EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: EMA Write PMS API Bundle

EMA Write PMS API Bundle

Usages:

• This Profile is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

• Key Elements Table
• Differential Table
• Snapshot Table
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Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	EmaWriteApiBundleRestrictions	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
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: transaction
link	ΣC	1..1	BackboneElement	Links related to this Bundle
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)
url	ΣC	1..1	uri	Reference details for the link
Slices for entry	ΣC	2..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by type: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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	0..1	Resource	A resource in the bundle
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
entry:medicinalProductDefinitionPut	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsMedicinalProductDefinition
resource		0..1	EmaWriteApiMedicinalProductDefinition	Detailed definition of a medicinal product
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. Required Pattern: PUT
url	ΣC	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsMedicinalProductDefinition
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
entry:packagedProductDefinitionPut	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsPackagedProductDefinition
resource		0..1	EmaWriteApiPackagedProductDefinition	A medically related item or items, in a container or package
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. Required Pattern: PUT
url	ΣC	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsPackagedProductDefinition
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
entry:activityDefinition	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: bdl-5, bdl-8, activityDefinitionUrlsMatchRequestMethod 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		0..1	EmaWriteApiActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
entry:regulatedAuthorization	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: bdl-5, bdl-8, regulatedAuthorizationUrlsMatchRequestMethod 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		0..1	EmaWriteApiRegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
issues	ΣC	0..1	OperationOutcome(5.0.0)	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Bundle.type	Base	required	Bundle Type	📍5.0.0	FHIR Std.
Bundle.link.relation	Base	required	Link Relation Types	📍5.0.0	FHIR Std.
Bundle.entry.request.​method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:medicinalProductDefinitionPut.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:packagedProductDefinitionPut.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:activityDefinition.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:regulatedAuthorization.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
activityDefinitionUrlsMatchRequestMethod	error	Bundle.entry:activityDefinition	When method is PUT or DELETE, both request.url and fullUrl must contain 'ActivityDefinition/<id>'. When method is POST, request.url must be 'ActivityDefinition' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('ActivityDefinition/') or (request.method = 'DELETE' and request.url.contains('ActivityDefinition/'))) and fullUrl.contains('ActivityDefinition/')) or (request.method = 'POST' and request.url = 'ActivityDefinition' and fullUrl.startsWith('urn:uuid:'))
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:medicinalProductDefinitionPut, Bundle.entry:packagedProductDefinitionPut, Bundle.entry:activityDefinition, Bundle.entry:regulatedAuthorization	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:medicinalProductDefinitionPut, Bundle.entry:packagedProductDefinitionPut, Bundle.entry:activityDefinition, Bundle.entry:regulatedAuthorization	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())
containsMedicinalProductDefinition	error	Bundle.entry:medicinalProductDefinitionPut.fullUrl, Bundle.entry:medicinalProductDefinitionPut.request.url	Checks if the string contains MedicinalProductDefinition/	contains('MedicinalProductDefinition/')
containsPackagedProductDefinition	error	Bundle.entry:packagedProductDefinitionPut.fullUrl, Bundle.entry:packagedProductDefinitionPut.request.url	Checks if the string contains PackagedProductDefinition/	contains('PackagedProductDefinition/')
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()
regulatedAuthorizationUrlsMatchRequestMethod	error	Bundle.entry:regulatedAuthorization	When method is PUT or DELETE, both request.url and fullUrl must contain 'RegulatedAuthorization/<id>'. When method is POST, request.url must be 'RegulatedAuthorization' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('RegulatedAuthorization/') or (request.method = 'DELETE' and request.url.contains('RegulatedAuthorization/'))) and fullUrl.contains('RegulatedAuthorization/')) or (request.method = 'POST' and request.url = 'RegulatedAuthorization' and fullUrl.startsWith('urn:uuid:'))

