RegulatedAuthorization

Release 5 Preview #1

This page is part of the FHIR Specification (v4.2.0: R5 Preview #1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

11.16.6 Resource RegulatedAuthorization - Detailed Descriptions

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the RegulatedAuthorization resource.

RegulatedAuthorization
Element Id	RegulatedAuthorization
Definition	The regulatory authorization of a medicinal product.
Cardinality	0..*
Type	DomainResource
Summary	true
RegulatedAuthorization.identifier
Element Id	RegulatedAuthorization.identifier
Definition	Business identifier for the marketing authorization, as assigned by a regulator.
Note	This is a business identifier, not a resource identifier (see discussion)
Cardinality	0..*
Type	Identifier
Summary	true
RegulatedAuthorization.subject
Element Id	RegulatedAuthorization.subject
Definition	The product that is being authorized.
Cardinality	0..1
Type	Reference(MedicinalProductDefinition \| PackagedProductDefinition \| DeviceDefinition \| ResearchStudy \| ActivityDefinition \| PlanDefinition \| ObservationDefinition)
Patterns	Reference(MedicinalProductDefinition,PackagedProductDefinition,DeviceDefinition,ResearchStudy,ActivityDefinition,PlanDefinition,ObservationDefinition): No common pattern
Summary	true
RegulatedAuthorization.type
Element Id	RegulatedAuthorization.type
Definition	Type of this authorization, for example drug marketing approval, orphan drug designation.
Cardinality	0..1
Type	CodeableConcept
Summary	true
RegulatedAuthorization.description
Element Id	RegulatedAuthorization.description
Definition	General textual supporting information.
Cardinality	0..1
Type	markdown
Summary	true
RegulatedAuthorization.region
Element Id	RegulatedAuthorization.region
Definition	The region (country, jurisdiction etc.) in which the marketing authorization has been granted.
Cardinality	0..*
Type	CodeableConcept
Summary	true
RegulatedAuthorization.status
Element Id	RegulatedAuthorization.status
Definition	The status of the marketing authorization.
Cardinality	0..1
Type	CodeableConcept
Summary	true
RegulatedAuthorization.statusDate
Element Id	RegulatedAuthorization.statusDate
Definition	The date at which the given status has become applicable.
Cardinality	0..1
Type	dateTime
Summary	true
RegulatedAuthorization.validityPeriod
Element Id	RegulatedAuthorization.validityPeriod
Definition	The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.
Cardinality	0..1
Type	Period
Summary	true
RegulatedAuthorization.basis
Element Id	RegulatedAuthorization.basis
Definition	The legal framework against which this authorization is granted, or other reasons for it.
Cardinality	0..*
Type	CodeableConcept
Summary	true
RegulatedAuthorization.relatedDate
Element Id	RegulatedAuthorization.relatedDate
Definition	Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on.
Cardinality	0..*
Summary	true
RegulatedAuthorization.relatedDate.date[x]
Element Id	RegulatedAuthorization.relatedDate.date[x]
Definition	Another date associated with the authorization.
Cardinality	1..1
Type	Period\|dateTime
[x] Note	See Choice of Data Types for further information about how to use [x]
Summary	true
RegulatedAuthorization.relatedDate.type
Element Id	RegulatedAuthorization.relatedDate.type
Definition	Type of this date, for example the data exclusitity period for a medicinal product.
Cardinality	1..1
Type	CodeableConcept
Summary	true
RegulatedAuthorization.jurisdictionalAuthorization
Element Id	RegulatedAuthorization.jurisdictionalAuthorization
Definition	Authorization in areas within a country.
Cardinality	0..*
Type	Reference(RegulatedAuthorization)
Summary	true
RegulatedAuthorization.holder
Element Id	RegulatedAuthorization.holder
Definition	Marketing Authorization Holder.
Cardinality	0..1
Type	Reference(Organization)
Summary	true
RegulatedAuthorization.regulator
Element Id	RegulatedAuthorization.regulator
Definition	Medicines Regulatory Agency.
Cardinality	0..1
Type	Reference(Organization)
Summary	true
RegulatedAuthorization.case
Element Id	RegulatedAuthorization.case
Definition	The case or regulatory procedure for granting or amending a marketing authorization.
Cardinality	0..1
Summary	true
RegulatedAuthorization.case.identifier
Element Id	RegulatedAuthorization.case.identifier
Definition	Identifier for this case.
Note	This is a business identifier, not a resource identifier (see discussion)
Cardinality	0..1
Type	Identifier
Summary	true
RegulatedAuthorization.case.type
Element Id	RegulatedAuthorization.case.type
Definition	Type of case.
Cardinality	0..1
Type	CodeableConcept
Summary	true
RegulatedAuthorization.case.status
Element Id	RegulatedAuthorization.case.status
Definition	The status of the case.
Cardinality	0..1
Type	CodeableConcept
Summary	true
RegulatedAuthorization.case.date[x]
Element Id	RegulatedAuthorization.case.date[x]
Definition	Date of case.
Cardinality	0..1
Type	Period\|dateTime
[x] Note	See Choice of Data Types for further information about how to use [x]
Summary	true
RegulatedAuthorization.case.application
Element Id	RegulatedAuthorization.case.application
Definition	Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure.
Cardinality	0..*
Type	See RegulatedAuthorization.case
Summary	true