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 - JSON Representation

Page standards status: Trial-use Maturity Level: 1

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{
  "resourceType" : "ValueSet",
  "id" : "apix-ctd-module-vs",
  "text" : {
    "status" : "extensions",
    "div" : "<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>"
  },
  "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/ValueSet/apix-ctd-module-vs",
  "version" : "0.1.0",
  "name" : "APIXCTDModuleVS",
  "title" : "APIX CTD/eCTD Module Value Set",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-02-24T20:04:21+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" : "Value set for CTD module codes used in APIX regulatory submissions",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
        }
      ]
    }
  ],
  "compose" : {
    "include" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
        "concept" : [
          {
            "code" : "m1",
            "display" : "Module 1"
          },
          {
            "code" : "m2",
            "display" : "Module 2"
          },
          {
            "code" : "m3",
            "display" : "Module 3"
          },
          {
            "code" : "m4",
            "display" : "Module 4"
          },
          {
            "code" : "m5",
            "display" : "Module 5"
          }
        ]
      }
    ]
  }
}