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 - TTL Representation
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:ValueSet ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "apix-ctd-module-vs"] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<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 ?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>"^^rdf:XMLLiteral ]
] ; #
fhir:extension ( [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-wg> ] ;
fhir:value [
a fhir:Code ;
fhir:v "brr" ]
] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm> ] ;
fhir:value [
a fhir:Integer ;
fhir:v 1 ;
( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom> ] ;
fhir:value [
a fhir:Canonical ;
fhir:v "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix> ] ] ) ]
] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status> ] ;
fhir:value [
a fhir:Code ;
fhir:v "trial-use" ;
( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom> ] ;
fhir:value [
a fhir:Canonical ;
fhir:v "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix> ] ] ) ]
] ) ; #
fhir:url [
fhir:v "http://hl7.org/fhir/uv/apix/ValueSet/apix-ctd-module-vs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/ValueSet/apix-ctd-module-vs>
] ; #
fhir:version [ fhir:v "0.1.0"] ; #
fhir:name [ fhir:v "APIXCTDModuleVS"] ; #
fhir:title [ fhir:v "APIX CTD/eCTD Module Value Set"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:experimental [ fhir:v false] ; #
fhir:date [ fhir:v "2026-02-24T20:04:21+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] )
] ) ; #
fhir:description [ fhir:v "Value set for CTD module codes used in APIX regulatory submissions"] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [
fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm> ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ] ] )
] ) ; #
fhir:compose [
( fhir:include [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section> ] ;
( fhir:concept [
fhir:code [ fhir:v "m1" ] ;
fhir:display [ fhir:v "Module 1" ] ] [
fhir:code [ fhir:v "m2" ] ;
fhir:display [ fhir:v "Module 2" ] ] [
fhir:code [ fhir:v "m3" ] ;
fhir:display [ fhir:v "Module 3" ] ] [
fhir:code [ fhir:v "m4" ] ;
fhir:display [ fhir:v "Module 4" ] ] [
fhir:code [ fhir:v "m5" ] ;
fhir:display [ fhir:v "Module 5" ] ] ) ] )
] . #