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 emaWriteApiRegulatedAuthorizationRestrictions resource profile.
| EmaWriteApiRegulatedAuthorizationRestrictions |
| RegulatedAuthorization | Marketing Authorization, Clinical Trial Authorization |
| identifier | 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 |
| application | Marketing Authorization.Marketing Authorization Application |