European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
0.4.0 - ci-build

European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v0.4.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EU EPI Regulated Authorization

Official URL: http://ema.europa.eu/fhir/StructureDefinition/EUEpiRegulatedAuthorization Version: 0.4.0
Draft as of 2024-10-25 Computable Name: EUEpiRegulatedAuthorization

This profile represents the constraints applied to the RegulatedAuthorization resource used to create ePI, as defined by the EU ePI Common Standard.

This profile represents the constraints applied to the RegulatedAuthorization resource used to create an Electronic Product Information (EPI).

Usage:

Formal Views of Profile Content

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

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... text 0..1 Narrative Text summary of the resource, for human interpretation.
... identifier 1..1 Identifier Identifier assigned by the health authority to the approval of an electronic medicinal product information.
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... subject 1..1 Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) In current implementation, a reference to the master list resource of the approved ePI.
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
.... display 1..1 string Text alternative for the resource
... description 1..1 markdown Brief description of the authorization.
... region 1..1 CodeableConcept The EU member states in which the authorization has been granted.
... status 1..1 CodeableConcept The current status of this authorization.
... statusDate 1..1 dateTime The date at which the current status was assigned.
... validityPeriod 1..1 Period The time period in which the regulatory approval is in effect, includes the date of authorization and/or expiration date.
... holder 1..1 Reference(Organization) The organization that has been granted this authorization, by the regulator.
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
.... display 1..1 string Text alternative for the resource
... regulator 1..1 Reference(Organization) The regulatory authority - EMA or NCA - granting the authorization.
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
.... display 1..1 string Text alternative for the resource
... case
.... identifier 1..1 Identifier Identifier by which this case can be referenced.
.... type 1..1 CodeableConcept The defining type of case.

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... text 0..1 Narrative Text summary of the resource, for human interpretation.
... contained 0..* Resource Contained, inline Resources
... identifier Σ 1..1 Identifier Identifier assigned by the health authority to the approval of an electronic medicinal product information.
.... 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..1 Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) In current implementation, a reference to the master list resource of the approved ePI.
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... type Σ 1..1 CodeableConcept Overall type of this authorization, the approval of an electronic medicinal product information.
Binding: RegulatedAuthorizationType (example): Overall type of this authorization.

... description Σ 1..1 markdown Brief description of the authorization.
... region Σ 1..1 CodeableConcept The EU member states in which the authorization has been granted.
Binding: JurisdictionValueSet (example): Jurisdiction codes


... status Σ 1..1 CodeableConcept The current status of this authorization.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 1..1 dateTime The date at which the current status was assigned.
... validityPeriod Σ 1..1 Period The time period in which the regulatory approval is in effect, includes the date of authorization and/or expiration date.
... holder Σ 1..1 Reference(Organization) The organization that has been granted this authorization, by the regulator.
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... regulator Σ 1..1 Reference(Organization) The regulatory authority - EMA or NCA - granting the authorization.
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
RegulatedAuthorization.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|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
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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.
... 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..1 Identifier Identifier assigned by the health authority to the approval of an electronic medicinal product information.
.... 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..1 Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) In current implementation, a reference to the master list resource of the approved ePI.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... type Σ 1..1 CodeableConcept Overall type of this authorization, the approval of an electronic medicinal product information.
Binding: RegulatedAuthorizationType (example): Overall type of this authorization.

... description Σ 1..1 markdown Brief description of the authorization.
... region Σ 1..1 CodeableConcept The EU member states in which the authorization has been granted.
Binding: JurisdictionValueSet (example): Jurisdiction codes


... status Σ 1..1 CodeableConcept The current status of this authorization.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 1..1 dateTime The date at which the current status was assigned.
... validityPeriod Σ 1..1 Period The time period in which the regulatory approval is in effect, 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... regulator Σ 1..1 Reference(Organization) The regulatory authority - EMA or NCA - granting the 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
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... 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 1..1 Identifier Identifier by which this case can be referenced.
.... type Σ 1..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.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
RegulatedAuthorization.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
RegulatedAuthorization.subject.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
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.holder.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
RegulatedAuthorization.regulator.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
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

