R6 Ballot (2nd Draft)

Publish-box (todo)

Example RegulatedAuthorization/example (XML)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

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

General example (id = "example")

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

<RegulatedAuthorization xmlns="http://hl7.org/fhir">
  <id value="example"/> 
  <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>
    <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/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.