CH IDMP (R5)
1.0.0-ballot - ballot Switzerland flag

This page is part of the CH IDMP (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: ManufacturedItemDefinition

Official URL: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition Version: 1.0.0-ballot
Active as of 2026-06-12 Computable Name: CHIDMPManufacturedItemDefinition

Copyright/Legal: CC0-1.0

Profile of the ManufacturedItemDefinition resource for representing the characteristics of a medicinal manufactured item as contained in a packaged medicinal product.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition 0..* ManufacturedItemDefinition ManufacturedItemDefinition
... 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 Σ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: EDQM - Pharmaceutical Dose Form (required)
... unitOfPresentation Σ 0..1 CodeableConcept The “real-world” units in which the quantity of the item is described
Binding: EDQM - Unit of Presentation (required)

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 required EDQM - Pharmaceutical Dose Form 📦1.0.0-ballot This IG
ManufacturedItemDefinition.​unitOfPresentation Base required EDQM - Unit of Presentation 📦1.0.0-ballot 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()

This structure is derived from ManufacturedItemDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition 0..* ManufacturedItemDefinition ManufacturedItemDefinition
... manufacturedDoseForm 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: EDQM - Pharmaceutical Dose Form (required)
... unitOfPresentation 0..1 CodeableConcept The “real-world” units in which the quantity of the item is described
Binding: EDQM - Unit of Presentation (required)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ManufacturedItemDefinition.​manufacturedDoseForm Base required EDQM - Pharmaceutical Dose Form 📦1.0.0-ballot This IG
ManufacturedItemDefinition.​unitOfPresentation Base required EDQM - Unit of Presentation 📦1.0.0-ballot This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition 0..* ManufacturedItemDefinition ManufacturedItemDefinition
... 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 ?!Σ 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 Σ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: EDQM - Pharmaceutical Dose Form (required)
... unitOfPresentation Σ 0..1 CodeableConcept The “real-world” units in which the quantity of the item is described
Binding: EDQM - Unit of Presentation (required)
... 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 Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... 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 required EDQM - Pharmaceutical Dose Form 📦1.0.0-ballot This IG
ManufacturedItemDefinition.​unitOfPresentation Base required EDQM - Unit of Presentation 📦1.0.0-ballot This IG
ManufacturedItemDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​property.type Base example Product Characteristic 📍5.0.0 FHIR Std.

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()

This structure is derived from ManufacturedItemDefinition

Summary

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition 0..* ManufacturedItemDefinition ManufacturedItemDefinition
... 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 Σ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: EDQM - Pharmaceutical Dose Form (required)
... unitOfPresentation Σ 0..1 CodeableConcept The “real-world” units in which the quantity of the item is described
Binding: EDQM - Unit of Presentation (required)

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 required EDQM - Pharmaceutical Dose Form 📦1.0.0-ballot This IG
ManufacturedItemDefinition.​unitOfPresentation Base required EDQM - Unit of Presentation 📦1.0.0-ballot 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

This structure is derived from ManufacturedItemDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition 0..* ManufacturedItemDefinition ManufacturedItemDefinition
... manufacturedDoseForm 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: EDQM - Pharmaceutical Dose Form (required)
... unitOfPresentation 0..1 CodeableConcept The “real-world” units in which the quantity of the item is described
Binding: EDQM - Unit of Presentation (required)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ManufacturedItemDefinition.​manufacturedDoseForm Base required EDQM - Pharmaceutical Dose Form 📦1.0.0-ballot This IG
ManufacturedItemDefinition.​unitOfPresentation Base required EDQM - Unit of Presentation 📦1.0.0-ballot This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ManufacturedItemDefinition 0..* ManufacturedItemDefinition ManufacturedItemDefinition
... 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 ?!Σ 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 Σ 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation)
Binding: EDQM - Pharmaceutical Dose Form (required)
... unitOfPresentation Σ 0..1 CodeableConcept The “real-world” units in which the quantity of the item is described
Binding: EDQM - Unit of Presentation (required)
... 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 Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... 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 required EDQM - Pharmaceutical Dose Form 📦1.0.0-ballot This IG
ManufacturedItemDefinition.​unitOfPresentation Base required EDQM - Unit of Presentation 📦1.0.0-ballot This IG
ManufacturedItemDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
ManufacturedItemDefinition.​property.type Base example Product Characteristic 📍5.0.0 FHIR Std.

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()

This structure is derived from ManufacturedItemDefinition

Summary

 

Other representations of profile: CSV, Excel, Schematron