Regulatory Workflows and Interactions - pharma
0.1.0 - ci-build International flag

Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

Example DocumentReference: Annotated ePI v2 (regulator comments, round 1)

Page standards status: Informative

identifier: Document Set Identifier/urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc, Document Version Number Identifier/urn:uuid:888a24fe-5349-56ad-bcd4-d5181ab7dc71

version: 2

status: Current

docStatus: Final

type: Labelling Comments

date: 2027-02-22 10:00:00+0100

author: Health Authority – Regulatory Review Division

RelatesTos

-CodeTarget
*ReplacesDocumentReference: identifier = Document Set Identifier: urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc,Document Version Number Identifier: urn:uuid:8ee1964d-f23e-5dc2-8f64-7fbbc2e94416; version = 1; status = current; docStatus = final; type = Proposed Labelling; date = 2027-01-11 10:00:00+0100; description = Proposed product information as annotated ePI, version 1: adds nausea (uncommon) to SmPC 4.8 and leaflet section 4.

description:

Regulator's tracked changes on v1: nausea frequency raised to common; intake with food required (SmPC 4.2, leaflet section 3).

content

Attachments

-ContentTypeUrlSizeHashTitleCreation
*application/fhir+xmlBinary: application/fhir+xml (6404 bytes base64)48028jcYmg+KSvZyKEK5Kw4HBKCUVRQ=epi-annotated-v2.xml2027-02-22 10:00:00+0100