German (DEU) Electronic Product Information (ePI) Product Leaflet (PL) Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: 01 DEU ePIL Bundle

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.

Usages:

• Examples for this Profile: Bundle/21792f15-0c33-4764-aa6f-7945c986241c and Bundle/dc2f861c-d1d1-420b-a171-dba26086cb58

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	EUEpiBundle	Contains a collection of resources Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
identifier	SΣC	1..1	Identifier	Globally unique identifier shared across all versions of the Implementation Guide (GI)
type	ΣC	1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document
timestamp	ΣC	1..1	instant	Persistent original date of approval.
Slices for entry	ΣC	4..*	BackboneElement	Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
entry:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Resource	A resource in the bundle
entry:composition	ΣC	1..1	BackboneElement	EPI Composition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	DEUePIPLCompositionPackageLeaflet	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization	ΣC	1..1	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLOrganization	A grouping of people or organizations with a common purpose
entry:product	ΣC	1..*	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLMedicinalProductDefinition	Detailed definition of a medicinal product
entry:package	ΣC	1..*	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLPackagedProductDefinition	A medically related item or items, in a container or package
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.type	required	Pattern Value: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 From the FHIR Standard
Bundle.entry.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:composition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:organization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:product.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:package.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-1	error	Bundle	total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history')
bdl-2	error	Bundle	entry.search only when a search : (type = 'searchset') or entry.search.empty()
bdl-5	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:product, Bundle.entry:package	must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists()
bdl-7	error	Bundle	FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) : (type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct()
bdl-8	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:product, Bundle.entry:package	fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not()
bdl-9	error	Bundle	A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists())
bdl-10	error	Bundle	A document must have a date : type = 'document' implies (timestamp.hasValue())
bdl-11	error	Bundle	A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition)
bdl-12	error	Bundle	A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader)
bdl-13	error	Bundle	A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
bdl-14	error	Bundle	entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH'
bdl-15	error	Bundle	Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated : type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST')
bdl-16	error	Bundle	Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. : issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning')
bdl-17	error	Bundle	Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. : type = 'document' implies issues.empty()
bdl-18	error	Bundle	Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
bdl-3a	error	Bundle	For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements : type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty())
bdl-3b	error	Bundle	For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH : type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
bdl-3c	error	Bundle	For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH : type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
bdl-3d	error	Bundle	For collections of type transaction-response or batch-response, all entries must contain response elements : type in ('transaction-response' | 'batch-response') implies entry.all(response.exists())
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from EUEpiBundle

