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Narrative

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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/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma"
          }
        ]
      }
    },
    {
      "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/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-code",
  "version": "0.1.0",
  "name": "APIXTaskCodeCS",
  "title": "APIX Task Code System",
  "status": "draft",
  "experimental": false,
  "date": "2026-10-25T20:05:09+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,
  "hierarchyMeaning": "is-a",
  "content": "complete",
  "count": 13,
  "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": "variation-type-ib",
      "display": "Type IB Variation",
      "definition": "Minor, post-approval change to a medicinal product's marketing authorization that has minimal impact on quality, safety, or efficacy"
    },
    {
      "code": "information-request",
      "display": "List of Questions / Information Request",
      "definition": "Regulator raises questions or requests additional data"
    },
    {
      "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"
    },
    {
      "code": "request-payment",
      "display": "Request Payment",
      "definition": "Requested payment of regulatory fees"
    },
    {
      "code": "icsr",
      "display": "Individual Case Safety Report",
      "definition": "Transmission of a single individual case safety report (ICSR) as an ICH E2B(R2) or E2B(R3) message. The input type gives the E2B version."
    },
    {
      "code": "susar",
      "display": "Suspected Unexpected Serious Adverse Reaction",
      "definition": "Transmission of a single SUSAR report from a clinical trial as an ICH E2B(R2) or E2B(R3) message. The input type gives the E2B version."
    },
    {
      "code": "clinical-trial-application",
      "display": "Clinical Trial Application",
      "definition": "Initial application to conduct a clinical trial (e.g., EU CTA under CTR, US IND, Health Canada CTA)."
    },
    {
      "code": "variation-type-ii",
      "display": "Type II Variation",
      "definition": "Major change that may significantly affect quality, safety, or efficacy (EU)."
    },
    {
      "code": "labelling-comments",
      "display": "Labelling Comments",
      "definition": "Regulator returns comments on, or a revised version of, the proposed product information for the applicant to accept or counter-propose."
    },
    {
      "code": "labelling-agreement",
      "display": "Labelling Agreement",
      "definition": "Regulator and applicant confirm the final agreed product information text."
    }
  ]
}