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

ValueSet: APIX CTD/eCTD Module Value Set

Official URL: http://hl7.org/fhir/uv/apix/ValueSet/apix-ctd-module-vs Version: 0.1.0
Standards status: Trial-use Active as of 2026-03-18 Maturity Level: 1 Computable Name: APIXCTDModuleVS

Value set for CTD module codes used in APIX regulatory submissions

References

Logical Definition (CLD)

Language: en

  • Include these codes as defined in http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section version 📦0.1.0
    CodeDisplayDefinition
    m1Module 1Module 1: Administrative Information
    m2Module 2Module 2: Overviews and Summaries
    m3Module 3Module 3: Quality (CMC)
    m4Module 4Module 4: Nonclinical Study Reports
    m5Module 5Module 5: Clinical Study Reports

 

Expansion

Expansion performed internally based on codesystem APIX CTD/eCTD Section Code System v0.1.0 (CodeSystem)

This value set contains 5 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  m1Module 1Module 1: Administrative Information
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  m2Module 2Module 2: Overviews and Summaries
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  m3Module 3Module 3: Quality (CMC)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  m4Module 4Module 4: Nonclinical Study Reports
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  m5Module 5Module 5: Clinical Study Reports

Description of the above table(s).