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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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="apix-task-code"/>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"/>
      </extension>
    </valueInteger>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"/>
      </extension>
    </valueCode>
  </extension>
  <url value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code"/>
  <version value="0.1.0"/>
  <name value="APIXTaskCodeCS"/>
  <title value="APIX Task Code System"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2026-10-19T12:20:49+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
  </contact>
  <description
               value="Code system for regulatory task types in APIX submissions"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="true"/>
  <hierarchyMeaning value="is-a"/>
  <content value="complete"/>
  <count value="13"/>
  <concept>
    <code value="initial-submission"/>
    <display value="Initial Submission"/>
    <definition
                value="First submission of a new application or major variation"/>
  </concept>
  <concept>
    <code value="supplement"/>
    <display value="Supplement / Variation"/>
    <definition
                value="Post-authorization change (Type IA, IB, II, extension, etc.)"/>
  </concept>
  <concept>
    <code value="variation-type-ib"/>
    <display value="Type IB Variation"/>
    <definition
                value="Minor, post-approval change to a medicinal product's marketing authorization that has minimal impact on quality, safety, or efficacy"/>
  </concept>
  <concept>
    <code value="information-request"/>
    <display value="List of Questions / Information Request"/>
    <definition
                value="Regulator raises questions or requests additional data"/>
  </concept>
  <concept>
    <code value="withdrawal"/>
    <display value="Withdrawal by Applicant"/>
    <definition value="Applicant withdraws the procedure"/>
  </concept>
  <concept>
    <code value="annual-report"/>
    <display value="Periodic Safety Update Report / Annual Report"/>
    <definition value="PSUR, DSUR, or other periodic report"/>
  </concept>
  <concept>
    <code value="request-payment"/>
    <display value="Request Payment"/>
    <definition value="Requested payment of regulatory fees"/>
  </concept>
  <concept>
    <code value="icsr-initial"/>
    <display value="Initial ICSR"/>
    <definition
                value="First ICH E2B(R3) report of a case, identified by its worldwide unique case identification number (C.1.8.1)."/>
  </concept>
  <concept>
    <code value="icsr-follow-up"/>
    <display value="Follow-up ICSR"/>
    <definition
                value="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)."/>
  </concept>
  <concept>
    <code value="clinical-trial-application"/>
    <display value="Clinical Trial Application"/>
    <definition
                value="Initial application to conduct a clinical trial (e.g., EU CTA under CTR, US IND, Health Canada CTA)."/>
  </concept>
  <concept>
    <code value="variation-type-ii"/>
    <display value="Type II Variation"/>
    <definition
                value="Major change that may significantly affect quality, safety, or efficacy (EU)."/>
  </concept>
  <concept>
    <code value="labelling-comments"/>
    <display value="Labelling Comments"/>
    <definition
                value="Regulator returns comments on, or a revised version of, the proposed product information for the applicant to accept or counter-propose."/>
  </concept>
  <concept>
    <code value="labelling-agreement"/>
    <display value="Labelling Agreement"/>
    <definition
                value="Regulator and applicant confirm the final agreed product information text."/>
  </concept>
</CodeSystem>