Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Examples
• XML
• JSON

Resource Profile: CMC eCTD 32P32 Document

Definition for a document bundle with the CMC eCTD 32P32 profiles (Product Batch Formula).

Usage:

• Examples for this Resource Profile: Bundle/BatchFormulaBundle and Bundle/BatchFormulaBundle2Layer

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
Bundle	C	0..*	Bundle	CMC eCTD 32P32 Bundle bdl-1: total only when a search or history bdl-2: entry.search only when a search bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) bdl-9: A document must have an identifier with a system and a value bdl-10: A document must have a date bdl-11: A document must have a Composition as the first resource bdl-12: A message must have a MessageHeader as the first resource bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource bdl-14: entry.request.method PATCH not allowed for history bdl-15: 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 bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. bdl-18: Self link is required for searchsets. bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
identifier	SΣC	0..1	Identifier	Persistent identifier for the bundle ele-1: All FHIR elements must have a @value or children
type	SΣC	1..1	code	document Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. ele-1: All FHIR elements must have a @value or children Required Pattern: document
timestamp	SΣC	1..1	instant	When the bundle was assembled ele-1: All FHIR elements must have a @value or children
Slices for entry	SΣC	4..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by profile:resource bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	SΣC	1..1	Resource	A resource in the bundle
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:Composition	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	EctdComposition32P32	A set of resources composed into a single coherent clinical statement with clinical attestation
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:Organization	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	CodedOrganization	A grouping of people or organizations with a common purpose
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:BatchFormulaMedicinalProduct	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	BatchFormulaMedicinalProduct	Detailed definition of a medicinal product
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:BatchFormula	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	BatchFormula	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:Ingredient	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	DrugProductIngredient	An ingredient of a manufactured item or pharmaceutical product
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:RoutineSubstance	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	SubstanceDefinitionHandle	The detailed description of a substance, typically at a level beyond what is used for prescribing
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:ExcipientRaw	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	ExcipientRaw	The detailed description of a substance, typically at a level beyond what is used for prescribing
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.type	required	Pattern: 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:BatchFormulaMedicinalProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:BatchFormula.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:Ingredient.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:RoutineSubstance.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:ExcipientRaw.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:BatchFormulaMedicinalProduct, Bundle.entry:BatchFormula, Bundle.entry:Ingredient, Bundle.entry:RoutineSubstance, Bundle.entry:ExcipientRaw	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:BatchFormulaMedicinalProduct, Bundle.entry:BatchFormula, Bundle.entry:Ingredient, Bundle.entry:RoutineSubstance, Bundle.entry:ExcipientRaw	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 Bundle

Name	Flags	Card.	Type	Description & Constraints
Bundle		0..*	Bundle	CMC eCTD 32P32 Bundle
identifier	S	0..1	Identifier	Persistent identifier for the bundle
type	S	1..1	code	document Required Pattern: document
timestamp	S	1..1	instant	When the bundle was assembled
Slices for entry	S	4..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by profile:resource
entry:All Slices				Content/Rules for all slices
fullUrl	S	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	Resource	A resource in the bundle
entry:Composition		1..1	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	EctdComposition32P32	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:Organization		1..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	CodedOrganization	A grouping of people or organizations with a common purpose
entry:BatchFormulaMedicinalProduct		1..1	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	BatchFormulaMedicinalProduct	Detailed definition of a medicinal product
entry:BatchFormula		1..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	BatchFormula	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
entry:Ingredient		0..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	DrugProductIngredient	An ingredient of a manufactured item or pharmaceutical product
entry:RoutineSubstance		0..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	SubstanceDefinitionHandle	The detailed description of a substance, typically at a level beyond what is used for prescribing
entry:ExcipientRaw		0..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	ExcipientRaw	The detailed description of a substance, typically at a level beyond what is used for prescribing
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Bundle	C	0..*	Bundle	CMC eCTD 32P32 Bundle bdl-1: total only when a search or history bdl-2: entry.search only when a search bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) bdl-9: A document must have an identifier with a system and a value bdl-10: A document must have a date bdl-11: A document must have a Composition as the first resource bdl-12: A message must have a MessageHeader as the first resource bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource bdl-14: entry.request.method PATCH not allowed for history bdl-15: 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 bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. bdl-18: Self link is required for searchsets. bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements
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 Set
identifier	SΣC	0..1	Identifier	Persistent identifier for the bundle
type	SΣC	1..1	code	document Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document
timestamp	SΣC	1..1	instant	When the bundle was assembled
total	ΣC	0..1	unsignedInt	If search, the total number of matches
link	ΣC	0..*	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	SΣC	4..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by profile:resource bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	SΣC	1..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	0..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:Composition	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	EctdComposition32P32	A set of resources composed into a single coherent clinical statement with clinical attestation
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	0..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:Organization	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	CodedOrganization	A grouping of people or organizations with a common purpose
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	0..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:BatchFormulaMedicinalProduct	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	BatchFormulaMedicinalProduct	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	0..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:BatchFormula	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	BatchFormula	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged 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	0..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:Ingredient	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	DrugProductIngredient	An ingredient of a manufactured item or pharmaceutical 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	0..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:RoutineSubstance	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	SubstanceDefinitionHandle	The detailed description of a substance, typically at a level beyond what is used for prescribing
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	0..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:ExcipientRaw	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	ExcipientRaw	The detailed description of a substance, typically at a level beyond what is used for prescribing
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	0..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)
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: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 from the FHIR Standard
Bundle.link.relation	required	LinkRelationTypes 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:BatchFormulaMedicinalProduct.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:BatchFormulaMedicinalProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:BatchFormula.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:BatchFormula.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:Ingredient.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:Ingredient.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:RoutineSubstance.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:RoutineSubstance.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:ExcipientRaw.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:ExcipientRaw.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:BatchFormulaMedicinalProduct, Bundle.entry:BatchFormula, Bundle.entry:Ingredient, Bundle.entry:RoutineSubstance, Bundle.entry:ExcipientRaw	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:BatchFormulaMedicinalProduct, Bundle.entry:BatchFormula, Bundle.entry:Ingredient, Bundle.entry:RoutineSubstance, Bundle.entry:ExcipientRaw	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 Bundle

