Regulatory Workflows and Interactions - pharma
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Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

: APIX Task Code System

Page standards status: Trial-use Maturity Level: 1

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{
  "resourceType" : "CodeSystem",
  "id" : "apix-task-code",
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem apix-task-code</b></p><a name=\"apix-task-code\"> </a><a name=\"hcapix-task-code\"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code</code> defines the following codes in a Is-A hierarchy:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">initial-submission<a name=\"apix-task-code-initial-submission\"> </a></td><td>Initial Submission</td><td>First submission of a new application or major variation</td></tr><tr><td style=\"white-space:nowrap\">supplement<a name=\"apix-task-code-supplement\"> </a></td><td>Supplement / Variation</td><td>Post-authorization change (Type IA, IB, II, extension, etc.)</td></tr><tr><td style=\"white-space:nowrap\">variation-type-ib<a name=\"apix-task-code-variation-type-ib\"> </a></td><td>Type IB Variation</td><td>Minor, post-approval change to a medicinal product's marketing authorization that has minimal impact on quality, safety, or efficacy</td></tr><tr><td style=\"white-space:nowrap\">information-request<a name=\"apix-task-code-information-request\"> </a></td><td>List of Questions / Information Request</td><td>Regulator raises questions or requests additional data</td></tr><tr><td style=\"white-space:nowrap\">withdrawal<a name=\"apix-task-code-withdrawal\"> </a></td><td>Withdrawal by Applicant</td><td>Applicant withdraws the procedure</td></tr><tr><td style=\"white-space:nowrap\">annual-report<a name=\"apix-task-code-annual-report\"> </a></td><td>Periodic Safety Update Report / Annual Report</td><td>PSUR, DSUR, or other periodic report</td></tr><tr><td style=\"white-space:nowrap\">request-payment<a name=\"apix-task-code-request-payment\"> </a></td><td>Request Payment</td><td>Requested payment of regulatory fees</td></tr><tr><td style=\"white-space:nowrap\">icsr-initial<a name=\"apix-task-code-icsr-initial\"> </a></td><td>Initial ICSR</td><td>First ICH E2B(R3) report of a case, identified by its worldwide unique case identification number (C.1.8.1).</td></tr><tr><td style=\"white-space:nowrap\">icsr-follow-up<a name=\"apix-task-code-icsr-follow-up\"> </a></td><td>Follow-up ICSR</td><td>ICH E2B(R3) report with new information for a case already reported; same worldwide unique case identification number (C.1.8.1) and a later date of most recent information (C.1.5).</td></tr><tr><td style=\"white-space:nowrap\">clinical-trial-application<a name=\"apix-task-code-clinical-trial-application\"> </a></td><td>Clinical Trial Application</td><td>Initial application to conduct a clinical trial (e.g., EU CTA under CTR, US IND, Health Canada CTA).</td></tr><tr><td style=\"white-space:nowrap\">variation-type-ii<a name=\"apix-task-code-variation-type-ii\"> </a></td><td>Type II Variation</td><td>Major change that may significantly affect quality, safety, or efficacy (EU).</td></tr><tr><td style=\"white-space:nowrap\">labelling-comments<a name=\"apix-task-code-labelling-comments\"> </a></td><td>Labelling Comments</td><td>Regulator returns comments on, or a revised version of, the proposed product information for the applicant to accept or counter-propose.</td></tr><tr><td style=\"white-space:nowrap\">labelling-agreement<a name=\"apix-task-code-labelling-agreement\"> </a></td><td>Labelling Agreement</td><td>Regulator and applicant confirm the final agreed product information text.</td></tr></table></div>"
  },
  "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" : "draft",
  "experimental" : false,
  "date" : "2026-10-19T12:20:49+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-initial",
      "display" : "Initial ICSR",
      "definition" : "First ICH E2B(R3) report of a case, identified by its worldwide unique case identification number (C.1.8.1)."
    },
    {
      "code" : "icsr-follow-up",
      "display" : "Follow-up ICSR",
      "definition" : "ICH E2B(R3) report with new information for a case already reported; same worldwide unique case identification number (C.1.8.1) and a later date of most recent information (C.1.5)."
    },
    {
      "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."
    }
  ]
}