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

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Resource Profile: EMA Write API MedicinalProductDefinition

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

Usages:

• Use this Profile: EMA Write PMS API Bundle
• Refer to this Profile: EMA Write API PackagedProductDefinition and EMA Write API Regulated Authorization

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	EmaWriteApiMedicinalProductDefinitionRestrictions	Detailed definition of a medicinal product
extension		1..*	EmaCoding	Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required)
Slices for identifier	Σ	0..3	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system
identifier:All Slices				Content/Rules for all slices
extension		0..0		Extension Slice: Unordered, Open by value:url
identifier:eurdId	Σ	0..1	EmaEurdIdentifier	Business identifier for this product. Could be an MPID
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId
value	ΣC	1..1	string	The value that is unique Example General: 123456
identifier:mpId	Σ	0..1	EmaMpIdentifier	Business identifier for this product. Could be an MPID
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	ΣC	1..1	string	The value that is unique Example General: 123456
identifier:apiv2Id	Σ	0..1	EmaApiV2Identifier	Business identifier for this product. Could be an MPID
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://spor.azure-api.net/pms/api/v2
value	ΣC	1..1	string	The value that is unique Example General: 123456
type	Σ	0..1	EmaRefTermCodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required)
domain	Σ	1..1	EmaRefTermCodeableConcept	If this medicine applies to human or veterinary uses Binding: Domain (required)
status	?!Σ	1..1	EmaRefTermCodeableConcept	The status within the lifecycle of this product record Binding: Record Status (required)
combinedPharmaceuticalDoseForm	Σ	0..1	EmaRefTermCodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required)
indication	Σ	1..1	markdown	Description of indication(s) for this product, used when structured indications are not required
extension		1..1	EmaCoding	Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required)
legalStatusOfSupply	Σ	1..1	EmaRefTermCodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required)
additionalMonitoringIndicator	Σ	1..1	EmaRefTermCodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required)
pediatricUseIndicator	Σ	1..1	EmaRefTermCodeableConcept	If authorised for use in children Binding: Paediatric Use Indicator (required)
Slices for classification	Σ	1..*	CodeableConcept	Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
classification:xevmpd	Σ	0..1	EmaXevmpdProductCodeableConcept	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.
extension		0..0		Extension Slice: Unordered, Open by value:url
classification:legalBasis	Σ	0..1	EmaLegalBasisCodeableConcept	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.
extension		0..0		Extension Slice: Unordered, Open by value:url
classification:lightAtc	Σ	1..*	EmaLightAtcCodeableConcept	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.
extension		0..0	(Complex)	The ATC Pending Extension URL: http://ema.europa.eu/fhir/extension/atcPending Slice: Unordered, Open by value:url
extension:All Slices				Content/Rules for all slices
coding	Σ	1..1	EmaAtcCoding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
code	ΣC	1..1	code	Symbol in syntax defined by the system
classification:productCategory	Σ	0..*	EmaProductCategoryCodeableConcept	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.
extension		0..0		Extension Slice: Unordered, Open by value:url
masterFile	Σ	1..1	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
Slices for contact	Σ	2..2	BackboneElement	A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code
contact:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization
contact:pharmacovigilanceQualifiedPersonContact	Σ	1..1	BackboneElement	A product specific contact, person (in a role), or an organization
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept	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(PractitionerRole)	A product specific contact, person (in a role), or an organization
contact:pharmacovigilanceEnquiryContact	Σ	1..1	BackboneElement	A product specific contact, person (in a role), or an organization
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	EmaPharmacovigilanceEnquiryContactCodeableConcept	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)	A product specific contact, person (in a role), or an organization
name	Σ	1..1	BackboneElement	The product's name, including full name and possibly coded parts
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	EmaRefTermCodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required)
Slices for part	Σ	1..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
part: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.
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required)
part:inventedName	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
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: http://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		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
part:fullName	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
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: http://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: 220000000001
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
part:pharmaceuticalDoseForm	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
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: http://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		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
usage	Σ	1..1	BackboneElement	Country and jurisdiction where the name applies
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	EmaRefTermCodeableConcept	Country code for where this name applies Binding: Country (required)
language	Σ	1..1	CodeableConcept	Language code for this name Binding: Language (required) Additional Bindings Purpose CommonLanguages Starter
crossReference	Σ	0..1	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
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	1..1	EmaRefTermCodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required)
characteristic	Σ	1..1	BackboneElement	Key product features such as "sugar free", "modified release"
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	EmaGmoCodeableConcept	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.
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​type	Base	required	Medicinal Product Type	📦1.2.1	This IG
MedicinalProductDefinition.​domain	Base	required	Domain	📦1.2.1	This IG
MedicinalProductDefinition.​status	Base	required	Record Status	📦1.2.1	This IG
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm	Base	required	Combined Pharmaceutical Dose Form	📦1.2.1	This IG
MedicinalProductDefinition.​legalStatusOfSupply	Base	required	Legal Status of Supply	📦1.2.1	This IG
MedicinalProductDefinition.​additionalMonitoringIndicator	Base	required	Additional Monitoring Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​pediatricUseIndicator	Base	required	Paediatric Use Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​classification	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:xevmpd	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:legalBasis	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:lightAtc	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:productCategory	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact:pharmacovigilanceQualifiedPersonContact.​type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact:pharmacovigilanceEnquiryContact.​type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.type	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part.type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part:inventedName.​type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:fullName.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:pharmaceuticalDoseForm.​type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.country	Base	required	Country	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.language	Base	required	Language	📦1.2.1	This IG
MedicinalProductDefinition.​crossReference.type	Base	required	Product Cross Reference Type	📦1.2.1	This IG
MedicinalProductDefinition.​characteristic.type	Base	example	Product Characteristic	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
trueOrFalseStringInvariant	error	MedicinalProductDefinition.classification:lightAtc.extension.value[x]:valueString	The string must be either 'true' or 'false'.	$this='true' or $this='false'

