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 Task: scenario4 05 labelling comments round 1 answered with a counter-proposal

Page standards status: Informative

Counter-proposal received (round 1)

TaskLabelling Comments (labelling-comments)
Procedure numberVAR-II-2027-0012
Version2
Statuscompleted
Business statusCounter-Proposal Received (counter-proposal-received)
RequesterHealth Authority – Regulatory Review Division
OwnerSynthPharma AG
Group identifierurn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be
Authored2027-02-22T10:00:00+01:00
Last modified2027-03-01T16:30:00+01:00
Based onscenario4-01-variation-submitted
Response due2027-03-04T23:59:59+01:00

Inputs (from the requester)

Outputs (from the owner)