UMC IDMP Request and Publish API
1.0.0 - CI Build International flag

UMC IDMP Request and Publish API, published by Uppsala Monitoring Centre. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/Uppsala-Monitoring-Centre/WHO-UMC-IDMP-Service/ and changes regularly. See the Directory of published versions

Resource Profile: Regulated Authorization (PhPID request)

Official URL: https://build.fhir.org/ig/Uppsala-Monitoring-Centre/WHO-UMC-IDMP-Service/StructureDefinition/RegulatedAuthorization-phpid-req Version: 1.0.0
Active as of 2026-08-05 Computable Name: RegulatedAuthorizationPhPIdReq

Regulated Authorization is a resource covering the authorization of a type of regulated product, treatment, facility or activity

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
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... holder Σ 1..1 Reference(Organization) The organization that has been granted this authorization, by the regulator

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression

This structure is derived from RegulatedAuthorization

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
... subject 1..1 Reference(MedicinalProductDefinition (request)) The product type, treatment, facility or activity that is being authorized
... holder 1..1 Reference(Organization) The organization that has been granted this authorization, by the regulator

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
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifier for the authorization, typically assigned by the authorizing body
... subject Σ 1..1 Reference(MedicinalProductDefinition (request)) 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: RegulatedAuthorizationType (example): Overall type of this authorization.
... description Σ 0..1 markdown General textual supporting information
... 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
... indication 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: ProductIntendedUse (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: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
... holder Σ 1..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.​language Base required All Languages 📍5.0.0 FHIR Std.
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.​intendedUse Base preferred Product Intended Use 📍5.0.0 FHIR Std.
RegulatedAuthorization.​basis Base example Regulated Authorization Basis 📍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

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
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... holder Σ 1..1 Reference(Organization) The organization that has been granted this authorization, by the regulator

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression

Differential View

This structure is derived from RegulatedAuthorization

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
... subject 1..1 Reference(MedicinalProductDefinition (request)) The product type, treatment, facility or activity that is being authorized
... holder 1..1 Reference(Organization) The organization that has been granted this authorization, by the regulator

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
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifier for the authorization, typically assigned by the authorizing body
... subject Σ 1..1 Reference(MedicinalProductDefinition (request)) 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: RegulatedAuthorizationType (example): Overall type of this authorization.
... description Σ 0..1 markdown General textual supporting information
... 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
... indication 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: ProductIntendedUse (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: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
... holder Σ 1..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.​language Base required All Languages 📍5.0.0 FHIR Std.
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.​intendedUse Base preferred Product Intended Use 📍5.0.0 FHIR Std.
RegulatedAuthorization.​basis Base example Regulated Authorization Basis 📍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

 

Other representations of profile: CSV, Excel, Schematron