SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI United States of America flag

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

Resource Profile: SubmittedManufacturedItem

Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem Version: 0.2.1
Standards status: Trial-use Maturity Level: 1 Computable Name: SubmittedManufacturedItem

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

Usage:

Formal Views of Profile Content

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

This structure is derived from ManufacturedItemDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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)
.... 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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
ManufacturedItemDefinition.manufacturedDoseFormrequiredSPLDoseForm
http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm
from this IG
ManufacturedItemDefinition.property.typerequiredSubmittedMedicinalProductCharacteristicTypes (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]requiredSPLColor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor
from this IG
ManufacturedItemDefinition.property:Shape.value[x]requiredSPLShape
http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape
from this IG
ManufacturedItemDefinition.property:Flavor.value[x]requiredSPLFlavor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.


Required Pattern: active
... manufacturedDoseForm SΣ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: SPL Dose Form (required)
... 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
..... 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
..... 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
...... 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)
.... property:Imprint Σ 0..1 BackboneElement General characteristics of this item
..... 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
...... 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.
...... text Σ 1..1 string Plain text representation of the concept
.... property:Score Σ 0..1 BackboneElement General characteristics of this item
..... 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
...... 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
.... property:Shape Σ 0..1 BackboneElement General characteristics of this item
..... 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
...... 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)
.... property:Size Σ 0..1 BackboneElement General characteristics of this item
..... 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
...... 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
.... property:Flavor Σ 0..* BackboneElement General characteristics of this item
..... 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
...... 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)
.... property:Image Σ 0..* BackboneElement General characteristics of this item
..... 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
...... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ManufacturedItemDefinition.statusrequiredPattern: active
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseFormrequiredSPLDoseForm
http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm
from this IG
ManufacturedItemDefinition.property.typerequiredSubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)
http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes
from this IG
ManufacturedItemDefinition.property:Color.typeexamplePattern: SPLCOLOR
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Color.value[x]requiredSPLColor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor
from this IG
ManufacturedItemDefinition.property:Imprint.typeexamplePattern: SPLIMPRINT
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Score.typeexamplePattern: SPLSCORE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Shape.typeexamplePattern: SPLSHAPE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Shape.value[x]requiredSPLShape
http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape
from this IG
ManufacturedItemDefinition.property:Size.typeexamplePattern: SPLSIZE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.typeexamplePattern: SPLFLAVOR
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.value[x]requiredSPLFlavor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor
from this IG
ManufacturedItemDefinition.property:Image.typeexamplePattern: SPLIMAGE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorManufacturedItemDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorManufacturedItemDefinitionIf 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-4errorManufacturedItemDefinitionIf 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-5errorManufacturedItemDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceManufacturedItemDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ManufacturedItemDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.statusrequiredPattern: active
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseFormrequiredSPLDoseForm
http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm
from this IG
ManufacturedItemDefinition.unitOfPresentationexampleUnitOfPresentation
http://hl7.org/fhir/ValueSet/unit-of-presentation
from the FHIR Standard
ManufacturedItemDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
ManufacturedItemDefinition.property.typerequiredSubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)
http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes
from this IG
ManufacturedItemDefinition.property:Color.typeexamplePattern: SPLCOLOR
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Color.value[x]requiredSPLColor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor
from this IG
ManufacturedItemDefinition.property:Imprint.typeexamplePattern: SPLIMPRINT
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Score.typeexamplePattern: SPLSCORE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Shape.typeexamplePattern: SPLSHAPE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Shape.value[x]requiredSPLShape
http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape
from this IG
ManufacturedItemDefinition.property:Size.typeexamplePattern: SPLSIZE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.typeexamplePattern: SPLFLAVOR
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.value[x]requiredSPLFlavor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor
from this IG
ManufacturedItemDefinition.property:Image.typeexamplePattern: SPLIMAGE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorManufacturedItemDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorManufacturedItemDefinitionIf 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-4errorManufacturedItemDefinitionIf 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-5errorManufacturedItemDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceManufacturedItemDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust 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:

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

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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)
.... 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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
ManufacturedItemDefinition.manufacturedDoseFormrequiredSPLDoseForm
http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm
from this IG
ManufacturedItemDefinition.property.typerequiredSubmittedMedicinalProductCharacteristicTypes (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]requiredSPLColor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor
from this IG
ManufacturedItemDefinition.property:Shape.value[x]requiredSPLShape
http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape
from this IG
ManufacturedItemDefinition.property:Flavor.value[x]requiredSPLFlavor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.


Required Pattern: active
... manufacturedDoseForm SΣ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: SPL Dose Form (required)
... 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
..... 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
..... 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
...... 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)
.... property:Imprint Σ 0..1 BackboneElement General characteristics of this item
..... 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
...... 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.
...... text Σ 1..1 string Plain text representation of the concept
.... property:Score Σ 0..1 BackboneElement General characteristics of this item
..... 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
...... 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
.... property:Shape Σ 0..1 BackboneElement General characteristics of this item
..... 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
...... 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)
.... property:Size Σ 0..1 BackboneElement General characteristics of this item
..... 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
...... 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
.... property:Flavor Σ 0..* BackboneElement General characteristics of this item
..... 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
...... 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)
.... property:Image Σ 0..* BackboneElement General characteristics of this item
..... 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
...... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ManufacturedItemDefinition.statusrequiredPattern: active
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseFormrequiredSPLDoseForm
http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm
from this IG
ManufacturedItemDefinition.property.typerequiredSubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)
http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes
from this IG
ManufacturedItemDefinition.property:Color.typeexamplePattern: SPLCOLOR
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Color.value[x]requiredSPLColor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor
from this IG
ManufacturedItemDefinition.property:Imprint.typeexamplePattern: SPLIMPRINT
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Score.typeexamplePattern: SPLSCORE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Shape.typeexamplePattern: SPLSHAPE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Shape.value[x]requiredSPLShape
http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape
from this IG
ManufacturedItemDefinition.property:Size.typeexamplePattern: SPLSIZE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.typeexamplePattern: SPLFLAVOR
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
ManufacturedItemDefinition.property:Flavor.value[x]requiredSPLFlavor
http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor
from this IG
ManufacturedItemDefinition.property:Image.typeexamplePattern: SPLIMAGE
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorManufacturedItemDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorManufacturedItemDefinitionIf 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-4errorManufacturedItemDefinitionIf 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-5errorManufacturedItemDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceManufacturedItemDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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