Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR v5.0.0-ballot. . 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-ballot | |||
| Active as of 2022-12-04 | 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 Binding: Type of Regulated Authorization (extensible) | |
 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 Binding: Regulated Authorization Type identifier systems (extensible) | |
| description | 0..1 | markdown | Brief description of the authorization | |
| region | 0..* | CodeableConcept | The jusrisdiction in which the authorization has been granted Binding: ISO Country two letter code (preferred) | |
| status | 0..1 | CodeableConcept | The current status of this authorization Binding: Authorization Status (preferred) | |
| 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 | 0..1 | BackboneElement | The regulatory procedure for granting or amending a regulated authorization. | |
 identifier | ||||
| system | 0..1 | uri | The namespace for the identifier value Binding: Case System Identifiers (preferred) | |
| type | 0..1 | CodeableConcept | The defining type of case Binding: Regulatory Activity Type (preferred) | |
| status | 0..1 | CodeableConcept | The status associated with the case Binding: General Status used across ePI resources (preferred) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.identifier.system | extensible | VsRegulatedAuthorization (a valid code from https://spor.ema.europa.eu/pmswi) |
| RegulatedAuthorization.type | extensible | VsRegulatedAuthorizationTypeIdSystems |
| RegulatedAuthorization.region | preferred | VsCountry |
| RegulatedAuthorization.status | preferred | VsAuthorizationStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| RegulatedAuthorization.case.identifier.system | preferred | VsCaseIdSystem |
| RegulatedAuthorization.case.type | preferred | VsRegulatoryActivityType |
| RegulatedAuthorization.case.status | preferred | VsGeneralStatus |
| 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 |
 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) |
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: Type of Regulated Authorization (extensible) Example General: http://www.acme.com/identifiers/patient |
| value | Σ | 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: Regulated Authorization Type identifier systems (extensible) |
| description | Σ | 0..1 | markdown | Brief description of the authorization |
| region | Σ | 0..* | CodeableConcept | The jusrisdiction 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: Authorization Status (preferred) |
| 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 |
| case | Σ | 0..1 | BackboneElement | The regulatory procedure for granting or amending a regulated authorization. |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 0..1 | CodeableConcept | The defining type of case Binding: Regulatory Activity Type (preferred) |
| status | Σ | 0..1 | CodeableConcept | The status associated with the case Binding: General Status used across ePI resources (preferred) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.identifier.use | required | IdentifierUse |
| RegulatedAuthorization.identifier.system | extensible | VsRegulatedAuthorization (a valid code from https://spor.ema.europa.eu/pmswi) |
| RegulatedAuthorization.type | extensible | VsRegulatedAuthorizationTypeIdSystems |
| RegulatedAuthorization.region | preferred | VsCountry |
| RegulatedAuthorization.status | preferred | VsAuthorizationStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| RegulatedAuthorization.case.type | preferred | VsRegulatoryActivityType |
| RegulatedAuthorization.case.status | preferred | VsGeneralStatus |
| 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: CommonLanguages (preferred): IETF language tag
| |||||
| 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: Type of Regulated Authorization (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 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: Regulated Authorization Type identifier systems (extensible) | ||||
| description | Σ | 0..1 | markdown | Brief description of the authorization | ||||
| region | Σ | 0..* | CodeableConcept | The jusrisdiction 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: Authorization Status (preferred) | ||||
| 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 regulatory procedure for granting or amending a regulated authorization. | ||||
| 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 | ||||
| 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 0..1 | uri | The namespace for the identifier value Binding: Case System Identifiers (preferred) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 0..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) | ||||
| type | Σ | 0..1 | CodeableConcept | The defining type of case Binding: Regulatory Activity Type (preferred) | ||||
| status | Σ | 0..1 | CodeableConcept | The status associated with the case Binding: General Status used across ePI resources (preferred) | ||||
 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 | preferred | CommonLanguages
| ||||
| RegulatedAuthorization.identifier.use | required | IdentifierUse | ||||
| RegulatedAuthorization.identifier.type | extensible | Identifier Type Codes | ||||
| RegulatedAuthorization.identifier.system | extensible | VsRegulatedAuthorization (a valid code from https://spor.ema.europa.eu/pmswi) | ||||
| RegulatedAuthorization.type | extensible | VsRegulatedAuthorizationTypeIdSystems | ||||
| RegulatedAuthorization.region | preferred | VsCountry | ||||
| RegulatedAuthorization.status | preferred | VsAuthorizationStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) | ||||
| RegulatedAuthorization.intendedUse | preferred | ProductIntendedUse | ||||
| RegulatedAuthorization.basis | example | RegulatedAuthorizationBasis | ||||
| RegulatedAuthorization.case.identifier.use | required | IdentifierUse | ||||
| RegulatedAuthorization.case.identifier.type | extensible | Identifier Type Codes | ||||
| RegulatedAuthorization.case.identifier.system | preferred | VsCaseIdSystem | ||||
| RegulatedAuthorization.case.type | preferred | VsRegulatoryActivityType | ||||
| RegulatedAuthorization.case.status | preferred | VsGeneralStatus |
This structure is derived from RegulatedAuthorization
Summary
Mandatory: 5 elements (1 nested mandatory element)
Structures
This structure refers to these other structures:
