Regulatory Workflows and Interactions - pharma
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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 v4 (regulator comments, round 2)

Page standards status: Informative

identifier: Document Set Identifier/urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc, Document Version Number Identifier/urn:uuid:4276a35e-3880-5996-9c35-550dd8ba6376

version: 4

status: Current

docStatus: Final

type: Labelling Comments

date: 2027-03-08 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:225a66eb-8819-5c4d-9625-cc4a2aae425f; version = 3; status = current; docStatus = final; type = Proposed Labelling; date = 2027-03-01 16:30:00+0100; description = Applicant accepts the frequency change and counter-proposes "may be taken with food to reduce nausea" (SmPC 4.2, leaflet section 3).

description:

Regulator accepts the counter-proposal and changes the leaflet wording to "feeling sick".

content

Attachments

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*application/fhir+xmlBinary: application/fhir+xml (6512 bytes base64)4882YNnou2CNoZZ2qTMxA/gLsasVIDA=epi-annotated-v4.xml2027-03-08 10:00:00+0100