Release 5 Draft Ballot
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

Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.

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

Business identifier for the authorization, typically this is 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 regulated product, treatment, facility or activity that is being authorized.

Cardinality0..1
TypeReference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location)
PatternsReference(MedicinalProductDefinition,BiologicallyDerivedProduct,NutritionProduct,PackagedProductDefinition,SubstanceDefinition,DeviceDefinition,ResearchStudy,ActivityDefinition,PlanDefinition,ObservationDefinition,Practitioner,Organization,Location): 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 territory (e.g., country, jurisdiction etc.) in which the 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 current status was assigned.

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

The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.

Cardinality0..1
TypePeriod
Summarytrue
RegulatedAuthorization.indication
Element IdRegulatedAuthorization.indication
Definition

Condition for which the use of the regulated product applies.

Cardinality0..1
TypeCodeableReference(ClinicalUseIssue)
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

The meaning of the related date for a regulated product, treatment, facility or activity. As an example, the data exclusivity period for a regulated 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

The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.

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

Additional information or supporting documentation about the authorization.

Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
RegulatedAuthorization.case
Element IdRegulatedAuthorization.case
Definition

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

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

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

Cardinality0..*
TypeSee RegulatedAuthorization.case
Summarytrue