Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Resource Profile: ManufacturedItemDefinition - Drug PQ

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq Version: 1.0.0
Active as of 2026-05-10 Computable Name: ManufacturedItemDefinitionDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.66

This ManufacturedItemDefinition profile represents information about the physical packaged medication item, such as a tablet or capsule.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... manufacturedDoseForm SΣ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
.... Slices for extension Content/Rules for all slices
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... property Σ 0..* BackboneElement General characteristics of this item
.... 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: Manufactured Item Property (preferred)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ManufacturedItemDefinition.​status Base required PublicationStatus 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​manufacturedDoseForm Base example Manufactured Dose Form 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​property.type Base preferred Manufactured Item Property 📦1.0.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error ManufacturedItemDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ManufacturedItemDefinition If 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-4 error ManufacturedItemDefinition If 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-5 error ManufacturedItemDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ManufacturedItemDefinition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition ManufacturedItemDefinition
... status S 1..1 code draft | active | retired | unknown
... manufacturedDoseForm S 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
.... Slices for extension Content/Rules for all slices
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... property
.... type S 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Manufactured Item Property (preferred)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ManufacturedItemDefinition.​property.type Base preferred Manufactured Item Property 📦1.0.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Unique identifier
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... 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: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... 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.
... property 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 SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Manufactured Item Property (preferred)
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueMarkdown markdown
..... valueAttachment Attachment
..... valueReference Reference(Binary)
... 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

Path Status Usage ValueSet Version Source
ManufacturedItemDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​status Base required PublicationStatus 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​manufacturedDoseForm Base example Manufactured Dose Form 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​unitOfPresentation Base example Unit Of Presentation 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​property.type Base preferred Manufactured Item Property 📦1.0.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error ManufacturedItemDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ManufacturedItemDefinition If 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-4 error ManufacturedItemDefinition If 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-5 error ManufacturedItemDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ManufacturedItemDefinition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Must-Support: 4 elements

Extensions

This structure refers to these extensions:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... manufacturedDoseForm SΣ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
.... Slices for extension Content/Rules for all slices
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... property Σ 0..* BackboneElement General characteristics of this item
.... 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: Manufactured Item Property (preferred)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ManufacturedItemDefinition.​status Base required PublicationStatus 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​manufacturedDoseForm Base example Manufactured Dose Form 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​property.type Base preferred Manufactured Item Property 📦1.0.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error ManufacturedItemDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ManufacturedItemDefinition If 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-4 error ManufacturedItemDefinition If 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-5 error ManufacturedItemDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ManufacturedItemDefinition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition ManufacturedItemDefinition
... status S 1..1 code draft | active | retired | unknown
... manufacturedDoseForm S 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
.... Slices for extension Content/Rules for all slices
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... property
.... type S 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Manufactured Item Property (preferred)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ManufacturedItemDefinition.​property.type Base preferred Manufactured Item Property 📦1.0.0 This IG

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Unique identifier
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... 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: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... 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.
... property 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 SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Manufactured Item Property (preferred)
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueMarkdown markdown
..... valueAttachment Attachment
..... valueReference Reference(Binary)
... 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

Path Status Usage ValueSet Version Source
ManufacturedItemDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​status Base required PublicationStatus 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​manufacturedDoseForm Base example Manufactured Dose Form 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​unitOfPresentation Base example Unit Of Presentation 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​property.type Base preferred Manufactured Item Property 📦1.0.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error ManufacturedItemDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ManufacturedItemDefinition If 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-4 error ManufacturedItemDefinition If 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-5 error ManufacturedItemDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ManufacturedItemDefinition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Must-Support: 4 elements

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron