UnicomIG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/unicom-ig/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• XML
• JSON
• TTL

Resource Profile: PPL Medicinal Product profile

Medicinal Product as defined in ISO IDMP

Usage:

• Refer to this Resource Profile: PPL Administrable Product profile, PPL Ingredient profile, PPL Packaged Product profile and PPL Marketing Authorisation profile
• Examples for this Resource Profile: MedicinalProductDefinition/Agen-5mg-Tablet-EE-MPD, MedicinalProductDefinition/CanifugCremolum-EE-MPD and MedicinalProductDefinition/Cefuroxime-MIP-1500mg-EE-MPD

Formal Views of Profile Content

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

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

This structure is derived from MedicinalProductDefinition

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition			MedicinalProductDefinition
Slices for identifier		1..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid		1..1	Identifier	MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:pmsid		0..1	Identifier	PMS ID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
domain		1..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
status		0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' Binding: EMA SPOR Record Status (preferred)
combinedPharmaceuticalDoseForm		1..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
legalStatusOfSupply		1..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
classification		1..*	CodeableConcept	Classification such as ATC (EMA and WHO coding). Binding: EMA SPOR ATC (preferred)
name		1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName		1..1	string	The full product name
Slices for part		0..*	BackboneElement	Medicinal product name part Slice: Unordered, Open by pattern:type
part:invented		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
part:strength		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
part:doseForm		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
usage		0..*	BackboneElement	Country and jurisdiction where the name applies
country
Slices for coding		1..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema		1..1	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
coding:iso		0..1	Coding	Code defined by a terminology system Binding: Country (ISO 3166-1-2) (required)
system		1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
language
Slices for coding		0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema		0..1	Coding	Code defined by a terminology system Binding: EMA SPOR Language (required)
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
coding:bcp		0..1	Coding	Code defined by a terminology system Binding: Language (FHIR) (required)
system		1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	SporRecordStatus (a valid code from Record Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/record-status-spor-vs from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs from this IG
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA) http://unicom-project.eu/fhir/ValueSet/atc-spor-vs from this IG
MedicinalProductDefinition.name.usage.country.coding:ema	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
MedicinalProductDefinition.name.usage.country.coding:iso	required	CountryISO (a valid code from https://www.hl7.org/fhir/valueset-country.html) http://unicom-project.eu/fhir/ValueSet/country-iso-vs from this IG
MedicinalProductDefinition.name.usage.language.coding:ema	required	LanguageEMA (a valid code from Language EMA) http://unicom-project.eu/fhir/ValueSet/language-ema-vs from this IG
MedicinalProductDefinition.name.usage.language.coding:bcp	required	LanguageBCP (a valid code from http://hl7.org/fhir/ValueSet/all-languages) http://unicom-project.eu/fhir/ValueSet/language-bcp-vs from this IG

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	Σ	1..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid	Σ	1..1	Identifier	MPID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:pmsid	Σ	0..1	Identifier	PMS ID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
domain	Σ	1..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
status	?!Σ	0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' Binding: EMA SPOR Record Status (preferred)
combinedPharmaceuticalDoseForm	Σ	1..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
legalStatusOfSupply	Σ	1..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
classification	Σ	1..*	CodeableConcept	Classification such as ATC (EMA and WHO coding). Binding: EMA SPOR ATC (preferred)
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
Slices for part	Σ	0..*	BackboneElement	Medicinal product name part Slice: Unordered, Open by pattern: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.
part:invented	Σ	0..1	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
part:strength	Σ	0..1	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
part:doseForm	Σ	0..1	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	CodeableConcept	Country code for where this name applies Binding: CountryValueSet (example): Jurisdiction codes
Slices for coding	Σ	1..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	1..1	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
coding:iso	Σ	0..1	Coding	Code defined by a terminology system Binding: Country (ISO 3166-1-2) (required)
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
language	Σ	1..1	CodeableConcept	Language code for this name Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system Binding: EMA SPOR Language (required)
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
coding:bcp	Σ	0..1	Coding	Code defined by a terminology system Binding: Language (FHIR) (required)
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	SporRecordStatus (a valid code from Record Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/record-status-spor-vs from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs from this IG
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA) http://unicom-project.eu/fhir/ValueSet/atc-spor-vs from this IG
MedicinalProductDefinition.name.part.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:invented.type	example	Pattern: 220000000002("Invented name part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:strength.type	example	Pattern: 220000000004("Strength part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:doseForm.type	example	Pattern: 220000000005("Pharmaceutical dose form part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.usage.country.coding:ema	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
MedicinalProductDefinition.name.usage.country.coding:iso	required	CountryISO (a valid code from https://www.hl7.org/fhir/valueset-country.html) http://unicom-project.eu/fhir/ValueSet/country-iso-vs from this IG
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.name.usage.language.coding:ema	required	LanguageEMA (a valid code from Language EMA) http://unicom-project.eu/fhir/ValueSet/language-ema-vs from this IG
MedicinalProductDefinition.name.usage.language.coding:bcp	required	LanguageBCP (a valid code from http://hl7.org/fhir/ValueSet/all-languages) http://unicom-project.eu/fhir/ValueSet/language-bcp-vs from this IG

