API for the Exchange of Medicinal Product Information (APIX), 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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: scenario1 06 technical response

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{
  "resourceType" : "Task",
  "id" : "scenario1-06-technical-response",
  "meta" : {
    "versionId" : "3",
    "lastUpdated" : "2025-12-05T10:00:00+01:00",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "additional",
    "div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><div style=\"font-family:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;background:linear-gradient(to bottom,#f2f6fa,#e8eef5);color:#1d1d1f;margin:0;padding:40px 20px;line-height:1.5;\"><div style=\"max-width:1000px;margin:0 auto;\"><div style=\"background:linear-gradient(135deg,#007aff,#5ac8fa);color:#ffffff;padding:40px 24px;border-radius:18px;text-align:center;box-shadow:0 10px 30px rgba(0,122,255,0.3);margin-bottom:36px;\"><div style=\"margin:0 0 8px 0;font-size:32px;font-weight:600;\">Task: Response to Information Request</div><p style=\"margin:0;opacity:0.95;font-size:17px;\">HL7 FHIR R5 – APIX Implementation Guide</p></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Task Description</div><div style=\"font-size:18px;line-height:1.6;color:#333333;\">Response to Questions: Submission of additional stability data</div></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Core Task Information</div><div style=\"display:grid;grid-template-columns:max-content auto;gap:12px 20px;align-items:baseline;\"><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Version ID</span><span style=\"color:#1d1d1f;\">3</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Task ID</span><span style=\"color:#1d1d1f;\">In production this would be the same as scenario1-05-technical-question</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Instance UUID</span><span style=\"color:#1d1d1f;\">urn:uuid:888e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3c</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Group Identifier</span><span style=\"color:#1d1d1f;\">urn:uuid:workflow-group-id-12345</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Parent Task</span><span style=\"color:#1d1d1f;\">scenario1-01-initial-submission</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Task Status</span><span style=\"color:#1d1d1f;\"><span style=\"padding:2px 8px;border-radius:12px;font-size:0.9em;font-weight:500;color:#ffffff;background:#17a2b8;\">requested</span></span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Business Status</span><span style=\"color:#1d1d1f;\"><span style=\"padding:2px 8px;border-radius:12px;font-size:0.9em;font-weight:500;color:#ffffff;background:#6c757d;\">Submitted</span></span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Intent</span><span style=\"color:#1d1d1f;\">proposal</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Priority</span><span style=\"color:#1d1d1f;\">routine</span></div><hr style=\"border:0;border-top:1px solid #eee;margin:20px 0;\"/><div style=\"display:grid;grid-template-columns:max-content auto;gap:12px 20px;align-items:baseline;\"><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Code</span><span style=\"color:#1d1d1f;\">Response to Information Request (response-to-questions)</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Authored</span><span style=\"color:#1d1d1f;\">2025-12-01T14:30:00+01:00</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Last Updated</span><span style=\"color:#1d1d1f;\">2025-12-05T10:00:00+01:00</span> <span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Request Start Time</span><span style=\"color:#1d1d1f;\">2025-12-01T14:30:00+01:00</span> <span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Request Answer By</span><span style=\"color:#1d1d1f;\">2025-12-08T14:30:00+01:00</span></div></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Parties Involved</div><div style=\"margin-bottom:24px;padding-bottom:16px;border-bottom:1px solid #eeeeee;\"><span style=\"font-weight:600;color:#007aff;margin-bottom:4px;display:block;\">Requester</span><div style=\"font-size:16px;font-weight:500;margin-bottom:8px;color:#1d1d1f;\">SynthPharma AG</div><div style=\"font-size:14px;color:#555555;line-height:1.5;\"><strong>Address:</strong> 123 Synthetic Research Blvd, 4000 Basel, Switzerland<br/><strong>Contact:</strong> Dr. John Doe, Head of Regulatory Affairs<br/><strong>Email:</strong> john.doe@synthpharma.example</div></div><div style=\"margin-bottom:0;padding-bottom:0;border-bottom:none;\"><span style=\"font-weight:600;color:#007aff;margin-bottom:4px;display:block;\">Performer</span><div style=\"font-size:16px;font-weight:500;margin-bottom:8px;color:#1d1d1f;\">European Medicines Agency – Human Medicines Evaluation Division</div><div style=\"font-size:14px;color:#555555;line-height:1.5;\"><strong>Address:</strong> Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands<br/><strong>Contact:</strong> Scientific