Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
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
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
legalStatusOfSupply		0..1	CodeableConcept	Legal status of supply on the medicinal product level.
classification		0..*	CodeableConcept	Allows the product to be classified by various systems Binding: Anatomical Therapeutic Chemical classification system (preferred)
ingredient		0..0
impurity		0..0
name		1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName		1..1	string	The full product name
Slices for namePart		0..*	BackboneElement	Medicinal product name part Slice: Ordered, Open by pattern:type
namePart:invented		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
namePart:strength		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
namePart:doseForm		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
countryLanguage		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
characteristic		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA)
MedicinalProductDefinition.characteristic.type	required	NoBinding (a valid code from Domain EMA)

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
modifierExtension	?!	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)
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)
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: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
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: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
legalStatusOfSupply	Σ	0..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems Binding: Anatomical Therapeutic Chemical classification system (preferred)
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
Slices for namePart	Σ	0..*	BackboneElement	Medicinal product name part Slice: Ordered, Open by pattern:type
namePart:All Slices				Content/Rules for all slices
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.
namePart:invented	Σ	0..1	BackboneElement	Coding words or phrases of the name
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. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
namePart:strength	Σ	0..1	BackboneElement	Coding words or phrases of the name
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. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
namePart:doseForm	Σ	0..1	BackboneElement	Coding words or phrases of the name
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. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
countryLanguage	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: Country ValueSet (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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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 / Code
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse
MedicinalProductDefinition.domain	example	MedicinalProductDomain
MedicinalProductDefinition.status	preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	CombinedDoseForm
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA)
MedicinalProductDefinition.name.namePart.type	example	ProductNamePartType
MedicinalProductDefinition.name.namePart:invented.type	example	Pattern: 220000000002("Invented name part")
MedicinalProductDefinition.name.namePart:strength.type	example	Pattern: 220000000004("Strength part")
MedicinalProductDefinition.name.namePart:doseForm.type	example	Pattern: 220000000005("Pharmaceutical dose form part")
MedicinalProductDefinition.name.countryLanguage.country	example	Country ValueSet
MedicinalProductDefinition.name.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
MedicinalProductDefinition.characteristic.type	required	NoBinding (a valid code from Domain EMA)

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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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	?!	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)
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible)
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	Σ	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)
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible)
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
value	Σ	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: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	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: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
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: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies.
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children Binding: PediatricUse (example): Suitability for age groups, in particular children.
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems Binding: Anatomical Therapeutic Chemical classification system (preferred)
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
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.
Slices for namePart	Σ	0..*	BackboneElement	Medicinal product name part Slice: Ordered, Open by pattern:type
namePart:All Slices				Content/Rules for all slices
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.
namePart:invented	Σ	0..1	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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
namePart:strength	Σ	0..1	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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
namePart:doseForm	Σ	0..1	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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
countryLanguage	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: Country ValueSet (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	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	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	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	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: Jurisdiction ValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	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	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
MedicinalProductDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse
MedicinalProductDefinition.identifier:mpid.type	extensible	Identifier Type Codes
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse
MedicinalProductDefinition.identifier:pmsid.type	extensible	Identifier Type Codes
MedicinalProductDefinition.type	example	MedicinalProductType
MedicinalProductDefinition.domain	example	MedicinalProductDomain
MedicinalProductDefinition.status	preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	CombinedDoseForm
MedicinalProductDefinition.route	example	SNOMEDCTRouteCodes
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA)
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType
MedicinalProductDefinition.contact.type	example	ProductContactType
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes
MedicinalProductDefinition.name.type	example	ProductNameType
MedicinalProductDefinition.name.namePart.type	example	ProductNamePartType
MedicinalProductDefinition.name.namePart:invented.type	example	Pattern: 220000000002("Invented name part")
MedicinalProductDefinition.name.namePart:strength.type	example	Pattern: 220000000004("Strength part")
MedicinalProductDefinition.name.namePart:doseForm.type	example	Pattern: 220000000005("Pharmaceutical dose form part")
MedicinalProductDefinition.name.countryLanguage.country	example	Country ValueSet
MedicinalProductDefinition.name.countryLanguage.jurisdiction	example	Jurisdiction ValueSet
MedicinalProductDefinition.name.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality
MedicinalProductDefinition.characteristic.type	required	NoBinding (a valid code from Domain EMA)

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-r4b	warning	MedicinalProductDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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 (6 nested mandatory elements)
Prohibited: 3 elements

Slices

This structure defines the following Slices:

