FHIR IG analytics
| Package | hl7.fhir.uv.rwi-pharma |
| Resource Type | Task |
| Id | Task-scenario1-02-validation.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: Type IB Variation
HL7 FHIR R5 – APIX Implementation Guide
Task Description
Validation of Type IB Variation
Core Task Information
Version ID2 Task IDin production system will be the same as scenario1-01-initial-submission Instance UUIDurn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189726 Procedure IDPROC-2025-12345 Group Identifierurn:uuid:workflow-group-id-12345 Task StatusacceptedBusiness StatusValidation SuccessfulIntentproposalPriorityroutine
CodeType IB Variation (variation-type-ib)Authored2025-11-15 09:00:00 UTC+01:00Last Updated2025-11-20 14:30:00 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
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 Documents8 documents
Module 1
Application Form
application-formhttp://example.org/FHIR/DocumentReference/application-form
Application Form
Annotated Label
annotated-labelhttp://example.org/FHIR/DocumentReference/annotated-label
SPC, Labelling and Package Leaflet
Clean Label
clean-labelhttp://example.org/FHIR/DocumentReference/clean-label
SPC, Labelling and Package Leaflet
Module 3
Stability Summary
cmc-stability-summaryhttp://example.org/FHIR/DocumentReference/stability-summary
Stability Summary and Conclusion
Stability Data
cmc-stability-datahttp://example.org/FHIR/DocumentReference/stability-data
Stability Data
DS Stability Data
cmc-ds-stability-datahttp://example.org/FHIR/DocumentReference/stability-drug-substance
Stability (Drug Substance)
Output Documents2 documents
Regulator Output
Acknowledgement of Receipt
acknowledgement-receipthttp://example.org/FHIR/DocumentReference/output-ack
Acknowledgement of Receipt
Validation Report
validation-reporthttp://example.org/FHIR/DocumentReference/output-validation
Validation Report
HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)
Generated Render
Generated Render
Source1
{
"resourceType": "Task",
"id": "scenario1-02-validation",
"meta": {
"versionId": "2",
"lastUpdated": "2025-11-20T14:30:00+01:00",
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
]
},
"text": {
"status": "additional",
"div": "<!-- snip (see above) -->"
},
"identifier": [
{
"use": "official",
"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:f1500e1d-599f-47a6-a38c-ca60a5189726"
},
{
"use": "official",
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-demo",
"code": "apixregulatorprocedureno",
"display": "APIX Regulator Procedure Number"
}
]
},
"system": "http://example.org/health.authority/procedure-number",
"value": "PROC-2025-12345"
}
],
"groupIdentifier": {
"use": "official",
"system": "http://example.org/health-authority/work-flow-group-id",
"value": "urn:uuid:workflow-group-id-12345"
},
"status": "accepted",
"businessStatus": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-business-status",
"code": "validation-successful",
"display": "Validation Successful"
}
]
},
"intent": "proposal",
"priority": "routine",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-code",
"code": "variation-type-ib",
"display": "Type IB Variation"
}
]
},
"authoredOn": "2025-11-15T09:00:00+01:00",
"lastModified": "2025-11-20T14:30:00+01:00",
"requester": {
"reference": "Organization/org-synthpharma-ag",
"display": "SynthPharma AG"
},
"owner": {
"reference": "Organization/org-ema-srm-hmed",
"display": "Health Authority"
},
"input": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section",
"code": "1.0",
"display": "Cover Letter"
}
]
},
"valueReference": {
"reference": "DocumentReference/doc1"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section",
"code": "application-form",
"display": "Application Form"
}
]
},
"valueReference": {
"reference": "DocumentReference/doc2"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section",
"code": "1.14.1.2",
"display": "Annotated draft labeling text"
}
]
},
"valueReference": {
"reference": "DocumentReference/doc3"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section",
"code": "1.14.1.3",
"display": "Draft labeling text"
}
]
},
"valueReference": {
"reference": "DocumentReference/doc4"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section",
"code": "1.3.2",
"display": "Mock-ups"
}
]
},
"valueReference": {
"reference": "DocumentReference/doc5"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/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/rwi-pharma/CodeSystem/ctd-section",
"code": "3.2.P.8.3",
"display": "Stability Data"
}
]
},
"valueReference": {
"reference": "DocumentReference/doc7"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/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/rwi-pharma/CodeSystem/ctd-section",
"code": "acknowledgement-receipt",
"display": "Acknowledgement of Receipt"
}
]
},
"valueReference": {
"reference": "DocumentReference/output-ack"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section",
"code": "validation-report",
"display": "Validation Report"
}
]
},
"valueReference": {
"reference": "DocumentReference/output-validation"
}
}
]
}
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