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: Acknowledgment of initial ICSR

Page standards status: Informative

identifier: Document Set Identifier/urn:uuid:0123b7d5-aa25-5e6f-acb0-d866c50a4975, Document Version Number Identifier/urn:uuid:b30a2831-3127-5859-8ab4-7bf7ea3ffb9e

version: 1

status: Current

docStatus: Final

type: ICSR Acknowledgment

date: 2026-10-02 09:45:12+0200

author: Health Authority – Regulatory Review Division

description:

ICH E2B(R3) acknowledgment: transmission AA, report CA.

content

Attachments

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*application/xmlBinary: application/xml (2684 bytes base64)2012NfRSyv+bVHNx7PmXK97LhQyHsws=icsr-initial-ack.xml2026-10-02 09:45:12+0200