task-shelf-life-extension-synthpharma-2025 - XML Representation - API for the Exchange of Medicinal Product Information (APIX) v0.1.0

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-shelf-life-extension-synthpharma-2025 - XML Representation

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<Task xmlns="http://hl7.org/fhir">
  <id value="task-shelf-life-extension-synthpharma-2025"/>
  <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">Type IB Variation (C.I.4) – Extension of shelf-life for the finished product SynthVac 50 mg film-coated tablets from 24 months to 36 months based on additional long-term stability data at 25°C/60% RH.</div>
  </text>
  <contained>
    <Organization>
      <id value="org-synthpharma-ag"/>
      <identifier>
        <system value="https://spor.ema.europa.eu/v1/organisations"/>
        <value value="ORG-987654"/>
      </identifier>
      <name value="SynthPharma AG"/>
      <contact>
        <name>
          <text
                value="Dr. John Doe, Head of Regulatory Affairs, Global Regulatory Strategy"/>
        </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"/>
      <identifier>
        <system value="https://spor.ema.europa.eu/v1/organisations"/>
        <value value="ORG-EMA-000001"/>
      </identifier>
      <name
            value="European Medicines Agency – Human Medicines Evaluation Division – Scientific and Regulatory Management"/>
      <contact>
        <name>
          <text value="Dr. Jane Doe, Scientific Officer"/>
        </name>
        <telecom>
          <system value="phone"/>
          <value value="+31-88-781-6000"/>
          <use value="work"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="jane.doe@example.eu"/>
          <use value="work"/>
        </telecom>
      </contact>
    </Organization>
  </contained>
  <contained>
    <DocumentReference>
      <id value="docref-cover-letter"/>
      <meta>
        <versionId value="1"/>
        <lastUpdated value="2025-11-15T09:00:00+01:00"/>
        <profile
                 value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"/>
      </meta>
      <status value="current"/>
      <type>
        <coding>
          <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
          <code value="1.0"/>
          <display value="Cover Letter"/>
        </coding>
      </type>
      <date value="2025-11-15T09:00:00+01:00"/>
      <content>
        <attachment>
          <contentType value="application/fhir+json"/>
          <data
                value="ewogICJyZXNvdXJjZVR5cGUiOiAiQ29tcG9zaXRpb24iLAogICJpZCI6ICJzaGVsZi1saWZlLXN0YXRlbWVudC1leGFtcGxlIiwKICAic3RhdHVzIjogImZpbmFsIiwKICAidHlwZSI6IHsKICAgICJjb2RpbmciOiBbCiAgICAgIHsKICAgICAgICAic3lzdGVtIjogImh0dHA6Ly9obDcub3JnL2ZoaXIvY29tcG9zaXRpb24tdHlwZSIsCiAgICAgICAgImNvZGUiOiAiNzIxMzgtMiIsCiAgICAgICAgImRpc3BsYXkiOiAiU2hlbGYgTGlmZSBEb2N1bWVudCIKICAgICAgfQogICAgXQogIH0sCiAgInN1YmplY3QiOiB7CiAgICAicmVmZXJlbmNlIjogIk1lZGljaW5hbFByb2R1Y3REZWZpbml0aW9uL2V4YW1wbGUtbXBkLTEyMyIKICB9LAogICJkYXRlIjogIjIwMjUtMTItMDVUMTI6MDA6MDBaIiwKICAiYXV0aG9yIjogWwogICAgewogICAgICAicmVmZXJlbmNlIjogIk9yZ2FuaXphdGlvbi9leGFtcGxlLW1hbnVmYWN0dXJlciIKICAgIH0KICBdLAogICJ0aXRsZSI6ICJTaGVsZiBMaWZlIFN0YXRlbWVudCBmb3IgUHJvZHVjdCBYWVoiLAogICJzZWN0aW9uIjogWwogICAgewogICAgICAidGl0bGUiOiAiU3RvcmFnZSBDb25kaXRpb25zIGFuZCBTaGVsZiBMaWZlIiwKICAgICAgImNvZGUiOiB7CiAgICAgICAgImNvZGluZyI6IFsKICAgICAgICAgIHsKICAgICAgICAgICAgInN5c3RlbSI6ICJodHRwOi8vZW1hLmV1cm9wYS5ldS9leGFtcGxlL3NlY3Rpb25jcyIsCiAgICAgICAgICAgICJjb2RlIjogInNoZWxmLWxpZmUiLAogICAgICAgICAgICAiZGlzcGxheSI6ICJTaGVsZiBsaWZlIgogICAgICAgICAgfQogICAgICAgIF0KICAgICAgfSwKICAgICAgInRleHQiOiB7CiAgICAgICAgInN0YXR1cyI6ICJhZGRpdGlvbmFsIiwKICAgICAgICAiZGl2IjogIjxkaXYgeG1sbnM9XCJodHRwOi8vd3d3LnczLm9yZy8xOTk5L3hodG1sXCI+XG48cD48Yj5Qcm9kdWN0OjwvYj4gWFlaIDEwMCBtZyB0YWJsZXRzPC9wPlxuPHA+PGI+QXNzaWduZWQgc2hlbGYgbGlmZTo8L2I+IDM2IG1vbnRoczwvcD5cbjxwPjxiPlN0b3JhZ2UgY29uZGl0aW9uOjwvYj4gU3RvcmUgYmVsb3cgMjXCsEM8L3A+XG48cD48Yj5BZnRlciBmaXJzdCBvcGVuaW5nOjwvYj4gNiBtb250aHM8L3A+XG48L2Rpdj4iCiAgICAgIH0KICAgIH0KICBdCn0="/>
