0.1.0 - ci-build
AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
![]() ![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() ![]() |
0..* | Resource | Contained, inline Resources | |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() ![]() |
Σ | 1..1 | AT_MedicinalProduct_Identifier | Business identifier for the authorization, typically assigned by the authorizing body (authorization number) |
![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
![]() ![]() ![]() |
Σ | 1..1 | Reference(Medicinal Product Definition) | The product type, treatment, facility or activity that is being authorized |
![]() ![]() ![]() |
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 |
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0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060 | |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |
![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000061 | |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |
![]() ![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |
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0..1 | string | Plain text representation of the concept | |
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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. |
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Σ | 0..* | AT_MedicinalProduct_Coding | Code defined by a terminology system Binding: The Regulatory Entitlement Status Value Set (required) |
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Σ | 0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator (authorization holder) |
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
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ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known |
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() ![]() ![]() |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/omswi |
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ΣC | 1..1 | string | This value contains the Location ID from the EMA SPOR OMS System Example General: 123456 |
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ΣC | 1..1 | string | The name of the marketing authorisation holder |
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Path | Conformance | ValueSet / Code | URI |
RegulatedAuthorization.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
RegulatedAuthorization.type | example | Pattern Value: 220000000061http://hl7.org/fhir/ValueSet/regulated-authorization-type From the FHIR Standard | |
RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
RegulatedAuthorization.status.coding | required | RegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus From this IG | |
RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | RegulatedAuthorization | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | RegulatedAuthorization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | RegulatedAuthorization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | RegulatedAuthorization | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | RegulatedAuthorization | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from RegulatedAuthorization
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
![]() ![]() ![]() |
1..1 | AT_MedicinalProduct_Identifier | Business identifier for the authorization, typically assigned by the authorizing body (authorization number) | |
![]() ![]() ![]() ![]() |
1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber | |
![]() ![]() ![]() |
1..1 | Reference(Medicinal Product Definition) | The product type, treatment, facility or activity that is being authorized | |
![]() ![]() ![]() |
1..1 | AT_MedicinalProduct_CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Required Pattern: At least the following | |
![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060 | |
![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000061 | |
![]() ![]() ![]() |
1..1 | AT_MedicinalProduct_CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status) | |
![]() ![]() ![]() ![]() |
0..* | AT_MedicinalProduct_Coding | Code defined by a terminology system Binding: The Regulatory Entitlement Status Value Set (required) | |
![]() ![]() ![]() |
0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator (authorization holder) | |
![]() ![]() ![]() ![]() |
1..1 | Identifier | Logical reference, when literal reference is not known | |
![]() ![]() ![]() ![]() ![]() |
1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/omswi | |
![]() ![]() ![]() ![]() ![]() |
1..1 | string | This value contains the Location ID from the EMA SPOR OMS System | |
![]() ![]() ![]() ![]() |
1..1 | string | The name of the marketing authorisation holder | |
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Path | Conformance | ValueSet | URI |
RegulatedAuthorization.status.coding | required | RegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus From this IG |
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
---|---|---|---|---|---|---|---|---|
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0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
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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 | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 1..1 | AT_MedicinalProduct_Identifier | Business identifier for the authorization, typically assigned by the authorizing body (authorization number) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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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. | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber | ||||
![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
![]() ![]() ![]() |
Σ | 1..1 | Reference(Medicinal Product Definition) | The product type, treatment, facility or activity that is being authorized | ||||
![]() ![]() ![]() |
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 | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060 | |||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |||||
![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000061 | |||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |||||
![]() ![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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Σ | 0..1 | markdown | General textual supporting information | ||||
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Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
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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. | ||||
![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() |
Σ | 0..* | AT_MedicinalProduct_Coding | Code defined by a terminology system Binding: The Regulatory Entitlement Status Value Set (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
![]() ![]() ![]() |
Σ | 0..1 | dateTime | The date at which the current status was assigned | ||||
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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 | ||||
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Σ | 0..* | CodeableReference(ClinicalUseDefinition) | Condition for which the use of the regulated product applies | ||||
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Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
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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. | ||||
![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator (authorization holder) | ||||
![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