This structure is derived from EmaWriteApiMedicinalProductDefinitionRestrictions

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition			EmaWriteApiMedicinalProductDefinitionRestrictions
extension		1..*	EmaCoding	Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required)
Slices for identifier		0..3	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system
identifier:All Slices				Content/Rules for all slices
extension		0..0		Extension
use		0..0		usual | official | temp | secondary | old (If known)
type		0..0		Description of identifier
period		0..0		Time period when id is/was valid for use
assigner		0..0		Organization that issued id (may be just text)
identifier:eurdId		0..1	EmaEurdIdentifier	Business identifier for this product. Could be an MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId
identifier:mpId		0..1	EmaMpIdentifier	Business identifier for this product. Could be an MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:apiv2Id		0..1	EmaApiV2Identifier	Business identifier for this product. Could be an MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://spor.azure-api.net/pms/api/v2
type		0..1	EmaRefTermCodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required)
domain		1..1	EmaRefTermCodeableConcept	If this medicine applies to human or veterinary uses Binding: Domain (required)
status		1..1	EmaRefTermCodeableConcept	The status within the lifecycle of this product record Binding: Record Status (required)
combinedPharmaceuticalDoseForm		0..1	EmaRefTermCodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required)
indication		1..1	markdown	Description of indication(s) for this product, used when structured indications are not required
extension		1..1	EmaCoding	Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required)
legalStatusOfSupply		1..1	EmaRefTermCodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required)
additionalMonitoringIndicator		1..1	EmaRefTermCodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required)
pediatricUseIndicator		1..1	EmaRefTermCodeableConcept	If authorised for use in children Binding: Paediatric Use Indicator (required)
Slices for classification		1..*	CodeableConcept	Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system
classification:xevmpd		0..1	EmaXevmpdProductCodeableConcept	Allows the product to be classified by various systems
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324
classification:legalBasis		0..1	EmaLegalBasisCodeableConcept	Allows the product to be classified by various systems
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045
classification:lightAtc		1..*	EmaLightAtcCodeableConcept	Allows the product to be classified by various systems
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
classification:productCategory		0..*	EmaProductCategoryCodeableConcept	Allows the product to be classified by various systems
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526
masterFile		1..1	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
Slices for contact		2..2	BackboneElement	A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code
contact:pharmacovigilanceQualifiedPersonContact		1..1	BackboneElement	A product specific contact, person (in a role), or an organization
type		0..1	EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
contact		1..1	Reference(PractitionerRole)	A product specific contact, person (in a role), or an organization
contact:pharmacovigilanceEnquiryContact		1..1	BackboneElement	A product specific contact, person (in a role), or an organization
type		0..1	EmaPharmacovigilanceEnquiryContactCodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
contact		1..1	Reference(Organization)	A product specific contact, person (in a role), or an organization
name		1..1	BackboneElement	The product's name, including full name and possibly coded parts
type		0..1	EmaRefTermCodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required)
Slices for part		1..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
part:All Slices				Content/Rules for all slices
type
coding		0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required)
part:inventedName		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: http://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
part:fullName		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: http://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000001
part:pharmaceuticalDoseForm		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: http://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
usage		1..1	BackboneElement	Country and jurisdiction where the name applies
country		1..1	EmaRefTermCodeableConcept	Country code for where this name applies Binding: Country (required)
language		1..1	CodeableConcept	Language code for this name Binding: Language (required)
crossReference		0..1	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
product
reference
identifier		1..1	Identifier	Logical reference, when literal reference is not known
system		0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/crossReference
type		1..1	EmaRefTermCodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required)
operation
type		0..1	CodeableReference(EMA Write API ActivityDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
confidentialityIndicator		1..1	EmaRefTermCodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: Data Classification (required)
characteristic		1..1	BackboneElement	Key product features such as "sugar free", "modified release"
type		1..1	EmaGmoCodeableConcept	A code expressing the type of characteristic
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​type	Base	required	Medicinal Product Type	📦1.2.1	This IG
MedicinalProductDefinition.​domain	Base	required	Domain	📦1.2.1	This IG
MedicinalProductDefinition.​status	Base	required	Record Status	📦1.2.1	This IG
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm	Base	required	Combined Pharmaceutical Dose Form	📦1.2.1	This IG
MedicinalProductDefinition.​legalStatusOfSupply	Base	required	Legal Status of Supply	📦1.2.1	This IG
MedicinalProductDefinition.​additionalMonitoringIndicator	Base	required	Additional Monitoring Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​pediatricUseIndicator	Base	required	Paediatric Use Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​name.type	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part.type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.country	Base	required	Country	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.language	Base	required	Language	📦1.2.1	This IG
MedicinalProductDefinition.​crossReference.type	Base	required	Product Cross Reference Type	📦1.2.1	This IG
MedicinalProductDefinition.​operation.confidentialityIndicator	Base	required	Data Classification	📦1.2.1	This IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	EmaWriteApiMedicinalProductDefinitionRestrictions	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
extension		1..*	EmaCoding	Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required)
Slices for identifier	Σ	0..3	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system
identifier:All Slices				Content/Rules for all slices
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	0..1	string	The value that is unique Example General: 123456
identifier:eurdId	Σ	0..1	EmaEurdIdentifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId
value	ΣC	1..1	string	The value that is unique Example General: 123456
identifier:mpId	Σ	0..1	EmaMpIdentifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	ΣC	1..1	string	The value that is unique Example General: 123456
identifier:apiv2Id	Σ	0..1	EmaApiV2Identifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://spor.azure-api.net/pms/api/v2
value	ΣC	1..1	string	The value that is unique Example General: 123456
type	Σ	0..1	EmaRefTermCodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required)
domain	Σ	1..1	EmaRefTermCodeableConcept	If this medicine applies to human or veterinary uses Binding: Domain (required)
status	?!Σ	1..1	EmaRefTermCodeableConcept	The status within the lifecycle of this product record Binding: Record Status (required)
combinedPharmaceuticalDoseForm	Σ	0..1	EmaRefTermCodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required)
indication	Σ	1..1	markdown	Description of indication(s) for this product, used when structured indications are not required
id		0..1	string	xml:id (or equivalent in JSON)
extension		1..1	EmaCoding	Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required)
value		0..1	markdown	Primitive value for markdown
legalStatusOfSupply	Σ	1..1	EmaRefTermCodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required)
additionalMonitoringIndicator	Σ	1..1	EmaRefTermCodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required)
pediatricUseIndicator	Σ	1..1	EmaRefTermCodeableConcept	If authorised for use in children Binding: Paediatric Use Indicator (required)
