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
language
Slices for coding		0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
coding:bcp		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG

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
Slices for identifier	Σ	0..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid	Σ	0..1	Identifier	MPID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:pmsid	Σ	0..1	Identifier	PMS ID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
status	?!Σ	0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
legalStatusOfSupply	Σ	0..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
Slices for classification	Σ	0..*	CodeableConcept	ATC or other classification Slice: Unordered, Open by pattern:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
classification:atc	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.
Slices for coding	Σ	0..*	Coding	ATC classification Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	ATC classification as EMA SPOR code
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
coding:who	Σ	0..1	Coding	ATC classification as WHO ATC code
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://www.whocc.no/atc
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
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
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
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
coding:iso	Σ	0..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
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
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
coding:bcp	Σ	0..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
MedicinalProductDefinition.classification	example	ProductClassification http://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard
MedicinalProductDefinition.classification:atc	example	ProductClassification http://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard

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
Slices for identifier	Σ	0..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid	Σ	0..1	Identifier	MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:pmsid	Σ	0..1	Identifier	PMS ID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
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: EMA SPOR Domain (required)
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' 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	Σ	0..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
indication	Σ	0..1	markdown	Description of indication(s) for this product, used when structured indications are not required
legalStatusOfSupply	Σ	0..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
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.
Slices for classification	Σ	0..*	CodeableConcept	ATC or other classification Slice: Unordered, Open by pattern:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
classification:atc	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.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	ATC classification Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	ATC classification as EMA SPOR code
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:who	Σ	0..1	Coding	ATC classification as WHO ATC code
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://www.whocc.no/atc
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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	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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:iso	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:bcp	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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	Conformance	ValueSet	URI
MedicinalProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:mpid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.type	example	MedicinalProductType http://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.route	example	SNOMEDCTRouteCodes http://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
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.classification:atc	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	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

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()

Summary

Mandatory: 0 element(8 nested mandatory elements)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of MedicinalProductDefinition.identifier
• The element 1 is sliced based on the value of MedicinalProductDefinition.classification
• The element 1 is sliced based on the value of MedicinalProductDefinition.classification.coding
• The element 1 is sliced based on the value of MedicinalProductDefinition.name.usage.country.coding
• The element 1 is sliced based on the value of MedicinalProductDefinition.name.usage.language.coding

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition			MedicinalProductDefinition
Slices for identifier		0..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid		0..1	Identifier	MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:pmsid		0..1	Identifier	PMS ID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
domain		0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
status		0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current'
combinedPharmaceuticalDoseForm		0..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
legalStatusOfSupply		0..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
Slices for classification		0..*	CodeableConcept	ATC or other classification Slice: Unordered, Open by pattern:coding.system
classification:atc		0..*	CodeableConcept	Allows the product to be classified by various systems
Slices for coding		0..*	Coding	ATC classification Slice: Unordered, Open by pattern:system
coding:ema		0..1	Coding	ATC classification as EMA SPOR code
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
coding:who		0..1	Coding	ATC classification as WHO ATC code
system		1..1	uri	Identity of the terminology system Required Pattern: http://www.whocc.no/atc
name		1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName		1..1	string	The full product name
usage		0..*	BackboneElement	Country and jurisdiction where the name applies
country
Slices for coding		0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
coding:iso		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
language
Slices for coding		0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
coding:bcp		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG

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
Slices for identifier	Σ	0..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid	Σ	0..1	Identifier	MPID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:pmsid	Σ	0..1	Identifier	PMS ID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
status	?!Σ	0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
legalStatusOfSupply	Σ	0..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
Slices for classification	Σ	0..*	CodeableConcept	ATC or other classification Slice: Unordered, Open by pattern:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
classification:atc	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.
Slices for coding	Σ	0..*	Coding	ATC classification Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	ATC classification as EMA SPOR code
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
coding:who	Σ	0..1	Coding	ATC classification as WHO ATC code
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://www.whocc.no/atc
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
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
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
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
coding:iso	Σ	0..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
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
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
coding:bcp	Σ	0..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
MedicinalProductDefinition.classification	example	ProductClassification http://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard
MedicinalProductDefinition.classification:atc	example	ProductClassification http://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard

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
Slices for identifier	Σ	0..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid	Σ	0..1	Identifier	MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:pmsid	Σ	0..1	Identifier	PMS ID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
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: EMA SPOR Domain (required)
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' 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	Σ	0..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
indication	Σ	0..1	markdown	Description of indication(s) for this product, used when structured indications are not required
legalStatusOfSupply	Σ	0..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
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.
Slices for classification	Σ	0..*	CodeableConcept	ATC or other classification Slice: Unordered, Open by pattern:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
classification:atc	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.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	ATC classification Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	ATC classification as EMA SPOR code
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:who	Σ	0..1	Coding	ATC classification as WHO ATC code
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://www.whocc.no/atc
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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	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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:iso	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:bcp	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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	Conformance	ValueSet	URI
MedicinalProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:mpid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.type	example	MedicinalProductType http://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.route	example	SNOMEDCTRouteCodes http://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
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.classification:atc	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	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

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()