Current Build

Medicinalproductauthorization-example.xml

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

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

Jump past Narrative

Example of medicinalproductauthorization (id = "example")

<MedicinalProductAuthorization 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> country</b> : EU <span> (Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)</span> </p> <p> <b> legalStatusOfSupply</b> : Subjecttomedicalprescription <span> (Details : {http://ema.europa.eu/example/legalstatusofsupply code 'Subjecttomedicalprescription'
           = 'Subjecttomedicalprescription)</span> </p> <p> <b> status</b> : active <span> (Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)</span> </p> <p> <b> statusDate</b> : Jan 14, 2015</p> <p> <b> validityPeriod</b> : Aug 16, 2015 --&gt; May 20, 2020</p> <p> <b> dataExclusivityPeriod</b> : Aug 15, 2010 --&gt; Aug 15, 2020</p> <p> <b> dateOfFirstAuthorization</b> : Aug 15, 2010</p> <p> <b> internationalBirthDate</b> : Aug 15, 2010</p> <blockquote> <p> <b> jurisdictionalAuthorization</b> </p> <p> <b> identifier</b> : 123-456-789</p> <p> <b> country</b> : NO <span> (Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span> </p> </blockquote> <blockquote> <p> <b> jurisdictionalAuthorization</b> </p> <p> <b> identifier</b> : 123-456-123</p> <p> <b> country</b> : NO <span> (Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span> </p> </blockquote> <p> <b> holder</b> : <a> Organization/example</a> </p> <p> <b> regulator</b> : <a> Organization/example</a> </p> <blockquote> <p> <b> procedure</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 'VariationTypeIA'
             = 'VariationTypeIA)</span> </p> <p> <b> date</b> : Aug 2, 2015 --&gt; Aug 21, 2015</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> 
  <country> 
    <coding> 
      <system value="http://ema.europa.eu/example/country"/> 
      <code value="EU"/> 
    </coding> 
  </country> 
  <legalStatusOfSupply> 
    <coding> 
      <system value="http://ema.europa.eu/example/legalstatusofsupply"/> 
      <code value="Subjecttomedicalprescription"/> 
    </coding> 
  </legalStatusOfSupply> 
  <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">
    <identifier> 
      <system value="http://ema.europa.eu/example/marketingauthorisationnumber"/> 
      <value value="123-456-789"/> 
    </identifier> 
    <country> 
      <coding> 
        <system value="http://ema.europa.eu/example/countryCode"/> 
        <code value="NO"/> 
      </coding> 
    </country> 
  </jurisdictionalAuthorization> 
  <jurisdictionalAuthorization id="2">
    <identifier> 
      <system value="http://ema.europa.eu/example/marketingauthorisationnumber"/> 
      <value value="123-456-123"/> 
    </identifier> 
    <country> 
      <coding> 
        <system value="http://ema.europa.eu/example/countryCode"/> 
        <code value="NO"/> 
      </coding> 
    </country> 
  </jurisdictionalAuthorization> 
  <holder> 
    <reference value="Organization/example"/> 
  </holder> 
  <regulator> 
    <reference value="Organization/example"/> 
  </regulator> 
  <procedure> 
    <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> 
  </procedure> 
</MedicinalProductAuthorization> 

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.