<?xml version="1.0" encoding="UTF-8"?><RegulatedAuthorization xmlns="http://hl7.org/fhir">
  <id value="example"/>
  <text><status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><p><b>identifier</b>: EU/1/11/999/001</p><p><b>region</b>: EU <span>(Details : {http://ema.europa.eu/example/country code &#39;EU&#39; = &#39;EU)</span></p><p><b>status</b>: active <span>(Details : {http://ema.europa.eu/example/authorisationstatus code &#39;active&#39; = &#39;active)</span></p><p><b>statusDate</b>: 2015-01-14</p><p><b>validityPeriod</b>: 2015-08-16 --&gt; 2020-05-20</p><p><b>jurisdictionalAuthorization</b>: <a>RegulatedAuthorization/Jurusdictional1</a></p><p><b>holder</b>: <a>Organization/example</a></p><p><b>regulator</b>: <a>Organization/example</a></p><blockquote><p><b>case</b></p><p><b>identifier</b>: EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: VariationTypeIA <span>(Details : {http://ema.europa.eu/example/marketingAuthorisationProcedureType code &#39;VariationTypeIA&#39; = &#39;VariationTypeIA)</span></p><p><b>date</b>: 2015-08-02 --&gt; 2015-08-21</p><h3>Applications</h3><table><tr><td>-</td></tr><tr><td>*</td></tr></table></blockquote></div></text><identifier>
    <system value="http://ema.europa.eu/example/marketingAuthorisationNumber"/>
    <value value="EU/1/11/999/001"/>
  </identifier>
  <region>
    <coding>
      <system value="http://ema.europa.eu/example/country"/>
      <code value="EU"/>
    </coding>
  </region>
  <status>
    <coding>
      <system value="http://ema.europa.eu/example/authorisationstatus"/>
      <code value="active"/>
    </coding>
  </status>
  <statusDate value="2015-01-14"/>
  <validityPeriod>
    <start value="2015-08-16"/>
    <end value="2020-05-20"/>
  </validityPeriod>
  <!--  dataExclusivityPeriod>
    <start value="2010-08-15"/>
    <end value="2020-08-15"/>
  </dataExclusivityPeriod>
  <dateOfFirstAuthorization value="2010-08-15"/>
  <internationalBirthDate value="2010-08-15"/  -->
  <jurisdictionalAuthorization id="1">
    <reference value="RegulatedAuthorization/Jurusdictional1"/>
  </jurisdictionalAuthorization>
  <holder>
    <reference value="Organization/example"/>
  </holder>
  <regulator>
    <reference value="Organization/example"/>
  </regulator>
  <case>
    <identifier>
      <system value="http://ema.europa.eu/example/procedureidentifier-number"/>
      <value value="EMEA/H/C/009999/IA/0099/G"/>
    </identifier>
    <type>
      <coding>
        <system value="http://ema.europa.eu/example/marketingAuthorisationProcedureType"/>
        <code value="VariationTypeIA"/>
      </coding>
    </type>
    <datePeriod>
      <start value="2015-08-02"/>
      <end value="2015-08-21"/>
    </datePeriod>
    <application>
      <identifier>
        <system value="http://ema.europa.eu/example/applicationidentifier-number"/>
        <value value="IA38G"/>
      </identifier>
      <type>
        <coding>
          <system value="http://ema.europa.eu/example/marketingAuthorisationApplicationType"/>
          <code value="GroupTypeIAVariationNotification"/>
        </coding>
      </type>
      <dateDateTime value="2015-08-01"/>
    </application>
  </case>
</RegulatedAuthorization>