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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 : Not linked to any 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://en.wikipedia.org/wiki/Identification_of_medicinal_products https://www.iso.org/obp/ui/#iso:std:iso:11615 )

RegulatedAuthorization	Marketing Authorisation, Authorization, Clinical Trial Authorisation Authorization
identifier	Marketing Authorisation.Marketing Authorisation Authorization.Marketing Authorization Number
subject	(the link to Medicinal Product or Packaged Medicinal Product)
type	n/a
description	n/a
region	Marketing Authorisation.Country Authorization.Country
status	Marketing Authorisation.Authorisation Authorization.Authorization Status
statusDate	Marketing Authorisation.Authorisation Authorization.Authorization Status Date
validityPeriod	Marketing Authorisation.Validity Authorization.Validity Period Start, Marketing Authorisation.Validity Authorization.Validity Period End
indication	n/a
intendedUse	n/a
basis	Marketing Authorisation.Status Authorization.Status Reasons.Legal Grounds
holder	Marketing Authorisation.Marketing Authorisation Authorization.Marketing Authorization Holder (Organisation)
regulator	Marketing Authorisation.Medicines Authorization.Medicines Regulatory Agency (Organisation)
attachedDocument	n/a
case	Marketing Authorisation.Marketing Authorisation Authorization.Marketing Authorization Procedure, Marketing Authorisation Authorization Procedure.Marketing Authorisation Authorization Application
identifier	Marketing Authorisation Authorization Procedure.Procedure Identifier / Number, Marketing Authorisation Authorization Application.Application Identifier / Number
type	Marketing Authorisation Authorization Procedure.Procedure Type, Marketing Authorisation Authorization Application.Application Type
status	n/a
date[x]	Marketing Authorisation Authorization Procedure.Procedure Date Start, Marketing Authorisation Authorization Procedure.Procedure Date End, Marketing Authorisation Authorization Application.Application Date
application	Marketing Authorisation.Marketing Authorisation Authorization.Marketing Authorization Application