This is the set of resources that conform to either of the profiles IDMP RegulatedAuthorization (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization) and RegulatedAuthorization (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization). E.g. what you have to deal with if you get resources conforming to one of them
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() | 0..* | left: IDMP RegulatedAuthorization; right: RegulatedAuthorization | ||
![]() ![]() | Σ | 0..1 | Meta | Metadata about the resource |
![]() ![]() | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language | |
![]() ![]() | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |
![]() ![]() | 0..* | Resource | Contained, inline Resources | |
![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() | Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body |
![]() ![]() | Σ | 0..* | Reference(IDMP MedicinalProductDefinition | IDMP PackagedProductDefinition | CH IDMP ManufacturedItemDefinition | IDMP Ingredient | #sd+33-ch-idmp-medicinalproductdefinition-ch-idmp-medicinalproductdefinition) | 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 Binding: ?? (required) |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() | Σ | 0..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() | Σ | 0..1 | markdown | General textual supporting information |
![]() ![]() | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ?? (example): Jurisdiction codes |
![]() ![]() | Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: ?? (required) |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() | Σ | 1..* | Coding | Code defined by a terminology system |
![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() | 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(ClinicalUseDefinition) | Condition for which the use of the regulated product applies |
![]() ![]() | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment Binding: ?? (preferred): The overall intended use of a product. |
![]() ![]() | Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted Binding: ?? (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it. |
![]() ![]() | Σ | 0..1 | Reference(Organization) {c} | The organization that has been granted this authorization, by the regulator |
![]() ![]() | Σ | 0..1 | Reference(Organization) {c} | The regulatory authority or authorizing body granting the authorization |
![]() ![]() | Σ | 0..* | Reference(DocumentReference) | 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) |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() | Σ | 0..1 | Identifier | Identifier by which this case can be referenced |
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | The defining type of case Binding: ?? (example): The type of a case involved in an application. |
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | The status associated with the case Binding: ?? (preferred): The lifecycle status of an artifact. |
![]() ![]() ![]() | Σ | 0..1 | Relevant date for this case | |
![]() ![]() ![]() ![]() | Period | |||
![]() ![]() ![]() ![]() | dateTime | |||
![]() ![]() ![]() | Σ | 0..* | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | |
Documentation for this format | ||||