Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

15.4 Resource ManufacturedItemDefinition - Content

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

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

15.4.1 Scope and Usage

For an overview of this resource and others in the Medication Definition domain, also see the module page

ManufacturedItemDefinition is to be used when you need to describe an actual physical medication item such as a tablet or capsule. This is typically for regulatory or manufacturing use cases, rather than day to day prescribing or dispensing.

This resource represents (for example) a single physical tablet. It can also represent physical liquids, powders, capsules etc. When prescribing, it is not usually necessary to represent the physical properties of the tablet that the patient will eventually receive and consume. Prescriptions make statements about types of products or substances, in general terms or more specific, which may be fulfilled by tablets (in some cases) but usually without directly talking about the details of those tablets. It is not usual to prescribe a red tablet with an "X" on it, so it is clear that this resource is not needed for the prescribing workflow itself. However it may be useful during a patient consultation (or perhaps in response to an adverse event), to look up which tablet is the red triangle with an "X" imprint. These definitional facts can be captured with this resource. They would likely never be on a prescription, but this resource supports the prescribing process as well as other downstream events. The weights, sizes, chemical properties and so on are naturally important to manufacturers, distributors, and regulators - who need every property detailing.

A defining aspect of this resource is that the item described is in the state as it comes from being manufactured, and has had no other preparatory steps - such as crushing or mixing. It is in the state ready for packaging and distribution to consumers, and not necessarily in the state ready for administration (for which see AdministrableProductDefinition). This is the state where medication items are commonly encountered, within packaging, before actually being used. It is a medication item "as manufactured", recognizing that other non-medication items are also manufactured, and that even the administrable form of a drug, and the packaging that an item is placed into, have been manufactured at some stage.

The manufactured item describes the physical characteristics of the item, as opposed to its pharmaceutical aspects (which may only apply after mixing with other items - to become an AdministrableProductDefinition), or its packaging, or legal aspects (which apply only to the whole group of packing and manufactured items). There are typically multiple instances of the item in the packaging (a PackagedProductDefinition resource) and this is indicated by the quantity within the containing package (e.g. 12 tablets), referencing a single copy of the manufactured item.

This is the only resource that treats the "tablet" (or whatever it may be) as a physical object. It is still definitional however - it describes all instances of this tablet. The resource aims to capture the definition of a single medication item type, such as a tablet of aspirin with a certain form, shape, manufacturer. It is not intended to describe and be instantiated for each medication item, i.e. it is not an actual real instance of a tablet, but rather represents (e.g.) all tablets of the same medication item type, that are described by the ManufacturedItemDefinition.

To define several package variations, e.g. pack of 10 tablets and of 50 tablets, you would need only one ManufacturedItemDefinition, referenced from both (and associated with a numeric quantity of 10 or 50 in the respective PackagedProductDefintions). To prescribe or dispense 100 tablets, you would not generally need this resource at all, because usually the code of the medication product as a whole is sufficient, plus a quantity, e.g. 100 of "ABC123" (meaning e.g. aspirin 75 mg).

This resource excludes devices and other items found in medication packaging such as scissors, applicators and so on (which would use DeviceDefinition), and components of packaging that are not considered devices, such bottle stoppers (use PackagedProductDefintion.package.package).

15.4.2 References to this Resource

15.4.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition TUDomainResourceThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierUnique identifier

... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (Required)
... name Σ0..1stringA descriptive name applied to this item
... unitOfPresentation Σ0..1CodeableConceptThe “real world” units in which the quantity of the item is described
UnitOfPresentation (Example)
... manufacturer Σ0..*Reference(Organization)Manufacturer of the item, one of several possible

... marketingStatus Σ0..*MarketingStatusAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated

... ingredient Σ0..*CodeableConceptThe ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
SNOMED CT Substance Codes (Example)

... property Σ0..*BackboneElementGeneral characteristics of this item

.... type Σ1..1CodeableConceptA code expressing the type of characteristic
ProductCharacteristic (Example)
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
... component Σ0..*BackboneElementPhysical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup

