EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Mappings for the emaWriteApiRegulatedAuthorization resource profile.
| EmaWriteApiRegulatedAuthorization |
| RegulatedAuthorization | Marketing Authorization, Clinical Trial Authorization |
| identifier | Marketing Authorization.Marketing Authorization Number |
| identifier (marketingAuthorizationIdentifier) | Marketing Authorization.Marketing Authorization Number |
| identifier (manufacturingAuthorizationNumberIdentifier) | Marketing Authorization.Marketing Authorization Number |
| identifier (eudraGmpNumberIdentifier) | Marketing Authorization.Marketing Authorization Number |
| subject | (the link to Medicinal Product or Packaged Medicinal Product) |
| type | n/a |
| region | Marketing Authorization.Country |
| status | Marketing Authorization.Authorization Status |
| statusDate | Marketing Authorization.Authorization Status Date |
| validityPeriod | Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End |
| holder | Marketing Authorization.Marketing Authorization Holder (Organisation) |
| regulator | Marketing Authorization.Medicines Regulatory Agency (Organisation) |
| attachedDocument | n/a |
| case | Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application |
| identifier | Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number |
| type | Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type |
| status | n/a |
| date[x] | Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date |
| date[x] (datePeriod) | Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date |
| application | Marketing Authorization.Marketing Authorization Application |
| identifier | Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number |
| type | Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type |
| status | n/a |
| date[x] | Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date |
| date[x] (dateDateTime) | Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date |
| application | Marketing Authorization.Marketing Authorization Application |
| EmaWriteApiRegulatedAuthorization |
| RegulatedAuthorization | Entity, Role, or Act |
| identifier | |
| identifier (marketingAuthorizationIdentifier) | |
| id | n/a |
| system | II.root or Role.id.root |
| value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
| identifier (manufacturingAuthorizationNumberIdentifier) | |
| id | n/a |
| system | II.root or Role.id.root |
| value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
| identifier (eudraGmpNumberIdentifier) | |
| id | n/a |
| system | II.root or Role.id.root |
| value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
| type | |
| id | n/a |
| coding | union(., ./translation) |
| holder | |
| id | n/a |
| extension | n/a |
| reference | N/A |
| type | N/A |
| identifier | .identifier |
| id | n/a |
| extension | n/a |
| use | Role.code or implied by context |
| type | Role.code or implied by context |
| system | II.root or Role.id.root |
| value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
| period | Role.effectiveTime or implied by context |
| assigner | II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper |
| display | N/A |
| regulator | |
| id | n/a |
| extension | n/a |
| reference | N/A |
| type | N/A |
| identifier | .identifier |
| id | n/a |
| extension | n/a |
| use | Role.code or implied by context |
| type | Role.code or implied by context |
| system | II.root or Role.id.root |
| value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
| period | Role.effectiveTime or implied by context |
| assigner | II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper |
| display | N/A |
| case | |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| application | |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |