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
| Page standards status: Informative |
{
"resourceType" : "Task",
"id" : "scenario2-02-icsr-initial-acknowledged",
"meta" : {
"versionId" : "2",
"lastUpdated" : "2026-10-02T09:45:12+02:00",
"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>Initial ICSR acknowledged (AA / CA)</b></p><table class=\"grid\"><tr><th>Task</th><td>Initial ICSR (<code>icsr-initial</code>)</td></tr><tr><th>Version</th><td>2</td></tr><tr><th>Status</th><td>completed</td></tr><tr><th>Business status</th><td>Report Accepted (CA) (<code>icsr-accepted</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:2b79691d-57aa-5afa-b857-b0fa634df1bd</td></tr><tr><th>Authored</th><td>2026-10-02T09:30:00+02:00</td></tr><tr><th>Last modified</th><td>2026-10-02T09:45:12+02:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href=\"DocumentReference-docref-icsr-initial.html\">Initial ICSR</a> <code>icsr-message</code></li></ul><p><b>Outputs (from the owner)</b></p><ul><li><a href=\"DocumentReference-docref-icsr-initial-ack.html\">Acknowledgment of initial ICSR</a> <code>icsr-acknowledgment</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:8b52452c-4933-5c55-874c-51601a112860"
}
],
"groupIdentifier" : {
"use" : "official",
"system" : "http://example.org/health-authority/work-flow-group-id",
"value" : "urn:uuid:2b79691d-57aa-5afa-b857-b0fa634df1bd"
},
"status" : "completed",
"businessStatus" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
"code" : "icsr-accepted",
"display" : "Report Accepted (CA)"
}
]
},
"intent" : "proposal",
"priority" : "routine",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code",
"code" : "icsr-initial",
"display" : "Initial ICSR"
}
]
},
"executionPeriod" : {
"start" : "2026-10-02T09:30:05+02:00",
"end" : "2026-10-02T09:45:12+02:00"
},
"authoredOn" : "2026-10-02T09:30:00+02:00",
"lastModified" : "2026-10-02T09:45:12+02:00",
"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" : "icsr-message",
"display" : "ICSR Message"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/docref-icsr-initial",
"display" : "Initial ICSR"
}
}
],
"output" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
"code" : "icsr-acknowledgment",
"display" : "ICSR Acknowledgment"
}
]
},
"valueReference" : {
🔗 "reference" : "DocumentReference/docref-icsr-initial-ack",
"display" : "Acknowledgment of initial ICSR"
}
}
]
}