UMC IDMP Request and Publish API
0.1.0 - 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 0.1.0 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

Official URL: http://who-umc.org/idmp/StructureDefinition/RegulatedAuthorization-who-php Version: 0.1.0
Active as of 2025-06-18 Computable Name: RegulatedAuthorizationWhoPhpRequest

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

Usages:

  • This Profile is not used by any profiles in this Implementation Guide

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

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf 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-4errorRegulatedAuthorizationIf 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-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

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 for PhPID 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 for PhPID 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

PathConformanceValueSetURI
RegulatedAuthorization.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
From the FHIR Standard
RegulatedAuthorization.typeexampleRegulatedAuthorizationType
http://hl7.org/fhir/ValueSet/regulated-authorization-type
From the FHIR Standard
RegulatedAuthorization.regionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
From the FHIR Standard
RegulatedAuthorization.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard
RegulatedAuthorization.intendedUsepreferredProductIntendedUse
http://hl7.org/fhir/ValueSet/product-intended-use
From the FHIR Standard
RegulatedAuthorization.basisexampleRegulatedAuthorizationBasis
http://hl7.org/fhir/ValueSet/regulated-authorization-basis
From the FHIR Standard
RegulatedAuthorization.case.typeexampleRegulatedAuthorizationCaseType
http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
From the FHIR Standard
RegulatedAuthorization.case.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf 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-4errorRegulatedAuthorizationIf 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-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

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

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf 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-4errorRegulatedAuthorizationIf 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-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

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 for PhPID 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 for PhPID 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

PathConformanceValueSetURI
RegulatedAuthorization.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
From the FHIR Standard
RegulatedAuthorization.typeexampleRegulatedAuthorizationType
http://hl7.org/fhir/ValueSet/regulated-authorization-type
From the FHIR Standard
RegulatedAuthorization.regionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
From the FHIR Standard
RegulatedAuthorization.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard
RegulatedAuthorization.intendedUsepreferredProductIntendedUse
http://hl7.org/fhir/ValueSet/product-intended-use
From the FHIR Standard
RegulatedAuthorization.basisexampleRegulatedAuthorizationBasis
http://hl7.org/fhir/ValueSet/regulated-authorization-basis
From the FHIR Standard
RegulatedAuthorization.case.typeexampleRegulatedAuthorizationCaseType
http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
From the FHIR Standard
RegulatedAuthorization.case.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf 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-4errorRegulatedAuthorizationIf 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-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron