| Name | Flags | Card. | Type | Description & Constraints |
|---|
  RegulatedAuthorization | TU | | DomainResource | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension |
  identifier | Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body
|
 subject | Σ | 0..* | Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) | The product type, treatment, facility or activity that is being authorized
|
| type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: Regulated Authorization Type (Example)
|
 description | Σ | 0..1 | markdown | General textual supporting information
|
| region | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted
Binding: Jurisdiction ValueSet (Example)
|
| status | Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: PublicationStatus (Preferred)
|
| statusDate | Σ | 0..1 | dateTime | The date at which the current status was assigned
|
| validityPeriod | 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
|
| indication | Σ | 0..* | CodeableReference(ClinicalUseDefinition) | Condition for which the use of the regulated product applies
|
| intendedUse | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment
Binding: Product Intended Use (Preferred)
|
| basis | Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted
Binding: Regulated Authorization Basis (Example)
|
| holder | Σ | 0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator
|
| regulator | Σ | 0..1 | Reference(Organization) | The regulatory authority or authorizing body granting the authorization
|
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization
|
  case | 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)
|
 identifier | Σ | 0..1 | Identifier | Identifier by which this case can be referenced
|
| type | Σ | 0..1 | CodeableConcept | The defining type of case
Binding: Regulated Authorization Case Type (Example)
|
| status | Σ | 0..1 | CodeableConcept | The status associated with the case
Binding: PublicationStatus (Preferred)
|
 date[x] | Σ | 0..1 | | Relevant date for this case
|
 datePeriod | | | Period | |
| dateDateTime | | | dateTime | |
 application | Σ | 0..* | see case | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
|
Documentation for this format |