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15.4.6 Resource ManufacturedItemDefinition - Detailed Descriptions

Biomedical Research and Regulation icon Work GroupMaturity Level: 2 Trial UseSecurity 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 intrinsically 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 intrinsically 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, expressible in different ways (e.g. by mass or volume).

Short Display The measurable amount of total quantity of all substances in the component, expressible 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, expressible in different ways (e.g. by mass or volume).

Short Display The measurable amount of the substance, expressible 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