Release 5 Preview #2
Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the RegulatedAuthorization resource.

RegulatedAuthorization
Element IdRegulatedAuthorization
Definition

The regulatory authorization of a medicinal product, device or process.

Cardinality0..*
TypeDomainResource
Summarytrue
RegulatedAuthorization.identifier
Element IdRegulatedAuthorization.identifier
Definition

Business identifier for the authorization, typically assigned by the authorizing body.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
RegulatedAuthorization.subject
Element IdRegulatedAuthorization.subject
Definition

The type of product or service that is being authorized.

Cardinality0..1
TypeReference(MedicinalProductDefinition | PackagedProductDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition)
PatternsReference(MedicinalProductDefinition,PackagedProductDefinition,DeviceDefinition,ResearchStudy,ActivityDefinition,PlanDefinition,ObservationDefinition): No common pattern
Summarytrue
RegulatedAuthorization.type
Element IdRegulatedAuthorization.type
Definition

Overall type of this authorization, for example drug marketing approval, orphan drug designation.

Cardinality0..1
TypeCodeableConcept
Summarytrue
RegulatedAuthorization.description
Element IdRegulatedAuthorization.description
Definition

General textual supporting information.

Cardinality0..1
Typemarkdown
Summarytrue
RegulatedAuthorization.region
Element IdRegulatedAuthorization.region
Definition

The region (country, jurisdiction etc.) in which the marketing authorization has been granted.

Cardinality0..*
TypeCodeableConcept
Summarytrue
RegulatedAuthorization.status
Element IdRegulatedAuthorization.status
Definition

The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications.

Cardinality0..1
TypeCodeableConcept
Summarytrue
RegulatedAuthorization.statusDate
Element IdRegulatedAuthorization.statusDate
Definition

The date at which the given status became applicable.

Cardinality0..1
TypedateTime
Summarytrue
RegulatedAuthorization.validityPeriod
Element IdRegulatedAuthorization.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.

Cardinality0..1
TypePeriod
Summarytrue
RegulatedAuthorization.indication[x]
Element IdRegulatedAuthorization.indication[x]
Definition

Condition for which the medicinal use applies.

Cardinality0..1
TypeCodeableConcept|Reference(ClinicalUseIssue)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
RegulatedAuthorization.intendedUse
Element IdRegulatedAuthorization.intendedUse
Definition

The intended use of the product, e.g. prevention, treatment.

Cardinality0..1
TypeCodeableConcept
Summarytrue
RegulatedAuthorization.basis
Element IdRegulatedAuthorization.basis
Definition

The legal or regulatory framework against which this authorization is granted, or other reasons for it.

Cardinality0..*
TypeCodeableConcept
Summarytrue
RegulatedAuthorization.relatedDate
Element IdRegulatedAuthorization.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.

Cardinality0..*
Summarytrue
RegulatedAuthorization.relatedDate.date[x]
Element IdRegulatedAuthorization.relatedDate.date[x]
Definition

Another date associated with the authorization.

Cardinality1..1
TypePeriod|dateTime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
RegulatedAuthorization.relatedDate.type
Element IdRegulatedAuthorization.relatedDate.type
Definition

Type of this date, for example the data exclusitity period for a medicinal product.

Cardinality1..1
TypeCodeableConcept
Summarytrue
RegulatedAuthorization.jurisdictionalAuthorization
Element IdRegulatedAuthorization.jurisdictionalAuthorization
Definition

Authorization in areas within a country.

Cardinality0..*
TypeReference(RegulatedAuthorization)
Summarytrue
RegulatedAuthorization.holder
Element IdRegulatedAuthorization.holder
Definition

The organization that holds the granted authorization.

Cardinality0..1
TypeReference(Organization)
Summarytrue
RegulatedAuthorization.regulator
Element IdRegulatedAuthorization.regulator
Definition

Medicines Regulatory Agency.

Cardinality0..1
TypeReference(Organization)
Summarytrue
RegulatedAuthorization.case
Element IdRegulatedAuthorization.case
Definition

The case or regulatory procedure for granting or amending a marketing authorization.

Cardinality0..1
Summarytrue
RegulatedAuthorization.case.identifier
Element IdRegulatedAuthorization.case.identifier
Definition

Identifier by which this case can be referenced.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..1
TypeIdentifier
Summarytrue
RegulatedAuthorization.case.type
Element IdRegulatedAuthorization.case.type
Definition

The defining type of case.

Cardinality0..1
TypeCodeableConcept
Summarytrue
RegulatedAuthorization.case.status
Element IdRegulatedAuthorization.case.status
Definition

The status associated with the case.

Cardinality0..1
TypeCodeableConcept
Summarytrue
RegulatedAuthorization.case.date[x]
Element IdRegulatedAuthorization.case.date[x]
Definition

Relevant date for this of case.

Cardinality0..1
TypePeriod|dateTime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
RegulatedAuthorization.case.application
Element IdRegulatedAuthorization.case.application
Definition

Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure.

Cardinality0..*
TypeSee RegulatedAuthorization.case
Summarytrue