Constraints

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

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	Σ	1..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid	Σ	1..1	Identifier	MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:pmsid	Σ	0..1	Identifier	PMS ID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
domain	Σ	1..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' Binding: EMA SPOR Record Status (preferred)
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
description	Σ	0..1	markdown	General description of this product
combinedPharmaceuticalDoseForm	Σ	1..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
indication	Σ	0..1	markdown	Description of indication(s) for this product, used when structured indications are not required
legalStatusOfSupply	Σ	1..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children Binding: PediatricUse (example): Suitability for age groups, in particular children.
classification	Σ	1..*	CodeableConcept	Classification such as ATC (EMA and WHO coding). Binding: EMA SPOR ATC (preferred)
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct	Σ	0..*	CodeableConcept	Package type for the product Binding: MedicinalProductPackageType (example): Types of medicinal product packs
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition | DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient	Σ	0..*	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
impurity	Σ	0..*	CodeableReference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in
code	Σ	0..*	Coding	A code that this product is known by, within some formal terminology Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
Slices for part	Σ	0..*	BackboneElement	Medicinal product name part Slice: Unordered, Open by pattern: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.
part:invented	Σ	0..1	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
part:strength	Σ	0..1	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
part:doseForm	Σ	0..1	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	CodeableConcept	Country code for where this name applies Binding: CountryValueSet (example): Jurisdiction codes
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	1..1	Coding	Code defined by a terminology system Binding: EMA SPOR Country (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: https://spor.ema.europa.eu/v1/lists/100000000002
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:iso	Σ	0..1	Coding	Code defined by a terminology system Binding: Country (ISO 3166-1-2) (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: https://www.hl7.org/fhir/valueset-country.html
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system Binding: EMA SPOR Language (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: https://spor.ema.europa.eu/v1/lists/100000072057
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:bcp	Σ	0..1	Coding	Code defined by a terminology system Binding: Language (FHIR) (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://hl7.org/fhir/ValueSet/all-languages
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product
type	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueMarkdown			markdown
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
MedicinalProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:mpid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.type	example	MedicinalProductType http://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	SporRecordStatus (a valid code from Record Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/record-status-spor-vs from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.route	example	SNOMEDCTRouteCodes http://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs from this IG
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring from the FHIR Standard
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures http://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA) http://unicom-project.eu/fhir/ValueSet/atc-spor-vs from this IG
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType http://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
MedicinalProductDefinition.impurity	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
MedicinalProductDefinition.contact.type	example	ProductContactType http://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes http://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard
MedicinalProductDefinition.name.type	example	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name.part.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:invented.type	example	Pattern: 220000000002("Invented name part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:strength.type	example	Pattern: 220000000004("Strength part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:doseForm.type	example	Pattern: 220000000005("Pharmaceutical dose form part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.usage.country.coding:ema	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
MedicinalProductDefinition.name.usage.country.coding:iso	required	CountryISO (a valid code from https://www.hl7.org/fhir/valueset-country.html) http://unicom-project.eu/fhir/ValueSet/country-iso-vs from this IG
MedicinalProductDefinition.name.usage.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.name.usage.language.coding:ema	required	LanguageEMA (a valid code from Language EMA) http://unicom-project.eu/fhir/ValueSet/language-ema-vs from this IG
MedicinalProductDefinition.name.usage.language.coding:bcp	required	LanguageBCP (a valid code from http://hl7.org/fhir/ValueSet/all-languages) http://unicom-project.eu/fhir/ValueSet/language-bcp-vs from this IG
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard
MedicinalProductDefinition.characteristic.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

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

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 7 elements(7 nested mandatory elements)

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from MedicinalProductDefinition

