This page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). 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
Biomedical Research and Regulation Work Group | Maturity Level: 2 | 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 | 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. |
Short Display | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product |
Cardinality | 0..* |
Type | DomainResource |
Summary | false |
RegulatedAuthorization.identifier | |
Element Id | RegulatedAuthorization.identifier |
Definition | Business identifier for the authorization, typically assigned by the authorizing body. |
Short Display | Business identifier for the authorization, typically assigned by the authorizing body |
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 type, treatment, facility or activity that is being authorized. |
Short Display | 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 |
RegulatedAuthorization.type | |
Element Id | RegulatedAuthorization.type |
Definition | Overall type of this authorization, for example drug marketing approval, orphan drug designation. |
Short Display | Overall type of this authorization, for example drug marketing approval, orphan drug designation |
Cardinality | 0..1 |
Terminology Binding | RegulatedAuthorizationType (Example) |
Type | CodeableConcept |
Summary | true |
RegulatedAuthorization.description | |
Element Id | RegulatedAuthorization.description |
Definition | General textual supporting information. |
Short Display | General textual supporting information |
Cardinality | 0..1 |
Type | markdown |
Summary | true |
RegulatedAuthorization.region | |
Element Id | RegulatedAuthorization.region |
Definition | The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted. |
Short Display | The territory in which the authorization has been granted |
Cardinality | 0..* |
Terminology Binding | Jurisdiction (Example) |
Type | CodeableConcept |
Summary | true |
RegulatedAuthorization.status | |
Element Id | RegulatedAuthorization.status |
Definition | The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications. |
Short Display | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications |
Cardinality | 0..1 |
Terminology Binding | PublicationStatus (Preferred) |
Type | CodeableConcept |
Summary | true |
RegulatedAuthorization.statusDate | |
Element Id | RegulatedAuthorization.statusDate |
Definition | The date at which the current status was assigned. |
Short Display | The date at which the current status was assigned |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
RegulatedAuthorization.validityPeriod | |
Element Id | RegulatedAuthorization.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. |
Short Display | 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 |
Cardinality | 0..1 |
Type | Period |
Summary | true |
RegulatedAuthorization.indication | |
Element Id | RegulatedAuthorization.indication |
Definition | Condition for which the use of the regulated product applies. |
Short Display | Condition for which the use of the regulated product applies |
Cardinality | 0..* |
Type | CodeableReference(ClinicalUseDefinition) |
Summary | true |
RegulatedAuthorization.intendedUse | |
Element Id | RegulatedAuthorization.intendedUse |
Definition | The intended use of the product, e.g. prevention, treatment, diagnosis. |
Short Display | The intended use of the product, e.g. prevention, treatment |
Cardinality | 0..1 |
Terminology Binding | ProductIntendedUse (Preferred) |
Type | CodeableConcept |
Summary | true |
RegulatedAuthorization.basis | |
Element Id | RegulatedAuthorization.basis |
Definition | The legal or regulatory framework against which this authorization is granted, or other reasons for it. |
Short Display | The legal/regulatory framework or reasons under which this authorization is granted |
Cardinality | 0..* |
Terminology Binding | RegulatedAuthorizationBasis (Example) |
Type | CodeableConcept |
Summary | true |
RegulatedAuthorization.holder | |
Element Id | RegulatedAuthorization.holder |
Definition | The organization that has been granted this authorization, by some authoritative body (the 'regulator'). |
Short Display | The organization that has been granted this authorization, by the regulator |
Cardinality | 0..1 |
Type | Reference(Organization) |
Summary | true |
RegulatedAuthorization.regulator | |
Element Id | RegulatedAuthorization.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. |
Short Display | The regulatory authority or authorizing body granting the authorization |
Cardinality | 0..1 |
Type | Reference(Organization) |
Summary | true |
RegulatedAuthorization.attachedDocument | |
Element Id | RegulatedAuthorization.attachedDocument |
Definition | Additional information or supporting documentation about the authorization. |
Short Display | Additional information or supporting documentation about the authorization |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
RegulatedAuthorization.case | |
Element Id | RegulatedAuthorization.case |
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). |
Short Display | 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) |
Cardinality | 0..1 |
Summary | true |
RegulatedAuthorization.case.identifier | |
Element Id | RegulatedAuthorization.case.identifier |
Definition | Identifier by which this case can be referenced. |
Short Display | Identifier by which this case can be referenced |
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 | The defining type of case. |
Short Display | The defining type of case |
Cardinality | 0..1 |
Terminology Binding | RegulatedAuthorizationCaseType (Example) |
Type | CodeableConcept |
Summary | true |
RegulatedAuthorization.case.status | |
Element Id | RegulatedAuthorization.case.status |
Definition | The status associated with the case. |
Short Display | The status associated with the case |
Cardinality | 0..1 |
Terminology Binding | PublicationStatus (Preferred) |
Type | CodeableConcept |
Summary | true |
RegulatedAuthorization.case.date[x] | |
Element Id | RegulatedAuthorization.case.date[x] |
Definition | Relevant date for this case. |
Short Display | Relevant date for this case |
Cardinality | 0..1 |
Type | Period|dateTime |
[x] Note | See Choice of Datatypes for further information about how to use [x] |
Summary | true |
RegulatedAuthorization.case.application | |
Element Id | RegulatedAuthorization.case.application |
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. |
Short Display | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure |
Cardinality | 0..* |
Type | See RegulatedAuthorization.case |
Summary | true |