Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi | Version: 1.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: RegulatedAuthorizationUvEpi | ||
RegulatedAuthorization (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from RegulatedAuthorization
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  RegulatedAuthorization | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
  identifier | 1..* | Identifier | Identifier assigned by the health authority to a single medicinal product | |
  system | 1..1 | uri | The namespace for the identifier value | |
 value | 1..1 | string | The value that is unique | |
 subject | 1..* | Reference(MedicinalProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized | |
| type | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation. | |
| description | 0..1 | markdown | Brief description of the authorization | |
| region | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ISO Country two letter code (preferred) | |
| status | 0..1 | CodeableConcept | The current status of this authorization | |
| statusDate | 0..1 | dateTime | The date at which the current status was assigned. | |
| indication | 0..* | CodeableReference(ClinicalUseDefinition Indication (ePI)) | Reference to the Clinical Use Definition | |
| reference | 1..1 | Reference() | Reference to a resource (by instance) | |
| holder | 1..1 | Reference(Organization (ePI)) | The organization that has been granted this authorization, by the regulator | |
| regulator | 0..1 | Reference(Organization (ePI)) | The regulatory authority or authorizing body granting the authorization | |
 case | ||||
 identifier | 0..1 | Identifier | Identifier by which this case can be referenced. | |
| type | 0..1 | CodeableConcept | The defining type of case. | |
| status | 0..1 | CodeableConcept | The status associated with the case. | |
| date[x] | 0..1 | Period, dateTime | Relevant date for this case. | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.region | preferred | VsCountry |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
 identifier | Σ | 1..* | Identifier | Identifier assigned by the health authority to a single medicinal product |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized |
| type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation. Binding: RegulatedAuthorizationType (example): Overall type of this authorization. |
| description | Σ | 0..1 | markdown | Brief description of the authorization |
| region | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ISO Country two letter code (preferred) |
| status | Σ | 0..1 | CodeableConcept | The current status of this authorization Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| statusDate | Σ | 0..1 | dateTime | The date at which the current status was assigned. |
| indication | Σ | 0..* | CodeableReference(ClinicalUseDefinition Indication (ePI)) | Reference to the Clinical Use Definition |
| reference | Σ | 1..1 | Reference() | Reference to a resource (by instance) |
| holder | Σ | 1..1 | Reference(Organization (ePI)) | The organization that has been granted this authorization, by the regulator |
| regulator | Σ | 0..1 | Reference(Organization (ePI)) | The regulatory authority or authorizing body granting the authorization |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.identifier.use | required | IdentifierUse |
| RegulatedAuthorization.type | example | RegulatedAuthorizationType |
| RegulatedAuthorization.region | preferred | VsCountry |
| RegulatedAuthorization.status | preferred | PublicationStatus |
| 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() |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| RegulatedAuthorization | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
| id | Σ | 0..1 | id | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| 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..* | Identifier | Identifier assigned by the health authority to a single medicinal product |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| period | Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized |
| type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation. Binding: RegulatedAuthorizationType (example): Overall type of this authorization. |
| description | Σ | 0..1 | markdown | Brief description of the authorization |
| region | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ISO Country two letter code (preferred) |
| status | Σ | 0..1 | CodeableConcept | The current status of this authorization Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| statusDate | Σ | 0..1 | dateTime | The date at which the current status was assigned. |
| validityPeriod | Σ | 0..1 | Period | The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date |
| indication | Σ | 0..* | CodeableReference(ClinicalUseDefinition Indication (ePI)) | Reference to the Clinical Use Definition |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| concept | Σ | 0..1 | CodeableConcept | Reference to a concept (by class) |
| reference | Σ | 1..1 | Reference() | Reference to a resource (by instance) |
| intendedUse | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product. |
| basis | Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it. |
| holder | Σ | 1..1 | Reference(Organization (ePI)) | The organization that has been granted this authorization, by the regulator |
| regulator | Σ | 0..1 | Reference(Organization (ePI)) | The regulatory authority or authorizing body granting the authorization |
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization |
| case | Σ | 0..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| identifier | Σ | 0..1 | Identifier | Identifier by which this case can be referenced. |
| type | Σ | 0..1 | CodeableConcept | The defining type of case. Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application. |
| status | Σ | 0..1 | CodeableConcept | The status associated with the case. Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
 date[x] | Σ | 0..1 | Relevant date for this case. | |
| datePeriod | Period | |||
| dateDateTime | dateTime | |||
| application | Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.language | required | AllLanguages |
| RegulatedAuthorization.identifier.use | required | IdentifierUse |
| RegulatedAuthorization.identifier.type | extensible | IdentifierTypeCodes |
| RegulatedAuthorization.type | example | RegulatedAuthorizationType |
| RegulatedAuthorization.region | preferred | VsCountry |
| RegulatedAuthorization.status | preferred | PublicationStatus |
| RegulatedAuthorization.intendedUse | preferred | ProductIntendedUse |
| RegulatedAuthorization.basis | example | RegulatedAuthorizationBasis |
| RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseType |
| RegulatedAuthorization.case.status | preferred | PublicationStatus |
| Id | Grade | Path(s) | Details | Requirements |
| 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: 5 elements (1 nested mandatory element)
