UnicomIG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/unicom-ig/tree/master and changes regularly. See the Directory of published versions
Mappings for the TransitionRegulatedAuthorization resource profile.
TransitionRegulatedAuthorization |
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 |
description | 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 |
indication | n/a |
intendedUse | n/a |
basis | Marketing Authorization.Status Reasons.Legal Grounds |
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 |