.... type Σ1..1CodeableConceptDefining type of the component e.g. shell, layer, ink
.... function Σ0..*CodeableConceptThe function of this component within the item e.g. delivers active ingredient, masks taste

.... amount Σ0..*QuantityThe measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume)

.... constituent Σ0..*BackboneElementA 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)

..... amount Σ0..*QuantityThe measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume)

..... location Σ0..*CodeableConceptThe type of location of the constituent within this component e.g. intragranular, blend

..... function Σ0..*CodeableConceptThe function of this constituent within the component e.g. binder

..... locationForIngredient Σ0..*CodeableReference(Ingredient)An 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

.... property Σ0..*see propertyGeneral characteristics of this component

.... component Σ0..*see componentA component that this component contains or is made from


doco Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

ManufacturedItemDefinition (DomainResource)Unique identifieridentifier : Identifier [0..*]The status of this item. Enables tracking the life-cycle of the content (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »A descriptive name applied to this itemname : string [0..1]Dose form as manufactured and before any transformation into the pharmaceutical productmanufacturedDoseForm : CodeableConcept [1..1] « null (Strength=Example)ManufacturedDoseForm?? »The “real world” units in which the quantity of the manufactured item is describedunitOfPresentation : CodeableConcept [0..1] « null (Strength=Example)UnitOfPresentation?? »Manufacturer of the item, one of several possiblemanufacturer : Reference [0..*] « Organization »Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associatedmarketingStatus : MarketingStatus [0..*]The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resourceingredient : CodeableConcept [0..*] « null (Strength=Example)SNOMEDCTSubstanceCodes?? »PropertyA code expressing the type of characteristictype : CodeableConcept [1..1] « null (Strength=Example)ProductCharacteristic?? »A value for the characteristicvalue[x] : DataType [0..1] « CodeableConcept|Quantity|date|boolean| Attachment »ComponentDefining type of the component e.g. shell, layer, inktype : CodeableConcept [1..1]The function of this component within the item e.g. delivers active ingredient, masks tastefunction : CodeableConcept [0..*]The measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume)amount : Quantity [0..*]ConstituentThe measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume)amount : Quantity [0..*]The type of location of the constituent within this component e.g. intragranular, blendlocation : CodeableConcept [0..*]The function of this constituent within the component e.g. binderfunction : CodeableConcept [0..*]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 itlocationForIngredient : CodeableReference [0..*] « Ingredient »General characteristics of this itemproperty[0..*]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)constituent[0..*]General characteristics of this componentproperty[0..*]A component that this component contains or is made fromcomponent[0..*]Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeupcomponent[0..*]

XML Template

<ManufacturedItemDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <name value="[string]"/><!-- 0..1 A descriptive name applied to this item -->
 <manufacturedDoseForm><!-- 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation) --></manufacturedDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept The “real world” units in which the quantity of the item is described --></unitOfPresentation>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of the item, one of several possible --></manufacturer>
 <marketingStatus><!-- 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 --></marketingStatus>
 <ingredient><!-- 0..* CodeableConcept The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource --></ingredient>
 <property>  <!-- 0..* General characteristics of this item -->
  <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
  <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]>
 </property>
 <component>  <!-- 0..* 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 -->
  <type><!-- 1..1 CodeableConcept Defining type of the component e.g. shell, layer, ink --></type>
  <function><!-- 0..* CodeableConcept The function of this component within the item e.g. delivers active ingredient, masks taste --></function>
  <amount><!-- 0..* Quantity The measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume) --></amount>
  <constituent>  <!-- 0..* 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) -->
   <amount><!-- 0..* Quantity The measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume) --></amount>
   <location><!-- 0..* CodeableConcept The type of location of the constituent within this component e.g. intragranular, blend --></location>
   <function><!-- 0..* CodeableConcept The function of this constituent within the component e.g. binder --></function>
   <locationForIngredient><!-- 0..* CodeableReference(Ingredient) An 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 --></locationForIngredient>
  </constituent>
  <property><!-- 0..* Content as for ManufacturedItemDefinition.property General characteristics of this component --></property>
  <component><!-- 0..* Content as for ManufacturedItemDefinition.component A component that this component contains or is made from --></component>
 </component>
</ManufacturedItemDefinition>

