These is a FHIR profile which expresses EMA ePI API business rules and constraints, specific to resource List in mode "Create" This is the List of documents in a ePI Create bundle

<status value="draft" /> <date value="2021-06-21T09:00:00.000-00:00" /> <description value="This profile expresses the ePI API user guidance in a computable FHIR manner" /> <purpose value="This enables automatic checking of the ePI API business rules and constraints, that go beyond the basic FHIR constraints" /> <fhirVersion value="4.0.0" /> <kind value="resource" /> <abstract value="false" /> <type value="List" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/List" /> <derivation value="constraint" /> <differential> <element id="List.id"> <path value="List.id" /> <min value="0" /> <max value="0" /> </element> <element id="List.identifier"> <path value="List.identifier" /> <max value="0" /> </element> <element id="List.status"> <path value="List.status" /> <fixedCode value="current" /> </element> <element id="List.mode"> <path value="List.mode" /> <fixedCode value="working" /> </element> <element id="List.title"> <path value="List.title" /> <max value="0" /> </element> <element id="List.code"> <path value="List.code" /> <max value="0" /> </element> <element id="List.subject"> <path value="List.subject" /> <max value="0" /> </element> <element id="List.encounter"> <path value="List.encounter" /> <max value="0" /> </element> <element id="List.date"> <path value="List.date" /> <max value="0" /> </element> <element id="List.source"> <path value="List.source" /> <max value="0" /> </element> <element id="List.orderedBy"> <path value="List.orderedBy" /> <max value="0" /> </element> <element id="List.note"> <path value="List.note" /> <max value="0" /> </element> <element id="List.entry"> <path value="List.entry" /> <min value="1" /> </element> <element id="List.entry.item"> <path value="List.entry.item" /> <min value="1" /> <max value="1" /> <type> <code value="Reference" /> <targetProfile value="http://ema.europa.eu/fhir/definition/epi/Bundle-document-create" /> </type> </element> <element id="List.emptyReason"> <path value="List.emptyReason" /> <max value="0" /> </element> </differential> </StructureDefinition>