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
<Task xmlns="http://hl7.org/fhir">
<id value="scenario1-06-technical-response"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-03-15T10:00:00+01:00"/>
<profile
value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">Response to Questions: Submission of additional stability data</div>
</text>
<contained>
<Organization>
<id value="org-synthpharma-ag"/>
<name value="SynthPharma AG"/>
<contact>
<name>
<text value="Dr. John Doe, Head of Regulatory Affairs"/>
</name>
<telecom>
<system value="email"/>
<value value="john.doe@synthpharma.example"/>
<use value="work"/>
</telecom>
</contact>
</Organization>
</contained>
<contained>
<Organization>
<id value="org-ema-srm-hmed"/>
<name
value="European Medicines Agency – Human Medicines Evaluation Division"/>
<contact>
<name>
<text value="Scientific and Regulatory Management"/>
</name>
<telecom>
<system value="email"/>
<value value="srm@ema.example.eu"/>
<use value="work"/>
</telecom>
</contact>
</Organization>
</contained>
<contained>
<DocumentReference>
<id value="docref-responses-qresponse"/>
<version value="1.0"/>
<status value="current"/>
<docStatus value="final"/>
<type>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
<code value="1.0"/>
<display value="Cover Letter / Response"/>
</coding>
</type>
<date value="2025-03-15T10:00:00+01:00"/>
<relatesTo>
<target>
<reference value="DocumentReference/docref-list-of-questions"/>
<display value="List of Questions (LoQ)"/>
</target>
</relatesTo>
<content>
<attachment>
<contentType value="application/fhir+json"/>
<url
value="https://api.synthpharma.example/questionnaire-responses/qr123.json"/>
<size value="18400"/>
<title value="Response to Questions (QuestionnaireResponse)"/>
<creation value="2025-03-15T09:45:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<contained>
<DocumentReference>
<id value="docref-stability-data-annex"/>
<version value="1.0"/>
<status value="current"/>
<docStatus value="final"/>
<type>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
<code value="3.2.P.8.3"/>
<display value="Stability Data"/>
</coding>
</type>
<date value="2025-03-15T10:00:00+01:00"/>
<content>
<attachment>
<contentType value="application/fhir+json"/>
<url
value="https://api.synthpharma.example/bundles/submission-123/m3/stability-data-v2.json"/>
<size value="5800000"/>
<title value="Updated Stability Data (Transaction Bundle)"/>
<creation value="2025-03-14T11:00:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type"/>
<code value="task-instance-uuid"/>
<display value="Task Instance UUID"/>
</coding>
</type>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:888e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3c"/>
</identifier>
<groupIdentifier>
<use value="official"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type"/>
<code value="submission-group-uuid"/>
<display value="Submission Group UUID"/>
</coding>
</type>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:workflow-group-id-12345"/>
</groupIdentifier>
<partOf>🔗
<reference value="Task/scenario1-05-technical-question"/>
<display value="Technical Question Task"/>
</partOf>
<status value="in-progress"/>
<businessStatus>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
<code value="submitted"/>
<display value="Submitted"/>
</coding>
</businessStatus>
<intent value="proposal"/>
<priority value="routine"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code"/>
<code value="response-to-questions"/>
<display value="Response to Information Request"/>
</coding>
</code>
<for>
<reference value="MedicinalProductDefinition/example-ma"/>
<display value="WonderDrug 50mg Tablets"/>
</for>
<authoredOn value="2025-03-15T10:00:00+01:00"/>
<lastModified value="2025-03-15T10:00:00+01:00"/>
<requester>
<reference value="#org-synthpharma-ag"/>
<display value="SynthPharma AG"/>
</requester>
<requestedPerformer>
<reference>
<reference value="#org-ema-srm-hmed"/>
<display value="European Medicines Agency"/>
</reference>
</requestedPerformer>
<output>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-output-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#docref-responses-qresponse"/>
<display value="Applicant QuestionnaireResponse"/>
</valueReference>
</output>
<output>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-output-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#docref-stability-data-annex"/>
<display value="Annex: Updated Stability Data"/>
</valueReference>
</output>
</Task>