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

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: scenario4 05 labelling comments round 1 answered with a counter-proposal

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{
  "resourceType" : "Task",
  "id" : "scenario4-05-labelling-comments-round1-response",
  "meta" : {
    "versionId" : "2",
    "lastUpdated" : "2027-03-01T16:30:00+01:00",
    "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>Counter-proposal received (round 1)</b></p><table class=\"grid\"><tr><th>Task</th><td>Labelling Comments (<code>labelling-comments</code>)</td></tr><tr><th>Procedure number</th><td>VAR-II-2027-0012</td></tr><tr><th>Version</th><td>2</td></tr><tr><th>Status</th><td>completed</td></tr><tr><th>Business status</th><td>Counter-Proposal Received (<code>counter-proposal-received</code>)</td></tr><tr><th>Requester</th><td>Health Authority – Regulatory Review Division</td></tr><tr><th>Owner</th><td>SynthPharma AG</td></tr><tr><th>Group identifier</th><td>urn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be</td></tr><tr><th>Authored</th><td>2027-02-22T10:00:00+01:00</td></tr><tr><th>Last modified</th><td>2027-03-01T16:30:00+01:00</td></tr><tr><th>Based on</th><td><a href=\"Task-scenario4-01-variation-submitted.html\">scenario4-01-variation-submitted</a></td></tr><tr><th>Response due</th><td>2027-03-04T23:59:59+01:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href=\"DocumentReference-docref-epi-annotated-v2.html\">Annotated ePI v2 (regulator comments, round 1)</a> <code>labelling-comments</code></li></ul><p><b>Outputs (from the owner)</b></p><ul><li><a href=\"DocumentReference-docref-epi-annotated-v3.html\">Annotated ePI v3 (counter-proposal, round 1)</a> <code>proposed-labelling</code></li><li><a href=\"DocumentReference-docref-epi-clean-v3.html\">Clean ePI v3 (counter-proposal, round 1)</a> <code>epi-bundle</code></li></ul></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:8d04eb3f-cad1-5a30-aa90-894f6ea36577"
    },
    {
      "use" : "official",
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo",
            "code" : "apixregulatorprocedureno",
            "display" : "APIX Regulator Procedure Number"
          }
        ]
      },
      "system" : "http://example.org/health-authority/procedure-number",
      "value" : "VAR-II-2027-0012"
    }
  ],
  "basedOn" : [
    {
      🔗 "reference" : "Task/scenario4-01-variation-submitted"
    }
  ],
  "groupIdentifier" : {
    "use" : "official",
    "system" : "http://example.org/health-authority/work-flow-group-id",
    "value" : "urn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be"
  },
  "status" : "completed",
  "businessStatus" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
        "code" : "counter-proposal-received",
        "display" : "Counter-Proposal Received"
      }
    ]
  },
  "intent" : "proposal",
  "priority" : "routine",
  "code" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code",
        "code" : "labelling-comments",
        "display" : "Labelling Comments"
      }
    ]
  },
  "requestedPeriod" : {
    "start" : "2027-02-22T10:00:00+01:00",
    "end" : "2027-03-04T23:59:59+01:00"
  },
  "executionPeriod" : {
    "start" : "2027-02-22T10:20:00+01:00",
    "end" : "2027-03-01T16:30:00+01:00"
  },
  "authoredOn" : "2027-02-22T10:00:00+01:00",
  "lastModified" : "2027-03-01T16:30:00+01:00",
  "requester" : {
    🔗 "reference" : "Organization/org-ema-srm-hmed",
    "display" : "Health Authority – Regulatory Review Division"
  },
  "owner" : {
    🔗 "reference" : "Organization/org-synthpharma-ag",
    "display" : "SynthPharma AG"
  },
  "input" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "labelling-comments",
            "display" : "Labelling Comments"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-epi-annotated-v2",
        "display" : "Annotated ePI v2 (regulator comments, round 1)"
      }
    }
  ],
  "output" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "proposed-labelling",
            "display" : "Proposed Labelling"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-epi-annotated-v3",
        "display" : "Annotated ePI v3 (counter-proposal, round 1)"
      }
    },
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "epi-bundle",
            "display" : "ePI Bundle"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-epi-clean-v3",
        "display" : "Clean ePI v3 (counter-proposal, round 1)"
      }
    }
  ]
}