API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

API for the Exchange of Medicinal Product Information (APIX), 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 CTD/eCTD Module Value Set - XML Representation

Page standards status: Trial-use Maturity Level: 1

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="apix-ctd-module-vs"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet apix-ctd-module-vs</b></p><a name="apix-ctd-module-vs"> </a><a name="hcapix-ctd-module-vs"> </a><ul><li>Include these codes as defined in <a href="CodeSystem-ctd-section.html"><code>http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section</code></a><span title="Version is not explicitly stated, which means it is fixed to the version provided in this specification"> version &#x1F4E6;0.1.0</span><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href="CodeSystem-ctd-section.html#ctd-section-m1">m1</a></td><td>Module 1</td><td>Module 1: Administrative Information</td></tr><tr><td><a href="CodeSystem-ctd-section.html#ctd-section-m2">m2</a></td><td>Module 2</td><td>Module 2: Overviews and Summaries</td></tr><tr><td><a href="CodeSystem-ctd-section.html#ctd-section-m3">m3</a></td><td>Module 3</td><td>Module 3: Quality (CMC)</td></tr><tr><td><a href="CodeSystem-ctd-section.html#ctd-section-m4">m4</a></td><td>Module 4</td><td>Module 4: Nonclinical Study Reports</td></tr><tr><td><a href="CodeSystem-ctd-section.html#ctd-section-m5">m5</a></td><td>Module 5</td><td>Module 5: Clinical Study Reports</td></tr></table></li></ul></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/ValueSet/apix-ctd-module-vs"/>
  <version value="0.1.0"/>
  <name value="APIXCTDModuleVS"/>
  <title value="APIX CTD/eCTD Module Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-02-24T20:04:21+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="Value set for CTD module codes used in APIX regulatory submissions"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
      <concept>
        <code value="m1"/>
        <display value="Module 1"/>
      </concept>
      <concept>
        <code value="m2"/>
        <display value="Module 2"/>
      </concept>
      <concept>
        <code value="m3"/>
        <display value="Module 3"/>
      </concept>
      <concept>
        <code value="m4"/>
        <display value="Module 4"/>
      </concept>
      <concept>
        <code value="m5"/>
        <display value="Module 5"/>
      </concept>
    </include>
  </compose>
</ValueSet>