API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
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
| Page standards status: Informative |
{
"resourceType" : "Task",
"id" : "scenario1-07-final-decision",
"meta" : {
"versionId" : "3",
"lastUpdated" : "2026-04-20T09:00:00+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: Approval Letter / Positive Decision</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;\">Final Decision: Approval for Type IB Variation</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 system will be the same as scenario1-01-initial-submission</span> <span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Instance UUID</span><span style=\"color:#1d1d1f;\">urn:uuid:999e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3d</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;\">Procedure ID</span><span style=\"color:#1d1d1f;\">PROC-2025-12345</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:#28a745;\">completed</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:#28a745;\">Approved</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;\">Type IB Variation (variation-type-ib)</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Authored</span><span style=\"color:#1d1d1f;\">2025-11-15T09:00:00+01:00</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Last Updated</span><span style=\"color:#1d1d1f;\">2026-04-20T09:00:00+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;\">8 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;\">Module 1</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;\">Cover Letter</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cover-letter</span><br/><a href=\"DocumentReference-doc1.html\">http://example.org/FHIR/DocumentReference/cover-letter</a><div>Cover Letter</div></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;\">Application Form</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">application-form</span><br/><a href=\"DocumentReference-doc2.html\">http://example.org/FHIR/DocumentReference/application-form</a><div>Application Form</div></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;\">Annotated Label</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">annotated-label</span><br/><a href=\"DocumentReference-doc3.html\">http://example.org/FHIR/DocumentReference/annotated-label</a><div>SPC, Labelling and Package Leaflet</div></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;\">Clean Label</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">clean-label</span><br/><a href=\"DocumentReference-doc4.html\">http://example.org/FHIR/DocumentReference/clean-labele</a><div>SPC, Labelling and Package Leaflet</div></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;\">Pack Mockup</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">pack-mockup</span><br/><a href=\"DocumentReference-doc5.html\">http://example.org/FHIR/DocumentReference/mock-ups</a><div>Mock-ups</div></div></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;\">Module 3</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;\">Stability Summary</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cmc-stability-summary</span><br/><a href=\"DocumentReference-doc6.html\">http://example.org/FHIR/DocumentReference/stability-summary</a><div>Stability Summary and Conclusion</div></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;\">Stability Data</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cmc-stability-data</span><br/><a href=\"DocumentReference-doc7.html\">http://example.org/FHIR/DocumentReference/stability-data</a><div>Stability Data</div></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;\">DS Stability Data</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cmc-ds-stability-data</span><br/><a href=\"DocumentReference-doc8.html\">http://example.org/FHIR/DocumentReference/stability-drug-substance</a><div>Stability (Drug Substance)</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;\">4 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;\">Regulator Output</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;\">Acknowledgement of Receipt</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e6f9eb;padding:2px 8px;border-radius:6px;font-size:13px;\">acknowledgement-receipt</span><br/><a href=\"DocumentReference-output-ack.html\">http://example.org/FHIR/DocumentReference/output-ack</a><div>Acknowledgement of Receipt</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;\">Validation Report</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e6f9eb;padding:2px 8px;border-radius:6px;font-size:13px;\">validation-report</span><br/><a href=\"DocumentReference-output-validation.html\">http://example.org/FHIR/DocumentReference/output-validation</a><div>Validation Report</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;\">Approval Letter</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-approval-letter.html\">http://example.org/FHIR/DocumentReference/docref-approval-letter</a><div>Approval Letter</div></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:#34c759;font-size:15px;\">Final Assessment Report</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-assessment-report.html\">http://example.org/FHIR/DocumentReference/docref-assessment-report</a><div>Final Assessment Report</div></div></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>"
},
"identifier" : [
{
"use" : "official",
"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:f1500e1d-599f-47a6-a38c-ca60a5189726"
},
{
"use" : "official",
"system" : "http://example.org/ema.europa.eu/procedure-number",
"value" : "PROC-2025-12345"
}
],
"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" : "approved",
"display" : "Approved"
}
]
},
"intent" : "proposal",
"priority" : "routine",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code",
"code" : "variation-type-ib",
"display" : "Type IB Variation"
}
]
},
"authoredOn" : "2025-11-15T09:00:00+01:00",
"lastModified" : "2026-04-20T09:00:00+01:00",
"requester" : {
🔗 "reference" : "Organization/org-synthpharma-ag",
"display" : "SynthPharma AG"
},
"owner" : {
🔗 "reference" : "Organization/org-ema-srm-hmed",
"display" : "European Medicines Agency"
},
"input" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "1.0",
"display" : "Cover Letter"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/doc1"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "application-form",
"display" : "Application Form"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/doc2"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "1.3.1",
"display" : "SPC, Labelling and Package Leaflet"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/doc3"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "1.3.1",
"display" : "SPC, Labelling and Package Leaflet"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/doc4"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "1.3.2",
"display" : "Mock-ups"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/doc5"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "3.2.P.8.1",
"display" : "Stability Summary and Conclusion"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/doc6"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "3.2.P.8.3",
"display" : "Stability Data"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/doc7"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "3.2.S.7",
"display" : "Stability (Drug Substance)"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/doc8"
}
}
],
"output" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "acknowledgement-receipt",
"display" : "Acknowledgement of Receipt"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/output-ack",
"display" : "Acknowledgement of Receipt"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "validation-report",
"display" : "Validation Report"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/output-validation",
"display" : "Validation Report"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "approval-letter",
"display" : "Approval Letter"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/docref-approval-letter",
"display" : "Approval Letter"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "assessment-report",
"display" : "Assessment Report"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/docref-assessment-report",
"display" : "Final Assessment Report"
}
}
]
}
IG © 2025+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.apix#0.1.0 based on FHIR 5.0.0.
Generated
2026-04-14
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