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Packagehl7.fhir.uv.apix
Resource TypeTask
IdTask-scenario1-01-initial-submission.json
FHIR VersionR5

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Narrative

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

Task: Type IB Variation

HL7 FHIR R5 – APIX Implementation Guide

Task Description
Type IB Variation
Core Task Information
Version ID1Task IDscenario1-01-initial-submissionInstance UUIDurn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189726Group Identifierurn:uuid:workflow-group-id-12345Procedure IDnot yet assignedTask StatusrequestedBusiness StatusSubmittedIntentproposalPriorityroutine

CodeType IB Variation (variation-type-ib)Authored2025-11-15 09:00:00 UTC+01:00Last Updated2025-11-15 09:00:00 UTC+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
Performer
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
Input Documents8 documents
Module 1
Cover Letter
cover-letter
Cover Letter.pdf
Application Form
application-form
Application Form.pdf
Annotated Label
annotated-label
Annotated Label.pdf
Clean Label
clean-label
Clean Label.pdf
Pack Mockup
pack-mockup
Pack Mockup.pdf
Module 3
Stability Summary
cmc-stability-summary
CMC Doc 1 - Summary.pdf
Stability Data
cmc-stability-data
CMC Doc 2 - Data.pdf
DS Stability Data
cmc-ds-stability-data
CMC Doc 3 - DS Data.pdf
Output Documents
No output content
HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)
Generated Render

Source1

{
  "resourceType": "Task",
  "id": "scenario1-01-initial-submission",
  "meta": {
    "versionId": "1",
    "lastUpdated": "2025-11-15T09:00:00+01:00",
    "profile": [
      "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
    ]
  },
  "language": "en",
  "text": {
    "status": "additional",
    "div": "<!-- snip (see above) -->"
  },
  "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": "requested",
  "businessStatus": {
    "coding": [
      {
        "system": "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
        "code": "submitted",
        "display": "Submitted"
      }
    ]
  },
  "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": "2025-11-15T09:00:00+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"
      }
    }
  ]
}