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Packagehl7.fhir.uv.apix
Resource TypeTask
IdTask-scenario1-05-technical-question.json
FHIR VersionR5

Resources that use this resource

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Resources that this resource uses

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Narrative

Note: links and images are rebased to the (stated) source

Task: Information Request

HL7 FHIR R5 – APIX Implementation Guide

Task Description
Regulatory Questions: Request for additional stability data
Core Task Information
Version ID1Task IDscenario1-05-technical-questionInstance UUIDurn:uuid:778e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3bGroup Identifierurn:uuid:workflow-group-id-12345Parent Taskscenario1-01-initial-submissionTask StatusrequestedBusiness StatusClock StopIntentproposalPriorityroutine
CodeInformation Request (information-request)Authored2025-03-01 14:30:00 UTC+01:00Last Updated2025-03-01 14:30:00 UTC+01:00 Request Start Time2025-12-01T14:30:00+01:00 Request Answer By2025-12-08T14:30:00+01:00
Parties Involved
Requester
European Medicines Agency – Human Medicines Evaluation Division
Address: Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands
Contact: Scientific and Regulatory Management
Email: srm@ema.example.eu
Performer
SynthPharma AG
Address: 123 Synthetic Research Blvd, 4000 Basel, Switzerland
Contact: Dr. John Doe, Head of Regulatory Affairs
Email: john.doe@synthpharma.example
Input Documents1 documents
Input Documents (Questions)
List of Questions (LoQ)
regulatory-document
list-of-questions-EMA.pdf
Output Documents
No output content
HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)
Generated Render

Source1

{
  "resourceType": "Task",
  "id": "scenario1-05-technical-question",
  "meta": {
    "versionId": "1",
    "lastUpdated": "2025-12-01T14:30:00+01:00",
    "profile": [
      "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
    ]
  },
  "language": "en",
  "text": {
    "status": "additional",
    "div": "<!-- snip (see above) -->"
  },
  "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": "requested",
  "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": "2025-12-01T14:30:00+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)"
      }
    }
  ]
}