abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitle- Values Differ
typeurlversion- Values Differ
| Left: | IDMP RegulatedAuthorization (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization) |
| Right: | RegulatedAuthorization (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0' vs '1.0.1' |
| Information | StructureDefinition.title | Values for title differ: 'IDMP RegulatedAuthorization' vs 'RegulatedAuthorization' |
| Information | StructureDefinition.date | Values for date differ: '2025-12-11T12:29:57+00:00' vs '2026-03-30T16:12:04+00:00' |
| Information | StructureDefinition.short | Values for short differ: 'IDMP RegulatedAuthorization' vs 'RegulatedAuthorization' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization | ||
| copyright | CC0-1.0 | ||
| date | 2025-12-11T12:29:57+00:00 | 2026-03-30T16:12:04+00:00 |
|
| description | Profile of the RegulatedAuthorization resource for representing the market authorization of a (packaged) medicinal product. | ||
| experimental | |||
| fhirVersion | 5.0.0 | ||
| jurisdiction | |||
| jurisdiction[0] | urn:iso:std:iso:3166#CH | ||
| kind | resource | ||
| name | CHIDMPRegulatedAuthorization | ||
| publisher | Federal Office of Public Health FOPH | ||
| purpose | |||
| status | active | ||
| title | IDMP RegulatedAuthorization | RegulatedAuthorization |
|
| type | RegulatedAuthorization | ||
| url | http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization | ||
| version | 1.0.0 | 1.0.1 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 RegulatedAuthorization | 0..* | RegulatedAuthorization | IDMP RegulatedAuthorization | 0..* | RegulatedAuthorization | RegulatedAuthorization | |||||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| |||||||||||
| text | 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..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 | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body | Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body | |||||||||
| subject | Σ | 0..* | Reference(IDMP MedicinalProductDefinition | IDMP PackagedProductDefinition | CH IDMP ManufacturedItemDefinition | IDMP Ingredient) | The product type, treatment, facility or activity that is being authorized | Σ | 0..* | Reference(MedicinalProductDefinition | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient) | 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: ?? (required) | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: ?? (required) | |||||||||
 id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| Slices for coding | Σ | 0..1 | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system | Σ | 0..1 | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system | |||||||||
| text | Σ | 0..1 | string | Plain text representation of the concept | Σ | 0..1 | string | Plain text representation of the concept | |||||||||
| description | Σ | 0..1 | markdown | General textual supporting information | Σ | 0..1 | markdown | General textual supporting information | |||||||||
| region | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ?? (example): Jurisdiction codes Required Pattern: {"coding":[{"system":"urn:iso:std:iso:3166","code":"CH"}]} | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ?? (example): Jurisdiction codes Required Pattern: {"coding":[{"system":"urn:iso:std:iso:3166","code":"CH"}]} | |||||||||
| status | Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: ?? (required) | Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: ?? (required) | |||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| Slices for coding | Σ | 1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system | Σ | 1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system | |||||||||
| text | Σ | 0..1 | string | Plain text representation of the concept | Σ | 0..1 | string | Plain text representation of the concept | |||||||||
| statusDate | Σ | 0..1 | dateTime | The date at which the current status was assigned | 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 | 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 | 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: ?? (preferred): The overall intended use of a product. | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment Binding: ?? (preferred): The overall intended use of a product. | |||||||||
| basis | 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..* | 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. | |||||||||
| holder | Σ | 0..1 | Reference(Organization) {c} | The organization that has been granted this authorization, by the regulator | Σ | 0..1 | Reference(Organization) {c} | The organization that has been granted this authorization, by the regulator | |||||||||
| regulator | Σ | 0..1 | Reference(Organization) {c} | The regulatory authority or authorizing body granting the authorization | Σ | 0..1 | Reference(Organization) {c} | The regulatory authority or authorizing body granting the authorization | |||||||||
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization | 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) | 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) | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| identifier | Σ | 0..1 | Identifier | Identifier by which this case can be referenced | Σ | 0..1 | Identifier | Identifier by which this case can be referenced | |||||||||
| type | 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 defining type of case Binding: ?? (example): The type of a case involved in an application. | |||||||||
| status | Σ | 0..1 | CodeableConcept | The status associated with the case Binding: ?? (preferred): The lifecycle status of an artifact. | Σ | 0..1 | CodeableConcept | The status associated with the case Binding: ?? (preferred): The lifecycle status of an artifact. | |||||||||
| date[x] | Σ | 0..1 | Period, dateTime | Relevant date for this case | Σ | 0..1 | Period, dateTime | Relevant date for this case | |||||||||
 application | Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | |||||||||
| Documentation for this format | |||||||||||||||||