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: Follow-up ICSR — case CH-SYNTHPHARMA-2026-000456

Page standards status: Informative

identifier: Document Set Identifier/urn:uuid:2a4760dd-5b90-5daa-9af8-2e479c3e1305, Document Version Number Identifier/urn:uuid:7713b9a6-5c3c-51ad-a580-5d6aaeabfd8a

version: 1

status: Current

docStatus: Final

type: ICSR Message

date: 2026-10-09 10:15:00+0200

author: SynthPharma AG

description:

Follow-up ICH E2B(R3) ICSR: drug withdrawn, reaction resolved (positive dechallenge).

content

Attachments

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