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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). | ||||
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ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known | ||||
![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
![]() ![]() ![]() ![]() ![]() |
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. | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/omswi | ||||
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | This value contains the Location ID from the EMA SPOR OMS System Example General: 123456 | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The name of the marketing authorisation holder | ||||
![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | The regulatory authority or authorizing body granting the authorization | ||||
![]() ![]() ![]() |
Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization | ||||
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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) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | Identifier | Identifier by which this case can be referenced | ||||
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Σ | 0..1 | CodeableConcept | The defining type of case Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application. | ||||
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Σ | 0..1 | CodeableConcept | The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 0..1 | Relevant date for this case | |||||
![]() ![]() ![]() ![]() ![]() |
Period | |||||||
![]() ![]() ![]() ![]() ![]() |
dateTime | |||||||
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Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | ||||
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Path | Conformance | ValueSet / Code | URI |
RegulatedAuthorization.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard | |
RegulatedAuthorization.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
RegulatedAuthorization.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
RegulatedAuthorization.type | example | Pattern Value: 220000000061http://hl7.org/fhir/ValueSet/regulated-authorization-type From the FHIR Standard | |
RegulatedAuthorization.region | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction From the FHIR Standard | |
RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
RegulatedAuthorization.status.coding | required | RegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus From this IG | |
RegulatedAuthorization.intendedUse | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-use From the FHIR Standard | |
RegulatedAuthorization.basis | example | RegulatedAuthorizationBasishttp://hl7.org/fhir/ValueSet/regulated-authorization-basis From the FHIR Standard | |
RegulatedAuthorization.holder.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types From the FHIR Standard | |
RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
RegulatedAuthorization.holder.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-type From the FHIR Standard | |
RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | RegulatedAuthorization | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | RegulatedAuthorization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | RegulatedAuthorization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | RegulatedAuthorization | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | RegulatedAuthorization | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from RegulatedAuthorization
Summary
Mandatory: 4 elements(4 nested mandatory elements)
Structures
This structure refers to these other structures:
Key Elements View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
![]() ![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() ![]() |
0..* | Resource | Contained, inline Resources | |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() ![]() |
Σ | 1..1 | AT_MedicinalProduct_Identifier | Business identifier for the authorization, typically assigned by the authorizing body (authorization number) |
![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() ![]() |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber |
![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
![]() ![]() ![]() |
Σ | 1..1 | Reference(Medicinal Product Definition) | The product type, treatment, facility or activity that is being authorized |
![]() ![]() ![]() |
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 |
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060 | |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |
![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000061 | |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |
![]() ![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |
![]() ![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |
![]() ![]() ![]() |
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. |
![]() ![]() ![]() ![]() |
Σ | 0..* | AT_MedicinalProduct_Coding | Code defined by a terminology system Binding: The Regulatory Entitlement Status Value Set (required) |
![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator (authorization holder) |
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
![]() ![]() ![]() ![]() |
ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known |
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() ![]() ![]() |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/omswi |
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | This value contains the Location ID from the EMA SPOR OMS System Example General: 123456 |
![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The name of the marketing authorisation holder |
![]() |
Path | Conformance | ValueSet / Code | URI |
RegulatedAuthorization.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
RegulatedAuthorization.type | example | Pattern Value: 220000000061http://hl7.org/fhir/ValueSet/regulated-authorization-type From the FHIR Standard | |
RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
RegulatedAuthorization.status.coding | required | RegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus From this IG | |
RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | RegulatedAuthorization | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | RegulatedAuthorization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | RegulatedAuthorization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | RegulatedAuthorization | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | RegulatedAuthorization | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Differential View
This structure is derived from RegulatedAuthorization
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
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0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
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1..1 | AT_MedicinalProduct_Identifier | Business identifier for the authorization, typically assigned by the authorizing body (authorization number) | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber | |
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1..1 | Reference(Medicinal Product Definition) | The product type, treatment, facility or activity that is being authorized | |
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1..1 | AT_MedicinalProduct_CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Required Pattern: At least the following | |
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
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1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060 | |