Slices for classification	Σ	1..*	CodeableConcept	Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
classification:xevmpd	Σ	0..1	EmaXevmpdProductCodeableConcept	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..0		Extension Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: XEVMPD medicinal product type (required)
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://spor.ema.europa.eu/v1/lists/200000000324
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
classification:legalBasis	Σ	0..1	EmaLegalBasisCodeableConcept	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..0		Extension Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: XEVMPD medicinal product type (required)
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://spor.ema.europa.eu/v1/lists/100000116045
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
classification:lightAtc	Σ	1..*	EmaLightAtcCodeableConcept	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..0	(Complex)	The ATC Pending Extension URL: http://ema.europa.eu/fhir/extension/atcPending Slice: Unordered, Open by value:url
extension:All Slices				Content/Rules for all slices
coding	Σ	1..1	EmaAtcCoding	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://spor.ema.europa.eu/v1/lists/100000093533
id		0..1	string	xml:id (or equivalent in JSON)
extension		0..*	string	Code System Name URL: http://ema.europa.eu/fhir/extension/codeSystemName
value		0..1	uri	Primitive value for uri
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
classification:productCategory	Σ	0..*	EmaProductCategoryCodeableConcept	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..0		Extension Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Category (required)
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://spor.ema.europa.eu/v1/lists/100000155526
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
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition | DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	1..1	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
Slices for contact	Σ	2..2	BackboneElement	A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code
contact: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
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
contact:pharmacovigilanceQualifiedPersonContact	Σ	1..1	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	EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept	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(PractitionerRole)	A product specific contact, person (in a role), or an organization
contact:pharmacovigilanceEnquiryContact	Σ	1..1	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	EmaPharmacovigilanceEnquiryContactCodeableConcept	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)	A product specific contact, person (in a role), or an organization
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in
name	Σ	1..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	EmaRefTermCodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required)
Slices for part	Σ	1..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
part: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.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required)
text	Σ	0..1	string	Plain text representation of the concept
part:inventedName	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	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) 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: http://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		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
part:fullName	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	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) 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: http://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: 220000000001
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
part:pharmaceuticalDoseForm	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	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) 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: http://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		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
usage	Σ	1..1	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	EmaRefTermCodeableConcept	Country code for where this name applies Binding: Country (required)
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: Language (required) Additional Bindings Purpose CommonLanguages Starter
crossReference	Σ	0..1	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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	Σ	0..1	CodeableConcept	Reference to a concept (by class)
reference	Σ	0..1	Reference()	Reference to a resource (by instance)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	ΣC	1..1	Identifier	Logical reference, when literal reference is not known
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	0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/crossReference
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)
display	ΣC	0..1	string	Text alternative for the resource
type	Σ	1..1	EmaRefTermCodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required)
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(EMA Write API ActivityDefinition)	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	1..1	EmaRefTermCodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: Data Classification (required)
characteristic	Σ	1..1	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	EmaGmoCodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueMarkdown			markdown
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​type	Base	required	Medicinal Product Type	📦1.2.1	This IG
MedicinalProductDefinition.​domain	Base	required	Domain	📦1.2.1	This IG
MedicinalProductDefinition.​status	Base	required	Record Status	📦1.2.1	This IG
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm	Base	required	Combined Pharmaceutical Dose Form	📦1.2.1	This IG
MedicinalProductDefinition.​legalStatusOfSupply	Base	required	Legal Status of Supply	📦1.2.1	This IG
MedicinalProductDefinition.​additionalMonitoringIndicator	Base	required	Additional Monitoring Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​pediatricUseIndicator	Base	required	Paediatric Use Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​classification	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:xevmpd	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:xevmpd.​coding	Base	required	XEVMPD medicinal product type	📦1.2.1	This IG
MedicinalProductDefinition.​classification:legalBasis	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:legalBasis.​coding	Base	required	XEVMPD medicinal product type	📦1.2.1	This IG
MedicinalProductDefinition.​classification:lightAtc	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:productCategory	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:productCategory.​coding	Base	required	Product Category	📦1.2.1	This IG
MedicinalProductDefinition.​contact.type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact:pharmacovigilanceQualifiedPersonContact.​type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact:pharmacovigilanceEnquiryContact.​type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.type	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part.type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part:inventedName.​type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:inventedName.​type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part:fullName.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:fullName.type.​coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part:pharmaceuticalDoseForm.​type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:pharmaceuticalDoseForm.​type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.country	Base	required	Country	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.jurisdiction	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.language	Base	required	Language	📦1.2.1	This IG
MedicinalProductDefinition.​crossReference.product.​reference.type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​crossReference.product.​reference.identifier.​use	Base	required	IdentifierUse	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​crossReference.product.​reference.identifier.​type	Base	extensible	Identifier Type Codes	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​crossReference.type	Base	required	Product Cross Reference Type	📦1.2.1	This IG
MedicinalProductDefinition.​operation.confidentialityIndicator	Base	required	Data Classification	📦1.2.1	This IG
MedicinalProductDefinition.​characteristic.type	Base	example	Product Characteristic	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
trueOrFalseStringInvariant	error	MedicinalProductDefinition.classification:lightAtc.extension.value[x]:valueString	The string must be either 'true' or 'false'.	$this='true' or $this='false'

