type: resource-definitionsresource: RegulatedAuthorization

RegulatedAuthorization Definitions

RegulatedAuthorization

Regulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product

Definition: Regulatory approval, clearance or licensing 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.

Cardinality: 0..*

Mappings: idmp=Marketing Authorization, Clinical Trial Authorization; w5=administrative.medication

RegulatedAuthorization.identifier

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

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

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: idmp=Marketing Authorization.Marketing Authorization Number; w5=FiveWs.class

RegulatedAuthorization.subject

The product type, treatment, facility or activity that is being authorized

Definition: The product type, treatment, facility or activity that is being authorized.

Cardinality: 0..*

Type: Reference(MedicinalProductDefinition, BiologicallyDerivedProduct, NutritionProduct, PackagedProductDefinition, ManufacturedItemDefinition, Ingredient, SubstanceDefinition, DeviceDefinition, ResearchStudy, ActivityDefinition, PlanDefinition, ObservationDefinition, Practitioner, Organization, Location)

Summary: true

Mappings: idmp=(the link to Medicinal Product or Packaged Medicinal Product)

RegulatedAuthorization.type

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

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:regulated-authorization-type

Summary: true

Mappings: idmp=n/a

RegulatedAuthorization.description

General textual supporting information

Definition: General textual supporting information.

Cardinality: 0..1

Type: markdown

Summary: true

Mappings: idmp=n/a

RegulatedAuthorization.region

The territory in which the authorization has been granted

Definition: The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:jurisdiction

Summary: true

Mappings: idmp=Marketing Authorization.Country

RegulatedAuthorization.status

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

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

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:publication-status

Summary: true

Is Modifier: true (Reason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid)

Mappings: idmp=Marketing Authorization.Authorization Status

RegulatedAuthorization.statusDate

The date at which the current status was assigned

Definition: The date at which the current status was assigned.

Cardinality: 0..1

Type: dateTime

Summary: true

Mappings: idmp=Marketing Authorization.Authorization Status Date

RegulatedAuthorization.validityPeriod

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

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

Cardinality: 0..1

Type: Period

Summary: true

Mappings: idmp=Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End

RegulatedAuthorization.indication

Condition for which the use of the regulated product applies

Definition: Condition for which the use of the regulated product applies.

Cardinality: 0..*

Type: CodeableReference

Summary: true

Mappings: idmp=n/a

RegulatedAuthorization.intendedUse

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

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

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:product-intended-use

Summary: true

Mappings: idmp=n/a

RegulatedAuthorization.basis

The legal/regulatory framework or reasons under which this authorization is granted

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:regulated-authorization-basis

Summary: true

Mappings: idmp=Marketing Authorization.Status Reasons.Legal Grounds

RegulatedAuthorization.holder

The organization that has been granted this authorization, by the regulator

Definition: The organization that has been granted this authorization, by some authoritative body (the 'regulator').

Cardinality: 0..1

Type: Reference(Organization)

Summary: true

Mappings: idmp=Marketing Authorization.Marketing Authorization Holder (Organisation)

RegulatedAuthorization.regulator

The regulatory authority or authorizing body granting the authorization

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.

Cardinality: 0..1

Type: Reference(Organization)

Summary: true

Mappings: idmp=Marketing Authorization.Medicines Regulatory Agency (Organisation)

RegulatedAuthorization.attachedDocument

Additional information or supporting documentation about the authorization

Definition: Additional information or supporting documentation about the authorization.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp=n/a

RegulatedAuthorization.case

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)

Definition: The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).

Cardinality: 0..1

Type: BackboneElement

Summary: true

Mappings: idmp=Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application

RegulatedAuthorization.case.identifier

Identifier by which this case can be referenced

Definition: Identifier by which this case can be referenced.

Cardinality: 0..1

Type: Identifier

Summary: true

Mappings: idmp=Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number

RegulatedAuthorization.case.type

The defining type of case

Definition: The defining type of case.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:regulated-authorization-case-type

Summary: true

Mappings: idmp=Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type

RegulatedAuthorization.case.status

The status associated with the case

Definition: The status associated with the case.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:publication-status

Summary: true

Mappings: idmp=n/a

RegulatedAuthorization.case.date[x]

Relevant date for this case

Definition: Relevant date for this case.

Cardinality: 0..1

Type: Period, dateTime

Summary: true

Mappings: idmp=Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date

RegulatedAuthorization.case.application

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

Definition: A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.

Cardinality: 0..*

Summary: true

Mappings: idmp=Marketing Authorization.Marketing Authorization Application