Structures
This structure refers to these other structures:
Maturity: 2
Differential View
This structure is derived from RegulatedAuthorization
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| RegulatedAuthorization | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
| identifier | 1..* | Identifier | Identifier assigned by the health authority to a single medicinal product | |
| system | 1..1 | uri | The namespace for the identifier value | |
| value | 1..1 | string | The value that is unique | |
| subject | 1..* | Reference(MedicinalProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized | |
| type | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation. | |
| description | 0..1 | markdown | Brief description of the authorization | |
| region | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ISO Country two letter code (preferred) | |
| status | 0..1 | CodeableConcept | The current status of this authorization | |
| statusDate | 0..1 | dateTime | The date at which the current status was assigned. | |
| indication | 0..* | CodeableReference(ClinicalUseDefinition Indication (ePI)) | Reference to the Clinical Use Definition | |
| reference | 1..1 | Reference() | Reference to a resource (by instance) | |
| holder | 1..1 | Reference(Organization (ePI)) | The organization that has been granted this authorization, by the regulator | |
| regulator | 0..1 | Reference(Organization (ePI)) | The regulatory authority or authorizing body granting the authorization | |
| case | ||||
| identifier | 0..1 | Identifier | Identifier by which this case can be referenced. | |
| type | 0..1 | CodeableConcept | The defining type of case. | |
| status | 0..1 | CodeableConcept | The status associated with the case. | |
| date[x] | 0..1 | Period, dateTime | Relevant date for this case. | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.region | preferred | VsCountry |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| identifier | Σ | 1..* | Identifier | Identifier assigned by the health authority to a single medicinal product |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized |
| type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation. Binding: RegulatedAuthorizationType (example): Overall type of this authorization. |
| description | Σ | 0..1 | markdown | Brief description of the authorization |
| region | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ISO Country two letter code (preferred) |
| status | Σ | 0..1 | CodeableConcept | The current status of this authorization Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| statusDate | Σ | 0..1 | dateTime | The date at which the current status was assigned. |
| indication | Σ | 0..* | CodeableReference(ClinicalUseDefinition Indication (ePI)) | Reference to the Clinical Use Definition |
| reference | Σ | 1..1 | Reference() | Reference to a resource (by instance) |
| holder | Σ | 1..1 | Reference(Organization (ePI)) | The organization that has been granted this authorization, by the regulator |
| regulator | Σ | 0..1 | Reference(Organization (ePI)) | The regulatory authority or authorizing body granting the authorization |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.identifier.use | required | IdentifierUse |
| RegulatedAuthorization.type | example | RegulatedAuthorizationType |
| RegulatedAuthorization.region | preferred | VsCountry |
| RegulatedAuthorization.status | preferred | PublicationStatus |
| 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| RegulatedAuthorization | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
| id | Σ | 0..1 | id | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| 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..* | Identifier | Identifier assigned by the health authority to a single medicinal product |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| period | Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized |
| type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation. Binding: RegulatedAuthorizationType (example): Overall type of this authorization. |
| description | Σ | 0..1 | markdown | Brief description of the authorization |
| region | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: ISO Country two letter code (preferred) |
| status | Σ | 0..1 | CodeableConcept | The current status of this authorization Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| statusDate | Σ | 0..1 | dateTime | The date at which the current status was assigned. |
| validityPeriod | Σ | 0..1 | Period | The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date |
| indication | Σ | 0..* | CodeableReference(ClinicalUseDefinition Indication (ePI)) | Reference to the Clinical Use Definition |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| concept | Σ | 0..1 | CodeableConcept | Reference to a concept (by class) |
| reference | Σ | 1..1 | Reference() | Reference to a resource (by instance) |
| intendedUse | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product. |
| basis | Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it. |
| holder | Σ | 1..1 | Reference(Organization (ePI)) | The organization that has been granted this authorization, by the regulator |
| regulator | Σ | 0..1 | Reference(Organization (ePI)) | The regulatory authority or authorizing body granting the authorization |
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization |
| case | Σ | 0..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| identifier | Σ | 0..1 | Identifier | Identifier by which this case can be referenced. |
| type | Σ | 0..1 | CodeableConcept | The defining type of case. Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application. |
| status | Σ | 0..1 | CodeableConcept | The status associated with the case. Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| date[x] | Σ | 0..1 | Relevant date for this case. | |
| datePeriod | Period | |||
| dateDateTime | dateTime | |||
| application | Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.language | required | AllLanguages |
| RegulatedAuthorization.identifier.use | required | IdentifierUse |
| RegulatedAuthorization.identifier.type | extensible | IdentifierTypeCodes |
| RegulatedAuthorization.type | example | RegulatedAuthorizationType |
| RegulatedAuthorization.region | preferred | VsCountry |
| RegulatedAuthorization.status | preferred | PublicationStatus |
| RegulatedAuthorization.intendedUse | preferred | ProductIntendedUse |
| RegulatedAuthorization.basis | example | RegulatedAuthorizationBasis |
| RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseType |
| RegulatedAuthorization.case.status | preferred | PublicationStatus |
| Id | Grade | Path(s) | Details | Requirements |
| 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: 5 elements (1 nested mandatory element)
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2023-07-26
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change