Profile Comparison between http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi vs http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
copyright
date	2023-07-26T13:32:34+00:00	2025-07-21T10:31:44+00:00	Values Differ
description	Description of the packaged authorized medicinal product(s) associated to this ePI document.
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	http://unstats.un.org/unsd/methods/m49/m49.htm#001
kind	resource
name	MedicinalProductDefinitionUvEpi
publisher	HL7 International - Biomedical Research & Regulation Work Group
purpose
status	active
title	MedicinalProductDefinition (ePI)
type	MedicinalProductDefinition
url	http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi
version	1.0.0	1.1.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	1..*	Identifier	Business identifier for this product. Could be an MPID	Σ	1..*	Identifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		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: ?? (required): Identifies the purpose for this identifier, if known .	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (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 Example General: http://www.acme.com/identifiers/patient	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	1..1	string	The value that is unique Example General: 123456	ΣC	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use	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)	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: ?? (example): Overall defining type of this medicinal product.	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized. Binding: ?? (example): Overall defining type of this medicinal product.
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses. Binding: ?? (example)	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses. Binding: ?? (example)
version	Σ	0..1	string	A business identifier relating to a specific version of the product.	Σ	0..1	string	A business identifier relating to a specific version of the product.
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record. Binding: ?? (preferred): The lifecycle status of an artifact.	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record. Binding: ?? (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which this status became applicable.	Σ	0..1	dateTime	The date at which this status became applicable.
description	Σ	0..1	markdown	General description of the medicinal product referred by the ePI	Σ	0..1	markdown	General description of the medicinal product referred by the ePI
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: ?? (example)	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: ?? (example)
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: ?? (example)	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: ?? (example)
indication	Σ	0..1	markdown	Narrative text of the authorized indication(s) for this product.	Σ	0..1	markdown	Narrative text of the authorized indication(s) for this product.
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator. Binding: ?? (example): The prescription supply types appropriate to a medicinal product	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator. Binding: ?? (example): The prescription supply types appropriate to a medicinal product
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: ?? (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: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons. Binding: ?? (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 pediatric use Binding: ?? (example): Suitability for age groups, in particular children.	Σ	0..1	CodeableConcept	If authorised for pediatric use Binding: ?? (example): Suitability for age groups, in particular children.
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems (e.g. ATC) Binding: ?? (example)	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems (e.g. ATC) Binding: ?? (example)
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ?? (preferred)	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ?? (preferred)
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
status	Σ	1..1	CodeableConcept	Status of the marketing of the medicinal product.	Σ	1..1	CodeableConcept	Status of the marketing of the medicinal product.
dateRange	Σ	0..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder	Σ	0..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
packagedMedicinalProduct	Σ	0..*	CodeableConcept	Package type for the product. Binding: ?? (example): Types of medicinal product packs	Σ	0..*	CodeableConcept	Package type for the product. Binding: ?? (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	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: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	Σ	0..*	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resources Binding: ?? (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: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	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: ?? (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	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)	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	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!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: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A specific contact, person (in a role), or an organization for this product	Σ	1..1	Reference(Organization | PractitionerRole)	A specific contact, person (in a role), or an organization for this product
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in	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: ?? (example): A coded concept that defines the type of a medication.	Σ	0..*	Coding	A code that this product is known by, within some formal terminology Binding: ?? (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	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name.	Σ	1..1	string	The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, Proprietary, Non-Proprietary Binding: ?? (example): Type of a name for a Medicinal Product.	Σ	0..1	CodeableConcept	Type of product name, such as rINN, Proprietary, Non-Proprietary Binding: ?? (example): Type of a name for a Medicinal Product.
part	Σ	0..*	BackboneElement	Coding words or phrases of the name	Σ	0..*	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name.	Σ	1..1	string	A fragment of a product name.
type	Σ	1..1	CodeableConcept	Type for this part of the name (e.g. strength part) Binding: ?? (example): Type of part of a name for a Medicinal Product.	Σ	1..1	CodeableConcept	Type for this part of the name (e.g. strength part) Binding: ?? (example): Type of part of a name for a Medicinal Product.
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	CodeableConcept	Country where this name applies Binding: ?? (example): Jurisdiction codes	Σ	1..1	CodeableConcept	Country where this name applies Binding: ?? (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction where this name applies Binding: ?? (example): Jurisdiction codes	Σ	0..1	CodeableConcept	Jurisdiction where this name applies Binding: ?? (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language for this name Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter	Σ	1..1	CodeableConcept	Language for this name Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product	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		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!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	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: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ?? (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	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!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	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	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	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: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1	CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment	A value for the characteristic	Σ	0..1	CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment	A value for the characteristic
Documentation for this format