EMA Write PMS API Implementation Guide - Enrichments
1.2.1 - ci-build

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Resource Profile: EMA Write API Marketing Regulated Authorization

Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorizationRestrictions Version: 1.2.1
Draft as of 2026-06-26 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

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
dom-2 error RegulatedAuthorization If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error RegulatedAuthorization 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error RegulatedAuthorization If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error RegulatedAuthorization If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice RegulatedAuthorization A resource should have narrative for robust management text.`div`.exists()

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization RegulatedAuthorization
... meta 0..0 Metadata about the resource
... implicitRules 0..0 A set of rules under which this content was created
... language 0..0 Language of the resource content
... contained 0..0 Contained, inline Resources
... modifierExtension 0..0 Extension
... description 0..0 General textual supporting information
... indication 0..0 Condition for which the use of the regulated product applies
... intendedUse 0..0 The intended use of the product, e.g. prevention, treatment
... basis 0..0 The legal/regulatory framework or reasons under which this authorization is granted

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
... id Σ 0..1 id Logical id of this artifact
... extension 0..* Extension Additional content defined by implementations
... identifier Σ 0..* Identifier Business identifier for the authorization, typically assigned by the authorizing body
... type 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.
... region Σ 0..* CodeableConcept The territory in which the authorization has been granted
Binding: JurisdictionValueSet (example): Jurisdiction codes
... 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): The lifecycle status of an artifact.
... 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
... 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)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..1 Identifier Identifier by which this case can be referenced
.... type Σ 0..1 CodeableConcept The defining type of case
Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
.... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... date[x] Σ 0..1 Relevant date for this case
..... datePeriod Period
..... dateDateTime dateTime
.... application Σ 0..* See case (RegulatedAuthorization) Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​type Base example Regulated Authorization Type 📍5.0.0 FHIR Std.
RegulatedAuthorization.​region Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
RegulatedAuthorization.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.type Base example Regulated Authorization Case Type 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.status Base preferred PublicationStatus 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error RegulatedAuthorization If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error RegulatedAuthorization 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error RegulatedAuthorization If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error RegulatedAuthorization If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice RegulatedAuthorization A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Summary

Prohibited: 10 elements

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
dom-2 error RegulatedAuthorization If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error RegulatedAuthorization 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error RegulatedAuthorization If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error RegulatedAuthorization If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice RegulatedAuthorization A resource should have narrative for robust management text.`div`.exists()

Differential View

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization RegulatedAuthorization
... meta 0..0 Metadata about the resource
... implicitRules 0..0 A set of rules under which this content was created
... language 0..0 Language of the resource content
... contained 0..0 Contained, inline Resources
... modifierExtension 0..0 Extension
... description 0..0 General textual supporting information
... indication 0..0 Condition for which the use of the regulated product applies
... intendedUse 0..0 The intended use of the product, e.g. prevention, treatment
... basis 0..0 The legal/regulatory framework or reasons under which this authorization is granted

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
... id Σ 0..1 id Logical id of this artifact
... extension 0..* Extension Additional content defined by implementations
... identifier Σ 0..* Identifier Business identifier for the authorization, typically assigned by the authorizing body
... type 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.
... region Σ 0..* CodeableConcept The territory in which the authorization has been granted
Binding: JurisdictionValueSet (example): Jurisdiction codes
... 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): The lifecycle status of an artifact.
... 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
... 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)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..1 Identifier Identifier by which this case can be referenced
.... type Σ 0..1 CodeableConcept The defining type of case
Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
.... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... date[x] Σ 0..1 Relevant date for this case
..... datePeriod Period
..... dateDateTime dateTime
.... application Σ 0..* See case (RegulatedAuthorization) Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​type Base example Regulated Authorization Type 📍5.0.0 FHIR Std.
RegulatedAuthorization.​region Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
RegulatedAuthorization.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.type Base example Regulated Authorization Case Type 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.status Base preferred PublicationStatus 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error RegulatedAuthorization If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error RegulatedAuthorization 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error RegulatedAuthorization If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error RegulatedAuthorization If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice RegulatedAuthorization A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Summary

Prohibited: 10 elements

 

Other representations of profile: CSV, Excel, Schematron