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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 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
identifier	FiveWs.class

15.6.7.1 15.6.7.2 IDMP Mapping ( https://en.wikipedia.org/wiki/Identification_of_medicinal_products )

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