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/cander2/apix-ig/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="List-Of-Questions-Response"/>
<type value="transaction"/>
<entry>
<fullUrl value="urn:uuid:task-003"/>
<resource>
<Task>
<id value="task-003"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Task_task-003"> </a><p class="res-header-id"><b>Generated Narrative: Task task-003</b></p><a name="task-003"> </a><a name="hctask-003"> </a><p><b>status</b>: Completed</p><p><b>intent</b>: order</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/task-code submit-response}">Submit Response to List of Questions</span></p><p><b>description</b>: Submission of responses to the List of Questions for Type II variation (shelf life extension)</p><p><b>for</b>: <a href="MedicinalProductDefinition/mpd-001">MedicinalProductDefinition/mpd-001</a></p><p><b>authoredOn</b>: 2025-06-29 18:15:00-0400</p><p><b>requester</b>: <a href="Organization/pharma-inc">Organization/pharma-inc</a></p><p><b>owner</b>: <a href="Organization/ema">Organization/ema</a></p></div>
</text>
<status value="completed"/>
<intent value="order"/>
<code>
<coding>
<system value="http://hl7.org/fhir/task-code"/>
<code value="submit-response"/>
<display value="Submit Response to List of Questions"/>
</coding>
</code>
<description
value="Submission of responses to the List of Questions for Type II variation (shelf life extension)"/>
<for>
<reference value="MedicinalProductDefinition/mpd-001"/>
</for>
<authoredOn value="2025-06-29T18:15:00-04:00"/>
<requester>
<reference value="Organization/pharma-inc"/>
</requester>
<owner>
<reference value="Organization/ema"/>
</owner>
</Task>
</resource>
<request>
<method value="POST"/>
<url value="Task"/>
</request>
</entry>
<entry>
<fullUrl value="urn:uuid:response-bundle-001"/>
<resource>
<Bundle>
<id value="response-bundle-001"/>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:questionnaire-response-001"/>
<resource>
<QuestionnaireResponse>
<id value="questionnaire-response-001"/>
<questionnaire value="Questionnaire/questionnaire-001"/>
<status value="completed"/>
<authored value="2025-06-29T18:15:00-04:00"/>
<item>
<linkId value="admin-1"/>
<text
value="Is the fee for the Type II variation fully paid and documented?"/>
<answer>
<valueString
value="Yes, the fee was paid on June 25, 2025, with documentation included in the application form."/>
</answer>
</item>
<item>
<linkId value="admin-2"/>
<text
value="Are all required metadata fields in the application form complete?"/>
<answer>
<valueString
value="All metadata fields are complete, as verified against EMA guidelines."/>
</answer>
</item>
<item>
<linkId value="labeling-1"/>
<text
value="Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance?"/>
<answer>
<valueString
value="No additional guidance is needed; the ePI clearly states storage at 2-8°C for 36 months."/>
</answer>
</item>
<item>
<linkId value="labeling-2"/>
<text
value="Is the patient leaflet revised to clarify the extended shelf life?"/>
<answer>
<valueString
value="Yes, the patient leaflet has been updated to reflect the 36-month shelf life."/>
</answer>
</item>
<item>
<linkId value="labeling-3"/>
<text
value="Is the updated ePI text sufficiently clear for all EU languages?"/>
<answer>
<valueString
value="The ePI text has been translated and reviewed for clarity in all EU languages."/>
</answer>
</item>
<item>
<linkId value="cmc-1"/>
<text
value="Do stability studies cover all required environmental conditions for 36 months?"/>
<answer>
<valueString
value="Yes, stability studies include temperature, humidity, and light conditions for 36 months, per ICH guidelines."/>
</answer>
</item>
<item>
<linkId value="cmc-2"/>
<text
value="Are analytical methods validated for detecting degradation over 36 months?"/>
<answer>
<valueString
value="Analytical methods are fully validated, with results included in the PQI submission."/>
</answer>
</item>
<item>
<linkId value="cmc-3"/>
<text
value="Are new impurities identified in extended stability studies?"/>
<answer>
<valueString
value="No new impurities were identified; all impurities are within acceptable limits."/>
</answer>
</item>
<item>
<linkId value="cmc-4"/>
<text
value="Is the container closure system validated for 36 months?"/>
<answer>
<valueString
value="The container closure system is validated for 36 months, with supporting data in the PQI Bundle."/>
</answer>
<answer>
<valueAttachment>
<contentType value="image/svg+xml"/>
<data
value="PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIxMDAiIGhlaWdodD0iMTAwIj48cmVjdCB3aWR0aD0iMTAwIiBoZWlnaHQ9IjEwMCIgZmlsbD0iI2ZmZiIvPjx0ZXh0IHg9IjUwIiB5PSI1MCIgZm9udC1zaXplPSIxNSIgZmlsbD0iIzAwMCIgdGV4dC1hbmNob3I9Im1pZGRsZSI+U1ZHIFBsYWNlaG9sZGVyPC90ZXh0Pjwvc3ZnPg=="/>
<title value="Container Closure System Diagram"/>
</valueAttachment>
</answer>
</item>
<item>
<linkId value="cmc-5"/>
<text
value="Are degradation products fully characterized for 36 months?"/>
<answer>
<valueString
value="Degradation products are fully characterized. No significant changes were observed in the 36-month stability studies.
All identified degradation products remain within acceptable limits, as detailed in the PQI submission."/>
</answer>
</item>
</QuestionnaireResponse>
</resource>
</entry>
</Bundle>
</resource>
<request>
<method value="POST"/>
<url value="Bundle"/>
</request>
</entry>
<entry>
<fullUrl value="urn:uuid:provenance-003"/>
<resource>
<Provenance>
<id value="provenance-003"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Provenance_provenance-003"> </a><p class="res-header-id"><b>Generated Narrative: Provenance provenance-003</b></p><a name="provenance-003"> </a><a name="hcprovenance-003"> </a><p>Provenance for <a href="Bundle-List-Of-Questions-Response.html#Bundle_response-bundle-001">Bundle: type = transaction</a></p><p>Summary</p><table class="grid"><tr><td>Recorded</td><td>2025-06-29 18:15:00-0400</td></tr></table><p><b>Agents</b></p><table class="grid"><tr><td><b>Type</b></td><td><b>who</b></td></tr><tr><td><span title="Codes:{http://hl7.org/fhir/provenance-participant-type author}">author</span></td><td><a href="Organization/pharma-inc">Organization/pharma-inc</a></td></tr></table></div>
</text>
<target>
<reference value="Bundle/response-bundle-001"/>
</target>
<recorded value="2025-06-29T18:15:00-04:00"/>
<agent>
<type>
<coding>
<system
value="http://hl7.org/fhir/provenance-participant-type"/>
<code value="author"/>
</coding>
</type>
<who>
<reference value="Organization/pharma-inc"/>
</who>
</agent>
<signature>
<type>
<system value="urn:iso-astm:E1762-95:2013"/>
<code value="1.2.840.10065.1.12.1.1"/>
</type>
<when value="2025-06-29T18:15:00-04:00"/>
<who>
<reference value="Organization/pharma-inc"/>
</who>
</signature>
</Provenance>
</resource>
<request>
<method value="POST"/>
<url value="Provenance"/>
</request>
</entry>
</Bundle>