JSON Template

{doco
  "resourceType" : "ManufacturedItemDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "status" : "<code>", // R!  draft | active | retired | unknown
  "name" : "<string>", // A descriptive name applied to this item
  "manufacturedDoseForm" : { CodeableConcept }, // R!  Dose form as manufactured (before any necessary transformation)
  "unitOfPresentation" : { CodeableConcept }, // The “real world” units in which the quantity of the item is described
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of the item, one of several possible
  "marketingStatus" : [{ 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" : [{ CodeableConcept }], // The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
  "property" : [{ // General characteristics of this item
    "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 5:
    "valueCodeableConcept" : { CodeableConcept },
    "valueQuantity" : { Quantity },
    "valueDate" : "<date>",
    "valueBoolean" : <boolean>,
    "valueAttachment" : { Attachment }
  }],
  "component" : [{ // 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
    "type" : { CodeableConcept }, // R!  Defining type of the component e.g. shell, layer, ink
    "function" : [{ CodeableConcept }], // The function of this component within the item e.g. delivers active ingredient, masks taste
    "amount" : [{ Quantity }], // The measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume)
    "constituent" : [{ // 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)
      "amount" : [{ Quantity }], // The measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume)
      "location" : [{ CodeableConcept }], // The type of location of the constituent within this component e.g. intragranular, blend
      "function" : [{ CodeableConcept }], // The function of this constituent within the component e.g. binder
      "locationForIngredient" : [{ CodeableReference(Ingredient) }] // An 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
    }],
    "property" : [{ Content as for ManufacturedItemDefinition.property }], // General characteristics of this component
    "component" : [{ Content as for ManufacturedItemDefinition.component }] // A component that this component contains or is made from
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:ManufacturedItemDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ManufacturedItemDefinition.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:ManufacturedItemDefinition.status [ code ]; # 1..1 draft | active | retired | unknown
  fhir:ManufacturedItemDefinition.name [ string ]; # 0..1 A descriptive name applied to this item
  fhir:ManufacturedItemDefinition.manufacturedDoseForm [ CodeableConcept ]; # 1..1 Dose form as manufactured (before any necessary transformation)
  fhir:ManufacturedItemDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 The “real world” units in which the quantity of the item is described
  fhir:ManufacturedItemDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of the item, one of several possible
  fhir:ManufacturedItemDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
  fhir:ManufacturedItemDefinition.ingredient [ CodeableConcept ], ... ; # 0..* The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
  fhir:ManufacturedItemDefinition.property [ # 0..* General characteristics of this item
    fhir:ManufacturedItemDefinition.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # ManufacturedItemDefinition.property.value[x] : 0..1 A value for the characteristic. One of these 5
      fhir:ManufacturedItemDefinition.property.valueCodeableConcept [ CodeableConcept ]
      fhir:ManufacturedItemDefinition.property.valueQuantity [ Quantity ]
      fhir:ManufacturedItemDefinition.property.valueDate [ date ]
      fhir:ManufacturedItemDefinition.property.valueBoolean [ boolean ]
      fhir:ManufacturedItemDefinition.property.valueAttachment [ Attachment ]
  ], ...;
  fhir:ManufacturedItemDefinition.component [ # 0..* 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
    fhir:ManufacturedItemDefinition.component.type [ CodeableConcept ]; # 1..1 Defining type of the component e.g. shell, layer, ink
    fhir:ManufacturedItemDefinition.component.function [ CodeableConcept ], ... ; # 0..* The function of this component within the item e.g. delivers active ingredient, masks taste
    fhir:ManufacturedItemDefinition.component.amount [ Quantity ], ... ; # 0..* The measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume)
    fhir:ManufacturedItemDefinition.component.constituent [ # 0..* 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)
      fhir:ManufacturedItemDefinition.component.constituent.amount [ Quantity ], ... ; # 0..* The measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume)
      fhir:ManufacturedItemDefinition.component.constituent.location [ CodeableConcept ], ... ; # 0..* The type of location of the constituent within this component e.g. intragranular, blend
      fhir:ManufacturedItemDefinition.component.constituent.function [ CodeableConcept ], ... ; # 0..* The function of this constituent within the component e.g. binder
      fhir:ManufacturedItemDefinition.component.constituent.locationForIngredient [ CodeableReference(Ingredient) ], ... ; # 0..* An 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
    ], ...;
    fhir:ManufacturedItemDefinition.component.property [ See ManufacturedItemDefinition.property ], ... ; # 0..* General characteristics of this component
    fhir:ManufacturedItemDefinition.component.component [ See ManufacturedItemDefinition.component ], ... ; # 0..* A component that this component contains or is made from
  ], ...;
]

