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

• Narrative Content
• XML
• JSON
• TTL

: scenario1-02-validation - XML Representation

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<Task xmlns="http://hl7.org/fhir">
  <id value="scenario1-02-validation"/>
  <meta>
    <versionId value="2"/>
    <lastUpdated value="2025-11-20T14:30:00+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: Validation of Type IB Variation</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"/>
      <type>
        <coding>
          <code value="cover-letter"/>
          <display value="Cover Letter"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc2"/>
      <type>
        <coding>
          <code value="application-form"/>
          <display value="Application Form"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc3"/>
      <type>
        <coding>
          <code value="annotated-label"/>
          <display value="Annotated Label"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc4"/>
      <type>
        <coding>
          <code value="clean-label"/>
          <display value="Clean Label"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc5"/>
      <type>
        <coding>
          <code value="pack-mockup"/>
          <display value="Pack Mockup"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc6"/>
      <type>
        <coding>
          <code value="cmc-stability-summary"/>
          <display value="Stability Summary"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc7"/>
      <type>
        <coding>
          <code value="cmc-stability-data"/>
          <display value="Stability Data"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc8"/>
      <type>
        <coding>
          <code value="cmc-stability-commitment"/>
          <display value="Stability Commitment"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc9"/>
      <type>
        <coding>
          <code value="cmc-ds-stability-summary"/>
          <display value="DS Stability Summary"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="doc10"/>
      <type>
        <coding>
          <code value="cmc-ds-stability-data"/>
          <display value="DS Stability Data"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="output-ack"/>
      <type>
        <coding>
          <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
          <code value="acknowledgement-receipt"/>
          <display value="Acknowledgement of Receipt"/>
        </coding>
      </type>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="output-validation"/>
      <type>
        <coding>
          <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
          <code value="validation-report"/>
          <display value="Validation Report"/>
        </coding>
      </type>
    </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>
  <identifier>
    <use value="official"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type"/>
        <code value="regulator-procedure-number"/>
        <display value="Regulator Procedure Number"/>
      </coding>
    </type>
    <system value="http://ema.europa.eu/procedure-number"/>
    <value value="EMEA/H/C/001234/IB/0025"/>
  </identifier>
  <basedOn>🔗 
    <reference value="Task/scenario1-01-initial-submission"/>
  </basedOn>
  <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="accepted"/>
  <businessStatus>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
      <code value="validation-successful"/>
      <display value="Validation Successful"/>
    </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="2025-11-20T14:30:00+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>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc1"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc2"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc3"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc4"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc5"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc6"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc7"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc8"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc9"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#doc10"/>
    </valueReference>
  </input>
  <output>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#output-ack"/>
    </valueReference>
  </output>
  <output>
    <type>
      <coding>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#output-validation"/>
    </valueReference>
  </output>
</Task>