SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: SubmittedManufacturedItem

Details around the actual item, i.e tablet, solution, etc. that is packaged as part of the medicinal product.

Usage:

• Use this Resource Profile: ProductSubmissionBundle
• Refer to this Resource Profile: SubmittedMedicinalPackaging and SubmittedMedicinalProductIngredient
• Examples for this Resource Profile: ManufacturedItemDefinition/AllopurinolTablet, ManufacturedItemDefinition/Enbrel25mgSolution, ManufacturedItemDefinition/Enbrel50mgSolution, ManufacturedItemDefinition/EnbrelKit... Show 3 more, ManufacturedItemDefinition/EnbrelPowder, ManufacturedItemDefinition/EnbrelSterileSolution and ManufacturedItemDefinition/LantusSolution

Formal Views of Profile Content

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

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

This structure is derived from ManufacturedItemDefinition

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition			ManufacturedItemDefinition
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
marketingStatusDates	S	0..1	Period	Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates
status		1..1	code	draft | active | retired | unknown Required Pattern: active
manufacturedDoseForm	S	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: SPL Dose Form (required)
Slices for property	S	0..*	BackboneElement	General characteristics of this item Slice: Unordered, Open by value:type
property:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required)
value[x]	S	1..1	CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)	A value for the characteristic
property:Color		0..*	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCOLOR
value[x]		0..1	CodeableConcept	A value for the characteristic Binding: SPL Color (required)
property:Imprint		0..1	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMPRINT
value[x]		0..1	CodeableConcept	Text is only allowed as the imprint is a string.
coding		0..0
text		1..1	string	Plain text representation of the concept
property:Score		0..1	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSCORE
value[x]		0..1	Quantity	A value for the characteristic
property:Shape		0..1	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSHAPE
value[x]		0..1	CodeableConcept	A value for the characteristic Binding: SPL Shape (required)
property:Size		0..1	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSIZE
value[x]		0..1	Quantity	A value for the characteristic
property:Flavor		0..*	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLFLAVOR
value[x]		0..1	CodeableConcept	A value for the characteristic Binding: SPL Flavor (required)
property:Image		0..*	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMAGE
value[x]		0..1	Attachment	A value for the characteristic
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.manufacturedDoseForm	required	SPLDoseForm http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm from this IG
ManufacturedItemDefinition.property.type	required	SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes from this IG
ManufacturedItemDefinition.property:Color.value[x]	required	SPLColor http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor from this IG
ManufacturedItemDefinition.property:Shape.value[x]	required	SPLShape http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape from this IG
ManufacturedItemDefinition.property:Flavor.value[x]	required	SPLFlavor http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor from this IG

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
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
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
marketingStatusDates	S	0..1	Period	Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored 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	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children Required Pattern: active
manufacturedDoseForm	SΣ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: SPL Dose Form (required) ele-1: All FHIR elements must have a @value or children
Slices for property	SΣ	0..*	BackboneElement	General characteristics of this item Slice: Unordered, Open by value:type ele-1: All FHIR elements must have a @value or children
property: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
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required) ele-1: All FHIR elements must have a @value or children
value[x]	SΣ	1..1		A value for the characteristic ele-1: All FHIR elements must have a @value or children
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:Color	Σ	0..*	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCOLOR
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Color (required) ele-1: All FHIR elements must have a @value or children
property:Imprint	Σ	0..1	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMPRINT
value[x]	Σ	0..1	CodeableConcept	Text is only allowed as the imprint is a string. ele-1: All FHIR elements must have a @value or children
text	Σ	1..1	string	Plain text representation of the concept ele-1: All FHIR elements must have a @value or children
property:Score	Σ	0..1	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSCORE
value[x]	Σ	0..1	Quantity	A value for the characteristic ele-1: All FHIR elements must have a @value or children
property:Shape	Σ	0..1	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSHAPE
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Shape (required) ele-1: All FHIR elements must have a @value or children
property:Size	Σ	0..1	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSIZE
value[x]	Σ	0..1	Quantity	A value for the characteristic ele-1: All FHIR elements must have a @value or children
property:Flavor	Σ	0..*	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLFLAVOR
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Flavor (required) ele-1: All FHIR elements must have a @value or children
property:Image	Σ	0..*	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMAGE
value[x]	Σ	0..1	Attachment	A value for the characteristic ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.status	required	Pattern: active http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	SPLDoseForm http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm from this IG
ManufacturedItemDefinition.property.type	required	SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes from this IG
ManufacturedItemDefinition.property:Color.type	example	Pattern: SPLCOLOR http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Color.value[x]	required	SPLColor http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor from this IG
ManufacturedItemDefinition.property:Imprint.type	example	Pattern: SPLIMPRINT http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Score.type	example	Pattern: SPLSCORE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Shape.type	example	Pattern: SPLSHAPE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Shape.value[x]	required	SPLShape http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape from this IG
ManufacturedItemDefinition.property:Size.type	example	Pattern: SPLSIZE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.type	example	Pattern: SPLFLAVOR http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.value[x]	required	SPLFlavor http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor from this IG
ManufacturedItemDefinition.property:Image.type	example	Pattern: SPLIMAGE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.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()

