API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
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 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
| Page standards status: Trial-use | Maturity Level: 1 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="apix-task-code"/>
<text>
<status value="generated"/>
<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:</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">response-to-questions<a name="apix-task-code-response-to-questions"> </a></td><td>Response to Information Request</td><td>Applicant response to regulator questions</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">validation-report<a name="apix-task-code-validation-report"> </a></td><td>Validation Report</td><td>Technical or business validation outcome</td></tr><tr><td style="white-space:nowrap">approval<a name="apix-task-code-approval"> </a></td><td>Approval Letter / Positive Decision</td><td>Final positive regulatory decision</td></tr><tr><td style="white-space:nowrap">rejection<a name="apix-task-code-rejection"> </a></td><td>Rejection / Negative Decision</td><td>Final negative regulatory decision</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></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="1">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
<valueCanonical
value="http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"/>
</extension>
</valueInteger>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="trial-use">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
<valueCanonical
value="http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"/>
</extension>
</valueCode>
</extension>
<url value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code"/>
<version value="0.1.0"/>
<name value="APIXTaskCodeCS"/>
<title value="APIX Task Code System"/>
<status value="active"/>
<experimental value="false"/>
<date value="2026-02-04T10:57:55+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
</contact>
<description
value="Code system for regulatory task types in APIX submissions"/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<caseSensitive value="true"/>
<content value="complete"/>
<count value="9"/>
<concept>
<code value="initial-submission"/>
<display value="Initial Submission"/>
<definition
value="First submission of a new application or major variation"/>
</concept>
<concept>
<code value="supplement"/>
<display value="Supplement / Variation"/>
<definition
value="Post-authorization change (Type IA, IB, II, extension, etc.)"/>
</concept>
<concept>
<code value="response-to-questions"/>
<display value="Response to Information Request"/>
<definition value="Applicant response to regulator questions"/>
</concept>
<concept>
<code value="information-request"/>
<display value="List of Questions / Information Request"/>
<definition
value="Regulator raises questions or requests additional data"/>
</concept>
<concept>
<code value="validation-report"/>
<display value="Validation Report"/>
<definition value="Technical or business validation outcome"/>
</concept>
<concept>
<code value="approval"/>
<display value="Approval Letter / Positive Decision"/>
<definition value="Final positive regulatory decision"/>
</concept>
<concept>
<code value="rejection"/>
<display value="Rejection / Negative Decision"/>
<definition value="Final negative regulatory decision"/>
</concept>
<concept>
<code value="withdrawal"/>
<display value="Withdrawal by Applicant"/>
<definition value="Applicant withdraws the procedure"/>
</concept>
<concept>
<code value="annual-report"/>
<display value="Periodic Safety Update Report / Annual Report"/>
<definition value="PSUR, DSUR, or other periodic report"/>
</concept>
</CodeSystem>