EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorizationRestrictions | Version: 1.2.0 | |||
| Draft as of 2025-08-08 | Computable Name: EmaWriteApiRegulatedAuthorizationRestrictions | |||
Defines the rule a Marketing RegulatedAuthorization resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |
Documentation for this format | ||||
This structure is derived from RegulatedAuthorization
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
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RegulatedAuthorization | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact |
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() |
Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body |
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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 |
![]() ![]() |
Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization. |
![]() ![]() |
Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: JurisdictionValueSet (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: PublicationStatus (preferred): The lifecycle status of an artifact. |
![]() ![]() |
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..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator |
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Σ | 0..1 | Reference(Organization) | The regulatory authority or authorizing body granting the authorization |
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Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization |
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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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0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() |
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: RegulatedAuthorizationCaseType (example): The type of a case involved in an application. |
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
![]() ![]() ![]() |
Σ | 0..1 | Relevant date for this case | |
![]() ![]() ![]() ![]() |
Period | |||
![]() ![]() ![]() ![]() |
dateTime | |||
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Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| RegulatedAuthorization.type | example | RegulatedAuthorizationTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-typefrom the FHIR Standard | |
| RegulatedAuthorization.region | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-typefrom the FHIR Standard | |
| RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard |
This structure is derived from RegulatedAuthorization
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |
Documentation for this format | ||||
Differential View
This structure is derived from RegulatedAuthorization
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
RegulatedAuthorization | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
![]() ![]() |
0..0 | |||
Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact |
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() |
Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body |
![]() ![]() |
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 |
![]() ![]() |
Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization. |
![]() ![]() |
Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: JurisdictionValueSet (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: PublicationStatus (preferred): The lifecycle status of an artifact. |
![]() ![]() |
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..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator |
![]() ![]() |
Σ | 0..1 | Reference(Organization) | 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..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() |
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: RegulatedAuthorizationCaseType (example): The type of a case involved in an application. |
![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
![]() ![]() ![]() |
Σ | 0..1 | Relevant date for this case | |
![]() ![]() ![]() ![]() |
Period | |||
![]() ![]() ![]() ![]() |
dateTime | |||
![]() ![]() ![]() |
Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| RegulatedAuthorization.type | example | RegulatedAuthorizationTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-typefrom the FHIR Standard | |
| RegulatedAuthorization.region | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-typefrom the FHIR Standard | |
| RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard |
This structure is derived from RegulatedAuthorization
Other representations of profile: CSV, Excel, Schematron