Changes since R4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition TUDomainResourceThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierUnique identifier

... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (Required)
... name Σ0..1stringA descriptive name applied to this item
... unitOfPresentation Σ0..1CodeableConceptThe “real world” units in which the quantity of the item is described
UnitOfPresentation (Example)
... manufacturer Σ0..*Reference(Organization)Manufacturer of the item, one of several possible

... marketingStatus Σ0..*MarketingStatusAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated

... ingredient Σ0..*CodeableConceptThe ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
SNOMED CT Substance Codes (Example)

... property Σ0..*BackboneElementGeneral characteristics of this item

.... type Σ1..1CodeableConceptA code expressing the type of characteristic
ProductCharacteristic (Example)
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
... component Σ0..*BackboneElementPhysical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup

.... type Σ1..1CodeableConceptDefining type of the component e.g. shell, layer, ink
.... function Σ0..*CodeableConceptThe function of this component within the item e.g. delivers active ingredient, masks taste

.... amount Σ0..*QuantityThe measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume)

.... constituent Σ0..*BackboneElementA 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)

..... amount Σ0..*QuantityThe measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume)

..... location Σ0..*CodeableConceptThe type of location of the constituent within this component e.g. intragranular, blend

..... function Σ0..*CodeableConceptThe function of this constituent within the component e.g. binder

..... locationForIngredient Σ0..*CodeableReference(Ingredient)An 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

.... property Σ0..*see propertyGeneral characteristics of this component

.... component Σ0..*see componentA component that this component contains or is made from


doco Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

ManufacturedItemDefinition (DomainResource)Unique identifieridentifier : Identifier [0..*]The status of this item. Enables tracking the life-cycle of the content (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »A descriptive name applied to this itemname : string [0..1]Dose form as manufactured and before any transformation into the pharmaceutical productmanufacturedDoseForm : CodeableConcept [1..1] « null (Strength=Example)ManufacturedDoseForm?? »The “real world” units in which the quantity of the manufactured item is describedunitOfPresentation : CodeableConcept [0..1] « null (Strength=Example)UnitOfPresentation?? »Manufacturer of the item, one of several possiblemanufacturer : Reference [0..*] « Organization »Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associatedmarketingStatus : MarketingStatus [0..*]The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resourceingredient : CodeableConcept [0..*] « null (Strength=Example)SNOMEDCTSubstanceCodes?? »PropertyA code expressing the type of characteristictype : CodeableConcept [1..1] « null (Strength=Example)ProductCharacteristic?? »A value for the characteristicvalue[x] : DataType [0..1] « CodeableConcept|Quantity|date|boolean| Attachment »ComponentDefining type of the component e.g. shell, layer, inktype : CodeableConcept [1..1]The function of this component within the item e.g. delivers active ingredient, masks tastefunction : CodeableConcept [0..*]The measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume)amount : Quantity [0..*]ConstituentThe measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume)amount : Quantity [0..*]The type of location of the constituent within this component e.g. intragranular, blendlocation : CodeableConcept [0..*]The function of this constituent within the component e.g. binderfunction : CodeableConcept [0..*]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 itlocationForIngredient : CodeableReference [0..*] « Ingredient »General characteristics of this itemproperty[0..*]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)constituent[0..*]General characteristics of this componentproperty[0..*]A component that this component contains or is made fromcomponent[0..*]Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeupcomponent[0..*]