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition			MedicinalProductDefinition
Slices for identifier		1..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid		1..1	Identifier	MPID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:pmsid		0..1	Identifier	PMS ID
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
domain		1..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
status		0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' Binding: EMA SPOR Record Status (preferred)
combinedPharmaceuticalDoseForm		1..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
legalStatusOfSupply		1..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
classification		1..*	CodeableConcept	Classification such as ATC (EMA and WHO coding). Binding: EMA SPOR ATC (preferred)
name		1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName		1..1	string	The full product name
Slices for part		0..*	BackboneElement	Medicinal product name part Slice: Unordered, Open by pattern:type
part:invented		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
part:strength		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
part:doseForm		0..1	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
usage		0..*	BackboneElement	Country and jurisdiction where the name applies
country
Slices for coding		1..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema		1..1	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
coding:iso		0..1	Coding	Code defined by a terminology system Binding: Country (ISO 3166-1-2) (required)
system		1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
language
Slices for coding		0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema		0..1	Coding	Code defined by a terminology system Binding: EMA SPOR Language (required)
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
coding:bcp		0..1	Coding	Code defined by a terminology system Binding: Language (FHIR) (required)
system		1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	SporRecordStatus (a valid code from Record Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/record-status-spor-vs from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs from this IG
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA) http://unicom-project.eu/fhir/ValueSet/atc-spor-vs from this IG
MedicinalProductDefinition.name.usage.country.coding:ema	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
MedicinalProductDefinition.name.usage.country.coding:iso	required	CountryISO (a valid code from https://www.hl7.org/fhir/valueset-country.html) http://unicom-project.eu/fhir/ValueSet/country-iso-vs from this IG
MedicinalProductDefinition.name.usage.language.coding:ema	required	LanguageEMA (a valid code from Language EMA) http://unicom-project.eu/fhir/ValueSet/language-ema-vs from this IG
MedicinalProductDefinition.name.usage.language.coding:bcp	required	LanguageBCP (a valid code from http://hl7.org/fhir/ValueSet/all-languages) http://unicom-project.eu/fhir/ValueSet/language-bcp-vs from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	Σ	1..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid	Σ	1..1	Identifier	MPID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
identifier:pmsid	Σ	0..1	Identifier	PMS ID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
domain	Σ	1..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
status	?!Σ	0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' Binding: EMA SPOR Record Status (preferred)
combinedPharmaceuticalDoseForm	Σ	1..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
legalStatusOfSupply	Σ	1..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
classification	Σ	1..*	CodeableConcept	Classification such as ATC (EMA and WHO coding). Binding: EMA SPOR ATC (preferred)
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
Slices for part	Σ	0..*	BackboneElement	Medicinal product name part Slice: Unordered, Open by pattern: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.
part:invented	Σ	0..1	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
part:strength	Σ	0..1	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
part:doseForm	Σ	0..1	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	CodeableConcept	Country code for where this name applies Binding: CountryValueSet (example): Jurisdiction codes
Slices for coding	Σ	1..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	1..1	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000000002
coding:iso	Σ	0..1	Coding	Code defined by a terminology system Binding: Country (ISO 3166-1-2) (required)
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.hl7.org/fhir/valueset-country.html
language	Σ	1..1	CodeableConcept	Language code for this name Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system Binding: EMA SPOR Language (required)
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072057
coding:bcp	Σ	0..1	Coding	Code defined by a terminology system Binding: Language (FHIR) (required)
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/ValueSet/all-languages
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	SporRecordStatus (a valid code from Record Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/record-status-spor-vs from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs from this IG
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA) http://unicom-project.eu/fhir/ValueSet/atc-spor-vs from this IG
MedicinalProductDefinition.name.part.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:invented.type	example	Pattern: 220000000002("Invented name part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:strength.type	example	Pattern: 220000000004("Strength part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:doseForm.type	example	Pattern: 220000000005("Pharmaceutical dose form part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.usage.country.coding:ema	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
MedicinalProductDefinition.name.usage.country.coding:iso	required	CountryISO (a valid code from https://www.hl7.org/fhir/valueset-country.html) http://unicom-project.eu/fhir/ValueSet/country-iso-vs from this IG
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.name.usage.language.coding:ema	required	LanguageEMA (a valid code from Language EMA) http://unicom-project.eu/fhir/ValueSet/language-ema-vs from this IG
MedicinalProductDefinition.name.usage.language.coding:bcp	required	LanguageBCP (a valid code from http://hl7.org/fhir/ValueSet/all-languages) http://unicom-project.eu/fhir/ValueSet/language-bcp-vs from this IG

