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