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 - XML Representation

Draft as of 2025-12-23

Raw xml | Download


<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="apix-business-status"/>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <url value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
  <version value="0.1.0"/>
  <name value="APIXBusinessStatusCS"/>
  <title value="APIX Regulatory Business Status"/>
  <status value="draft"/>
  <date value="2025-12-23T01:31:13+00:00"/>
  <publisher value="Gravitate Health Project"/>
  <contact>
    <name value="Gravitate Health Project"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.gravitatehealth.eu/"/>
    </telecom>
  </contact>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <concept>
    <code value="submitted"/>
    <display value="Submitted"/>
    <definition value="The application has been submitted by the applicant."/>
  </concept>
  <concept>
    <code value="received"/>
    <display value="Received"/>
    <definition
                value="The application or submission has been received by the regulator."/>
  </concept>
  <concept>
    <code value="validation-successful"/>
    <display value="Validation Successful"/>
    <definition
                value="The technical and administrative validation has been completed successfully."/>
  </concept>
  <concept>
    <code value="validation-failed"/>
    <display value="Validation Failed"/>
    <definition value="The submission failed validation and cannot proceed."/>
  </concept>
  <concept>
    <code value="under-assessment"/>
    <display value="Under Assessment"/>
    <definition
                value="The submission is currently undergoing scientific review."/>
  </concept>
  <concept>
    <code value="clock-stop"/>
    <display value="Clock Stop"/>
    <definition
                value="The review timeline is paused, typically waiting for applicant response to questions."/>
  </concept>
  <concept>
    <code value="clock-restart"/>
    <display value="Clock Restart"/>
    <definition
                value="The review timeline has resumed following receipt of a response."/>
  </concept>
  <concept>
    <code value="consolidated-review"/>
    <display value="Consolidated Review"/>
    <definition
                value="Comments from multiple assessors are being consolidated."/>
  </concept>
  <concept>
    <code value="decision-pending"/>
    <display value="Decision Pending"/>
    <definition
                value="The assessment is complete and the final decision is being prepared."/>
  </concept>
  <concept>
    <code value="approved"/>
    <display value="Approved"/>
    <definition value="The application has been approved."/>
  </concept>
  <concept>
    <code value="rejected"/>
    <display value="Rejected"/>
    <definition value="The application has been rejected."/>
  </concept>
  <concept>
    <code value="withdrawn"/>
    <display value="Withdrawn"/>
    <definition value="The application has been withdrawn by the applicant."/>
  </concept>
  <concept>
    <code value="payment-requested"/>
    <display value="Payment Requested"/>
    <definition value="A fee payment has been requested by the regulator."/>
  </concept>
  <concept>
    <code value="payment-received"/>
    <display value="Payment Received"/>
    <definition value="The fee payment has been received and confirmed."/>
  </concept>
</CodeSystem>