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15.6.7 Resource RegulatedAuthorization - Mappings

Biomedical Research and Regulation Work Group

Maturity Level : N/A

Standards Status : Informative

Security Category : Anonymous

Compartments : No defined compartments

Mappings for the regulatedauthorization resource (see Mappings to Other Standards for further information & status).

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

RegulatedAuthorization	administrative.medication
identifier	FiveWs.class

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

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