European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v0.4.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: EUEpiRegulatedAuthorization - Mappings

Draft as of 2024-10-25

Mappings for the EUEpiRegulatedAuthorization resource profile.

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

EUEpiRegulatedAuthorization
RegulatedAuthorization	administrative.medication
identifier	FiveWs.class

Mappings for IDMP Mapping (https://www.iso.org/obp/ui/#iso:std:iso:11615)

EUEpiRegulatedAuthorization
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

Mappings for RIM Mapping (http://hl7.org/v3)

EUEpiRegulatedAuthorization
RegulatedAuthorization	Entity, Role, or Act
text	Act.text?
contained	N/A
extension	N/A
modifierExtension	N/A
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
subject
id	n/a
extension	n/a
reference	N/A
type	N/A
identifier	.identifier
display	N/A
holder
id	n/a
extension	n/a
reference	N/A
type	N/A
identifier	.identifier
display	N/A
regulator
id	n/a
extension	n/a
reference	N/A
type	N/A
identifier	.identifier
display	N/A
case
id	n/a
extension	n/a
modifierExtension	N/A