This structure is derived from EmaWriteApiBundleRestrictions

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle		0..*	EmaWriteApiBundleRestrictions	Contains a collection of resources
type		1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Required Pattern: transaction
link		1..1	BackboneElement	Links related to this Bundle
Slices for entry		2..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by type:resource
entry:All Slices				Content/Rules for all slices
request		1..1	BackboneElement	Additional execution information (transaction/batch/history)
entry:medicinalProductDefinitionPut		1..1	BackboneElement	Entry in the bundle - will have a resource or information
fullUrl	C	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsMedicinalProductDefinition
resource		0..1	EmaWriteApiMedicinalProductDefinition	Detailed definition of a medicinal product
request
method		1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Required Pattern: PUT
url	C	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsMedicinalProductDefinition
entry:packagedProductDefinitionPut		1..*	BackboneElement	Entry in the bundle - will have a resource or information
fullUrl	C	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsPackagedProductDefinition
resource		0..1	EmaWriteApiPackagedProductDefinition	A medically related item or items, in a container or package
request
method		1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Required Pattern: PUT
url	C	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsPackagedProductDefinition
entry:activityDefinition	C	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: activityDefinitionUrlsMatchRequestMethod
resource		0..1	EmaWriteApiActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
entry:regulatedAuthorization	C	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: regulatedAuthorizationUrlsMatchRequestMethod
resource		0..1	EmaWriteApiRegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
activityDefinitionUrlsMatchRequestMethod	error	Bundle.entry:activityDefinition	When method is PUT or DELETE, both request.url and fullUrl must contain 'ActivityDefinition/<id>'. When method is POST, request.url must be 'ActivityDefinition' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('ActivityDefinition/') or (request.method = 'DELETE' and request.url.contains('ActivityDefinition/'))) and fullUrl.contains('ActivityDefinition/')) or (request.method = 'POST' and request.url = 'ActivityDefinition' and fullUrl.startsWith('urn:uuid:'))
containsMedicinalProductDefinition	error	Bundle.entry:medicinalProductDefinitionPut.fullUrl, Bundle.entry:medicinalProductDefinitionPut.request.url	Checks if the string contains MedicinalProductDefinition/	contains('MedicinalProductDefinition/')
containsPackagedProductDefinition	error	Bundle.entry:packagedProductDefinitionPut.fullUrl, Bundle.entry:packagedProductDefinitionPut.request.url	Checks if the string contains PackagedProductDefinition/	contains('PackagedProductDefinition/')
regulatedAuthorizationUrlsMatchRequestMethod	error	Bundle.entry:regulatedAuthorization	When method is PUT or DELETE, both request.url and fullUrl must contain 'RegulatedAuthorization/<id>'. When method is POST, request.url must be 'RegulatedAuthorization' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('RegulatedAuthorization/') or (request.method = 'DELETE' and request.url.contains('RegulatedAuthorization/'))) and fullUrl.contains('RegulatedAuthorization/')) or (request.method = 'POST' and request.url = 'RegulatedAuthorization' and fullUrl.startsWith('urn:uuid:'))

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	EmaWriteApiBundleRestrictions	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
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: transaction
link	ΣC	1..1	BackboneElement	Links related to this Bundle
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)
url	ΣC	1..1	uri	Reference details for the link
Slices for entry	ΣC	2..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by type: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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	0..1	Resource	A resource in the bundle
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
entry:medicinalProductDefinitionPut	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsMedicinalProductDefinition
resource		0..1	EmaWriteApiMedicinalProductDefinition	Detailed definition of a medicinal product
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. Required Pattern: PUT
url	ΣC	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsMedicinalProductDefinition
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
entry:packagedProductDefinitionPut	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsPackagedProductDefinition
resource		0..1	EmaWriteApiPackagedProductDefinition	A medically related item or items, in a container or package
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. Required Pattern: PUT
url	ΣC	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsPackagedProductDefinition
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
entry:activityDefinition	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: bdl-5, bdl-8, activityDefinitionUrlsMatchRequestMethod 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		0..1	EmaWriteApiActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
entry:regulatedAuthorization	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: bdl-5, bdl-8, regulatedAuthorizationUrlsMatchRequestMethod 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		0..1	EmaWriteApiRegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
issues	ΣC	0..1	OperationOutcome(5.0.0)	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Bundle.type	Base	required	Bundle Type	📍5.0.0	FHIR Std.
Bundle.link.relation	Base	required	Link Relation Types	📍5.0.0	FHIR Std.
Bundle.entry.search.​mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry.request.​method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:medicinalProductDefinitionPut.​search.mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry:medicinalProductDefinitionPut.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:packagedProductDefinitionPut.​search.mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry:packagedProductDefinitionPut.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:activityDefinition.​search.mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry:activityDefinition.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:regulatedAuthorization.​search.mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry:regulatedAuthorization.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
activityDefinitionUrlsMatchRequestMethod	error	Bundle.entry:activityDefinition	When method is PUT or DELETE, both request.url and fullUrl must contain 'ActivityDefinition/<id>'. When method is POST, request.url must be 'ActivityDefinition' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('ActivityDefinition/') or (request.method = 'DELETE' and request.url.contains('ActivityDefinition/'))) and fullUrl.contains('ActivityDefinition/')) or (request.method = 'POST' and request.url = 'ActivityDefinition' and fullUrl.startsWith('urn:uuid:'))
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:medicinalProductDefinitionPut, Bundle.entry:packagedProductDefinitionPut, Bundle.entry:activityDefinition, Bundle.entry:regulatedAuthorization	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:medicinalProductDefinitionPut, Bundle.entry:packagedProductDefinitionPut, Bundle.entry:activityDefinition, Bundle.entry:regulatedAuthorization	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())
containsMedicinalProductDefinition	error	Bundle.entry:medicinalProductDefinitionPut.fullUrl, Bundle.entry:medicinalProductDefinitionPut.request.url	Checks if the string contains MedicinalProductDefinition/	contains('MedicinalProductDefinition/')
containsPackagedProductDefinition	error	Bundle.entry:packagedProductDefinitionPut.fullUrl, Bundle.entry:packagedProductDefinitionPut.request.url	Checks if the string contains PackagedProductDefinition/	contains('PackagedProductDefinition/')
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()
regulatedAuthorizationUrlsMatchRequestMethod	error	Bundle.entry:regulatedAuthorization	When method is PUT or DELETE, both request.url and fullUrl must contain 'RegulatedAuthorization/<id>'. When method is POST, request.url must be 'RegulatedAuthorization' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('RegulatedAuthorization/') or (request.method = 'DELETE' and request.url.contains('RegulatedAuthorization/'))) and fullUrl.contains('RegulatedAuthorization/')) or (request.method = 'POST' and request.url = 'RegulatedAuthorization' and fullUrl.startsWith('urn:uuid:'))