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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	DEUePIPLCompositionPackageLeaflet	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization		1..1	BackboneElement	Entry resource in the EPI bundle.
resource		1..1	DEUePIPLOrganization	A grouping of people or organizations with a common purpose
entry:product		1..*	BackboneElement	Entry resource in the EPI bundle.
resource		1..1	DEUePIPLMedicinalProductDefinition	Detailed definition of a medicinal product
entry:package		1..*	BackboneElement	Entry resource in the EPI bundle.
resource		1..1	DEUePIPLPackagedProductDefinition	A medically related item or items, in a container or package
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	EUEpiBundle	Contains a collection of resources Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
identifier	SΣC	1..1	Identifier	Globally unique identifier shared across all versions of the Implementation Guide (GI)
type	ΣC	1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document
timestamp	ΣC	1..1	instant	Persistent original date of approval.
total	ΣC	0..1	unsignedInt	If search, the total number of matches
link	ΣC	0..*	BackboneElement	Support to XHTML content styling referencing an CSS stylesheet.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
relation	ΣC	1..1	code	See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required) Required Pattern: stylesheet
url	ΣC	1..1	uri	Reference details for the link
Slices for entry	ΣC	4..*	BackboneElement	Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
entry:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Resource	A resource in the bundle
entry:composition	ΣC	1..1	BackboneElement	EPI Composition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	DEUePIPLCompositionPackageLeaflet	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization	ΣC	1..1	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLOrganization	A grouping of people or organizations with a common purpose
entry:product	ΣC	1..*	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLMedicinalProductDefinition	Detailed definition of a medicinal product
entry:package	ΣC	1..*	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLPackagedProductDefinition	A medically related item or items, in a container or package
signature	Σ	0..1	Signature	Digital Signature
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
Bundle.type	required	Pattern Value: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 From the FHIR Standard
Bundle.link.relation	required	Pattern Value: stylesheet http://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0 From the FHIR Standard
Bundle.entry.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:composition.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:composition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:organization.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:organization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:product.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:product.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:package.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:package.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-1	error	Bundle	total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history')
bdl-2	error	Bundle	entry.search only when a search : (type = 'searchset') or entry.search.empty()
bdl-5	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:product, Bundle.entry:package	must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists()
bdl-7	error	Bundle	FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) : (type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct()
bdl-8	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:product, Bundle.entry:package	fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not()
bdl-9	error	Bundle	A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists())
bdl-10	error	Bundle	A document must have a date : type = 'document' implies (timestamp.hasValue())
bdl-11	error	Bundle	A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition)
bdl-12	error	Bundle	A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader)
bdl-13	error	Bundle	A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
bdl-14	error	Bundle	entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH'
bdl-15	error	Bundle	Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated : type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST')
bdl-16	error	Bundle	Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. : issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning')
bdl-17	error	Bundle	Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. : type = 'document' implies issues.empty()
bdl-18	error	Bundle	Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
bdl-3a	error	Bundle	For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements : type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty())
bdl-3b	error	Bundle	For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH : type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
bdl-3c	error	Bundle	For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH : type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
bdl-3d	error	Bundle	For collections of type transaction-response or batch-response, all entries must contain response elements : type in ('transaction-response' | 'batch-response') implies entry.all(response.exists())
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from EUEpiBundle

Summary

Mandatory: 4 elements
Must-Support: 1 element

Structures

This structure refers to these other structures:

• 05 DEU ePIL Composition (http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLCompositionPackageLeaflet)
• 02 DEU ePIL Organization (http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLOrganization)
• 03 DEU ePIL Medicinal Product Definition (http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLMedicinalProductDefinition)
• 04 DEU ePIL Packaged Product Definition (http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLPackagedProductDefinition)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	EUEpiBundle	Contains a collection of resources Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
identifier	SΣC	1..1	Identifier	Globally unique identifier shared across all versions of the Implementation Guide (GI)
type	ΣC	1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document
timestamp	ΣC	1..1	instant	Persistent original date of approval.
Slices for entry	ΣC	4..*	BackboneElement	Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
entry:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Resource	A resource in the bundle
entry:composition	ΣC	1..1	BackboneElement	EPI Composition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	DEUePIPLCompositionPackageLeaflet	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization	ΣC	1..1	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLOrganization	A grouping of people or organizations with a common purpose
entry:product	ΣC	1..*	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLMedicinalProductDefinition	Detailed definition of a medicinal product
entry:package	ΣC	1..*	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLPackagedProductDefinition	A medically related item or items, in a container or package
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.type	required	Pattern Value: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 From the FHIR Standard
Bundle.entry.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:composition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:organization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:product.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:package.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-1	error	Bundle	total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history')
bdl-2	error	Bundle	entry.search only when a search : (type = 'searchset') or entry.search.empty()
bdl-5	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:product, Bundle.entry:package	must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists()
bdl-7	error	Bundle	FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) : (type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct()
bdl-8	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:product, Bundle.entry:package	fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not()
bdl-9	error	Bundle	A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists())
bdl-10	error	Bundle	A document must have a date : type = 'document' implies (timestamp.hasValue())
bdl-11	error	Bundle	A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition)
bdl-12	error	Bundle	A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader)
bdl-13	error	Bundle	A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
bdl-14	error	Bundle	entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH'
bdl-15	error	Bundle	Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated : type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST')
bdl-16	error	Bundle	Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. : issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning')
bdl-17	error	Bundle	Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. : type = 'document' implies issues.empty()
bdl-18	error	Bundle	Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
bdl-3a	error	Bundle	For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements : type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty())
bdl-3b	error	Bundle	For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH : type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
bdl-3c	error	Bundle	For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH : type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
bdl-3d	error	Bundle	For collections of type transaction-response or batch-response, all entries must contain response elements : type in ('transaction-response' | 'batch-response') implies entry.all(response.exists())
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Differential View