This structure is derived from EmaWriteApiMedicinalProductDefinitionRestrictions

Summary

Mandatory: 17 elements(9 nested mandatory elements)
Prohibited: 5 elements

Structures

This structure refers to these other structures:

• EMA EURD Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaEurdIdentifier)
• EMA MP Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaMpIdentifier)
• EMA API V2 Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaApiV2Identifier)
• EMA Generic ReferentialTerm CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept)
• EMA XEVMPD Product CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaXevmpdProductCodeableConcept)
• EMA Legal Basis CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaLegalBasisCodeableConcept)
• EMA Light ATC CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaLightAtcCodeableConcept)
• EMA Product Category CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaProductCategoryCodeableConcept)
• EMA Pharmacovigilance Qualified Person Type CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaPharmacovigilanceQualifiedPersonTypeCodeableConcept)
• EMA Pharmacovigilance Qualified Person Type CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaPharmacovigilanceEnquiryContactCodeableConcept)
• The MPD Name Part Type Coding (http://ema.europa.eu/fhir/StructureDefinition/emaNamePartTypeCoding)
• EMA Write API ActivityDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition)
• EMA Genetically Modified Organisms CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaGmoCodeableConcept)

Extensions

This structure refers to these extensions:

• http://ema.europa.eu/fhir/extension/authorisedDoseForm
• http://ema.europa.eu/fhir/extension/language

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of MedicinalProductDefinition.identifier (Closed)
• The element 1 is sliced based on the value of MedicinalProductDefinition.classification (Closed)
• The element 1 is sliced based on the value of MedicinalProductDefinition.contact (Closed)
• The element 1 is sliced based on the value of MedicinalProductDefinition.name.part

