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

API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. 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 Regulatory Business Status - TTL Representation

Draft as of 2025-12-23

Raw ttl | Download


@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:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "apix-business-status"] ; # 
  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-business-status</b></p><a name=\"apix-business-status\"> </a><a name=\"hcapix-business-status\"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status</code> defines the following codes:</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\">submitted<a name=\"apix-business-status-submitted\"> </a></td><td>Submitted</td><td>The application has been submitted by the applicant.</td></tr><tr><td style=\"white-space:nowrap\">received<a name=\"apix-business-status-received\"> </a></td><td>Received</td><td>The application or submission has been received by the regulator.</td></tr><tr><td style=\"white-space:nowrap\">validation-successful<a name=\"apix-business-status-validation-successful\"> </a></td><td>Validation Successful</td><td>The technical and administrative validation has been completed successfully.</td></tr><tr><td style=\"white-space:nowrap\">validation-failed<a name=\"apix-business-status-validation-failed\"> </a></td><td>Validation Failed</td><td>The submission failed validation and cannot proceed.</td></tr><tr><td style=\"white-space:nowrap\">under-assessment<a name=\"apix-business-status-under-assessment\"> </a></td><td>Under Assessment</td><td>The submission is currently undergoing scientific review.</td></tr><tr><td style=\"white-space:nowrap\">clock-stop<a name=\"apix-business-status-clock-stop\"> </a></td><td>Clock Stop</td><td>The review timeline is paused, typically waiting for applicant response to questions.</td></tr><tr><td style=\"white-space:nowrap\">clock-restart<a name=\"apix-business-status-clock-restart\"> </a></td><td>Clock Restart</td><td>The review timeline has resumed following receipt of a response.</td></tr><tr><td style=\"white-space:nowrap\">consolidated-review<a name=\"apix-business-status-consolidated-review\"> </a></td><td>Consolidated Review</td><td>Comments from multiple assessors are being consolidated.</td></tr><tr><td style=\"white-space:nowrap\">decision-pending<a name=\"apix-business-status-decision-pending\"> </a></td><td>Decision Pending</td><td>The assessment is complete and the final decision is being prepared.</td></tr><tr><td style=\"white-space:nowrap\">approved<a name=\"apix-business-status-approved\"> </a></td><td>Approved</td><td>The application has been approved.</td></tr><tr><td style=\"white-space:nowrap\">rejected<a name=\"apix-business-status-rejected\"> </a></td><td>Rejected</td><td>The application has been rejected.</td></tr><tr><td style=\"white-space:nowrap\">withdrawn<a name=\"apix-business-status-withdrawn\"> </a></td><td>Withdrawn</td><td>The application has been withdrawn by the applicant.</td></tr><tr><td style=\"white-space:nowrap\">payment-requested<a name=\"apix-business-status-payment-requested\"> </a></td><td>Payment Requested</td><td>A fee payment has been requested by the regulator.</td></tr><tr><td style=\"white-space:nowrap\">payment-received<a name=\"apix-business-status-payment-received\"> </a></td><td>Payment Received</td><td>The fee payment has been received and confirmed.</td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status>
  ] ; # 
  fhir:version [ fhir:v "0.1.0"] ; # 
  fhir:name [ fhir:v "APIXBusinessStatusCS"] ; # 
  fhir:title [ fhir:v "APIX Regulatory Business Status"] ; # 
  fhir:status [ fhir:v "draft"] ; # 
  fhir:date [ fhir:v "2025-12-23T01:31:13+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "Gravitate Health Project"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "Gravitate Health Project" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://www.gravitatehealth.eu/" ]     ] )
  ] ) ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "submitted" ] ;
fhir:display [ fhir:v "Submitted" ] ;
fhir:definition [ fhir:v "The application has been submitted by the applicant." ]
  ] [
fhir:code [ fhir:v "received" ] ;
fhir:display [ fhir:v "Received" ] ;
fhir:definition [ fhir:v "The application or submission has been received by the regulator." ]
  ] [
fhir:code [ fhir:v "validation-successful" ] ;
fhir:display [ fhir:v "Validation Successful" ] ;
fhir:definition [ fhir:v "The technical and administrative validation has been completed successfully." ]
  ] [
fhir:code [ fhir:v "validation-failed" ] ;
fhir:display [ fhir:v "Validation Failed" ] ;
fhir:definition [ fhir:v "The submission failed validation and cannot proceed." ]
  ] [
fhir:code [ fhir:v "under-assessment" ] ;
fhir:display [ fhir:v "Under Assessment" ] ;
fhir:definition [ fhir:v "The submission is currently undergoing scientific review." ]
  ] [
fhir:code [ fhir:v "clock-stop" ] ;
fhir:display [ fhir:v "Clock Stop" ] ;
fhir:definition [ fhir:v "The review timeline is paused, typically waiting for applicant response to questions." ]
  ] [
fhir:code [ fhir:v "clock-restart" ] ;
fhir:display [ fhir:v "Clock Restart" ] ;
fhir:definition [ fhir:v "The review timeline has resumed following receipt of a response." ]
  ] [
fhir:code [ fhir:v "consolidated-review" ] ;
fhir:display [ fhir:v "Consolidated Review" ] ;
fhir:definition [ fhir:v "Comments from multiple assessors are being consolidated." ]
  ] [
fhir:code [ fhir:v "decision-pending" ] ;
fhir:display [ fhir:v "Decision Pending" ] ;
fhir:definition [ fhir:v "The assessment is complete and the final decision is being prepared." ]
  ] [
fhir:code [ fhir:v "approved" ] ;
fhir:display [ fhir:v "Approved" ] ;
fhir:definition [ fhir:v "The application has been approved." ]
  ] [
fhir:code [ fhir:v "rejected" ] ;
fhir:display [ fhir:v "Rejected" ] ;
fhir:definition [ fhir:v "The application has been rejected." ]
  ] [
fhir:code [ fhir:v "withdrawn" ] ;
fhir:display [ fhir:v "Withdrawn" ] ;
fhir:definition [ fhir:v "The application has been withdrawn by the applicant." ]
  ] [
fhir:code [ fhir:v "payment-requested" ] ;
fhir:display [ fhir:v "Payment Requested" ] ;
fhir:definition [ fhir:v "A fee payment has been requested by the regulator." ]
  ] [
fhir:code [ fhir:v "payment-received" ] ;
fhir:display [ fhir:v "Payment Received" ] ;
fhir:definition [ fhir:v "The fee payment has been received and confirmed." ]
  ] ) . #