ManufacturedItemDefinition

Release 5

This page is part of the FHIR Specification (v5.0.0: R5 - STU). This is the current published version in it's permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

15.4.6 Resource ManufacturedItemDefinition - Detailed Descriptions

Biomedical Research and Regulation icon

Work Group

Maturity Level: 2

Trial Use

Security Category: Anonymous

Compartments: No defined compartments

Detailed Descriptions for the elements in the ManufacturedItemDefinition resource.

ManufacturedItemDefinition
Element Id	ManufacturedItemDefinition
Definition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.
Short Display	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
Cardinality	0..*
Type	DomainResource
Summary	false
ManufacturedItemDefinition.identifier
Element Id	ManufacturedItemDefinition.identifier
Definition	Unique identifier.
Short Display	Unique identifier
Note	This is a business identifier, not a resource identifier (see discussion)
Cardinality	0..*
Type	Identifier
Summary	true
ManufacturedItemDefinition.status
Element Id	ManufacturedItemDefinition.status
Definition	The status of this item. Enables tracking the life-cycle of the content.
Short Display	draft \| active \| retired \| unknown
Cardinality	1..1
Terminology Binding	PublicationStatus (Required)
Type	code
Is Modifier	true (Reason: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration)
Summary	true
Comments	Allows filtering of manufactured items that are appropriate for use versus not.
ManufacturedItemDefinition.name
Element Id	ManufacturedItemDefinition.name
Definition	A descriptive name applied to this item.
Short Display	A descriptive name applied to this item
Cardinality	0..1
Type	string
Summary	true
ManufacturedItemDefinition.manufacturedDoseForm
Element Id	ManufacturedItemDefinition.manufacturedDoseForm
Definition	Dose form as manufactured and before any transformation into the pharmaceutical product.
Short Display	Dose form as manufactured (before any necessary transformation)
Cardinality	1..1
Terminology Binding	Manufactured Dose Form (Example)
Type	CodeableConcept
Summary	true
ManufacturedItemDefinition.unitOfPresentation
Element Id	ManufacturedItemDefinition.unitOfPresentation
Definition	The “real-world” units in which the quantity of the manufactured item is described.
Short Display	The “real-world” units in which the quantity of the item is described
Cardinality	0..1
Terminology Binding	Unit Of Presentation (Example)
Type	CodeableConcept
Summary	true
ManufacturedItemDefinition.manufacturer
Element Id	ManufacturedItemDefinition.manufacturer
Definition	Manufacturer of the item, one of several possible.
Short Display	Manufacturer of the item, one of several possible
Cardinality	0..*
Type	Reference(Organization)
Summary	true
ManufacturedItemDefinition.marketingStatus
Element Id	ManufacturedItemDefinition.marketingStatus
Definition	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.
Short Display	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Cardinality	0..*
Type	MarketingStatus
Summary	true
ManufacturedItemDefinition.ingredient
Element Id	ManufacturedItemDefinition.ingredient
Definition	The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource.
Short Display	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
Cardinality	0..*
Terminology Binding	SNOMED CT Substance Codes (Example)
Type	CodeableConcept
Summary	true
ManufacturedItemDefinition.property
Element Id	ManufacturedItemDefinition.property
Definition	General characteristics of this item.
Short Display	General characteristics of this item
Cardinality	0..*
Summary	true
ManufacturedItemDefinition.property.type
Element Id	ManufacturedItemDefinition.property.type
Definition	A code expressing the type of characteristic.
Short Display	A code expressing the type of characteristic
Cardinality	1..1
Terminology Binding	Product Characteristic (Example)
Type	CodeableConcept
Summary	true
ManufacturedItemDefinition.property.value[x]
Element Id	ManufacturedItemDefinition.property.value[x]
Definition	A value for the characteristic.
Short Display	A value for the characteristic
Cardinality	0..1
Type	CodeableConcept\|Quantity\|date\|boolean\|markdown\|Attachment\|Reference(Binary)
[x] Note	See Choice of Datatypes for further information about how to use [x]
Summary	true
ManufacturedItemDefinition.component
Element Id	ManufacturedItemDefinition.component
Definition	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.
Short Display	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
Cardinality	0..*
Summary	true
ManufacturedItemDefinition.component.type
Element Id	ManufacturedItemDefinition.component.type
Definition	Defining type of the component e.g. shell, layer, ink.
Short Display	Defining type of the component e.g. shell, layer, ink
Cardinality	1..1
Type	CodeableConcept
Summary	true
ManufacturedItemDefinition.component.function
Element Id	ManufacturedItemDefinition.component.function
Definition	The function of this component within the item e.g. delivers active ingredient, masks taste.
Short Display	The function of this component within the item e.g. delivers active ingredient, masks taste
Cardinality	0..*
Type	CodeableConcept
Summary	true
ManufacturedItemDefinition.component.amount
Element Id	ManufacturedItemDefinition.component.amount
Definition	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
Short Display	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Cardinality	0..*
Type	Quantity
Summary	true
ManufacturedItemDefinition.component.constituent
Element Id	ManufacturedItemDefinition.component.constituent
Definition	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).
Short Display	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)
Cardinality	0..*
Summary	true
ManufacturedItemDefinition.component.constituent.amount
Element Id	ManufacturedItemDefinition.component.constituent.amount
Definition	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).
Short Display	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Cardinality	0..*
Type	Quantity
Summary	true
ManufacturedItemDefinition.component.constituent.location
Element Id	ManufacturedItemDefinition.component.constituent.location
Definition	The physical location of the constituent/ingredient within the component. Example – if the component is the bead in the capsule, then the location would be where the ingredient resides within the product part – intragranular, extra-granular, etc.
Short Display	The physical location of the constituent/ingredient within the component
Cardinality	0..*
Type	CodeableConcept
Summary	true
ManufacturedItemDefinition.component.constituent.function
Element Id	ManufacturedItemDefinition.component.constituent.function
Definition	The function of this constituent within the component e.g. binder.
Short Display	The function of this constituent within the component e.g. binder
Cardinality	0..*
Type	CodeableConcept
Summary	true
ManufacturedItemDefinition.component.constituent.hasIngredient
Element Id	ManufacturedItemDefinition.component.constituent.hasIngredient
Definition	The ingredient that is the constituent of the given component.
Short Display	The ingredient that is the constituent of the given component
Cardinality	0..*
Type	CodeableReference(Ingredient)
Summary	true
ManufacturedItemDefinition.component.property
Element Id	ManufacturedItemDefinition.component.property
Definition	General characteristics of this component.
Short Display	General characteristics of this component
Cardinality	0..*
Type	See ManufacturedItemDefinition.property
Summary	true
ManufacturedItemDefinition.component.component
Element Id	ManufacturedItemDefinition.component.component
Definition	A component that this component contains or is made from.
Short Display	A component that this component contains or is made from
Cardinality	0..*
Type	See ManufacturedItemDefinition.component
Summary	true