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: scenario2 02 initial ICSR acknowledged

Page standards status: Informative

Initial ICSR acknowledged (AA / CA)

TaskInitial ICSR (icsr-initial)
Version2
Statuscompleted
Business statusReport Accepted (CA) (icsr-accepted)
RequesterSynthPharma AG
OwnerHealth Authority – Regulatory Review Division
Group identifierurn:uuid:2b79691d-57aa-5afa-b857-b0fa634df1bd
Authored2026-10-02T09:30:00+02:00
Last modified2026-10-02T09:45:12+02:00

Inputs (from the requester)

Outputs (from the owner)