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
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
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
marketingStatusDates	S	0..1	Period	Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Unique identifier
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active
name	Σ	0..1	string	A descriptive name applied to this item
manufacturedDoseForm	SΣ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: SPL Dose Form (required)
unitOfPresentation	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property	SΣ	0..*	BackboneElement	General characteristics of this item Slice: Unordered, Open by value:type
property: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
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required)
value[x]	SΣ	1..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:Color	Σ	0..*	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCOLOR
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Color (required)
property:Imprint	Σ	0..1	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMPRINT
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	CodeableConcept	Text is only allowed as the imprint is a string.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
text	Σ	1..1	string	Plain text representation of the concept
property:Score	Σ	0..1	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSCORE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	A value for the characteristic
property:Shape	Σ	0..1	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSHAPE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Shape (required)
property:Size	Σ	0..1	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSIZE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	A value for the characteristic
property:Flavor	Σ	0..*	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLFLAVOR
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Flavor (required)
property:Image	Σ	0..*	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMAGE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Attachment	A value for the characteristic
component	Σ	0..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
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
type	Σ	1..1	CodeableConcept	Defining type of the component e.g. shell, layer, ink
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
amount	Σ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
constituent	Σ	0..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
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
amount	Σ	0..*	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
location	Σ	0..*	CodeableConcept	The physical location of the constituent/ingredient within the component
function	Σ	0..*	CodeableConcept	The function of this constituent within the component e.g. binder
hasIngredient	Σ	0..*	CodeableReference(Ingredient)	The ingredient that is the constituent of the given component
property	Σ	0..*	See property (ManufacturedItemDefinition)	General characteristics of this component
component	Σ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.status	required	Pattern: active http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	SPLDoseForm http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm from this IG
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation http://hl7.org/fhir/ValueSet/unit-of-presentation from the FHIR Standard
ManufacturedItemDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
ManufacturedItemDefinition.property.type	required	SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes from this IG
ManufacturedItemDefinition.property:Color.type	example	Pattern: SPLCOLOR http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Color.value[x]	required	SPLColor http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor from this IG
ManufacturedItemDefinition.property:Imprint.type	example	Pattern: SPLIMPRINT http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Score.type	example	Pattern: SPLSCORE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Shape.type	example	Pattern: SPLSHAPE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Shape.value[x]	required	SPLShape http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape from this IG
ManufacturedItemDefinition.property:Size.type	example	Pattern: SPLSIZE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.type	example	Pattern: SPLFLAVOR http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.value[x]	required	SPLFlavor http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor from this IG
ManufacturedItemDefinition.property:Image.type	example	Pattern: SPLIMAGE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.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 ManufacturedItemDefinition

Summary

Mandatory: 0 element(2 nested mandatory elements)
Must-Support: 5 elements
Prohibited: 1 element

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ManufacturedItemDefinition.property