This structure is derived from EmaWriteApiBundleRestrictions

Summary

Mandatory: 3 elements(1 nested mandatory element)

Structures

This structure refers to these other structures:

• EMA Write API MedicinalProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition)
• EMA Write API PackagedProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition)
• EMA Write API ActivityDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition)
• EMA Write API Regulated Authorization (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Bundle.entry

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	EmaWriteApiBundleRestrictions	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
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: transaction
link	ΣC	1..1	BackboneElement	Links related to this Bundle
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)
url	ΣC	1..1	uri	Reference details for the link
Slices for entry	ΣC	2..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by type: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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	0..1	Resource	A resource in the bundle
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
entry:medicinalProductDefinitionPut	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsMedicinalProductDefinition
resource		0..1	EmaWriteApiMedicinalProductDefinition	Detailed definition of a medicinal product
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. Required Pattern: PUT
url	ΣC	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsMedicinalProductDefinition
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
entry:packagedProductDefinitionPut	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsPackagedProductDefinition
resource		0..1	EmaWriteApiPackagedProductDefinition	A medically related item or items, in a container or package
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. Required Pattern: PUT
url	ΣC	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsPackagedProductDefinition
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
entry:activityDefinition	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: bdl-5, bdl-8, activityDefinitionUrlsMatchRequestMethod 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		0..1	EmaWriteApiActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
entry:regulatedAuthorization	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: bdl-5, bdl-8, regulatedAuthorizationUrlsMatchRequestMethod 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		0..1	EmaWriteApiRegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)
issues	ΣC	0..1	OperationOutcome(5.0.0)	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Bundle.type	Base	required	Bundle Type	📍5.0.0	FHIR Std.
Bundle.link.relation	Base	required	Link Relation Types	📍5.0.0	FHIR Std.
Bundle.entry.request.​method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:medicinalProductDefinitionPut.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:packagedProductDefinitionPut.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:activityDefinition.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:regulatedAuthorization.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
activityDefinitionUrlsMatchRequestMethod	error	Bundle.entry:activityDefinition	When method is PUT or DELETE, both request.url and fullUrl must contain 'ActivityDefinition/<id>'. When method is POST, request.url must be 'ActivityDefinition' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('ActivityDefinition/') or (request.method = 'DELETE' and request.url.contains('ActivityDefinition/'))) and fullUrl.contains('ActivityDefinition/')) or (request.method = 'POST' and request.url = 'ActivityDefinition' and fullUrl.startsWith('urn:uuid:'))
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:medicinalProductDefinitionPut, Bundle.entry:packagedProductDefinitionPut, Bundle.entry:activityDefinition, Bundle.entry:regulatedAuthorization	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:medicinalProductDefinitionPut, Bundle.entry:packagedProductDefinitionPut, Bundle.entry:activityDefinition, Bundle.entry:regulatedAuthorization	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())
containsMedicinalProductDefinition	error	Bundle.entry:medicinalProductDefinitionPut.fullUrl, Bundle.entry:medicinalProductDefinitionPut.request.url	Checks if the string contains MedicinalProductDefinition/	contains('MedicinalProductDefinition/')
containsPackagedProductDefinition	error	Bundle.entry:packagedProductDefinitionPut.fullUrl, Bundle.entry:packagedProductDefinitionPut.request.url	Checks if the string contains PackagedProductDefinition/	contains('PackagedProductDefinition/')
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()
regulatedAuthorizationUrlsMatchRequestMethod	error	Bundle.entry:regulatedAuthorization	When method is PUT or DELETE, both request.url and fullUrl must contain 'RegulatedAuthorization/<id>'. When method is POST, request.url must be 'RegulatedAuthorization' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('RegulatedAuthorization/') or (request.method = 'DELETE' and request.url.contains('RegulatedAuthorization/'))) and fullUrl.contains('RegulatedAuthorization/')) or (request.method = 'POST' and request.url = 'RegulatedAuthorization' and fullUrl.startsWith('urn:uuid:'))

