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"/>
<type value="transaction"/>
<entry>
<fullUrl value="urn:uuid:task-002"/>
<resource>
<Task>
<id value="task-002"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Task_task-002"> </a><p class="res-header-id"><b>Generated Narrative: Task task-002</b></p><a name="task-002"> </a><a name="hctask-002"> </a><p><b>status</b>: Requested</p><p><b>intent</b>: order</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/task-code respond-to-questions}">Respond to List of Questions</span></p><p><b>description</b>: Provide 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 17:56:00-0400</p><p><b>requester</b>: <a href="Organization/ema">Organization/ema</a></p><p><b>owner</b>: <a href="Organization/pharma-inc">Organization/pharma-inc</a></p></div>
</text>
<status value="requested"/>
<intent value="order"/>
<code>
<coding>
<system value="http://hl7.org/fhir/task-code"/>
<code value="respond-to-questions"/>
<display value="Respond to List of Questions"/>
</coding>
</code>
<description
value="Provide responses to the List of Questions for Type II variation (shelf life extension)"/>
<for>
<reference value="MedicinalProductDefinition/mpd-001"/>
</for>
<authoredOn value="2025-06-29T17:56:00-04:00"/>
<requester>
<reference value="Organization/ema"/>
</requester>
<owner>
<reference value="Organization/pharma-inc"/>
</owner>
</Task>
</resource>
<request>
<method value="POST"/>
<url value="Task"/>
</request>
</entry>
<entry>
<fullUrl value="urn:uuid:loq-bundle-001"/>
<resource>
<Bundle>
<id value="loq-bundle-001"/>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:questionnaire-001"/>
<resource>
<Questionnaire>
<id value="questionnaire-001"/>
<title
value="List of Questions for Type II Variation (Shelf Life Extension)"/>
<status value="active"/>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="administrative"/>
</valueCoding>
</extension>
<linkId value="admin-1"/>
<text
value="Is the fee for the Type II variation fully paid and documented?"/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="administrative"/>
</valueCoding>
</extension>
<linkId value="admin-2"/>
<text
value="Are all required metadata fields in the application form complete?"/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="labeling-storage"/>
</valueCoding>
</extension>
<linkId value="labeling-1"/>
<text
value="Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance?"/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="labeling-patient-info"/>
</valueCoding>
</extension>
<linkId value="labeling-2"/>
<text
value="Is the patient leaflet revised to clarify the extended shelf life?"/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="labeling-clarity"/>
</valueCoding>
</extension>
<linkId value="labeling-3"/>
<text
value="Is the updated ePI text sufficiently clear for all EU languages?"/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="cmc-stability"/>
</valueCoding>
</extension>
<linkId value="cmc-1"/>
<text
value="Are there any new stability studies conducted, or the submission includes only the data available from additional timepoints from previously submitted studies?"/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="cmc-analytical"/>
</valueCoding>
</extension>
<linkId value="cmc-2"/>
<text
value="Are there any new stability studies conducted, or the submission includes only the data available from additional timepoints from previously submitted studies?"/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="cmc-impurities"/>
</valueCoding>
</extension>
<linkId value="cmc-3"/>
<text
value="Are the test methods used the same as in the previously submitted stability information?"/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="cmc-container"/>
</valueCoding>
</extension>
<linkId value="cmc-4"/>
<text
value=" Are there any new degradation products identified within the newly submitted data? "/>
<type value="string"/>
</item>
<item>
<extension
url="http://example.org/fhir/StructureDefinition/question-category">
<valueCoding>
<system value="http://example.org/codes"/>
<code value="cmc-degradation"/>
</valueCoding>
</extension>
<linkId value="cmc-5"/>
<text
value="Any changes in the packaging configuration and/or storage of the samples during stability?"/>
<type value="string"/>
</item>
</Questionnaire>
</resource>
</entry>
</Bundle>
</resource>
<request>
<method value="POST"/>
<url value="Bundle"/>
</request>
</entry>
<entry>
<fullUrl value="urn:uuid:provenance-002"/>
<resource>
<Provenance>
<id value="provenance-002"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Provenance_provenance-002"> </a><p class="res-header-id"><b>Generated Narrative: Provenance provenance-002</b></p><a name="provenance-002"> </a><a name="hcprovenance-002"> </a><p>Provenance for <a href="Bundle-List-Of-Questions.html#Bundle_loq-bundle-001">Bundle: type = transaction</a></p><p>Summary</p><table class="grid"><tr><td>Recorded</td><td>2025-06-29 17:56:00-0400</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/ema">Organization/ema</a></td></tr></table></div>
</text>
<target>
<reference value="Bundle/loq-bundle-001"/>
</target>
<recorded value="2025-06-29T17:56:00-04:00"/>
<agent>
<type>
<coding>
<system
value="http://hl7.org/fhir/provenance-participant-type"/>
<code value="author"/>
</coding>
</type>
<who>
<reference value="Organization/ema"/>
</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="2025-06-29T17:56:00-04:00"/>
<who>
<reference value="Organization/ema"/>
</who>
</signature>
</Provenance>
</resource>
<request>
<method value="POST"/>
<url value="Provenance"/>
</request>
</entry>
</Bundle>