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 |