This structure is derived from EUEpiBundle

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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	DEUePIPLCompositionPackageLeaflet	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization		1..1	BackboneElement	Entry resource in the EPI bundle.
resource		1..1	DEUePIPLOrganization	A grouping of people or organizations with a common purpose
entry:product		1..*	BackboneElement	Entry resource in the EPI bundle.
resource		1..1	DEUePIPLMedicinalProductDefinition	Detailed definition of a medicinal product
entry:package		1..*	BackboneElement	Entry resource in the EPI bundle.
resource		1..1	DEUePIPLPackagedProductDefinition	A medically related item or items, in a container or package
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	EUEpiBundle	Contains a collection of resources Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
identifier	SΣC	1..1	Identifier	Globally unique identifier shared across all versions of the Implementation Guide (GI)
type	ΣC	1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document
timestamp	ΣC	1..1	instant	Persistent original date of approval.
total	ΣC	0..1	unsignedInt	If search, the total number of matches
link	ΣC	0..*	BackboneElement	Support to XHTML content styling referencing an CSS stylesheet.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
relation	ΣC	1..1	code	See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required) Required Pattern: stylesheet
url	ΣC	1..1	uri	Reference details for the link
Slices for entry	ΣC	4..*	BackboneElement	Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
entry:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Resource	A resource in the bundle
entry:composition	ΣC	1..1	BackboneElement	EPI Composition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	DEUePIPLCompositionPackageLeaflet	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization	ΣC	1..1	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLOrganization	A grouping of people or organizations with a common purpose
entry:product	ΣC	1..*	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLMedicinalProductDefinition	Detailed definition of a medicinal product
entry:package	ΣC	1..*	BackboneElement	Entry resource in the EPI bundle. Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	DEUePIPLPackagedProductDefinition	A medically related item or items, in a container or package
signature	Σ	0..1	Signature	Digital Signature
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
Bundle.type	required	Pattern Value: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 From the FHIR Standard
Bundle.link.relation	required	Pattern Value: stylesheet http://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0 From the FHIR Standard
Bundle.entry.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:composition.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:composition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:organization.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:organization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:product.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:product.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:package.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:package.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-1	error	Bundle	total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history')
bdl-2	error	Bundle	entry.search only when a search : (type = 'searchset') or entry.search.empty()
bdl-5	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:product, Bundle.entry:package	must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists()
bdl-7	error	Bundle	FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) : (type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct()
bdl-8	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:product, Bundle.entry:package	fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not()
bdl-9	error	Bundle	A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists())
bdl-10	error	Bundle	A document must have a date : type = 'document' implies (timestamp.hasValue())
bdl-11	error	Bundle	A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition)
bdl-12	error	Bundle	A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader)
bdl-13	error	Bundle	A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
bdl-14	error	Bundle	entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH'
bdl-15	error	Bundle	Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated : type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST')
bdl-16	error	Bundle	Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. : issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning')
bdl-17	error	Bundle	Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. : type = 'document' implies issues.empty()
bdl-18	error	Bundle	Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
bdl-3a	error	Bundle	For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements : type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty())
bdl-3b	error	Bundle	For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH : type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
bdl-3c	error	Bundle	For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH : type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
bdl-3d	error	Bundle	For collections of type transaction-response or batch-response, all entries must contain response elements : type in ('transaction-response' | 'batch-response') implies entry.all(response.exists())
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from EUEpiBundle

Summary

Mandatory: 4 elements
Must-Support: 1 element

Structures

This structure refers to these other structures:

• 05 DEU ePIL Composition (http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLCompositionPackageLeaflet)
• 02 DEU ePIL Organization (http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLOrganization)
• 03 DEU ePIL Medicinal Product Definition (http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLMedicinalProductDefinition)
• 04 DEU ePIL Packaged Product Definition (http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLPackagedProductDefinition)

Other representations of profile: CSV, Excel, Schematron