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	EmaWriteApiMedicinalProductDefinitionRestrictions	Detailed definition of a medicinal product
extension		1..*	EmaCoding	Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required)
Slices for identifier	Σ	0..3	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system
identifier:All Slices				Content/Rules for all slices
extension		0..0		Extension Slice: Unordered, Open by value:url
identifier:eurdId	Σ	0..1	EmaEurdIdentifier	Business identifier for this product. Could be an MPID
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId
value	ΣC	1..1	string	The value that is unique Example General: 123456
identifier:mpId	Σ	0..1	EmaMpIdentifier	Business identifier for this product. Could be an MPID
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	ΣC	1..1	string	The value that is unique Example General: 123456
identifier:apiv2Id	Σ	0..1	EmaApiV2Identifier	Business identifier for this product. Could be an MPID
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://spor.azure-api.net/pms/api/v2
value	ΣC	1..1	string	The value that is unique Example General: 123456
type	Σ	0..1	EmaRefTermCodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required)
domain	Σ	1..1	EmaRefTermCodeableConcept	If this medicine applies to human or veterinary uses Binding: Domain (required)
status	?!Σ	1..1	EmaRefTermCodeableConcept	The status within the lifecycle of this product record Binding: Record Status (required)
combinedPharmaceuticalDoseForm	Σ	0..1	EmaRefTermCodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required)
indication	Σ	1..1	markdown	Description of indication(s) for this product, used when structured indications are not required
extension		1..1	EmaCoding	Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required)
legalStatusOfSupply	Σ	1..1	EmaRefTermCodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required)
additionalMonitoringIndicator	Σ	1..1	EmaRefTermCodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required)
pediatricUseIndicator	Σ	1..1	EmaRefTermCodeableConcept	If authorised for use in children Binding: Paediatric Use Indicator (required)
Slices for classification	Σ	1..*	CodeableConcept	Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
classification:xevmpd	Σ	0..1	EmaXevmpdProductCodeableConcept	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.
extension		0..0		Extension Slice: Unordered, Open by value:url
classification:legalBasis	Σ	0..1	EmaLegalBasisCodeableConcept	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.
extension		0..0		Extension Slice: Unordered, Open by value:url
classification:lightAtc	Σ	1..*	EmaLightAtcCodeableConcept	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.
extension		0..0	(Complex)	The ATC Pending Extension URL: http://ema.europa.eu/fhir/extension/atcPending Slice: Unordered, Open by value:url
extension:All Slices				Content/Rules for all slices
coding	Σ	1..1	EmaAtcCoding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
code	ΣC	1..1	code	Symbol in syntax defined by the system
classification:productCategory	Σ	0..*	EmaProductCategoryCodeableConcept	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.
extension		0..0		Extension Slice: Unordered, Open by value:url
masterFile	Σ	1..1	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
Slices for contact	Σ	2..2	BackboneElement	A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code
contact:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization
contact:pharmacovigilanceQualifiedPersonContact	Σ	1..1	BackboneElement	A product specific contact, person (in a role), or an organization
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept	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(PractitionerRole)	A product specific contact, person (in a role), or an organization
contact:pharmacovigilanceEnquiryContact	Σ	1..1	BackboneElement	A product specific contact, person (in a role), or an organization
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	EmaPharmacovigilanceEnquiryContactCodeableConcept	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)	A product specific contact, person (in a role), or an organization
name	Σ	1..1	BackboneElement	The product's name, including full name and possibly coded parts
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	EmaRefTermCodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required)
Slices for part	Σ	1..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
part: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.
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required)
part:inventedName	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
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: http://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		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
part:fullName	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
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: http://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: 220000000001
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
part:pharmaceuticalDoseForm	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
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: http://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		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
usage	Σ	1..1	BackboneElement	Country and jurisdiction where the name applies
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	EmaRefTermCodeableConcept	Country code for where this name applies Binding: Country (required)
language	Σ	1..1	CodeableConcept	Language code for this name Binding: Language (required) Additional Bindings Purpose CommonLanguages Starter
crossReference	Σ	0..1	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
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	1..1	EmaRefTermCodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required)
characteristic	Σ	1..1	BackboneElement	Key product features such as "sugar free", "modified release"
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	EmaGmoCodeableConcept	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.
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​type	Base	required	Medicinal Product Type	📦1.2.1	This IG
MedicinalProductDefinition.​domain	Base	required	Domain	📦1.2.1	This IG
MedicinalProductDefinition.​status	Base	required	Record Status	📦1.2.1	This IG
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm	Base	required	Combined Pharmaceutical Dose Form	📦1.2.1	This IG
MedicinalProductDefinition.​legalStatusOfSupply	Base	required	Legal Status of Supply	📦1.2.1	This IG
MedicinalProductDefinition.​additionalMonitoringIndicator	Base	required	Additional Monitoring Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​pediatricUseIndicator	Base	required	Paediatric Use Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​classification	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:xevmpd	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:legalBasis	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:lightAtc	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:productCategory	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact:pharmacovigilanceQualifiedPersonContact.​type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact:pharmacovigilanceEnquiryContact.​type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.type	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part.type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part:inventedName.​type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:fullName.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:pharmaceuticalDoseForm.​type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.country	Base	required	Country	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.language	Base	required	Language	📦1.2.1	This IG
MedicinalProductDefinition.​crossReference.type	Base	required	Product Cross Reference Type	📦1.2.1	This IG
MedicinalProductDefinition.​characteristic.type	Base	example	Product Characteristic	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
trueOrFalseStringInvariant	error	MedicinalProductDefinition.classification:lightAtc.extension.value[x]:valueString	The string must be either 'true' or 'false'.	$this='true' or $this='false'

