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
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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
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indication | Σ | 0..* | CodeableReference( ClinicalUseDefinition) | Condition for which the use of the regulated product applies
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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
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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)
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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
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Documentation for this format |