FHIR IG analytics
| Package | hl7.fhir.uv.rwi-pharma |
| Resource Type | Task |
| Id | Task-scenario1-06-technical-response.json |
| FHIR Version | R5 |
Resources that use this resource
No resources found
Resources that this resource uses
No resources found
Narrative
Note: links and images are rebased to the (stated) source
Task: Response to Information Request
HL7 FHIR R5 – APIX Implementation Guide
Task Description
Response to Questions: Submission of additional stability data
Core Task Information
Version ID3Task IDIn production this would be the same as scenario1-05-technical-questionInstance UUIDurn:uuid:888e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3cGroup Identifierurn:uuid:workflow-group-id-12345Parent Taskscenario1-01-initial-submissionTask StatusrequestedBusiness StatusSubmittedIntentproposalPriorityroutine
CodeResponse to Information Request (response-to-questions)Authored2025-12-01T14:30:00+01:00Last Updated2025-12-05T10:00:00+01:00 Request Start Time2025-12-01T14:30:00+01:00 Request Answer By2025-12-08T14:30:00+01:00
Parties Involved
Requester
SynthPharma AG
Address: 123 Synthetic Research Blvd, 4000 Basel, Switzerland
Contact: Dr. John Doe, Head of Regulatory Affairs
Email: john.doe@synthpharma.example
Contact: Dr. John Doe, Head of Regulatory Affairs
Email: john.doe@synthpharma.example
Performer
Health Authority – Regulatory Review Division
Address: Regulatory Authority Headquarters, 1083 HS Capital City, Country
Contact: Scientific and Regulatory Management
Email: regulatory@health-authority.example
Contact: Scientific and Regulatory Management
Email: regulatory@health-authority.example
Input Documents1 documents
Input Documents (Questions)
List of Questions (LoQ)
regulatory-documenthttp://example.org/FHIR/DocumentReference/docref-list-of-questions
list of questions
Output Documents2 documents
Output Documents (Responses)
Applicant Responses
regulatory-documenthttp://example.org/FHIR/DocumentReference/docref-responses-qresponse
Applicant QuestionnaireResponse
Annex: Raw Stability Data
regulatory-documenthttp://example.org/FHIR/DocumentReference/docref-stability-data-annex
Annex: Updated Stability Data
HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)
Generated Render
Generated Render
Source1
{
"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"
]
},
"text": {
"status": "additional",
"div": "<!-- snip (see above) -->"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-demo",
"code": "apixtaskinstance",
"display": "APIX Task Instance ID"
}
]
},
"system": "http://example.org/health-authority/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/health-authority/work-flow-group-id",
"value": "urn:uuid:workflow-group-id-12345"
},
"status": "completed",
"businessStatus": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-business-status",
"code": "clock-restart",
"display": "Clock Restart"
}
]
},
"intent": "proposal",
"priority": "routine",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/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": "Health Authority"
},
"owner": {
"reference": "Organization/org-synthpharma-ag",
"display": "SynthPharma AG"
},
"input": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/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/rwi-pharma/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/rwi-pharma/CodeSystem/ctd-section",
"code": "3.2.P.8.3",
"display": "Stability Data"
}
]
},
"valueReference": {
"reference": "DocumentReference/docref-stability-data-annex",
"display": "Annex: Updated Stability Data"
}
}
]
}
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