Differential View

This structure is derived from EmaWriteApiBundleRestrictions

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle		0..*	EmaWriteApiBundleRestrictions	Contains a collection of resources
type		1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Required Pattern: transaction
link		1..1	BackboneElement	Links related to this Bundle
Slices for entry		2..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by type:resource
entry:All Slices				Content/Rules for all slices
request		1..1	BackboneElement	Additional execution information (transaction/batch/history)
entry:medicinalProductDefinitionPut		1..1	BackboneElement	Entry in the bundle - will have a resource or information
fullUrl	C	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsMedicinalProductDefinition
resource		0..1	EmaWriteApiMedicinalProductDefinition	Detailed definition of a medicinal product
request
method		1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Required Pattern: PUT
url	C	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsMedicinalProductDefinition
entry:packagedProductDefinitionPut		1..*	BackboneElement	Entry in the bundle - will have a resource or information
fullUrl	C	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsPackagedProductDefinition
resource		0..1	EmaWriteApiPackagedProductDefinition	A medically related item or items, in a container or package
request
method		1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Required Pattern: PUT
url	C	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsPackagedProductDefinition
entry:activityDefinition	C	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: activityDefinitionUrlsMatchRequestMethod
resource		0..1	EmaWriteApiActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
entry:regulatedAuthorization	C	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: regulatedAuthorizationUrlsMatchRequestMethod
resource		0..1	EmaWriteApiRegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
activityDefinitionUrlsMatchRequestMethod	error	Bundle.entry:activityDefinition	When method is PUT or DELETE, both request.url and fullUrl must contain 'ActivityDefinition/<id>'. When method is POST, request.url must be 'ActivityDefinition' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('ActivityDefinition/') or (request.method = 'DELETE' and request.url.contains('ActivityDefinition/'))) and fullUrl.contains('ActivityDefinition/')) or (request.method = 'POST' and request.url = 'ActivityDefinition' and fullUrl.startsWith('urn:uuid:'))
containsMedicinalProductDefinition	error	Bundle.entry:medicinalProductDefinitionPut.fullUrl, Bundle.entry:medicinalProductDefinitionPut.request.url	Checks if the string contains MedicinalProductDefinition/	contains('MedicinalProductDefinition/')
containsPackagedProductDefinition	error	Bundle.entry:packagedProductDefinitionPut.fullUrl, Bundle.entry:packagedProductDefinitionPut.request.url	Checks if the string contains PackagedProductDefinition/	contains('PackagedProductDefinition/')
regulatedAuthorizationUrlsMatchRequestMethod	error	Bundle.entry:regulatedAuthorization	When method is PUT or DELETE, both request.url and fullUrl must contain 'RegulatedAuthorization/<id>'. When method is POST, request.url must be 'RegulatedAuthorization' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('RegulatedAuthorization/') or (request.method = 'DELETE' and request.url.contains('RegulatedAuthorization/'))) and fullUrl.contains('RegulatedAuthorization/')) or (request.method = 'POST' and request.url = 'RegulatedAuthorization' and fullUrl.startsWith('urn:uuid:'))

