Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0-ballot. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions
| Active as of 2022-12-04 |
Mappings for the RegulatedAuthorization-uv-epi resource profile.
| RegulatedAuthorizationUvEpi | ||
| 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 | |
| RegulatedAuthorizationUvEpi | ||
| RegulatedAuthorization | administrative.medication | |
| identifier | FiveWs.class | |
| 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 | |
| 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 | |
IG © 2021+ . Package hl7.fhir.uv.emedicinal-product-info#1.0.0-ballot based on FHIR 5.0.0-ballot. Generated 2022-12-04
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