Summary

Mandatory: 7 elements
Must-Support: 6 elements

Structures

This structure refers to these other structures:

• eCTD Batch Formula (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32)
• Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
• Batch Formula Drug Product Identification (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product)
• Drug Product Batch Formula (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula)
• Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)
• Drug Substance Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance)
• Excipient Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient)

Slices

This structure defines the following Slices:

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

Maturity: 2

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Bundle	C	0..*	Bundle	CMC eCTD 32P32 Bundle bdl-1: total only when a search or history bdl-2: entry.search only when a search bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) bdl-9: A document must have an identifier with a system and a value bdl-10: A document must have a date bdl-11: A document must have a Composition as the first resource bdl-12: A message must have a MessageHeader as the first resource bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource bdl-14: entry.request.method PATCH not allowed for history bdl-15: 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 bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. bdl-18: Self link is required for searchsets. bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
identifier	SΣC	0..1	Identifier	Persistent identifier for the bundle ele-1: All FHIR elements must have a @value or children
type	SΣC	1..1	code	document Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. ele-1: All FHIR elements must have a @value or children Required Pattern: document
timestamp	SΣC	1..1	instant	When the bundle was assembled ele-1: All FHIR elements must have a @value or children
Slices for entry	SΣC	4..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by profile:resource bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	SΣC	1..1	Resource	A resource in the bundle
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:Composition	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	EctdComposition32P32	A set of resources composed into a single coherent clinical statement with clinical attestation
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:Organization	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	CodedOrganization	A grouping of people or organizations with a common purpose
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:BatchFormulaMedicinalProduct	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	BatchFormulaMedicinalProduct	Detailed definition of a medicinal product
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:BatchFormula	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	BatchFormula	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:Ingredient	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	DrugProductIngredient	An ingredient of a manufactured item or pharmaceutical product
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:RoutineSubstance	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	SubstanceDefinitionHandle	The detailed description of a substance, typically at a level beyond what is used for prescribing
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
entry:ExcipientRaw	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
fullUrl	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) ele-1: All FHIR elements must have a @value or children
resource	S	1..1	ExcipientRaw	The detailed description of a substance, typically at a level beyond what is used for prescribing
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
url	Σ	1..1	uri	URL for HTTP equivalent of this entry ele-1: All FHIR elements must have a @value or children
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history) ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	Σ	1..1	string	Status response code (text optional) ele-1: All FHIR elements must have a @value or children
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.type	required	Pattern: 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:BatchFormulaMedicinalProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:BatchFormula.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:Ingredient.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:RoutineSubstance.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:ExcipientRaw.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:BatchFormulaMedicinalProduct, Bundle.entry:BatchFormula, Bundle.entry:Ingredient, Bundle.entry:RoutineSubstance, Bundle.entry:ExcipientRaw	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:BatchFormulaMedicinalProduct, Bundle.entry:BatchFormula, Bundle.entry:Ingredient, Bundle.entry:RoutineSubstance, Bundle.entry:ExcipientRaw	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 Bundle