XML Template

<ManufacturedItemDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <name value="[string]"/><!-- 0..1 A descriptive name applied to this item -->
 <manufacturedDoseForm><!-- 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation) --></manufacturedDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept The “real world” units in which the quantity of the item is described --></unitOfPresentation>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of the item, one of several possible --></manufacturer>
 <marketingStatus><!-- 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 --></marketingStatus>
 <ingredient><!-- 0..* CodeableConcept The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource --></ingredient>
 <property>  <!-- 0..* General characteristics of this item -->
  <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
  <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]>
 </property>
 <component>  <!-- 0..* 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 -->
  <type><!-- 1..1 CodeableConcept Defining type of the component e.g. shell, layer, ink --></type>
  <function><!-- 0..* CodeableConcept The function of this component within the item e.g. delivers active ingredient, masks taste --></function>
  <amount><!-- 0..* Quantity The measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume) --></amount>
  <constituent>  <!-- 0..* 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) -->
   <amount><!-- 0..* Quantity The measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume) --></amount>
   <location><!-- 0..* CodeableConcept The type of location of the constituent within this component e.g. intragranular, blend --></location>
   <function><!-- 0..* CodeableConcept The function of this constituent within the component e.g. binder --></function>
   <locationForIngredient><!-- 0..* CodeableReference(Ingredient) An 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 --></locationForIngredient>
  </constituent>
  <property><!-- 0..* Content as for ManufacturedItemDefinition.property General characteristics of this component --></property>
  <component><!-- 0..* Content as for ManufacturedItemDefinition.component A component that this component contains or is made from --></component>
 </component>
</ManufacturedItemDefinition>