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 Binding: Type of Regulated Authorization (extensible) | |
| 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 Binding: Regulated Authorization Type identifier systems (extensible) | |
| description | 0..1 | markdown | Brief description of the authorization | |
| region | 0..* | CodeableConcept | The jusrisdiction in which the authorization has been granted Binding: ISO Country two letter code (preferred) | |
| status | 0..1 | CodeableConcept | The current status of this authorization Binding: Authorization Status (preferred) | |
| 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 | 0..1 | BackboneElement | The regulatory procedure for granting or amending a regulated authorization. | |
| identifier | ||||
| system | 0..1 | uri | The namespace for the identifier value Binding: Case System Identifiers (preferred) | |
| type | 0..1 | CodeableConcept | The defining type of case Binding: Regulatory Activity Type (preferred) | |
| status | 0..1 | CodeableConcept | The status associated with the case Binding: General Status used across ePI resources (preferred) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.identifier.system | extensible | VsRegulatedAuthorization (a valid code from https://spor.ema.europa.eu/pmswi) |
| RegulatedAuthorization.type | extensible | VsRegulatedAuthorizationTypeIdSystems |
| RegulatedAuthorization.region | preferred | VsCountry |
| RegulatedAuthorization.status | preferred | VsAuthorizationStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| RegulatedAuthorization.case.identifier.system | preferred | VsCaseIdSystem |
| RegulatedAuthorization.case.type | preferred | VsRegulatoryActivityType |
| RegulatedAuthorization.case.status | preferred | VsGeneralStatus |
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 |
| 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) |
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: Type of Regulated Authorization (extensible) Example General: http://www.acme.com/identifiers/patient |
| value | Σ | 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: Regulated Authorization Type identifier systems (extensible) |
| description | Σ | 0..1 | markdown | Brief description of the authorization |
| region | Σ | 0..* | CodeableConcept | The jusrisdiction 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: Authorization Status (preferred) |
| 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 |
| case | Σ | 0..1 | BackboneElement | The regulatory procedure for granting or amending a regulated authorization. |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 0..1 | CodeableConcept | The defining type of case Binding: Regulatory Activity Type (preferred) |
| status | Σ | 0..1 | CodeableConcept | The status associated with the case Binding: General Status used across ePI resources (preferred) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| RegulatedAuthorization.identifier.use | required | IdentifierUse |
| RegulatedAuthorization.identifier.system | extensible | VsRegulatedAuthorization (a valid code from https://spor.ema.europa.eu/pmswi) |
| RegulatedAuthorization.type | extensible | VsRegulatedAuthorizationTypeIdSystems |
| RegulatedAuthorization.region | preferred | VsCountry |
| RegulatedAuthorization.status | preferred | VsAuthorizationStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| RegulatedAuthorization.case.type | preferred | VsRegulatoryActivityType |
| RegulatedAuthorization.case.status | preferred | VsGeneralStatus |
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: CommonLanguages (preferred): IETF language tag
| |||||
| 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: Type of Regulated Authorization (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 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: Regulated Authorization Type identifier systems (extensible) | ||||
| description | Σ | 0..1 | markdown | Brief description of the authorization | ||||
| region | Σ | 0..* | CodeableConcept | The jusrisdiction 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: Authorization Status (preferred) | ||||
| 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 regulatory procedure for granting or amending a regulated authorization. | ||||
| 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 | ||||
| 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 0..1 | uri | The namespace for the identifier value Binding: Case System Identifiers (preferred) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 0..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) | ||||
| type | Σ | 0..1 | CodeableConcept | The defining type of case Binding: Regulatory Activity Type (preferred) | ||||
| status | Σ | 0..1 | CodeableConcept | The status associated with the case Binding: General Status used across ePI resources (preferred) | ||||
| 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 | preferred | CommonLanguages
| ||||
| RegulatedAuthorization.identifier.use | required | IdentifierUse | ||||
| RegulatedAuthorization.identifier.type | extensible | Identifier Type Codes | ||||
| RegulatedAuthorization.identifier.system | extensible | VsRegulatedAuthorization (a valid code from https://spor.ema.europa.eu/pmswi) | ||||
| RegulatedAuthorization.type | extensible | VsRegulatedAuthorizationTypeIdSystems | ||||
| RegulatedAuthorization.region | preferred | VsCountry | ||||
| RegulatedAuthorization.status | preferred | VsAuthorizationStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) | ||||
| RegulatedAuthorization.intendedUse | preferred | ProductIntendedUse | ||||
| RegulatedAuthorization.basis | example | RegulatedAuthorizationBasis | ||||
| RegulatedAuthorization.case.identifier.use | required | IdentifierUse | ||||
| RegulatedAuthorization.case.identifier.type | extensible | Identifier Type Codes | ||||
| RegulatedAuthorization.case.identifier.system | preferred | VsCaseIdSystem | ||||
| RegulatedAuthorization.case.type | preferred | VsRegulatoryActivityType | ||||
| RegulatedAuthorization.case.status | preferred | VsGeneralStatus |
This structure is derived from RegulatedAuthorization
Summary
Mandatory: 5 elements (1 nested mandatory element)
Structures
This structure refers to these other structures:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ . Package hl7.fhir.uv.emedicinal-product-info#1.0.0-ballot based on FHIR 5.0.0-ballot. Generated 2022-12-04
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