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
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
| 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 |
RegulatedAuthorization | |||
  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) | PackagedProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized | |
| type |
1..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 |
1..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 | URI |
| RegulatedAuthorization.region | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom this IG |
| 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) | PackagedProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized |
| type |
Σ | 1..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 | 1..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 | URI |
| RegulatedAuthorization.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.type | example | RegulatedAuthorizationTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-typefrom the FHIR Standard | |
| RegulatedAuthorization.region | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom this IG | |
| RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom 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() |
| 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) | PackagedProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized | ||||
| type |
Σ | 1..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 | 1..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 | URI |
| RegulatedAuthorization.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| RegulatedAuthorization.type | example | RegulatedAuthorizationTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-typefrom the FHIR Standard | |
| RegulatedAuthorization.region | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom this IG | |
| RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| RegulatedAuthorization.intendedUse | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-usefrom the FHIR Standard | |
| RegulatedAuthorization.basis | example | RegulatedAuthorizationBasishttp://hl7.org/fhir/ValueSet/regulated-authorization-basisfrom the FHIR Standard | |
| RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-typefrom the FHIR Standard | |
| RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom 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: 7 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 |
RegulatedAuthorization | |||
| 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) | PackagedProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized | |
| type |
1..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 |
1..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 | URI |
| RegulatedAuthorization.region | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom this IG |
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) | PackagedProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized |
| type |
Σ | 1..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 | 1..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 | URI |
| RegulatedAuthorization.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.type | example | RegulatedAuthorizationTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-typefrom the FHIR Standard | |
| RegulatedAuthorization.region | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom this IG | |
| RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom 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() |
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) | PackagedProductDefinition (ePI)) | The product type, treatment, facility or activity that is being authorized | ||||
| type |
Σ | 1..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 | 1..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 | URI |
| RegulatedAuthorization.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| RegulatedAuthorization.type | example | RegulatedAuthorizationTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-typefrom the FHIR Standard | |
| RegulatedAuthorization.region | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom this IG | |
| RegulatedAuthorization.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| RegulatedAuthorization.intendedUse | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-usefrom the FHIR Standard | |
| RegulatedAuthorization.basis | example | RegulatedAuthorizationBasishttp://hl7.org/fhir/ValueSet/regulated-authorization-basisfrom the FHIR Standard | |
| RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-typefrom the FHIR Standard | |
| RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom 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: 7 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 2024-04-08
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