<status value="draft" /> <date value="2026-03-26T14:42:10+01:00" /> <publisher value="ACS PharmaProtect GmbH" /> <contact> <name value="ACS PharmaProtect GmbH" /> <telecom> <system value="url" /> <value value="https://www.pharmaprotect.de" /> </telecom> <telecom> <system value="email" /> <value value="andreas.schaefer@wambo.com" /> </telecom> </contact> <description value="This profile defines constraints on the EUEpiBundle to ensure a unique identifier across all Implementation Guides (GIs). All new versions of a GI must retain the same Bundle ID." /> <fhirVersion value="5.0.0" /> <mapping> <identity value="w5" /> <uri value="http://hl7.org/fhir/fivews" /> <name value="FiveWs Pattern Mapping" /> </mapping> <mapping> <identity value="v2" /> <uri value="http://hl7.org/v2" /> <name value="HL7 V2 Mapping" /> </mapping> <mapping> <identity value="rim" /> <uri value="http://hl7.org/v3" /> <name value="RIM Mapping" /> </mapping> <mapping> <identity value="cda" /> <uri value="http://hl7.org/v3/cda" /> <name value="CDA (R2)" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="Bundle" /> <baseDefinition value="http://ema.europa.eu/fhir/StructureDefinition/EUEpiBundle" /> <derivation value="constraint" /> <snapshot> <extension url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version"> <valueString value="1.0.0" /> </extension> </snapshot> <differential> <element id="Bundle"> <path value="Bundle" /> </element> <element id="Bundle.identifier"> <path value="Bundle.identifier" /> <short value="Globally unique identifier shared across all versions of the Implementation Guide (GI)" /> <definition value="A UUID that uniquely identifies the Bundle across all GIs. All new versions of a GI must retain the same Bundle ID." /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Bundle.entry"> <path value="Bundle.entry" /> <min value="4" /> </element> <element id="Bundle.entry:composition"> <path value="Bundle.entry" /> <sliceName value="composition" /> </element> <element id="Bundle.entry:composition.resource"> <path value="Bundle.entry.resource" /> <type> <code value="Composition" /> <profile value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Composition" /> </type> </element> <element id="Bundle.entry:organization"> <path value="Bundle.entry" /> <sliceName value="organization" /> <min value="1" /> <max value="2" /> </element> <element id="Bundle.entry:organization.resource"> <path value="Bundle.entry.resource" /> <type> <code value="Organization" /> <profile value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Organization" /> </type> </element> <element id="Bundle.entry:product"> <path value="Bundle.entry" /> <sliceName value="product" /> <min value="1" /> <max value="*" /> </element> <element id="Bundle.entry:product.resource"> <path value="Bundle.entry.resource" /> <type> <code value="MedicinalProductDefinition" /> <profile value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-MedicinalProductDefinition" /> </type> </element> <element id="Bundle.entry:package"> <path value="Bundle.entry" /> <sliceName value="package" /> <min value="1" /> <max value="*" /> </element> <element id="Bundle.entry:package.resource"> <path value="Bundle.entry.resource" /> <type> <code value="PackagedProductDefinition" /> <profile value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-PackagedProductDefinition" /> </type> </element> </differential> </StructureDefinition>

Generated Narrative: StructureDefinition DEU-ePIL-Bundle

Name	Flags	Card.	Type	Description & Constraints
Bundle		0 .. *	EUEpiBundle	Contains a collection of resources
identifier	S	1..1	Identifier	Globally unique identifier shared across all versions of the Implementation Guide (GI)
entry		4..*	BackboneElement	Entry resource in the EPI bundle.
Slices for entry				Content/Rules for all slices
entry:composition		1 .. 1	BackboneElement	EPI Composition
resource		1 .. 1	DEU_ePIL_Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization		1..2	BackboneElement	Entry resource in the EPI bundle.
resource		1 .. 1	DEU_ePIL_Organization	A grouping of people or organizations with a common purpose
entry:product		1..*	BackboneElement	Entry resource in the EPI bundle.
resource		1 .. 1	DEU_ePIL_MedicinalProductDefinition	Detailed definition of a medicinal product
entry:package		1..*	BackboneElement	Entry resource in the EPI bundle.
resource		1 .. 1	DEU_ePIL_PackagedProductDefinition	A medically related item or items, in a container or package
Documentation for this format