This structure is derived from RegulatedAuthorization

Summary

Mandatory: 18 elements(2 nested mandatory elements)

Differential View

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... text 0..1 Narrative Text summary of the resource, for human interpretation.
... identifier 1..1 Identifier Identifier assigned by the health authority to the approval of an electronic medicinal product information.
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... subject 1..1 Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) In current implementation, a reference to the master list resource of the approved ePI.
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
.... display 1..1 string Text alternative for the resource
... description 1..1 markdown Brief description of the authorization.
... region 1..1 CodeableConcept The EU member states in which the authorization has been granted.
... status 1..1 CodeableConcept The current status of this authorization.
... statusDate 1..1 dateTime The date at which the current status was assigned.
... validityPeriod 1..1 Period The time period in which the regulatory approval is in effect, includes the date of authorization and/or expiration date.
... holder 1..1 Reference(Organization) The organization that has been granted this authorization, by the regulator.
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
.... display 1..1 string Text alternative for the resource
... regulator 1..1 Reference(Organization) The regulatory authority - EMA or NCA - granting the authorization.
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
.... display 1..1 string Text alternative for the resource
... case
.... identifier 1..1 Identifier Identifier by which this case can be referenced.
.... type 1..1 CodeableConcept The defining type of case.

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... text 0..1 Narrative Text summary of the resource, for human interpretation.
... contained 0..* Resource Contained, inline Resources
... identifier Σ 1..1 Identifier Identifier assigned by the health authority to the approval of an electronic medicinal product information.
.... 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..1 Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) In current implementation, a reference to the master list resource of the approved ePI.
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... type Σ 1..1 CodeableConcept Overall type of this authorization, the approval of an electronic medicinal product information.
Binding: RegulatedAuthorizationType (example): Overall type of this authorization.

... description Σ 1..1 markdown Brief description of the authorization.
... region Σ 1..1 CodeableConcept The EU member states in which the authorization has been granted.
Binding: JurisdictionValueSet (example): Jurisdiction codes


... status Σ 1..1 CodeableConcept The current status of this authorization.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 1..1 dateTime The date at which the current status was assigned.
... validityPeriod Σ 1..1 Period The time period in which the regulatory approval is in effect, includes the date of authorization and/or expiration date.
... holder Σ 1..1 Reference(Organization) The organization that has been granted this authorization, by the regulator.
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... regulator Σ 1..1 Reference(Organization) The regulatory authority - EMA or NCA - granting the authorization.
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
RegulatedAuthorization.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|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

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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.
... 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..1 Identifier Identifier assigned by the health authority to the approval of an electronic medicinal product information.
.... 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..1 Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) In current implementation, a reference to the master list resource of the approved ePI.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... type Σ 1..1 CodeableConcept Overall type of this authorization, the approval of an electronic medicinal product information.
Binding: RegulatedAuthorizationType (example): Overall type of this authorization.

... description Σ 1..1 markdown Brief description of the authorization.
... region Σ 1..1 CodeableConcept The EU member states in which the authorization has been granted.
Binding: JurisdictionValueSet (example): Jurisdiction codes


... status Σ 1..1 CodeableConcept The current status of this authorization.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 1..1 dateTime The date at which the current status was assigned.
... validityPeriod Σ 1..1 Period The time period in which the regulatory approval is in effect, 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... regulator Σ 1..1 Reference(Organization) The regulatory authority - EMA or NCA - granting the 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
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
.... display ΣC 1..1 string Text alternative for the resource
... 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 1..1 Identifier Identifier by which this case can be referenced.
.... type Σ 1..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.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
RegulatedAuthorization.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
RegulatedAuthorization.subject.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
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.holder.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
RegulatedAuthorization.regulator.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
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

This structure is derived from RegulatedAuthorization

Summary

Mandatory: 18 elements(2 nested mandatory elements)

 

Other representations of profile: CSV, Excel, Schematron