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

: scenario4 10 Type II variation approved

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{
  "resourceType" : "Task",
  "id" : "scenario4-10-variation-approved",
  "meta" : {
    "versionId" : "4",
    "lastUpdated" : "2027-03-17T09:00:00+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>Type II variation approved</b></p><table class=\"grid\"><tr><th>Task</th><td>Type II Variation (<code>variation-type-ii</code>)</td></tr><tr><th>Procedure number</th><td>VAR-II-2027-0012</td></tr><tr><th>Version</th><td>4</td></tr><tr><th>Status</th><td>completed</td></tr><tr><th>Business status</th><td>Approved (<code>approved</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:60ac55b8-8d46-58ff-b1b2-e8015d4960be</td></tr><tr><th>Authored</th><td>2027-01-11T10:00:00+01:00</td></tr><tr><th>Last modified</th><td>2027-03-17T09:00:00+01:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href=\"DocumentReference-docref-var-cover-letter.html\">Variation cover letter</a> <code>cover-letter</code></li><li><a href=\"DocumentReference-docref-var-application-form.html\">Variation application form</a> <code>application-form</code></li><li><a href=\"DocumentReference-docref-var-change-description.html\">Change description and justification</a> <code>change-description</code></li><li><a href=\"DocumentReference-docref-epi-annotated-v1.html\">Annotated ePI v1 (proposal)</a> <code>proposed-labelling</code></li><li><a href=\"DocumentReference-docref-epi-clean-v1.html\">Clean ePI v1 (proposal)</a> <code>epi-bundle</code></li></ul><p><b>Outputs (from the owner)</b></p><ul><li><a href=\"DocumentReference-docref-var-validation-report.html\">Variation validation report</a> <code>validation-report</code></li><li><a href=\"DocumentReference-docref-var-approval-letter.html\">Variation approval letter</a> <code>approval-letter</code></li><li><a href=\"DocumentReference-docref-epi-approved.html\">Approved ePI</a> <code>approved-labelling</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:86c83ea7-80e5-5efa-aa1a-4cd36f9a425e"
    },
    {
      "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"
    }
  ],
  "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" : "approved",
        "display" : "Approved"
      }
    ]
  },
  "intent" : "proposal",
  "priority" : "routine",
  "code" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code",
        "code" : "variation-type-ii",
        "display" : "Type II Variation"
      }
    ]
  },
  "executionPeriod" : {
    "start" : "2027-01-15T14:00:00+01:00",
    "end" : "2027-03-17T09:00:00+01:00"
  },
  "authoredOn" : "2027-01-11T10:00:00+01:00",
  "lastModified" : "2027-03-17T09:00:00+01:00",
  "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" : "cover-letter",
            "display" : "Cover Letter"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-var-cover-letter",
        "display" : "Variation cover letter"
      }
    },
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "application-form",
            "display" : "Application Form"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-var-application-form",
        "display" : "Variation application form"
      }
    },
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "change-description",
            "display" : "Change Description and Justification"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-var-change-description",
        "display" : "Change description and justification"
      }
    },
    {
      "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-v1",
        "display" : "Annotated ePI v1 (proposal)"
      }
    },
    {
      "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-v1",
        "display" : "Clean ePI v1 (proposal)"
      }
    }
  ],
  "output" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "validation-report",
            "display" : "Validation Report"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-var-validation-report",
        "display" : "Variation validation report"
      }
    },
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "approval-letter",
            "display" : "Approval Letter"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-var-approval-letter",
        "display" : "Variation approval letter"
      }
    },
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
            "code" : "approved-labelling",
            "display" : "Approved Labelling"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-epi-approved",
        "display" : "Approved ePI"
      }
    }
  ]
}