UMC IDMP Request and Publish API
0.1.0 - CI Build

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 2025-11-19 | 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

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.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
subject | Σ | 1..1 | Reference(MedicinalProductDefinition for PhPID request) | The product type, treatment, facility or activity that is being authorized
holder | Σ | 1..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator
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()`
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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
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
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
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

Mandatory: 2 elements

Structures

This structure refers to these other structures:

- MedicinalProductDefinition for PhPID request (http://who-umc.org/idmp/StructureDefinition/MedicinalProductDefinition-who-php-req)

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
subject | Σ | 1..1 | Reference(MedicinalProductDefinition for PhPID request) | The product type, treatment, facility or activity that is being authorized
holder | Σ | 1..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator
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()`
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()`

Differential View

This structure is derived from RegulatedAuthorization

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
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
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
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

Mandatory: 2 elements

Structures

This structure refers to these other structures:

- MedicinalProductDefinition for PhPID request (http://who-umc.org/idmp/StructureDefinition/MedicinalProductDefinition-who-php-req)

Other representations of profile: CSV, Excel, Schematron