and Regulatory Management<br/><strong>Email:</strong> srm@ema.example.eu</div></div></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Input Documents<span style=\"background:#007aff;color:#ffffff;font-size:14px;font-weight:600;padding:6px 14px;border-radius:20px;\">1 documents</span></div><div style=\"margin:24px 0;padding:20px;background:#f8fbff;border-radius:14px;border-left:5px solid #007aff;\"><div style=\"margin:0 0 16px 0;font-size:18px;color:#007aff;font-weight:600;\">Input Documents (Questions)</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">List of Questions (LoQ)</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">regulatory-document</span><br/><a href=\"DocumentReference-docref-list-of-questions.html\">http://example.org/FHIR/DocumentReference/docref-list-of-questions</a><div>list of questions</div></div></div></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Output Documents<span style=\"background:#34c759;color:#ffffff;font-size:14px;font-weight:600;padding:6px 14px;border-radius:20px;\">2 documents</span></div><div style=\"margin:24px 0;padding:20px;background:#f2fff5;border-radius:14px;border-left:5px solid #34c759;\"><div style=\"margin:0 0 16px 0;font-size:18px;color:#34c759;font-weight:600;\">Output Documents (Responses)</div><div style=\"background:#ffffff;border:1px solid #ccebd3;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#34c759;font-size:15px;\">Applicant Responses</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e6f9eb;padding:2px 8px;border-radius:6px;font-size:13px;\">regulatory-document</span><br/><a href=\"DocumentReference-docref-responses-qresponse.html\">http://example.org/FHIR/DocumentReference/docref-responses-qresponse</a><div>Applicant QuestionnaireResponse</div></div><div style=\"background:#ffffff;border:1px solid #ccebd3;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#34c759;font-size:15px;\">Annex: Raw Stability Data</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e6f9eb;padding:2px 8px;border-radius:6px;font-size:13px;\">regulatory-document</span><br/><a href=\"DocumentReference-docref-stability-data-annex.html\">http://example.org/FHIR/DocumentReference/docref-stability-data-annex</a><div>Annex: Updated Stability Data</div></div><div style=\"text-align:center;padding:50px;color:#666666;font-size:14px;\">HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)<br/>Generated Render</div></div></div></div></div></div>"
  },
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "RI",
            "display" : "Resource identifier"
          }
        ]
      },
      "system" : "http://example.org/european-med-agency/task-id",
      "value" : "urn:uuid:778e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3b"
    }
  ],
  "basedOn" : [
    {
      🔗 "reference" : "Task/scenario1-01-initial-submission",
      "display" : "Initial Submission Task"
    }
  ],
  "groupIdentifier" : {
    "use" : "official",
    "system" : "http://example.org/european-med-agency/work-flow-group-id",
    "value" : "urn:uuid:workflow-group-id-12345"
  },
  "status" : "completed",
  "businessStatus" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
        "code" : "clock-stop",
        "display" : "Clock Stop"
      }
    ]
  },
  "intent" : "proposal",
  "priority" : "routine",
  "code" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code",
        "code" : "information-request",
        "display" : "List of Questions / Information Request"
      }
    ]
  },
  "requestedPeriod" : {
    "start" : "2025-12-01T14:30:00+01:00",
    "end" : "2025-12-08T14:30:00+01:00"
  },
  "authoredOn" : "2025-12-01T14:30:00+01:00",
  "lastModified" : "2025-12-05T10:00:00+01:00",
  "requester" : {
    🔗 "reference" : "Organization/org-ema-srm-hmed",
    "display" : "European Medicines Agency"
  },
  "owner" : {
    🔗 "reference" : "Organization/org-synthpharma-ag",
    "display" : "SynthPharma AG"
  },
  "input" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
            "code" : "list-of-questions",
            "display" : "List of Questions"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-list-of-questions",
        "display" : "List of Questions (LoQ)"
      }
    }
  ],
  "output" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
            "code" : "applicant-questionnaireResponse\"",
            "display" : "Applicant QuestionnaireResponse"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-responses-qresponse",
        "display" : "Applicant QuestionnaireResponse"
      }
    },
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
            "code" : "3.2.P.8.3",
            "display" : "Stability Data"
          }
        ]
      },
      "valueReference" : {
        🔗 "reference" : "DocumentReference/docref-stability-data-annex",
        "display" : "Annex: Updated Stability Data"
      }
    }
  ]
}