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	EmaWriteApiBundleRestrictions	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
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: transaction
link	ΣC	1..1	BackboneElement	Links related to this Bundle
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)
url	ΣC	1..1	uri	Reference details for the link
Slices for entry	ΣC	2..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by type: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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	0..1	Resource	A resource in the bundle
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
entry:medicinalProductDefinitionPut	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsMedicinalProductDefinition
resource		0..1	EmaWriteApiMedicinalProductDefinition	Detailed definition of a medicinal product
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. Required Pattern: PUT
url	ΣC	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsMedicinalProductDefinition
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
entry:packagedProductDefinitionPut	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) Constraints: containsPackagedProductDefinition
resource		0..1	EmaWriteApiPackagedProductDefinition	A medically related item or items, in a container or package
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. Required Pattern: PUT
url	ΣC	1..1	uri	URL for HTTP equivalent of this entry Constraints: containsPackagedProductDefinition
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
entry:activityDefinition	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: bdl-5, bdl-8, activityDefinitionUrlsMatchRequestMethod 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		0..1	EmaWriteApiActivityDefinition	The definition of a specific activity to be taken, independent of any particular patient or context
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
entry:regulatedAuthorization	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information Constraints: bdl-5, bdl-8, regulatedAuthorizationUrlsMatchRequestMethod 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	0..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		0..1	EmaWriteApiRegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
search	ΣC	0..1	BackboneElement	Search related information
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
mode	Σ	0..1	code	match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
score	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	1..1	BackboneElement	Additional execution information (transaction/batch/history)
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
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.
url	Σ	1..1	uri	URL for HTTP equivalent of this entry
ifNoneMatch	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
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
status	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a location)
etag	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
issues	ΣC	0..1	OperationOutcome(5.0.0)	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Bundle.type	Base	required	Bundle Type	📍5.0.0	FHIR Std.
Bundle.link.relation	Base	required	Link Relation Types	📍5.0.0	FHIR Std.
Bundle.entry.search.​mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry.request.​method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:medicinalProductDefinitionPut.​search.mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry:medicinalProductDefinitionPut.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:packagedProductDefinitionPut.​search.mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry:packagedProductDefinitionPut.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:activityDefinition.​search.mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry:activityDefinition.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.
Bundle.entry:regulatedAuthorization.​search.mode	Base	required	Search Entry Mode	📍5.0.0	FHIR Std.
Bundle.entry:regulatedAuthorization.​request.method	Base	required	H T T P Verb	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
activityDefinitionUrlsMatchRequestMethod	error	Bundle.entry:activityDefinition	When method is PUT or DELETE, both request.url and fullUrl must contain 'ActivityDefinition/<id>'. When method is POST, request.url must be 'ActivityDefinition' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('ActivityDefinition/') or (request.method = 'DELETE' and request.url.contains('ActivityDefinition/'))) and fullUrl.contains('ActivityDefinition/')) or (request.method = 'POST' and request.url = 'ActivityDefinition' and fullUrl.startsWith('urn:uuid:'))
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:medicinalProductDefinitionPut, Bundle.entry:packagedProductDefinitionPut, Bundle.entry:activityDefinition, Bundle.entry:regulatedAuthorization	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:medicinalProductDefinitionPut, Bundle.entry:packagedProductDefinitionPut, Bundle.entry:activityDefinition, Bundle.entry:regulatedAuthorization	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())
containsMedicinalProductDefinition	error	Bundle.entry:medicinalProductDefinitionPut.fullUrl, Bundle.entry:medicinalProductDefinitionPut.request.url	Checks if the string contains MedicinalProductDefinition/	contains('MedicinalProductDefinition/')
containsPackagedProductDefinition	error	Bundle.entry:packagedProductDefinitionPut.fullUrl, Bundle.entry:packagedProductDefinitionPut.request.url	Checks if the string contains PackagedProductDefinition/	contains('PackagedProductDefinition/')
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()
regulatedAuthorizationUrlsMatchRequestMethod	error	Bundle.entry:regulatedAuthorization	When method is PUT or DELETE, both request.url and fullUrl must contain 'RegulatedAuthorization/<id>'. When method is POST, request.url must be 'RegulatedAuthorization' and fullUrl must start with 'urn:uuid:'.	((request.method = 'PUT' and request.url.contains('RegulatedAuthorization/') or (request.method = 'DELETE' and request.url.contains('RegulatedAuthorization/'))) and fullUrl.contains('RegulatedAuthorization/')) or (request.method = 'POST' and request.url = 'RegulatedAuthorization' and fullUrl.startsWith('urn:uuid:'))

This structure is derived from EmaWriteApiBundleRestrictions

Summary

Mandatory: 3 elements(1 nested mandatory element)

Structures

This structure refers to these other structures:

• EMA Write API MedicinalProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition)
• EMA Write API PackagedProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition)
• EMA Write API ActivityDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition)
• EMA Write API Regulated Authorization (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Bundle.entry