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

• Narrative Content
• XML
• JSON
• TTL

: Type-II-Variation - XML Representation

Raw xml | Download

<Bundle xmlns="http://hl7.org/fhir">
  <id value="Type-II-Variation"/>
  <type value="transaction"/>
  <entry>
    <fullUrl value="urn:uuid:task-001"/>
    <resource>
      <Task>
        <id value="task-001"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Task_task-001"> </a><p class="res-header-id"><b>Generated Narrative: Task task-001</b></p><a name="task-001"> </a><a name="hctask-001"> </a><p><b>status</b>: Requested</p><p><b>intent</b>: proposal</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/task-code submit-variation}">Submit Type II Variation</span></p><p><b>description</b>: Type II variation for shelf life extension from 24 to 36 months</p><p><b>for</b>: <a href="MedicinalProductDefinition/mpd-001">MedicinalProductDefinition/mpd-001</a></p><p><b>authoredOn</b>: 2025-06-29</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="requested"/>
        <intent value="proposal"/>
        <code>
          <coding>
            <system value="http://hl7.org/fhir/task-code"/>
            <code value="submit-variation"/>
            <display value="Submit Type II Variation"/>
          </coding>
        </code>
        <description
                     value="Type II variation for shelf life extension from 24 to 36 months"/>
        <for>
          <reference value="MedicinalProductDefinition/mpd-001"/>
        </for>
        <authoredOn value="2025-06-29"/>
        <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:doc-ref-001"/>
    <resource>
      <DocumentReference>
        <id value="doc-ref-001"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_doc-ref-001"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference doc-ref-001</b></p><a name="doc-ref-001"> </a><a name="hcdoc-ref-001"> </a><p><b>status</b>: Current</p><p><b>type</b>: <span title="Codes:{http://loinc.org 51851-4}">Administrative report</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style="display: none">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>Type II Variation Application Form Collection Bundle</td></tr></table></blockquote><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style="display: none">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>ePI Storage Update Document Bundle</td></tr></table></blockquote><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style="display: none">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>PQI Stability Data Collection Bundle</td></tr></table></blockquote></div>
        </text>
        <status value="current"/>
        <type>
          <coding>
            <system value="http://loinc.org"/>
            <code value="51851-4"/>
            <display value="Administrative report"/>
          </coding>
        </type>
        <content>
          <attachment>
            <contentType value="application/json"/>
            <data value="base64 data placeholder"/>
            <size value="1234"/>
            <hash value="qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c="/>
            <title
                   value="Type II Variation Application Form Collection Bundle"/>
          </attachment>
        </content>
        <content>
          <attachment>
            <contentType value="application/json"/>
            <data value="base64 data placeholder"/>
            <size value="1234"/>
            <hash value="qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c="/>
            <title value="ePI Storage Update Document Bundle"/>
          </attachment>
        </content>
        <content>
          <attachment>
            <contentType value="application/json"/>
            <data value="base64 data placeholder"/>
            <size value="1234"/>
            <hash value="qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c="/>
            <title value="PQI Stability Data Collection Bundle"/>
          </attachment>
        </content>
      </DocumentReference>
    </resource>
    <request>
      <method value="POST"/>
      <url value="DocumentReference"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:provenance-001"/>
    <resource>
      <Provenance>
        <id value="provenance-001"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Provenance_provenance-001"> </a><p class="res-header-id"><b>Generated Narrative: Provenance provenance-001</b></p><a name="provenance-001"> </a><a name="hcprovenance-001"> </a><p>Provenance for <a href="Bundle-Type-II-Variation.html#DocumentReference_doc-ref-001">Bundle: type = transaction</a></p><p>Summary</p><table class="grid"><tr><td>Recorded</td><td>2025-06-29 17:25:00-0400</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="DocumentReference/doc-ref-001"/>
        </target>
        <recorded value="2025-06-29T17:25:00-04:00"/>
        <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="2025-06-29T17:25:00-04:00"/>
          <who>
            <reference value="Organization/pharma-inc"/>
          </who>
        </signature>
      </Provenance>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Provenance"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:application-form-001"/>
    <resource>
      <Bundle>
        <id value="application-form-001"/>
        <type value="collection"/>
        <entry>
          <fullUrl value="urn:uuid:activity-definition-001"/>
          <resource>
            <ActivityDefinition>
              <id value="activity-definition-001"/>
              <status value="draft"/>
              <description
                           value="Type II variation application for shelf life extension from 24 to 36 months"/>
            </ActivityDefinition>
          </resource>
        </entry>
      </Bundle>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Bundle"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:epi-bundle-001"/>
    <resource>
      <Bundle>
        <id value="epi-bundle-001"/>
        <type value="document"/>
        <entry>
          <fullUrl value="urn:uuid:epi-composition-001"/>
          <resource>
            <Composition>
              <id value="epi-composition-001"/>
              <status value="preliminary"/>
              <type>
                <coding>
                  <system value="http://loinc.org"/>
                  <code value="34391-3"/>
                  <display value="Product Labeling"/>
                </coding>
              </type>
              <title value="Updated ePI for Monoclonal Antibody"/>
              <section>
                <title value="Storage"/>
                <text>
                  <status value="generated"/>
                  <div xmlns="http://www.w3.org/1999/xhtml">Store at 2-8°C for up to 36 months.</div>
                </text>
              </section>
            </Composition>
          </resource>
        </entry>
      </Bundle>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Bundle"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:pqi-bundle-001"/>
    <resource>
      <Bundle>
        <id value="pqi-bundle-001"/>
        <type value="collection"/>
        <entry>
          <fullUrl value="urn:uuid:observation-001"/>
          <resource>
            <Observation>
              <id value="observation-001"/>
              <status value="final"/>
              <code>
                <coding>
                  <system value="http://loinc.org"/>
                  <code value="76662-2"/>
                  <display value="Stability study"/>
                </coding>
              </code>
              <valueString
                           value="Stability data supports shelf life extension to 36 months"/>
            </Observation>
          </resource>
        </entry>
      </Bundle>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Bundle"/>
    </request>
  </entry>
</Bundle>