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000061 | |
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1..1 | AT_MedicinalProduct_CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status) | |
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0..* | AT_MedicinalProduct_Coding | Code defined by a terminology system Binding: The Regulatory Entitlement Status Value Set (required) | |
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0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator (authorization holder) | |
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1..1 | Identifier | Logical reference, when literal reference is not known | |
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1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/omswi | |
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1..1 | string | This value contains the Location ID from the EMA SPOR OMS System | |
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1..1 | string | The name of the marketing authorisation holder | |
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Path | Conformance | ValueSet | URI |
RegulatedAuthorization.status.coding | required | RegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus From this IG |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
---|---|---|---|---|---|---|---|---|
![]() ![]() |
0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
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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 | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 1..1 | AT_MedicinalProduct_Identifier | Business identifier for the authorization, typically assigned by the authorizing body (authorization number) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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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. | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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Σ | 1..1 | Reference(Medicinal Product Definition) | The product type, treatment, facility or activity that is being authorized | ||||
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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 | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060 | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000061 | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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Σ | 0..1 | markdown | General textual supporting information | ||||
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Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
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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. | ||||
![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | AT_MedicinalProduct_Coding | Code defined by a terminology system Binding: The Regulatory Entitlement Status Value Set (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | dateTime | The date at which the current status was assigned | ||||
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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 | ||||
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Σ | 0..* | CodeableReference(ClinicalUseDefinition) | Condition for which the use of the regulated product applies | ||||
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Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
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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. | ||||
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Σ | 0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator (authorization holder) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
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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). | ||||
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ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
![]() ![]() ![]() ![]() ![]() |
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. | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/omswi | ||||
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | This value contains the Location ID from the EMA SPOR OMS System Example General: 123456 | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The name of the marketing authorisation holder | ||||
![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | The regulatory authority or authorizing body granting the authorization | ||||
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Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization | ||||
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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) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | Identifier | Identifier by which this case can be referenced | ||||
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Σ | 0..1 | CodeableConcept | The defining type of case Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application. | ||||
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Σ | 0..1 | CodeableConcept | The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 0..1 | Relevant date for this case | |||||
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Period | |||||||
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dateTime | |||||||
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Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | ||||
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Path | Conformance | ValueSet / Code | URI |
RegulatedAuthorization.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard | |
RegulatedAuthorization.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
RegulatedAuthorization.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
RegulatedAuthorization.type | example | Pattern Value: 220000000061http://hl7.org/fhir/ValueSet/regulated-authorization-type From the FHIR Standard | |
RegulatedAuthorization.region | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction From the FHIR Standard | |
RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
RegulatedAuthorization.status.coding | required | RegulatoryEntitlementStatusVs(a valid code from Regulatory Entitlement Status)https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus From this IG | |
RegulatedAuthorization.intendedUse | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-use From the FHIR Standard | |
RegulatedAuthorization.basis | example | RegulatedAuthorizationBasishttp://hl7.org/fhir/ValueSet/regulated-authorization-basis From the FHIR Standard | |
RegulatedAuthorization.holder.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types From the FHIR Standard | |
RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
RegulatedAuthorization.holder.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-type From the FHIR Standard | |
RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | RegulatedAuthorization | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | RegulatedAuthorization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | RegulatedAuthorization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | RegulatedAuthorization | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | RegulatedAuthorization | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from RegulatedAuthorization
Summary
Mandatory: 4 elements(4 nested mandatory elements)
Structures
This structure refers to these other structures:
Other representations of profile: CSV, Excel, Schematron