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Packagehl7.fhir.uv.apix
Resource TypeCodeSystem
IdCodeSystem-apix-task-code.json
FHIR VersionR5
Sourcehttps://build.fhir.org/ig/HL7/APIX---API-Exchange-for-Medicinal-Products/CodeSystem-apix-task-code.html
URLhttp://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code
Version0.1.0
Statusactive
Date2026-02-05T04:12:11+00:00
NameAPIXTaskCodeCS
TitleAPIX Task Code System
Realmuv
Authorityhl7
DescriptionCode system for regulatory task types in APIX submissions
Contentcomplete

Resources that use this resource

ValueSet
apix-submission-type-vsAPIX Submission Types
apix-task-code-vsAPIX Task Codes ValueSet

Resources that this resource uses

No resources found


Narrative

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

Generated Narrative: CodeSystem apix-task-code

This case-sensitive code system http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code defines the following codes:

CodeDisplayDefinition
initial-submission Initial SubmissionFirst submission of a new application or major variation
supplement Supplement / VariationPost-authorization change (Type IA, IB, II, extension, etc.)
response-to-questions Response to Information RequestApplicant response to regulator questions
information-request List of Questions / Information RequestRegulator raises questions or requests additional data
validation-report Validation ReportTechnical or business validation outcome
approval Approval Letter / Positive DecisionFinal positive regulatory decision
rejection Rejection / Negative DecisionFinal negative regulatory decision
withdrawal Withdrawal by ApplicantApplicant withdraws the procedure
annual-report Periodic Safety Update Report / Annual ReportPSUR, DSUR, or other periodic report

Source1

{
  "resourceType": "CodeSystem",
  "id": "apix-task-code",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 1,
      "_valueInteger": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use",
      "_valueCode": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code",
  "version": "0.1.0",
  "name": "APIXTaskCodeCS",
  "title": "APIX Task Code System",
  "status": "active",
  "experimental": false,
  "date": "2026-02-05T04:12:11+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "contact": [
    {
      "name": "HL7 International / Biomedical Research and Regulation",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description": "Code system for regulatory task types in APIX submissions",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "caseSensitive": true,
  "content": "complete",
  "count": 9,
  "concept": [
    {
      "code": "initial-submission",
      "display": "Initial Submission",
      "definition": "First submission of a new application or major variation"
    },
    {
      "code": "supplement",
      "display": "Supplement / Variation",
      "definition": "Post-authorization change (Type IA, IB, II, extension, etc.)"
    },
    {
      "code": "response-to-questions",
      "display": "Response to Information Request",
      "definition": "Applicant response to regulator questions"
    },
    {
      "code": "information-request",
      "display": "List of Questions / Information Request",
      "definition": "Regulator raises questions or requests additional data"
    },
    {
      "code": "validation-report",
      "display": "Validation Report",
      "definition": "Technical or business validation outcome"
    },
    {
      "code": "approval",
      "display": "Approval Letter / Positive Decision",
      "definition": "Final positive regulatory decision"
    },
    {
      "code": "rejection",
      "display": "Rejection / Negative Decision",
      "definition": "Final negative regulatory decision"
    },
    {
      "code": "withdrawal",
      "display": "Withdrawal by Applicant",
      "definition": "Applicant withdraws the procedure"
    },
    {
      "code": "annual-report",
      "display": "Periodic Safety Update Report / Annual Report",
      "definition": "PSUR, DSUR, or other periodic report"
    }
  ]
}