JSON Template

{doco
  "resourceType" : "ManufacturedItemDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "status" : "<code>", // R!  draft | active | retired | unknown
  "name" : "<string>", // A descriptive name applied to this item
  "manufacturedDoseForm" : { CodeableConcept }, // R!  Dose form as manufactured (before any necessary transformation)
  "unitOfPresentation" : { CodeableConcept }, // The “real world” units in which the quantity of the item is described
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of the item, one of several possible
  "marketingStatus" : [{ 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" : [{ CodeableConcept }], // The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
  "property" : [{ // General characteristics of this item
    "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 5:
    "valueCodeableConcept" : { CodeableConcept },
    "valueQuantity" : { Quantity },
    "valueDate" : "<date>",
    "valueBoolean" : <boolean>,
    "valueAttachment" : { Attachment }
  }],
  "component" : [{ // 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
    "type" : { CodeableConcept }, // R!  Defining type of the component e.g. shell, layer, ink
    "function" : [{ CodeableConcept }], // The function of this component within the item e.g. delivers active ingredient, masks taste
    "amount" : [{ Quantity }], // The measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume)
    "constituent" : [{ // 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)
      "amount" : [{ Quantity }], // The measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume)
      "location" : [{ CodeableConcept }], // The type of location of the constituent within this component e.g. intragranular, blend
      "function" : [{ CodeableConcept }], // The function of this constituent within the component e.g. binder
      "locationForIngredient" : [{ CodeableReference(Ingredient) }] // An 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
    }],
    "property" : [{ Content as for ManufacturedItemDefinition.property }], // General characteristics of this component
    "component" : [{ Content as for ManufacturedItemDefinition.component }] // A component that this component contains or is made from
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:ManufacturedItemDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ManufacturedItemDefinition.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:ManufacturedItemDefinition.status [ code ]; # 1..1 draft | active | retired | unknown
  fhir:ManufacturedItemDefinition.name [ string ]; # 0..1 A descriptive name applied to this item
  fhir:ManufacturedItemDefinition.manufacturedDoseForm [ CodeableConcept ]; # 1..1 Dose form as manufactured (before any necessary transformation)
  fhir:ManufacturedItemDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 The “real world” units in which the quantity of the item is described
  fhir:ManufacturedItemDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of the item, one of several possible
  fhir:ManufacturedItemDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
  fhir:ManufacturedItemDefinition.ingredient [ CodeableConcept ], ... ; # 0..* The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
  fhir:ManufacturedItemDefinition.property [ # 0..* General characteristics of this item
    fhir:ManufacturedItemDefinition.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # ManufacturedItemDefinition.property.value[x] : 0..1 A value for the characteristic. One of these 5
      fhir:ManufacturedItemDefinition.property.valueCodeableConcept [ CodeableConcept ]
      fhir:ManufacturedItemDefinition.property.valueQuantity [ Quantity ]
      fhir:ManufacturedItemDefinition.property.valueDate [ date ]
      fhir:ManufacturedItemDefinition.property.valueBoolean [ boolean ]
      fhir:ManufacturedItemDefinition.property.valueAttachment [ Attachment ]
  ], ...;
  fhir:ManufacturedItemDefinition.component [ # 0..* 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
    fhir:ManufacturedItemDefinition.component.type [ CodeableConcept ]; # 1..1 Defining type of the component e.g. shell, layer, ink
    fhir:ManufacturedItemDefinition.component.function [ CodeableConcept ], ... ; # 0..* The function of this component within the item e.g. delivers active ingredient, masks taste
    fhir:ManufacturedItemDefinition.component.amount [ Quantity ], ... ; # 0..* The measurable amount of substance in this component, expressable in different ways (e.g. by mass or volume)
    fhir:ManufacturedItemDefinition.component.constituent [ # 0..* 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)
      fhir:ManufacturedItemDefinition.component.constituent.amount [ Quantity ], ... ; # 0..* The measurable amount of this constituent in this component, expressable in different ways (e.g. by mass or volume)
      fhir:ManufacturedItemDefinition.component.constituent.location [ CodeableConcept ], ... ; # 0..* The type of location of the constituent within this component e.g. intragranular, blend
      fhir:ManufacturedItemDefinition.component.constituent.function [ CodeableConcept ], ... ; # 0..* The function of this constituent within the component e.g. binder
      fhir:ManufacturedItemDefinition.component.constituent.locationForIngredient [ CodeableReference(Ingredient) ], ... ; # 0..* An 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
    ], ...;
    fhir:ManufacturedItemDefinition.component.property [ See ManufacturedItemDefinition.property ], ... ; # 0..* General characteristics of this component
    fhir:ManufacturedItemDefinition.component.component [ See ManufacturedItemDefinition.component ], ... ; # 0..* A component that this component contains or is made from
  ], ...;
]

Changes since Release 4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

15.4.3.1 Terminology Bindings

PathDefinitionTypeReference
ManufacturedItemDefinition.status

The lifecycle status of an artifact.

RequiredPublicationStatus
ManufacturedItemDefinition.manufacturedDoseForm

Dose form for a medication, as manufactured (and before any mixing etc.), not necessarily ready for administration to the patient.

ExampleManufacturedDoseForm
ManufacturedItemDefinition.unitOfPresentation

The presentation type in which an administrable medicinal product is given to a patient.

ExampleUnitOfPresentation
ManufacturedItemDefinition.ingredient

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

ExampleSNOMEDCTSubstanceCodes
ManufacturedItemDefinition.property.type

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

ExampleProductCharacteristic

15.4.4 Search Parameters

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
dose-formtokenDose form as manufactured and before any transformation into the pharmaceutical productManufacturedItemDefinition.manufacturedDoseForm
identifiertokenUnique identifierManufacturedItemDefinition.identifier
ingredient DtokenAn ingredient of this itemManufacturedItemDefinition.ingredient
name DtokenA descriptive name applied to this itemManufacturedItemDefinition.name
statustokenThe status of this item. Enables tracking the life-cycle of the content.ManufacturedItemDefinition.status