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

• Narrative Content
• XML
• JSON
• TTL

: Initial ICSR — case CH-SYNTHPHARMA-2026-000456

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{
  "resourceType" : "DocumentReference",
  "id" : "docref-icsr-initial",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference docref-icsr-initial</b></p><a name=\"docref-icsr-initial\"> </a><a name=\"hcdocref-icsr-initial\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-apix-documentreference.html\">APIX Regulatory DocumentReference</a></p></div><p><b>identifier</b>: Document Set Identifier/urn:uuid:2460574f-c235-510e-bc4c-96e063c30df2, Document Version Number Identifier/urn:uuid:c79a91e1-9537-5933-82dd-7ccf8e9e4eb0</p><p><b>version</b>: 1</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type icsr-message}\">ICSR Message</span></p><p><b>date</b>: 2026-10-02 09:30:00+0200</p><p><b>author</b>: <a href=\"Organization-org-synthpharma-ag.html\">SynthPharma AG</a></p><p><b>description</b>: </p><div><p>Initial ICH E2B(R3) ICSR for case CH-SYNTHPHARMA-2026-000456 (nausea with WonderDrug 50 mg).</p>\n</div><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style=\"display: none\">*</td><td>application/xml</td><td><a href=\"Binary-binary-icsr-initial.html\">Binary: application/xml (10720 bytes base64)</a></td><td>8038</td><td><code>S+dAYt27+1cEPbqbQxUmGUOT98o=</code></td><td>icsr-initial.xml</td><td>2026-10-02 09:30:00+0200</td></tr></table></blockquote></div>"
  },
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo",
            "code" : "docsetid",
            "display" : "Document Set Identifier"
          }
        ]
      },
      "system" : "http://example.org/synthpharma/document-set-id",
      "value" : "urn:uuid:2460574f-c235-510e-bc4c-96e063c30df2"
    },
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo",
            "code" : "docverid",
            "display" : "Document Version Number Identifier"
          }
        ]
      },
      "system" : "http://example.org/synthpharma/document-version-id",
      "value" : "urn:uuid:c79a91e1-9537-5933-82dd-7ccf8e9e4eb0"
    }
  ],
  "version" : "1",
  "status" : "current",
  "docStatus" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
        "code" : "icsr-message",
        "display" : "ICSR Message"
      }
    ]
  },
  "date" : "2026-10-02T09:30:00+02:00",
  "author" : [
    {
      🔗 "reference" : "Organization/org-synthpharma-ag",
      "display" : "SynthPharma AG"
    }
  ],
  "description" : "Initial ICH E2B(R3) ICSR for case CH-SYNTHPHARMA-2026-000456 (nausea with WonderDrug 50 mg).",
  "content" : [
    {
      "attachment" : {
        "contentType" : "application/xml",
        "url" : "Binary/binary-icsr-initial",
        "size" : "8038",
        "hash" : "S+dAYt27+1cEPbqbQxUmGUOT98o=",
        "title" : "icsr-initial.xml",
        "creation" : "2026-10-02T09:30:00+02:00"
      }
    }
  ]
}