-<RegulatedAuthorization xmlns="http://hl7.org/fhir">
 <!-- OrphanDesignationStatus is not specifically handled yet  -->
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e7"/>
-<subject>
 </subject>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/AuthorisationType"/>
 <!-- ISO name: /MedicinalProduct/OrphanDesignationStatus  -->
 <code value="OrphanDesignationStatus-Yes"/>
 </coding>
 </type>
 </RegulatedAuthorization>