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

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization
copyright
date	2023-07-26T13:32:34+00:00	2026-04-03T02:13:18+00:00	Values Differ
description	RegulatedAuthorization (ePI)
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	http://unstats.un.org/unsd/methods/m49/m49.htm#001
kind	resource
name	RegulatedAuthorizationUvEpi
publisher	HL7 International - Biomedical Research & Regulation Work Group	HL7 International / Biomedical Research and Regulation	Values Differ
purpose
status	active
title	RegulatedAuthorization (ePI)
type	RegulatedAuthorization
url	http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-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
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for 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	Identifier assigned by the health authority to a single medicinal product	Σ	1..*	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
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)
subject	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The product type, treatment, facility or activity that is being authorized	Σ	1..*	Reference(MedicinalProductDefinition (ePI) | PackagedProductDefinition (ePI))	The product type, treatment, facility or activity that is being authorized
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation. Binding: ?? (example): Overall type of this authorization.	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: ?? (example): Overall type of this authorization.
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
description	Σ	0..1	markdown	Brief description of the authorization	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: ?? (preferred)	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: ?? (example): Jurisdiction codes	Example/preferred bindings differ at RegulatedAuthorization.region using binding from RegulatedAuthorizationUvEpi
status	Σ	0..1	CodeableConcept	The current status of this authorization Binding: ?? (preferred): The lifecycle status of an artifact.	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: ?? (preferred): The lifecycle status of an artifact.	Example/preferred bindings differ at RegulatedAuthorization.status using binding from RegulatedAuthorizationUvEpi
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
statusDate	Σ	0..1	dateTime	The date at which the current status was assigned.	Σ	0..1	dateTime	The date at which the current status was assigned.
validityPeriod	Σ	0..1	Period	The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date	Σ	0..1	Period	The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition Indication (ePI))	Reference to the Clinical Use Definition	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
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
concept	Σ	0..1	CodeableConcept	Reference to a concept (by class)	Σ	0..1	CodeableConcept	Reference to a concept (by class)
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
reference	Σ	1..1	Reference()	Reference to a resource (by instance)	Σ	0..1	Reference()	Reference to a resource (by instance)	Element minimum cardinalities differ: '1' vs '0'
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ?? (preferred): The overall intended use of a product.	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ?? (preferred): The overall intended use of a product.	Example/preferred bindings differ at RegulatedAuthorization.intendedUse using binding from RegulatedAuthorizationUvEpi
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: ?? (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: ?? (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
holder	Σ	1..1	Reference(Organization (ePI))	The organization that has been granted this authorization, by the regulator	Σ	1..1	Reference(Organization (ePI))	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization (ePI))	The regulatory authority or authorizing body granting the authorization	Σ	0..1	Reference(Organization (ePI))	The regulatory authority or authorizing body granting the authorization
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization
case	Σ	0..1	BackboneElement	The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)	Σ	0..1	BackboneElement	The case or regulatory procedure for granting or amending a regulated authorization.
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
identifier	Σ	0..1	Identifier	Identifier by which this case can be referenced.	Σ	0..1	Identifier	Identifier by which this case can be referenced
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
use					?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known .	Added this element
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.	Added this element
system					Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient	Added this element
value					ΣC	1..1	string	The value that is unique Example General: 123456	Added this element
period					Σ	0..1	Period	Time period when id is/was valid for use	Added this element
assigner					Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)	Added this element
type	Σ	0..1	CodeableConcept	The defining type of case. Binding: ?? (example): The type of a case involved in an application.	Σ	0..1	CodeableConcept	The defining type of case Binding: ?? (example): The type of a case involved in an application.
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
status	Σ	0..1	CodeableConcept	The status associated with the case. Binding: ?? (preferred): The lifecycle status of an artifact.	Σ	0..1	CodeableConcept	The status associated with the case Binding: ?? (preferred): The lifecycle status of an artifact.	Example/preferred bindings differ at RegulatedAuthorization.case.status using binding from RegulatedAuthorizationUvEpi
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
date[x]	Σ	0..1	Period, dateTime	Relevant date for this case.	Σ	0..1	Period, dateTime	Relevant date for this case
application	Σ	0..*	See case (RegulatedAuthorization)	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure	Σ	0..*	See case (RegulatedAuthorization)	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
Documentation for this format