EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) 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 |
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 |
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 |
text | Act.text? |
contained | N/A |
modifierExtension | N/A |
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) |
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 |
modifierExtension | N/A |
application | |
id | n/a |
extension | n/a |
modifierExtension | N/A |