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="scenario1-01-initial-submission"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-15T09:00:00+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">Task: Initial Submission of Type IB Variation (Shelf-Life)</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="doc1"/>
<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="cover-letter"/>
<display value="Cover Letter"/>
</coding>
</type>
<category>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"/>
<code value="m1"/>
<display value="Module 1"/>
</coding>
</category>
<content>
<attachment>
<contentType value="application/pdf"/>
<url
value="https://api.synthpharma.example/binaries/submission-123/m1/cover-letter.pdf"/>
<size value="1250000"/>
<title value="Cover Letter.pdf"/>
<creation value="2025-11-15T08:30:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<contained>
<DocumentReference>
<id value="doc2"/>
<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="application-form"/>
<display value="Application Form"/>
</coding>
</type>
<category>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"/>
<code value="m1"/>
<display value="Module 1"/>
</coding>
</category>
<content>
<attachment>
<contentType value="application/pdf"/>
<url
value="https://api.synthpharma.example/binaries/submission-123/m1/app-form.pdf"/>
<size value="3400000"/>
<title value="Application Form.pdf"/>
<creation value="2025-11-15T08:35:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<contained>
<DocumentReference>
<id value="doc3"/>
<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="annotated-label"/>
<display value="Annotated Label"/>
</coding>
</type>
<category>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"/>
<code value="m1"/>
<display value="Module 1"/>
</coding>
</category>
<content>
<attachment>
<contentType value="application/fhir+json"/>
<url
value="https://api.synthpharma.example/bundles/submission-123/m1/annotated-label.json"/>
<size value="45000"/>
<title value="Annotated Label (Bundle)"/>
<creation value="2025-11-14T16:00:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<contained>
<DocumentReference>
<id value="doc4"/>
<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="clean-label"/>
<display value="Clean Label"/>
</coding>
</type>
<category>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"/>
<code value="m1"/>
<display value="Module 1"/>
</coding>
</category>
<content>
<attachment>
<contentType value="application/fhir+json"/>
<url
value="https://api.synthpharma.example/bundles/submission-123/m1/clean-label.json"/>
<size value="42000"/>
<title value="Clean Label (Bundle)"/>
<creation value="2025-11-14T16:05:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<contained>
<DocumentReference>
<id value="doc5"/>
<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="pack-mockup"/>
<display value="Pack Mockup"/>
</coding>
</type>
<content>
<attachment>
<contentType value="text/html"/>
<url
value="https://api.synthpharma.example/binaries/submission-123/m1/mockup.html"/>
<size value="890000"/>
<title value="Pack Mockup.html"/>
<creation value="2025-11-14T10:00:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<contained>
<DocumentReference>
<id value="doc6"/>
<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="cmc-stability-summary"/>
<display value="Stability Summary"/>
</coding>
</type>
<category>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"/>
<code value="m3"/>
<display value="Module 3"/>
</coding>
</category>
<content>
<attachment>
<contentType value="application/fhir+json"/>
<url
value="https://api.synthpharma.example/bundles/submission-123/m3/stability-summary.json"/>
<size value="156000"/>
<title value="CMC Doc 1 - Summary (Transaction Bundle)"/>
<creation value="2025-11-12T14:30:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<contained>
<DocumentReference>
<id value="doc7"/>
<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="cmc-stability-data"/>
<display value="Stability Data"/>
</coding>
</type>
<category>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"/>
<code value="m3"/>
<display value="Module 3"/>
</coding>
</category>
<content>
<attachment>
<contentType value="application/fhir+json"/>
<url
value="https://api.synthpharma.example/bundles/submission-123/m3/stability-data.json"/>
<size value="5600000"/>
<title value="CMC Doc 2 - Data (Transaction Bundle)"/>
<creation value="2025-11-12T14:35:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<contained>
<DocumentReference>
<id value="doc8"/>
<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="cmc-stability-commitment"/>
<display value="Stability Commitment"/>
</coding>
</type>
<category>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"/>
<code value="m3"/>
<display value="Module 3"/>
</coding>
</category>
<content>
<attachment>
<contentType value="application/fhir+json"/>
<url
value="https://api.synthpharma.example/bundles/submission-123/m3/stability-commitment.json"/>
<size value="24000"/>
<title value="CMC Doc 3 - Commitment (Transaction Bundle)"/>
<creation value="2025-11-12T14:40:00+01:00"/>
</attachment>
</content>
</DocumentReference>
</contained>
<identifier>
<use value="official"/>
<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:workflow-step1-instance"/>
</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>
<status value="requested"/>
<businessStatus>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
<code value="submitted"/>
<display value="Submitted"/>
</coding>
</businessStatus>
<intent value="order"/>
<priority value="routine"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-type"/>
<code value="variation-type-ib"/>
<display value="Type IB Variation"/>
</coding>
</code>
<authoredOn value="2025-11-15T09:00:00+01:00"/>
<lastModified value="2025-11-15T09:00:00+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>
<input>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#doc1"/>
</valueReference>
</input>
<input>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#doc2"/>
</valueReference>
</input>
<input>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#doc3"/>
</valueReference>
</input>
<input>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#doc4"/>
</valueReference>
</input>
<input>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#doc5"/>
</valueReference>
</input>
<input>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#doc6"/>
</valueReference>
</input>
<input>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#doc7"/>
</valueReference>
</input>
<input>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="regulatory-document"/>
<display value="Regulatory Document"/>
</coding>
</type>
<valueReference>
<reference value="#doc8"/>
</valueReference>
</input>
</Task>