http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|5.0.0
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.
| Name | Flags | Card | Type | Description & Constraints |
|---|---|---|---|---|
RegulatedAuthorization | 0..* | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | ||
Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body | |
Σ | 0..* | Reference | The product type, treatment, facility or activity that is being authorized | |
Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation RegulatedAuthorizationType (example) | |
Σ | 0..1 | markdown | General textual supporting information | |
Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Jurisdiction (example) | |
Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications PublicationStatus (preferred) | |
Σ | 0..1 | dateTime | The date at which the current status was assigned | |
Σ | 0..1 | Period | 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 | |
Σ | 0..* | CodeableReference | Condition for which the use of the regulated product applies | |
Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment ProductIntendedUse (preferred) | |
Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted RegulatedAuthorizationBasis (example) | |
Σ | 0..1 | Reference | The organization that has been granted this authorization, by the regulator | |
Σ | 0..1 | Reference | The regulatory authority or authorizing body granting the authorization | |
Σ | 0..* | Reference | Additional information or supporting documentation about the authorization | |
Σ | 0..1 | BackboneElement | 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) | |
Σ | 0..1 | Identifier | Identifier by which this case can be referenced | |
Σ | 0..1 | CodeableConcept | The defining type of case RegulatedAuthorizationCaseType (example) | |
Σ | 0..1 | CodeableConcept | The status associated with the case PublicationStatus (preferred) | |
Σ | 0..1 | Relevant date for this case | ||
Σ | 0..1 | Period | ||
Σ | 0..1 | dateTime | ||
Σ | 0..* | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure |