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 follow-up ICSR

Page standards status: Informative

identifier: Document Set Identifier/urn:uuid:282d1ef0-0241-5542-b30c-cd5e47a60605, Document Version Number Identifier/urn:uuid:eb5e1a4c-7bdb-5776-94bb-cdfe0e288f28

version: 1

status: Current

docStatus: Final

type: ICSR Acknowledgment

date: 2026-10-09 10:30:02+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)201297lcw5/C3iV1076arZKeS+R8ciQ=icsr-follow-up-ack.xml2026-10-09 10:30:02+0200