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Biomedical Research and Regulation icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the ManufacturedItemDefinition resource.

ManufacturedItemDefinition
Element IdManufacturedItemDefinition
Definition

The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.

Short DisplayThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
Cardinality0..*
TypeDomainResource
Summaryfalse
ManufacturedItemDefinition.identifier
Element IdManufacturedItemDefinition.identifier
Definition

Unique identifier.

Short DisplayUnique identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
ManufacturedItemDefinition.status
Element IdManufacturedItemDefinition.status
Definition

The status of this item. Enables tracking the life-cycle of the content.

Short Displaydraft | active | retired | unknown
Cardinality1..1
Terminology BindingPublicationStatus (Required)
Typecode
Is Modifiertrue (Reason: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration)
Summarytrue
Comments

Allows filtering of manufactured items that are appropriate for use versus not.

ManufacturedItemDefinition.name
Element IdManufacturedItemDefinition.name
Definition

A descriptive name applied to this item.

Short DisplayA descriptive name applied to this item
Cardinality0..1
Typestring
Summarytrue
ManufacturedItemDefinition.manufacturedDoseForm
Element IdManufacturedItemDefinition.manufacturedDoseForm
Definition

Dose form as manufactured and before any transformation into the pharmaceutical product.

Short DisplayDose form as manufactured (before any necessary transformation)
Cardinality1..1
Terminology BindingManufacturedDoseForm (Example)
TypeCodeableConcept
Summarytrue
ManufacturedItemDefinition.unitOfPresentation
Element IdManufacturedItemDefinition.unitOfPresentation
Definition

The “real world” units in which the quantity of the manufactured item is described.

Short DisplayThe “real world” units in which the quantity of the item is described
Cardinality0..1
Terminology BindingUnitOfPresentation (Example)
TypeCodeableConcept
Summarytrue
ManufacturedItemDefinition.manufacturer
Element IdManufacturedItemDefinition.manufacturer
Definition

Manufacturer of the item, one of several possible.

Short DisplayManufacturer of the item, one of several possible
Cardinality0..*
TypeReference(Organization)
Summarytrue
ManufacturedItemDefinition.marketingStatus
Element IdManufacturedItemDefinition.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 DisplayAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Cardinality0..*
TypeMarketingStatus
Summarytrue
ManufacturedItemDefinition.ingredient
Element IdManufacturedItemDefinition.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 DisplayThe ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
Cardinality0..*
Terminology BindingSNOMED CT Substance Codes (Example)
TypeCodeableConcept
Summarytrue
ManufacturedItemDefinition.property
Element IdManufacturedItemDefinition.property
Definition

General characteristics of this item.

Short DisplayGeneral characteristics of this item
Cardinality0..*
Summarytrue
ManufacturedItemDefinition.property.type
Element IdManufacturedItemDefinition.property.type
Definition

A code expressing the type of characteristic.

Short DisplayA code expressing the type of characteristic
Cardinality1..1
Terminology BindingProductCharacteristic (Example)
TypeCodeableConcept
Summarytrue
ManufacturedItemDefinition.property.value[x]
Element IdManufacturedItemDefinition.property.value[x]
Definition

A value for the characteristic.

Short DisplayA value for the characteristic
Cardinality0..1
TypeCodeableConcept|Quantity|date|boolean|Attachment
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
ManufacturedItemDefinition.component
Element IdManufacturedItemDefinition.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 DisplayPhysical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
Cardinality0..*
Summarytrue
ManufacturedItemDefinition.component.type
Element IdManufacturedItemDefinition.component.type
Definition

Defining type of the component e.g. shell, layer, ink.

Short DisplayDefining type of the component e.g. shell, layer, ink
Cardinality1..1
TypeCodeableConcept
Summarytrue
ManufacturedItemDefinition.component.function
Element IdManufacturedItemDefinition.component.function
Definition

The function of this component within the item e.g. delivers active ingredient, masks taste.

Short DisplayThe function of this component within the item e.g. delivers active ingredient, masks taste
Cardinality0..*
TypeCodeableConcept
Summarytrue
ManufacturedItemDefinition.component.amount
Element IdManufacturedItemDefinition.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 DisplayThe measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Cardinality0..*
TypeQuantity
Summarytrue
ManufacturedItemDefinition.component.constituent
Element IdManufacturedItemDefinition.component.constituent
Definition

A reference to an 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 DisplayA reference to an 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)
Cardinality0..*
Summarytrue
ManufacturedItemDefinition.component.constituent.amount
Element IdManufacturedItemDefinition.component.constituent.amount
Definition

The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).

Short DisplayThe measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Cardinality0..*
TypeQuantity
Summarytrue
ManufacturedItemDefinition.component.constituent.location
Element IdManufacturedItemDefinition.component.constituent.location
Definition

The type of location of the constituent within this component e.g. intragranular, blend.

Short DisplayThe type of location of the constituent within this component e.g. intragranular, blend
Cardinality0..*
TypeCodeableConcept
Summarytrue
ManufacturedItemDefinition.component.constituent.function
Element IdManufacturedItemDefinition.component.constituent.function
Definition

The function of this constituent within the component e.g. binder.

Short DisplayThe function of this constituent within the component e.g. binder
Cardinality0..*
TypeCodeableConcept
Summarytrue
ManufacturedItemDefinition.component.constituent.locationForIngredient
Element IdManufacturedItemDefinition.component.constituent.locationForIngredient
Definition

An ingredient that this component is the location for in this manufactured item. The component is physically made of this ingredient (and possibly others), rather than just being a container for it.

Short DisplayAn ingredient that this component is the location of in this manufactured item. The component is physically made of this ingredient (and possibly others), rather than just being a container for it
Cardinality0..*
TypeCodeableReference(Ingredient)
Summarytrue
ManufacturedItemDefinition.component.property
Element IdManufacturedItemDefinition.component.property
Definition

General characteristics of this component.

Short DisplayGeneral characteristics of this component
Cardinality0..*
TypeSee ManufacturedItemDefinition.property
Summarytrue
ManufacturedItemDefinition.component.component
Element IdManufacturedItemDefinition.component.component
Definition

A component that this component contains or is made from.

Short DisplayA component that this component contains or is made from
Cardinality0..*
TypeSee ManufacturedItemDefinition.component
Summarytrue