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"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Task scenario1-07-final-decision</b></p><a name=\"scenario1-07-final-decision\"> </a><a name=\"hcscenario1-07-final-decision\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 3; Last updated: 2026-04-20 09:00:00+0100</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-apix-task.html\">APIX Regulatory Task</a></p></div><p><b>identifier</b>: Resource identifier/urn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189726\u00a0(use:\u00a0official,\u00a0)</p><p><b>groupIdentifier</b>: <code>http://example.org/european-med-agency/work-flow-group-id</code>/urn:uuid:workflow-group-id-12345\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Completed</p><p><b>businessStatus</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status approved}\">Approved</span></p><p><b>intent</b>: proposal</p><p><b>priority</b>: Routine</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code variation-type-ib}\">Type IB Variation</span></p><p><b>authoredOn</b>: 2025-11-15 09:00:00+0100</p><p><b>lastModified</b>: 2026-04-20 09:00:00+0100</p><p><b>requester</b>: <a href=\"Organization-org-synthpharma-ag.html\">SynthPharma AG</a></p><p><b>owner</b>: <a href=\"Organization-org-ema-srm-hmed.html\">European Medicines Agency</a></p><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.0}\">Cover Letter</span></p><p><b>value</b>: <a href=\"DocumentReference-doc1.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Cover Letter; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:\">Application Form</span></p><p><b>value</b>: <a href=\"DocumentReference-doc2.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Application Form; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.1}\">SPC, Labelling and Package Leaflet</span></p><p><b>value</b>: <a href=\"DocumentReference-doc3.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = SPC, Labelling and Package Leaflet; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.1}\">SPC, Labelling and Package Leaflet</span></p><p><b>value</b>: <a href=\"DocumentReference-doc4.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = SPC, Labelling and Package Leaflet; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.2}\">Mock-ups</span></p><p><b>value</b>: <a href=\"DocumentReference-doc5.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Mock-ups</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.P.8.1}\">Stability Summary and Conclusion</span></p><p><b>value</b>: <a href=\"DocumentReference-doc6.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Summary and Conclusion; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.P.8.3}\">Stability Data</span></p><p><b>value</b>: <a href=\"DocumentReference-doc7.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Data; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.S.7}\">Stability (Drug Substance)</span></p><p><b>value</b>: <a href=\"DocumentReference-doc8.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability (Drug Substance); category = Module 3</a></p></blockquote><blockquote><p><b>output</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type cover-letter}\">Cover Letter</span></p><p><b>value</b>: <a href=\"DocumentReference-docref-approval-letter.html\">Approval Letter</a></p></blockquote><blockquote><p><b>output</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type cover-letter}\">Cover Letter</span></p><p><b>value</b>: <a href=\"DocumentReference-docref-assessment-report.html\">Final Assessment Report</a></p></blockquote></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"
}
],
"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" : [
{
"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/apix-task-input-type",
"code" : "cover-letter",
"display" : "Cover Letter"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/docref-approval-letter",
"display" : "Approval Letter"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "cover-letter",
"display" : "Cover Letter"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/docref-assessment-report",
"display" : "Final Assessment Report"
}
}
]
}