Constraints

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

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	Σ	1..*	Identifier	Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:mpid	Σ	1..1	Identifier	MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:pmsid	Σ	0..1	Identifier	PMS ID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pmsId
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
domain	Σ	1..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: EMA SPOR Domain (required)
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	Status of the product's data. Default 200000005004 'Current' Binding: EMA SPOR Record Status (preferred)
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
description	Σ	0..1	markdown	General description of this product
combinedPharmaceuticalDoseForm	Σ	1..1	CodeableConcept	Authorised dose form for the product, incl combination package dose forms Binding: EMA SPOR Authorised Dose Form (required)
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
indication	Σ	0..1	markdown	Description of indication(s) for this product, used when structured indications are not required
legalStatusOfSupply	Σ	1..1	CodeableConcept	Legal status of supply on the medicinal product level. Binding: EMA SPOR Legal Status for the Supply (required)
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children Binding: PediatricUse (example): Suitability for age groups, in particular children.
classification	Σ	1..*	CodeableConcept	Classification such as ATC (EMA and WHO coding). Binding: EMA SPOR ATC (preferred)
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct	Σ	0..*	CodeableConcept	Package type for the product Binding: MedicinalProductPackageType (example): Types of medicinal product packs
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition | DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient	Σ	0..*	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
impurity	Σ	0..*	CodeableReference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in
code	Σ	0..*	Coding	A code that this product is known by, within some formal terminology Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
Slices for part	Σ	0..*	BackboneElement	Medicinal product name part Slice: Unordered, Open by pattern: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.
part:invented	Σ	0..1	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000002
display		1..1	string	Representation defined by the system Fixed Value: Invented name part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
part:strength	Σ	0..1	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000004
display		1..1	string	Representation defined by the system Fixed Value: Strength part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
part:doseForm	Σ	0..1	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000005
display		1..1	string	Representation defined by the system Fixed Value: Pharmaceutical dose form part
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	CodeableConcept	Country code for where this name applies Binding: CountryValueSet (example): Jurisdiction codes
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	1..1	Coding	Code defined by a terminology system Binding: EMA SPOR Country (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: https://spor.ema.europa.eu/v1/lists/100000000002
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:iso	Σ	0..1	Coding	Code defined by a terminology system Binding: Country (ISO 3166-1-2) (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: https://www.hl7.org/fhir/valueset-country.html
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..*	Coding	EMA or ISO codes for country Slice: Unordered, Open by pattern:system
coding:ema	Σ	0..1	Coding	Code defined by a terminology system Binding: EMA SPOR Language (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: https://spor.ema.europa.eu/v1/lists/100000072057
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:bcp	Σ	0..1	Coding	Code defined by a terminology system Binding: Language (FHIR) (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://hl7.org/fhir/ValueSet/all-languages
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product
type	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueMarkdown			markdown
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
MedicinalProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:mpid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:mpid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
MedicinalProductDefinition.identifier:pmsid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.type	example	MedicinalProductType http://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard
MedicinalProductDefinition.domain	required	Domain (a valid code from Domain EMA) http://unicom-project.eu/fhir/ValueSet/domain-vs from this IG
MedicinalProductDefinition.status	preferred	SporRecordStatus (a valid code from Record Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/record-status-spor-vs from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	required	AuthorisedDoseForm http://unicom-project.eu/fhir/ValueSet/authorised-doseform-vs from this IG
MedicinalProductDefinition.route	example	SNOMEDCTRouteCodes http://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupply	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs from this IG
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring from the FHIR Standard
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures http://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard
MedicinalProductDefinition.classification	preferred	SporAtc (a valid code from ATC Human EMA) http://unicom-project.eu/fhir/ValueSet/atc-spor-vs from this IG
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType http://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
MedicinalProductDefinition.impurity	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
MedicinalProductDefinition.contact.type	example	ProductContactType http://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes http://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard
MedicinalProductDefinition.name.type	example	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name.part.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:invented.type	example	Pattern: 220000000002("Invented name part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:strength.type	example	Pattern: 220000000004("Strength part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.part:doseForm.type	example	Pattern: 220000000005("Pharmaceutical dose form part") http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.usage.country.coding:ema	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
MedicinalProductDefinition.name.usage.country.coding:iso	required	CountryISO (a valid code from https://www.hl7.org/fhir/valueset-country.html) http://unicom-project.eu/fhir/ValueSet/country-iso-vs from this IG
MedicinalProductDefinition.name.usage.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
MedicinalProductDefinition.name.usage.language.coding:ema	required	LanguageEMA (a valid code from Language EMA) http://unicom-project.eu/fhir/ValueSet/language-ema-vs from this IG
MedicinalProductDefinition.name.usage.language.coding:bcp	required	LanguageBCP (a valid code from http://hl7.org/fhir/ValueSet/all-languages) http://unicom-project.eu/fhir/ValueSet/language-bcp-vs from this IG
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard
MedicinalProductDefinition.characteristic.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

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

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 7 elements(7 nested mandatory elements)

Slices

This structure defines the following Slices:

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