Differential View

This structure is derived from EmaWriteApiMedicinalProductDefinitionRestrictions

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition			EmaWriteApiMedicinalProductDefinitionRestrictions
extension		1..*	EmaCoding	Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required)
Slices for identifier		0..3	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system
identifier:All Slices				Content/Rules for all slices
extension		0..0		Extension
use		0..0		usual | official | temp | secondary | old (If known)
type		0..0		Description of identifier
period		0..0		Time period when id is/was valid for use
assigner		0..0		Organization that issued id (may be just text)
identifier:eurdId		0..1	EmaEurdIdentifier	Business identifier for this product. Could be an MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId
identifier:mpId		0..1	EmaMpIdentifier	Business identifier for this product. Could be an MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:apiv2Id		0..1	EmaApiV2Identifier	Business identifier for this product. Could be an MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://spor.azure-api.net/pms/api/v2
type		0..1	EmaRefTermCodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required)
domain		1..1	EmaRefTermCodeableConcept	If this medicine applies to human or veterinary uses Binding: Domain (required)
status		1..1	EmaRefTermCodeableConcept	The status within the lifecycle of this product record Binding: Record Status (required)
combinedPharmaceuticalDoseForm		0..1	EmaRefTermCodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required)
indication		1..1	markdown	Description of indication(s) for this product, used when structured indications are not required
extension		1..1	EmaCoding	Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required)
legalStatusOfSupply		1..1	EmaRefTermCodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required)
additionalMonitoringIndicator		1..1	EmaRefTermCodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required)
pediatricUseIndicator		1..1	EmaRefTermCodeableConcept	If authorised for use in children Binding: Paediatric Use Indicator (required)
Slices for classification		1..*	CodeableConcept	Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system
classification:xevmpd		0..1	EmaXevmpdProductCodeableConcept	Allows the product to be classified by various systems
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324
classification:legalBasis		0..1	EmaLegalBasisCodeableConcept	Allows the product to be classified by various systems
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045
classification:lightAtc		1..*	EmaLightAtcCodeableConcept	Allows the product to be classified by various systems
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
classification:productCategory		0..*	EmaProductCategoryCodeableConcept	Allows the product to be classified by various systems
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526
masterFile		1..1	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
Slices for contact		2..2	BackboneElement	A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code
contact:pharmacovigilanceQualifiedPersonContact		1..1	BackboneElement	A product specific contact, person (in a role), or an organization
type		0..1	EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
contact		1..1	Reference(PractitionerRole)	A product specific contact, person (in a role), or an organization
contact:pharmacovigilanceEnquiryContact		1..1	BackboneElement	A product specific contact, person (in a role), or an organization
type		0..1	EmaPharmacovigilanceEnquiryContactCodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
contact		1..1	Reference(Organization)	A product specific contact, person (in a role), or an organization
name		1..1	BackboneElement	The product's name, including full name and possibly coded parts
type		0..1	EmaRefTermCodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required)
Slices for part		1..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
part:All Slices				Content/Rules for all slices
type
coding		0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required)
part:inventedName		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: http://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
part:fullName		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: http://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000001
part:pharmaceuticalDoseForm		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: http://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
usage		1..1	BackboneElement	Country and jurisdiction where the name applies
country		1..1	EmaRefTermCodeableConcept	Country code for where this name applies Binding: Country (required)
language		1..1	CodeableConcept	Language code for this name Binding: Language (required)
crossReference		0..1	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
product
reference
identifier		1..1	Identifier	Logical reference, when literal reference is not known
system		0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/crossReference
type		1..1	EmaRefTermCodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required)
operation
type		0..1	CodeableReference(EMA Write API ActivityDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
confidentialityIndicator		1..1	EmaRefTermCodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: Data Classification (required)
characteristic		1..1	BackboneElement	Key product features such as "sugar free", "modified release"
type		1..1	EmaGmoCodeableConcept	A code expressing the type of characteristic
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​type	Base	required	Medicinal Product Type	📦1.2.1	This IG
MedicinalProductDefinition.​domain	Base	required	Domain	📦1.2.1	This IG
MedicinalProductDefinition.​status	Base	required	Record Status	📦1.2.1	This IG
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm	Base	required	Combined Pharmaceutical Dose Form	📦1.2.1	This IG
MedicinalProductDefinition.​legalStatusOfSupply	Base	required	Legal Status of Supply	📦1.2.1	This IG
MedicinalProductDefinition.​additionalMonitoringIndicator	Base	required	Additional Monitoring Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​pediatricUseIndicator	Base	required	Paediatric Use Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​name.type	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part.type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.country	Base	required	Country	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.language	Base	required	Language	📦1.2.1	This IG
MedicinalProductDefinition.​crossReference.type	Base	required	Product Cross Reference Type	📦1.2.1	This IG
MedicinalProductDefinition.​operation.confidentialityIndicator	Base	required	Data Classification	📦1.2.1	This IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	EmaWriteApiMedicinalProductDefinitionRestrictions	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
extension		1..*	EmaCoding	Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required)
Slices for identifier	Σ	0..3	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system
identifier:All Slices				Content/Rules for all slices
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	0..1	string	The value that is unique Example General: 123456
identifier:eurdId	Σ	0..1	EmaEurdIdentifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId
value	ΣC	1..1	string	The value that is unique Example General: 123456
identifier:mpId	Σ	0..1	EmaMpIdentifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	ΣC	1..1	string	The value that is unique Example General: 123456
identifier:apiv2Id	Σ	0..1	EmaApiV2Identifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://spor.azure-api.net/pms/api/v2
value	ΣC	1..1	string	The value that is unique Example General: 123456
type	Σ	0..1	EmaRefTermCodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required)
domain	Σ	1..1	EmaRefTermCodeableConcept	If this medicine applies to human or veterinary uses Binding: Domain (required)
status	?!Σ	1..1	EmaRefTermCodeableConcept	The status within the lifecycle of this product record Binding: Record Status (required)
combinedPharmaceuticalDoseForm	Σ	0..1	EmaRefTermCodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required)
indication	Σ	1..1	markdown	Description of indication(s) for this product, used when structured indications are not required
id		0..1	string	xml:id (or equivalent in JSON)
extension		1..1	EmaCoding	Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required)
value		0..1	markdown	Primitive value for markdown
legalStatusOfSupply	Σ	1..1	EmaRefTermCodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required)
additionalMonitoringIndicator	Σ	1..1	EmaRefTermCodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required)
pediatricUseIndicator	Σ	1..1	EmaRefTermCodeableConcept	If authorised for use in children Binding: Paediatric Use Indicator (required)
Slices for classification	Σ	1..*	CodeableConcept	Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