• The element MedicinalProductDefinition.identifier is sliced based on the value of pattern:system
• The element MedicinalProductDefinition.name.namePart is sliced based on the value of pattern:type (ordered)
• The element MedicinalProductDefinition.name.countryLanguage.country.coding is sliced based on the value of pattern:system
• The element MedicinalProductDefinition.name.countryLanguage.language.coding is sliced based on the value of pattern:system

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
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
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
legalStatusOfSupply		0..1	CodeableConcept	Legal status of supply on the medicinal product level.
classification		0..*	CodeableConcept	Allows the product to be classified by various systems Binding: Anatomical Therapeutic Chemical classification system (preferred)
ingredient		0..0
impurity		0..0
name		1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName		1..1	string	The full product name
Slices for namePart		0..*	BackboneElement	Medicinal product name part Slice: Ordered, Open by pattern:type
namePart:invented		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
namePart:strength		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
namePart:doseForm		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
countryLanguage		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
characteristic		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA)
MedicinalProductDefinition.characteristic.type	required	NoBinding (a valid code from Domain EMA)

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
modifierExtension	?!	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)
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)
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: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
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: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
legalStatusOfSupply	Σ	0..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems Binding: Anatomical Therapeutic Chemical classification system (preferred)
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
Slices for namePart	Σ	0..*	BackboneElement	Medicinal product name part Slice: Ordered, Open by pattern:type
namePart:All Slices				Content/Rules for all slices
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.
namePart:invented	Σ	0..1	BackboneElement	Coding words or phrases of the name
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. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
namePart:strength	Σ	0..1	BackboneElement	Coding words or phrases of the name
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. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
namePart:doseForm	Σ	0..1	BackboneElement	Coding words or phrases of the name
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. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
countryLanguage	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: Country ValueSet (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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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 / Code
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse
MedicinalProductDefinition.domain	example	MedicinalProductDomain
MedicinalProductDefinition.status	preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	CombinedDoseForm
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA)
MedicinalProductDefinition.name.namePart.type	example	ProductNamePartType
MedicinalProductDefinition.name.namePart:invented.type	example	Pattern: 220000000002("Invented name part")
MedicinalProductDefinition.name.namePart:strength.type	example	Pattern: 220000000004("Strength part")
MedicinalProductDefinition.name.namePart:doseForm.type	example	Pattern: 220000000005("Pharmaceutical dose form part")
MedicinalProductDefinition.name.countryLanguage.country	example	Country ValueSet
MedicinalProductDefinition.name.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
MedicinalProductDefinition.characteristic.type	required	NoBinding (a valid code from Domain EMA)

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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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	?!	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)
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible)
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	Σ	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)
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible)
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
value	Σ	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: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	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: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
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: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies.
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children Binding: PediatricUse (example): Suitability for age groups, in particular children.
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems Binding: Anatomical Therapeutic Chemical classification system (preferred)
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
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.
Slices for namePart	Σ	0..*	BackboneElement	Medicinal product name part Slice: Ordered, Open by pattern:type
namePart:All Slices				Content/Rules for all slices
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.
namePart:invented	Σ	0..1	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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
namePart:strength	Σ	0..1	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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
namePart:doseForm	Σ	0..1	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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
countryLanguage	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: Country ValueSet (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	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	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	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	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: Jurisdiction ValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
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	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	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	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
MedicinalProductDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse
MedicinalProductDefinition.identifier:mpid.type	extensible	Identifier Type Codes
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse
MedicinalProductDefinition.identifier:pmsid.type	extensible	Identifier Type Codes
MedicinalProductDefinition.type	example	MedicinalProductType
MedicinalProductDefinition.domain	example	MedicinalProductDomain
MedicinalProductDefinition.status	preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	CombinedDoseForm
MedicinalProductDefinition.route	example	SNOMEDCTRouteCodes
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA)
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType
MedicinalProductDefinition.contact.type	example	ProductContactType
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes
MedicinalProductDefinition.name.type	example	ProductNameType
MedicinalProductDefinition.name.namePart.type	example	ProductNamePartType
MedicinalProductDefinition.name.namePart:invented.type	example	Pattern: 220000000002("Invented name part")
MedicinalProductDefinition.name.namePart:strength.type	example	Pattern: 220000000004("Strength part")
MedicinalProductDefinition.name.namePart:doseForm.type	example	Pattern: 220000000005("Pharmaceutical dose form part")
MedicinalProductDefinition.name.countryLanguage.country	example	Country ValueSet
MedicinalProductDefinition.name.countryLanguage.jurisdiction	example	Jurisdiction ValueSet
MedicinalProductDefinition.name.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality
MedicinalProductDefinition.characteristic.type	required	NoBinding (a valid code from Domain EMA)

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-r4b	warning	MedicinalProductDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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()