Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions 
| Page standards status: Trial-use | Maturity Level: 2 |
Mappings for the RegulatedAuthorization-uv-epi resource profile.
| RegulatedAuthorizationUvEpi | ||
| RegulatedAuthorization | administrative.medication | |
| identifier | FiveWs.class | |
| RegulatedAuthorizationUvEpi | ||
| 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 | |
| RegulatedAuthorizationUvEpi | ||
| RegulatedAuthorization | Entity, Role, or Act | |
| text | Act.text? | |
| contained | N/A | |
| extension | N/A | |
| modifierExtension | N/A | |
| 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 | |
| indication | ||
| id | n/a | |
| extension | n/a | |
| concept | N/A | |
| reference | N/A | |
| case | ||
| id | n/a | |
| extension | n/a | |
| modifierExtension | N/A | |
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2023-07-26
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