AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Mappings for the at-medprod-marketingRegulatedAuthorization resource profile.
| AT_MedicinalProduct_MarketingRegulatedAuthorization |
| RegulatedAuthorization | Marketing Authorization, Clinical Trial Authorization |
| subject | (the link to Medicinal Product or Packaged Medicinal Product) |
| description | n/a |
| region | Marketing Authorization.Country |
| 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 |
| AT_MedicinalProduct_MarketingRegulatedAuthorization |
| RegulatedAuthorization | Entity, Role, or Act |
| text | Act.text? |
| contained | n/a |
| extension | n/a |
| modifierExtension | n/a |
| identifier | n/a,II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] |
| 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 |
| type | n/a,CD |
| status | n/a,CD |
| id | n/a |
| extension | n/a |
| coding | n/a,CV |
| text | ./originalText[mediaType/code="text/plain"]/data |
| holder | |
| id | n/a |
| extension | n/a |
| reference | n/a |
| type | n/a |
| identifier | .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 |
| display | n/a |
| case | |
| id | n/a |
| extension | n/a |
| modifierExtension | n/a |