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AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Marketing Regulated Authorization

Official URL: https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-marketingregulatedauthorization Version: 0.1.0
Draft as of 2025-07-01 Computable Name: AT_MedicinalProduct_MarketingRegulatedAuthorization

Contains the authorisation information of a medicinal product

Usages:

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

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... 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
Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... subject Σ 1..1 Reference(Medicinal Product Definition) The product type, treatment, facility or activity that is being authorized
... type Σ 1..1 AT_MedicinalProduct_CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000061
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... status Σ 1..1 AT_MedicinalProduct_CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status)
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... coding Σ 0..* AT_MedicinalProduct_Coding Code defined by a terminology system
Binding: The Regulatory Entitlement Status Value Set (required)
... holder Σ 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator (authorization holder)
.... 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
..... 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
Required Pattern: https://spor.ema.europa.eu/omswi
..... value ΣC 1..1 string This value contains the Location ID from the EMA SPOR OMS System
Example General: 123456
.... display ΣC 1..1 string The name of the marketing authorisation holder

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
RegulatedAuthorization.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
RegulatedAuthorization.typeexamplePattern Value: 220000000061
http://hl7.org/fhir/ValueSet/regulated-authorization-type
From the FHIR Standard
RegulatedAuthorization.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard
RegulatedAuthorization.status.codingrequiredRegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)
https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
From this IG
RegulatedAuthorization.holder.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

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..1 AT_MedicinalProduct_Identifier Business identifier for the authorization, typically assigned by the authorizing body (authorization number)
.... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
... subject 1..1 Reference(Medicinal Product Definition) The product type, treatment, facility or activity that is being authorized
... type 1..1 AT_MedicinalProduct_CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000061
.... coding 0..* AT_MedicinalProduct_Coding Code defined by a terminology system
Binding: The Regulatory Entitlement Status Value Set (required)
... holder 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator (authorization holder)
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://spor.ema.europa.eu/omswi
..... value 1..1 string This value contains the Location ID from the EMA SPOR OMS System
.... display 1..1 string The name of the marketing authorisation holder

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
RegulatedAuthorization.status.codingrequiredRegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)
https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
From this IG
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..1 AT_MedicinalProduct_Identifier Business identifier for the authorization, typically assigned by the authorizing body (authorization number)
.... 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
Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
.... 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(Medicinal Product Definition) The product type, treatment, facility or activity that is being authorized
... type Σ 1..1 AT_MedicinalProduct_CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000061
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 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 1..1 AT_MedicinalProduct_CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status)
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 0..* AT_MedicinalProduct_Coding Code defined by a terminology system
Binding: The Regulatory Entitlement Status Value Set (required)
.... 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
... 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 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator (authorization holder)
.... 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
..... 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
Required Pattern: https://spor.ema.europa.eu/omswi
..... value ΣC 1..1 string This value contains the Location ID from the EMA SPOR OMS System
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)
.... display ΣC 1..1 string The name of the marketing authorisation holder
... regulator Σ 0..1 Reference(Organization) The regulatory authority or authorizing body granting the authorization
... attachedDocument Σ 0..* Reference(DocumentReference) Additional information or supporting documentation about the authorization
... case Σ 0..1 BackboneElement The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..1 Identifier Identifier by which this case can be referenced
.... type Σ 0..1 CodeableConcept The defining type of case
Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
.... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... date[x] Σ 0..1 Relevant date for this case
..... datePeriod Period
..... dateDateTime dateTime
.... application Σ 0..* See case (RegulatedAuthorization) Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
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.typeexamplePattern Value: 220000000061
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.status.codingrequiredRegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)
https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
From this IG
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.holder.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
RegulatedAuthorization.holder.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
RegulatedAuthorization.case.typeexampleRegulatedAuthorizationCaseType
http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
From the FHIR Standard
RegulatedAuthorization.case.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

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
Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... subject Σ 1..1 Reference(Medicinal Product Definition) The product type, treatment, facility or activity that is being authorized
... type Σ 1..1 AT_MedicinalProduct_CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000061
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... status Σ 1..1 AT_MedicinalProduct_CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status)
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... coding Σ 0..* AT_MedicinalProduct_Coding Code defined by a terminology system
Binding: The Regulatory Entitlement Status Value Set (required)
... holder Σ 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator (authorization holder)
.... 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
..... 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
Required Pattern: https://spor.ema.europa.eu/omswi
..... value ΣC 1..1 string This value contains the Location ID from the EMA SPOR OMS System
Example General: 123456
.... display ΣC 1..1 string The name of the marketing authorisation holder

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
RegulatedAuthorization.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
RegulatedAuthorization.typeexamplePattern Value: 220000000061
http://hl7.org/fhir/ValueSet/regulated-authorization-type
From the FHIR Standard
RegulatedAuthorization.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard
RegulatedAuthorization.status.codingrequiredRegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)
https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
From this IG
RegulatedAuthorization.holder.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
... identifier 1..1 AT_MedicinalProduct_Identifier Business identifier for the authorization, typically assigned by the authorizing body (authorization number)
.... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
... subject 1..1 Reference(Medicinal Product Definition) The product type, treatment, facility or activity that is being authorized
... type 1..1 AT_MedicinalProduct_CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000061
.... coding 0..* AT_MedicinalProduct_Coding Code defined by a terminology system
Binding: The Regulatory Entitlement Status Value Set (required)
... holder 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator (authorization holder)
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://spor.ema.europa.eu/omswi
..... value 1..1 string This value contains the Location ID from the EMA SPOR OMS System
.... display 1..1 string The name of the marketing authorisation holder

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
RegulatedAuthorization.status.codingrequiredRegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)
https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
From this IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..1 AT_MedicinalProduct_Identifier Business identifier for the authorization, typically assigned by the authorizing body (authorization number)
.... 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
Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
.... 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(Medicinal Product Definition) The product type, treatment, facility or activity that is being authorized
... type Σ 1..1 AT_MedicinalProduct_CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000061
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 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 1..1 AT_MedicinalProduct_CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status)
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 0..* AT_MedicinalProduct_Coding Code defined by a terminology system
Binding: The Regulatory Entitlement Status Value Set (required)
.... 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
... 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 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator (authorization holder)
.... 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
..... 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
Required Pattern: https://spor.ema.europa.eu/omswi
..... value ΣC 1..1 string This value contains the Location ID from the EMA SPOR OMS System
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)
.... display ΣC 1..1 string The name of the marketing authorisation holder
... regulator Σ 0..1 Reference(Organization) The regulatory authority or authorizing body granting the authorization
... attachedDocument Σ 0..* Reference(DocumentReference) Additional information or supporting documentation about the authorization
... case Σ 0..1 BackboneElement The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..1 Identifier Identifier by which this case can be referenced
.... type Σ 0..1 CodeableConcept The defining type of case
Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
.... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... date[x] Σ 0..1 Relevant date for this case
..... datePeriod Period
..... dateDateTime dateTime
.... application Σ 0..* See case (RegulatedAuthorization) Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
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.typeexamplePattern Value: 220000000061
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.status.codingrequiredRegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)
https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
From this IG
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.holder.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
RegulatedAuthorization.holder.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
RegulatedAuthorization.case.typeexampleRegulatedAuthorizationCaseType
http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
From the FHIR Standard
RegulatedAuthorization.case.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

 

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