classification:xevmpd	Σ	0..1	EmaXevmpdProductCodeableConcept	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..0		Extension Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: XEVMPD medicinal product type (required)
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://spor.ema.europa.eu/v1/lists/200000000324
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
classification:legalBasis	Σ	0..1	EmaLegalBasisCodeableConcept	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..0		Extension Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: XEVMPD medicinal product type (required)
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://spor.ema.europa.eu/v1/lists/100000116045
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
classification:lightAtc	Σ	1..*	EmaLightAtcCodeableConcept	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..0	(Complex)	The ATC Pending Extension URL: http://ema.europa.eu/fhir/extension/atcPending Slice: Unordered, Open by value:url
extension:All Slices				Content/Rules for all slices
coding	Σ	1..1	EmaAtcCoding	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://spor.ema.europa.eu/v1/lists/100000093533
id		0..1	string	xml:id (or equivalent in JSON)
extension		0..*	string	Code System Name URL: http://ema.europa.eu/fhir/extension/codeSystemName
value		0..1	uri	Primitive value for uri
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
classification:productCategory	Σ	0..*	EmaProductCategoryCodeableConcept	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..0		Extension Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Category (required)
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://spor.ema.europa.eu/v1/lists/100000155526
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
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition | DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	1..1	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
Slices for contact	Σ	2..2	BackboneElement	A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code
contact: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
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
contact:pharmacovigilanceQualifiedPersonContact	Σ	1..1	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	EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept	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(PractitionerRole)	A product specific contact, person (in a role), or an organization
contact:pharmacovigilanceEnquiryContact	Σ	1..1	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	EmaPharmacovigilanceEnquiryContactCodeableConcept	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)	A product specific contact, person (in a role), or an organization
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in
name	Σ	1..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	EmaRefTermCodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required)
Slices for part	Σ	1..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
part: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.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required)
text	Σ	0..1	string	Plain text representation of the concept
part:inventedName	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	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) 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: http://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		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
part:fullName	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	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) 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: http://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: 220000000001
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
part:pharmaceuticalDoseForm	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	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	EmaNamePartTypeCoding	Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) 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: http://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		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
usage	Σ	1..1	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	EmaRefTermCodeableConcept	Country code for where this name applies Binding: Country (required)
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: Language (required) Additional Bindings Purpose CommonLanguages Starter
crossReference	Σ	0..1	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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	Σ	0..1	CodeableConcept	Reference to a concept (by class)
reference	Σ	0..1	Reference()	Reference to a resource (by instance)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	ΣC	1..1	Identifier	Logical reference, when literal reference is not known
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	0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/crossReference
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)
display	ΣC	0..1	string	Text alternative for the resource
type	Σ	1..1	EmaRefTermCodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required)
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(EMA Write API ActivityDefinition)	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	1..1	EmaRefTermCodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: Data Classification (required)
characteristic	Σ	1..1	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	EmaGmoCodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueMarkdown			markdown
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProductDefinition.​type	Base	required	Medicinal Product Type	📦1.2.1	This IG
MedicinalProductDefinition.​domain	Base	required	Domain	📦1.2.1	This IG
MedicinalProductDefinition.​status	Base	required	Record Status	📦1.2.1	This IG
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm	Base	required	Combined Pharmaceutical Dose Form	📦1.2.1	This IG
MedicinalProductDefinition.​legalStatusOfSupply	Base	required	Legal Status of Supply	📦1.2.1	This IG
MedicinalProductDefinition.​additionalMonitoringIndicator	Base	required	Additional Monitoring Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​pediatricUseIndicator	Base	required	Paediatric Use Indicator	📦1.2.1	This IG
MedicinalProductDefinition.​classification	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:xevmpd	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:xevmpd.​coding	Base	required	XEVMPD medicinal product type	📦1.2.1	This IG
MedicinalProductDefinition.​classification:legalBasis	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:legalBasis.​coding	Base	required	XEVMPD medicinal product type	📦1.2.1	This IG
MedicinalProductDefinition.​classification:lightAtc	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:productCategory	Base	example	Product Classification	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​classification:productCategory.​coding	Base	required	Product Category	📦1.2.1	This IG
MedicinalProductDefinition.​contact.type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact:pharmacovigilanceQualifiedPersonContact.​type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​contact:pharmacovigilanceEnquiryContact.​type	Base	example	Product Contact Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.type	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part.type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part:inventedName.​type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:inventedName.​type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part:fullName.type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:fullName.type.​coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.part:pharmaceuticalDoseForm.​type	Base	example	Product Name Part Type	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.part:pharmaceuticalDoseForm.​type.coding	Base	required	Medicinal Product Name Part Type	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.country	Base	required	Country	📦1.2.1	This IG
MedicinalProductDefinition.​name.usage.jurisdiction	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​name.usage.language	Base	required	Language	📦1.2.1	This IG
MedicinalProductDefinition.​crossReference.product.​reference.type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​crossReference.product.​reference.identifier.​use	Base	required	IdentifierUse	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​crossReference.product.​reference.identifier.​type	Base	extensible	Identifier Type Codes	📍5.0.0	FHIR Std.
MedicinalProductDefinition.​crossReference.type	Base	required	Product Cross Reference Type	📦1.2.1	This IG
MedicinalProductDefinition.​operation.confidentialityIndicator	Base	required	Data Classification	📦1.2.1	This IG
MedicinalProductDefinition.​characteristic.type	Base	example	Product Characteristic	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
trueOrFalseStringInvariant	error	MedicinalProductDefinition.classification:lightAtc.extension.value[x]:valueString	The string must be either 'true' or 'false'.	$this='true' or $this='false'

