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
| Page standards status: Informative |
Profile: APIX Regulatory DocumentReference
identifier: Document Set Identifier/urn:uuid:e41a6eb1-4998-5415-a891-a769b7756a65, Document Version Number Identifier/urn:uuid:2ef55f48-ebfc-554c-bcc8-97b781963b88
version: 1
status: Current
docStatus: Final
type: Request for Information
date: 2026-10-01 11:00:00+0200
author: Health Authority – Regulatory Review Division
description:
Request for information raised during assessment (three questions).
content
Attachments
ContentType Url Size Hash Title Creation application/pdf Binary: application/pdf (3084 bytes base64) 2313 g8KC3IPgI8OCBElZZfBVMBv2Xf0=cta-request-for-information.pdf 2026-10-01 11:00:00+0200