Maturity: 1

Differential View

This structure is derived from ManufacturedItemDefinition

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition			ManufacturedItemDefinition
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
marketingStatusDates	S	0..1	Period	Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates
status		1..1	code	draft | active | retired | unknown Required Pattern: active
manufacturedDoseForm	S	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: SPL Dose Form (required)
Slices for property	S	0..*	BackboneElement	General characteristics of this item Slice: Unordered, Open by value:type
property:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required)
value[x]	S	1..1	CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)	A value for the characteristic
property:Color		0..*	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCOLOR
value[x]		0..1	CodeableConcept	A value for the characteristic Binding: SPL Color (required)
property:Imprint		0..1	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMPRINT
value[x]		0..1	CodeableConcept	Text is only allowed as the imprint is a string.
coding		0..0
text		1..1	string	Plain text representation of the concept
property:Score		0..1	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSCORE
value[x]		0..1	Quantity	A value for the characteristic
property:Shape		0..1	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSHAPE
value[x]		0..1	CodeableConcept	A value for the characteristic Binding: SPL Shape (required)
property:Size		0..1	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSIZE
value[x]		0..1	Quantity	A value for the characteristic
property:Flavor		0..*	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLFLAVOR
value[x]		0..1	CodeableConcept	A value for the characteristic Binding: SPL Flavor (required)
property:Image		0..*	BackboneElement	General characteristics of this item
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMAGE
value[x]		0..1	Attachment	A value for the characteristic
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.manufacturedDoseForm	required	SPLDoseForm http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm from this IG
ManufacturedItemDefinition.property.type	required	SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes from this IG
ManufacturedItemDefinition.property:Color.value[x]	required	SPLColor http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor from this IG
ManufacturedItemDefinition.property:Shape.value[x]	required	SPLShape http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape from this IG
ManufacturedItemDefinition.property:Flavor.value[x]	required	SPLFlavor http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
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
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
marketingStatusDates	S	0..1	Period	Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored 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	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children Required Pattern: active
manufacturedDoseForm	SΣ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: SPL Dose Form (required) ele-1: All FHIR elements must have a @value or children
Slices for property	SΣ	0..*	BackboneElement	General characteristics of this item Slice: Unordered, Open by value:type ele-1: All FHIR elements must have a @value or children
property: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
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required) ele-1: All FHIR elements must have a @value or children
value[x]	SΣ	1..1		A value for the characteristic ele-1: All FHIR elements must have a @value or children
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:Color	Σ	0..*	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCOLOR
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Color (required) ele-1: All FHIR elements must have a @value or children
property:Imprint	Σ	0..1	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMPRINT
value[x]	Σ	0..1	CodeableConcept	Text is only allowed as the imprint is a string. ele-1: All FHIR elements must have a @value or children
text	Σ	1..1	string	Plain text representation of the concept ele-1: All FHIR elements must have a @value or children
property:Score	Σ	0..1	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSCORE
value[x]	Σ	0..1	Quantity	A value for the characteristic ele-1: All FHIR elements must have a @value or children
property:Shape	Σ	0..1	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSHAPE
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Shape (required) ele-1: All FHIR elements must have a @value or children
property:Size	Σ	0..1	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSIZE
value[x]	Σ	0..1	Quantity	A value for the characteristic ele-1: All FHIR elements must have a @value or children
property:Flavor	Σ	0..*	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLFLAVOR
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Flavor (required) ele-1: All FHIR elements must have a @value or children
property:Image	Σ	0..*	BackboneElement	General characteristics of this item 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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMAGE
value[x]	Σ	0..1	Attachment	A value for the characteristic ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.status	required	Pattern: active http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	SPLDoseForm http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm from this IG
ManufacturedItemDefinition.property.type	required	SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes from this IG
ManufacturedItemDefinition.property:Color.type	example	Pattern: SPLCOLOR http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Color.value[x]	required	SPLColor http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor from this IG
ManufacturedItemDefinition.property:Imprint.type	example	Pattern: SPLIMPRINT http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Score.type	example	Pattern: SPLSCORE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Shape.type	example	Pattern: SPLSHAPE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Shape.value[x]	required	SPLShape http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape from this IG
ManufacturedItemDefinition.property:Size.type	example	Pattern: SPLSIZE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.type	example	Pattern: SPLFLAVOR http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.value[x]	required	SPLFlavor http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor from this IG
ManufacturedItemDefinition.property:Image.type	example	Pattern: SPLIMAGE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
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
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
marketingStatusDates	S	0..1	Period	Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Unique identifier
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active
name	Σ	0..1	string	A descriptive name applied to this item
manufacturedDoseForm	SΣ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: SPL Dose Form (required)
unitOfPresentation	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property	SΣ	0..*	BackboneElement	General characteristics of this item Slice: Unordered, Open by value:type
property: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
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required)
value[x]	SΣ	1..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:Color	Σ	0..*	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCOLOR
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Color (required)
property:Imprint	Σ	0..1	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMPRINT
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	CodeableConcept	Text is only allowed as the imprint is a string.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
text	Σ	1..1	string	Plain text representation of the concept
property:Score	Σ	0..1	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSCORE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	A value for the characteristic
property:Shape	Σ	0..1	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSHAPE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Shape (required)
property:Size	Σ	0..1	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLSIZE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	A value for the characteristic
property:Flavor	Σ	0..*	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLFLAVOR
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	CodeableConcept	A value for the characteristic Binding: SPL Flavor (required)
property:Image	Σ	0..*	BackboneElement	General characteristics of this item
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
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLIMAGE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Attachment	A value for the characteristic
component	Σ	0..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
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
type	Σ	1..1	CodeableConcept	Defining type of the component e.g. shell, layer, ink
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
amount	Σ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
constituent	Σ	0..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
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
amount	Σ	0..*	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
location	Σ	0..*	CodeableConcept	The physical location of the constituent/ingredient within the component
function	Σ	0..*	CodeableConcept	The function of this constituent within the component e.g. binder
hasIngredient	Σ	0..*	CodeableReference(Ingredient)	The ingredient that is the constituent of the given component
property	Σ	0..*	See property (ManufacturedItemDefinition)	General characteristics of this component
component	Σ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.status	required	Pattern: active http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	SPLDoseForm http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm from this IG
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation http://hl7.org/fhir/ValueSet/unit-of-presentation from the FHIR Standard
ManufacturedItemDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
ManufacturedItemDefinition.property.type	required	SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes from this IG
ManufacturedItemDefinition.property:Color.type	example	Pattern: SPLCOLOR http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Color.value[x]	required	SPLColor http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor from this IG
ManufacturedItemDefinition.property:Imprint.type	example	Pattern: SPLIMPRINT http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Score.type	example	Pattern: SPLSCORE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Shape.type	example	Pattern: SPLSHAPE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Shape.value[x]	required	SPLShape http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape from this IG
ManufacturedItemDefinition.property:Size.type	example	Pattern: SPLSIZE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.type	example	Pattern: SPLFLAVOR http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.value[x]	required	SPLFlavor http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor from this IG
ManufacturedItemDefinition.property:Image.type	example	Pattern: SPLIMAGE http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.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 ManufacturedItemDefinition

Summary

Mandatory: 0 element(2 nested mandatory elements)
Must-Support: 5 elements
Prohibited: 1 element

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ManufacturedItemDefinition.property

Maturity: 1