<status value="draft" /> <description value="Representation of a product authorization regulated by Anvisa" /> <fhirVersion value="5.0.0" /> <kind value="resource" /> <abstract value="false" /> <type value="RegulatedAuthorization" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization" /> <derivation value="constraint" /> <differential> <element id="RegulatedAuthorization"> <path value="RegulatedAuthorization" /> <short value="Representation of a product authorization regulated by Anvisa" /> </element> <element id="RegulatedAuthorization.extension:anvisaNomenclature"> <path value="RegulatedAuthorization.extension" /> <sliceName value="anvisaNomenclature" /> <short value="The Anvisa's nomenclature name" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://udi.anvisa.gov.br/fhir/StructureDefinition/AnvisaNomenclature" /> </type> </element> <element id="RegulatedAuthorization.extension:riskClassification"> <path value="RegulatedAuthorization.extension" /> <sliceName value="riskClassification" /> <short value="The risk classification of the product" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://udi.anvisa.gov.br/fhir/StructureDefinition/RiskClassification" /> </type> </element> <element id="RegulatedAuthorization.identifier"> <path value="RegulatedAuthorization.identifier" /> <min value="1" /> <max value="1" /> </element> <element id="RegulatedAuthorization.identifier.use"> <path value="RegulatedAuthorization.identifier.use" /> <max value="0" /> </element> <element id="RegulatedAuthorization.identifier.type"> <path value="RegulatedAuthorization.identifier.type" /> <max value="0" /> </element> <element id="RegulatedAuthorization.identifier.system"> <path value="RegulatedAuthorization.identifier.system" /> <max value="0" /> </element> <element id="RegulatedAuthorization.identifier.value"> <path value="RegulatedAuthorization.identifier.value" /> <short value="The Premarket Authorization Number of the regularization" /> <min value="1" /> <maxLength value="11" /> </element> <element id="RegulatedAuthorization.identifier.period"> <path value="RegulatedAuthorization.identifier.period" /> <max value="0" /> </element> <element id="RegulatedAuthorization.identifier.assigner"> <path value="RegulatedAuthorization.identifier.assigner" /> <max value="0" /> </element> <element id="RegulatedAuthorization.subject"> <path value="RegulatedAuthorization.subject" /> <max value="0" /> </element> <element id="RegulatedAuthorization.type"> <path value="RegulatedAuthorization.type" /> <max value="0" /> </element> <element id="RegulatedAuthorization.description"> <path value="RegulatedAuthorization.description" /> <short value="The registered product name" /> <min value="1" /> </element> <element id="RegulatedAuthorization.region"> <path value="RegulatedAuthorization.region" /> <max value="0" /> </element> <element id="RegulatedAuthorization.status"> <path value="RegulatedAuthorization.status" /> <short value="The status of the regularization" /> <min value="1" /> <binding> <strength value="required" /> <valueSet value="https://udi.anvisa.gov.br/fhir/ValueSet/RegularizationStatus" /> </binding> </element> <element id="RegulatedAuthorization.statusDate"> <path value="RegulatedAuthorization.statusDate" /> <max value="0" /> </element> <element id="RegulatedAuthorization.validityPeriod.start"> <path value="RegulatedAuthorization.validityPeriod.start" /> <short value="The start of the valid life period, referring to a date when the regularization was released publicly" /> </element> <element id="RegulatedAuthorization.validityPeriod.end"> <path value="RegulatedAuthorization.validityPeriod.end" /> <short value="The end of the valid life period, referring to a date when the regularization was canceled or expired" /> </element> <element id="RegulatedAuthorization.indication"> <path value="RegulatedAuthorization.indication" /> <max value="0" /> </element> <element id="RegulatedAuthorization.intendedUse"> <path value="RegulatedAuthorization.intendedUse" /> <max value="0" /> </element> <element id="RegulatedAuthorization.basis"> <path value="RegulatedAuthorization.basis" /> <max value="0" /> </element> <element id="RegulatedAuthorization.holder"> <path value="RegulatedAuthorization.holder" /> <short value="A reference to the regularization holder company" /> <min value="1" /> <type> <code value="Reference" /> <targetProfile value="https://udi.anvisa.gov.br/fhir/StructureDefinition/Holder" /> </type> </element> <element id="RegulatedAuthorization.regulator"> <path value="RegulatedAuthorization.regulator" /> <max value="0" /> </element> <element id="RegulatedAuthorization.attachedDocument"> <path value="RegulatedAuthorization.attachedDocument" /> <max value="0" /> </element> <element id="RegulatedAuthorization.case"> <path value="RegulatedAuthorization.case" /> <max value="0" /> </element> </differential> </StructureDefinition>