Name	Flags	Card.	Type	Description & Constraints
Bundle		0..*	Bundle	CMC eCTD 32P32 Bundle
identifier	S	0..1	Identifier	Persistent identifier for the bundle
type	S	1..1	code	document Required Pattern: document
timestamp	S	1..1	instant	When the bundle was assembled
Slices for entry	S	4..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by profile:resource
entry:All Slices				Content/Rules for all slices
fullUrl	S	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	Resource	A resource in the bundle
entry:Composition		1..1	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	EctdComposition32P32	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:Organization		1..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	CodedOrganization	A grouping of people or organizations with a common purpose
entry:BatchFormulaMedicinalProduct		1..1	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	BatchFormulaMedicinalProduct	Detailed definition of a medicinal product
entry:BatchFormula		1..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	BatchFormula	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
entry:Ingredient		0..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	DrugProductIngredient	An ingredient of a manufactured item or pharmaceutical product
entry:RoutineSubstance		0..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	SubstanceDefinitionHandle	The detailed description of a substance, typically at a level beyond what is used for prescribing
entry:ExcipientRaw		0..*	BackboneElement	Entry in the bundle - will have a resource or information
resource		1..1	ExcipientRaw	The detailed description of a substance, typically at a level beyond what is used for prescribing
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Bundle	C	0..*	Bundle	CMC eCTD 32P32 Bundle bdl-1: total only when a search or history bdl-2: entry.search only when a search bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) bdl-9: A document must have an identifier with a system and a value bdl-10: A document must have a date bdl-11: A document must have a Composition as the first resource bdl-12: A message must have a MessageHeader as the first resource bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource bdl-14: entry.request.method PATCH not allowed for history bdl-15: 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 bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. bdl-18: Self link is required for searchsets. bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements
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 Set
identifier	SΣC	0..1	Identifier	Persistent identifier for the bundle
type	SΣC	1..1	code	document Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document
timestamp	SΣC	1..1	instant	When the bundle was assembled
total	ΣC	0..1	unsignedInt	If search, the total number of matches
link	ΣC	0..*	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	SΣC	4..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open by profile:resource bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	SΣC	1..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	0..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:Composition	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	EctdComposition32P32	A set of resources composed into a single coherent clinical statement with clinical attestation
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	0..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:Organization	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	CodedOrganization	A grouping of people or organizations with a common purpose
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	0..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:BatchFormulaMedicinalProduct	ΣC	1..1	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	BatchFormulaMedicinalProduct	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	0..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:BatchFormula	ΣC	1..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	BatchFormula	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged 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	0..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:Ingredient	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	DrugProductIngredient	An ingredient of a manufactured item or pharmaceutical 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	0..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:RoutineSubstance	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	SubstanceDefinitionHandle	The detailed description of a substance, typically at a level beyond what is used for prescribing
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	0..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:ExcipientRaw	ΣC	0..*	BackboneElement	Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference 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	SΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	S	1..1	ExcipientRaw	The detailed description of a substance, typically at a level beyond what is used for prescribing
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	0..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)
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: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 from the FHIR Standard
Bundle.link.relation	required	LinkRelationTypes 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:BatchFormulaMedicinalProduct.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:BatchFormulaMedicinalProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:BatchFormula.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:BatchFormula.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:Ingredient.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:Ingredient.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:RoutineSubstance.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:RoutineSubstance.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard
Bundle.entry:ExcipientRaw.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard
Bundle.entry:ExcipientRaw.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:BatchFormulaMedicinalProduct, Bundle.entry:BatchFormula, Bundle.entry:Ingredient, Bundle.entry:RoutineSubstance, Bundle.entry:ExcipientRaw	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:BatchFormulaMedicinalProduct, Bundle.entry:BatchFormula, Bundle.entry:Ingredient, Bundle.entry:RoutineSubstance, Bundle.entry:ExcipientRaw	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 Bundle

Summary

Mandatory: 7 elements
Must-Support: 6 elements

Structures

This structure refers to these other structures:

• eCTD Batch Formula (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32)
• Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
• Batch Formula Drug Product Identification (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product)
• Drug Product Batch Formula (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula)
• Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)
• Drug Substance Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance)
• Excipient Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient)

Slices

This structure defines the following Slices:

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

Maturity: 2