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

: scenario2 01 initial ICSR submitted

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{
  "resourceType" : "Task",
  "id" : "scenario2-01-icsr-initial",
  "meta" : {
    "versionId" : "1",
    "lastUpdated" : "2026-10-02T09:30:00+02:00",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Initial ICSR submitted</b></p><table class=\"grid\"><tr><th>Task</th><td>Initial ICSR (<code>icsr-initial</code>)</td></tr><tr><th>Version</th><td>1</td></tr><tr><th>Status</th><td>requested</td></tr><tr><th>Business status</th><td>Submitted (<code>submitted</code>)</td></tr><tr><th>Requester</th><td>SynthPharma AG</td></tr><tr><th>Owner</th><td>Health Authority – Regulatory Review Division</td></tr><tr><th>Group identifier</th><td>urn:uuid:2b79691d-57aa-5afa-b857-b0fa634df1bd</td></tr><tr><th>Authored</th><td>2026-10-02T09:30:00+02:00</td></tr><tr><th>Last modified</th><td>2026-10-02T09:30:00+02:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href=\"DocumentReference-docref-icsr-initial.html\">Initial ICSR</a> <code>icsr-message</code></li></ul><p><b>Outputs (from the owner)</b></p><p>None</p></div>"
  },
  "identifier" : [
    {
      "use" : "official",
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo",
            "code" : "apixtaskinstance",
            "display" : "APIX Task Instance ID"
          }
        ]
      },
      "system" : "http://example.org/health-authority/task-id",
      "value" : "urn:uuid:8b52452c-4933-5c55-874c-51601a112860"
    }
  ],
  "groupIdentifier" : {
    "use" : "official",
    "system" : "http://example.org/health-authority/work-flow-group-id",
    "value" : "urn:uuid:2b79691d-57aa-5afa-b857-b0fa634df1bd"
  },
  "status" : "requested",
  "businessStatus" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
        "code" : "submitted",
        "display" : "Submitted"
      }
    ]
  },
  "intent" : "proposal",
  "priority" : "routine",
  "code" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code",
        "code" : "icsr-initial",
        "display" : "Initial ICSR"
      }
    ]
  },
  "authoredOn" : "2026-10-02T09:30:00+02:00",
  "lastModified" : "2026-10-02T09:30:00+02:00",
  "requester" : {
    🔗 "reference" : "Organization/org-synthpharma-ag",
    "display" : "SynthPharma AG"
  },
  "owner" : {
    🔗 "reference" : "Organization/org-ema-srm-hmed",
    "display" : "Health Authority – Regulatory Review Division"
  },
  "input" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "icsr-message",
            "display" : "ICSR Message"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-icsr-initial",
        "display" : "Initial ICSR"
      }
    }
  ]
}