This structure is derived from EmaWriteApiMedicinalProductDefinitionRestrictions

Summary

Mandatory: 17 elements(9 nested mandatory elements)
Prohibited: 5 elements

Structures

This structure refers to these other structures:

• EMA EURD Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaEurdIdentifier)
• EMA MP Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaMpIdentifier)
• EMA API V2 Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaApiV2Identifier)
• EMA Generic ReferentialTerm CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept)
• EMA XEVMPD Product CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaXevmpdProductCodeableConcept)
• EMA Legal Basis CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaLegalBasisCodeableConcept)
• EMA Light ATC CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaLightAtcCodeableConcept)
• EMA Product Category CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaProductCategoryCodeableConcept)
• EMA Pharmacovigilance Qualified Person Type CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaPharmacovigilanceQualifiedPersonTypeCodeableConcept)
• EMA Pharmacovigilance Qualified Person Type CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaPharmacovigilanceEnquiryContactCodeableConcept)
• The MPD Name Part Type Coding (http://ema.europa.eu/fhir/StructureDefinition/emaNamePartTypeCoding)
• EMA Write API ActivityDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition)
• EMA Genetically Modified Organisms CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaGmoCodeableConcept)

Extensions

This structure refers to these extensions:

• http://ema.europa.eu/fhir/extension/authorisedDoseForm
• http://ema.europa.eu/fhir/extension/language

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of MedicinalProductDefinition.identifier (Closed)
• The element 1 is sliced based on the value of MedicinalProductDefinition.classification (Closed)
• The element 1 is sliced based on the value of MedicinalProductDefinition.contact (Closed)
• The element 1 is sliced based on the value of MedicinalProductDefinition.name.part