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Regulatedauthorization-example.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: Not linked to any defined compartments

Raw XML (canonical form + also see XML Format Specification)

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Example of regulatedauthorization (id = "example")

<?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</b> </p> <p> <b> id</b> : example</p> <p> <b> identifier</b> : EU/1/11/999/001</p> <p> <b> region</b> : <span> EU</span> </p> <p> <b> status</b> : <span> 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> : <span> VariationTypeIA</span> </p> <p> <b> date</b> : 2015-08-02 --&gt; 2015-08-21</p> <h3> Applications</h3> <table> <tr> <td> -</td> <td> <b> Identifier</b> </td> <td> <b> Type</b> </td> <td> <b> Date[x]</b> </td> </tr> <tr> <td> *</td> <td> IA38G</td> <td> <span> GroupTypeIAVariationNotification</span> </td> <td> 2015-08-01</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> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.