Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Resource Profile: RegulatedAuthorization (ePI)

Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi Version: 1.1.0
Standards status: Trial-use Active as of 2026-04-03 Computable Name: RegulatedAuthorizationUvEpi

RegulatedAuthorization (ePI)

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

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
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... subject Σ 1..* Reference(MedicinalProductDefinition (ePI) | PackagedProductDefinition (ePI)) The product type, treatment, facility or activity that is being authorized
... statusDate Σ 0..1 dateTime The date at which the current status was assigned.
... holder Σ 1..1 Reference(Organization (ePI)) The organization that has been granted this authorization, by the regulator
... regulator Σ 0..1 Reference(Organization (ePI)) The regulatory authority or authorizing body granting the authorization
... case Σ 0..1 BackboneElement The case or regulatory procedure for granting or amending a regulated authorization.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​identifier.use Base required IdentifierUse 📍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()

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
... identifier 1..* Identifier Business identifier for the authorization, typically assigned by the authorizing body
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... subject 1..* Reference(MedicinalProductDefinition (ePI) | PackagedProductDefinition (ePI)) The product type, treatment, facility or activity that is being authorized
... type
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... statusDate 0..1 dateTime The date at which the current status was assigned.
... indication
.... concept
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
... basis
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... holder 1..1 Reference(Organization (ePI)) The organization that has been granted this authorization, by the regulator
... regulator 0..1 Reference(Organization (ePI)) The regulatory authority or authorizing body granting the authorization
... case 0..1 BackboneElement The case or regulatory procedure for granting or amending a regulated authorization.
.... identifier
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... type
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... status
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system

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 1..* Identifier Business identifier for the authorization, typically assigned by the authorizing body
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... subject Σ 1..* Reference(MedicinalProductDefinition (ePI) | PackagedProductDefinition (ePI)) 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... 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
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... concept Σ 0..1 CodeableConcept Reference to a concept (by class)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... reference Σ 0..1 Reference() Reference to a resource (by instance)
... 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... holder Σ 1..1 Reference(Organization (ePI)) The organization that has been granted this authorization, by the regulator
... regulator Σ 0..1 Reference(Organization (ePI)) 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.
.... 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
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... type Σ 0..1 CodeableConcept The defining type of case
Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... 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.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
RegulatedAuthorization.​identifier.type Base extensible Identifier Type Codes 📍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.identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.identifier.type Base extensible Identifier Type Codes 📍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()

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
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... subject Σ 1..* Reference(MedicinalProductDefinition (ePI) | PackagedProductDefinition (ePI)) The product type, treatment, facility or activity that is being authorized
... statusDate Σ 0..1 dateTime The date at which the current status was assigned.
... holder Σ 1..1 Reference(Organization (ePI)) The organization that has been granted this authorization, by the regulator
... regulator Σ 0..1 Reference(Organization (ePI)) The regulatory authority or authorizing body granting the authorization
... case Σ 0..1 BackboneElement The case or regulatory procedure for granting or amending a regulated authorization.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​identifier.use Base required IdentifierUse 📍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()

Differential 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
... identifier 1..* Identifier Business identifier for the authorization, typically assigned by the authorizing body
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... subject 1..* Reference(MedicinalProductDefinition (ePI) | PackagedProductDefinition (ePI)) The product type, treatment, facility or activity that is being authorized
... type
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... statusDate 0..1 dateTime The date at which the current status was assigned.
... indication
.... concept
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
... basis
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... holder 1..1 Reference(Organization (ePI)) The organization that has been granted this authorization, by the regulator
... regulator 0..1 Reference(Organization (ePI)) The regulatory authority or authorizing body granting the authorization
... case 0..1 BackboneElement The case or regulatory procedure for granting or amending a regulated authorization.
.... identifier
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... type
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... status
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system

doco Documentation for this format

Snapshot ViewView

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 1..* Identifier Business identifier for the authorization, typically assigned by the authorizing body
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... subject Σ 1..* Reference(MedicinalProductDefinition (ePI) | PackagedProductDefinition (ePI)) 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... 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
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... concept Σ 0..1 CodeableConcept Reference to a concept (by class)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... reference Σ 0..1 Reference() Reference to a resource (by instance)
... 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... holder Σ 1..1 Reference(Organization (ePI)) The organization that has been granted this authorization, by the regulator
... regulator Σ 0..1 Reference(Organization (ePI)) 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.
.... 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
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... type Σ 0..1 CodeableConcept The defining type of case
Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... 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.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
RegulatedAuthorization.​identifier.type Base extensible Identifier Type Codes 📍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.identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.identifier.type Base extensible Identifier Type Codes 📍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()

 

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