Release 5 R6 Ballot (3rd Draft)
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Example RegulatedAuthorization/example (XML)

Biomedical Research and Regulation Work Group Maturity Level : N/A Standards Status : Informative Compartments : No defined compartments

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

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General example (id = "example") 

<?xml version="1.0" encoding="UTF-8"?>

<RegulatedAuthorization xmlns="http://hl7.org/fhir">
  <id value="example"/> 
  display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border:
       1px solid #8da1b4; border-radius: 5px; line-height: 60% dataExclusivityPeriod&gt;
    &lt;start value=&quot;2010-08-15&quot;/&gt;
    &lt;end value=&quot;2020-08-15&quot;/&gt;
  &lt;/dataExclusivityPeriod&gt;
  &lt;dateOfFirstAuthorization value=&quot;2010-08-15&quot;/&gt;
  &lt;internationalBirthDate value=&quot;2010-08-15&quot;/ &amp;#10; jurisdictionalAuthorizat
        ion id=&quot;1&quot;&gt;
    &lt;reference value=&quot;RegulatedAuthorization/Jurusdictional1&quot;/&gt;
  &lt;/jurisdictionalAuthorization 

  <identifier> 
    <system value="http://ema.europa.eu/example/marketingAuthorizationNumber"/> 
    <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/authorizationstatus"/> 
      <code value="active"/> 
    </coding> 
  </status> 
  <statusDate value="2015-01-14"/> 
  <validityPeriod> 
    <start value="2014-09-03"/> 
    <end value="2020-05-20"/> 
  </validityPeriod> 
      <!--   dataExclusivityPeriod>

  <!--  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">

  <internationalBirthDate value="2010-08-15"/  -->
  <!--  jurisdictionalAuthorization id="1">
    <reference value="RegulatedAuthorization/Jurusdictional1"/>
  </jurisdictionalAuthorization   -->

  </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/marketingAuthorizationProcedureType"/> 
        <code value="VariationTypeIA"/> 
      </coding> 
    </type> 
    <datePeriod> 
      <start value="2014-09-02"/> 
      <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/marketingAuthorizationApplicationType"/> 
          <code value="GroupTypeIAVariationNotification"/> 
        </coding> 
      </type> 
      <dateDateTime value="2015-08-01"/> 
    </application> 
    <application> 
      <identifier> 
        <system value="http://ema.europa.eu/example/applicationidentifier-number"/> 
        <value value="IA38F"/> 
      </identifier> 
      <type> 
        <coding> 
          <system value="http://ema.europa.eu/example/marketingAuthorizationApplicationType"/> 
          <code value="GroupTypeIAVariationNotification"/> 
        </coding> 
      </type> 
      <dateDateTime value="2014-09-01"/> 
    </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.