          <title value="Cover_Letter_SynthVac_ShelfLife_Extension_2025.json"/>
          <creation value="2025-11-15T09:00:00+01:00"/>
        </attachment>
      </content>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="docref-labeling"/>
      <meta>
        <versionId value="1"/>
        <lastUpdated value="2025-11-15T09:00:00+01:00"/>
        <profile
                 value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"/>
      </meta>
      <status value="current"/>
      <type>
        <coding>
          <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
          <code value="1.3.1"/>
          <display value="SPC, Labelling and Package Leaflet"/>
        </coding>
      </type>
      <date value="2025-11-15T09:00:00+01:00"/>
      <content>
        <attachment>
          <contentType value="application/fhir+json"/>
          <data
                value="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"/>
          <title value="SynthVac_Annotated_SmPC_PIL_36months.json"/>
          <creation value="2025-11-15T09:00:00+01:00"/>
        </attachment>
      </content>
    </DocumentReference>
  </contained>
  <contained>
    <DocumentReference>
      <id value="docref-quality"/>
      <meta>
        <versionId value="1"/>
        <lastUpdated value="2025-11-15T09:00:00+01:00"/>
        <profile
                 value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"/>
      </meta>
      <status value="current"/>
      <type>
        <coding>
          <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
          <code value="2.3"/>
          <display value="Quality Overall Summary"/>
        </coding>
      </type>
      <date value="2025-11-15T09:00:00+01:00"/>
      <content>
        <attachment>
          <contentType value="application/fhir+json"/>
          <data
                value="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"/>
          <title value="3.2.S.7_Stability_Summary_and_Conclusions.json"/>
          <creation value="2025-11-15T09:00:00+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:5f3e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3a"/>
  </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="https://ema.europa.eu/fhir/identifier/procedure"/>
    <value value="EU/1/23/4567/001-IB/023"/>
  </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:a1b2c3d4-e5f6-7890-g1h2-i3j4k5l6m7n8"/>
  </groupIdentifier>
  <status value="requested"/>
  <intent value="proposal"/>
  <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"/>
  </requester>
  <requestedPerformer>
    <reference>
      <reference value="Organization/org-mah-98765"/>
      <display value="PharmaCorp International Ltd"/>
    </reference>
  </requestedPerformer>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#docref-cover-letter"/>
      <display value="Cover Letter"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#docref-labeling"/>
      <display value="Annotated Labeling"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
        <code value="regulatory-document"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#docref-quality"/>
      <display value="Quality Overall Summary"/>
    </valueReference>
  </input>
</Task>