Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Resource Profile: Ingredient (ePI)

Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi Version: 1.1.0
Standards status: Trial-use Active as of 2026-04-03 Computable Name: IngredientUvEpi

Ingredient (ePI)

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
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
Constraints: ing-1
... 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
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... status ?!Σ 1..1 code draft|active|retired|unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... for Σ 0..* Reference(ManufacturedItemDefinition (ePI)) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen.
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... strength Σ 0..* BackboneElement The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... basis Σ 0..1 CodeableConcept A code that indicates if the strength is reckoned based on the substance or the moiety.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Ingredient.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Ingredient.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Ingredient.role Base example Ingredient Role 📍5.0.0 FHIR Std.
Ingredient.substance.​code Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Ingredient If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Ingredient 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 Ingredient 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 Ingredient If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Ingredient 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()
ing-1 error Ingredient If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
... identifier 0..1 Identifier An identifier or code by which the ingredient can be referenced.
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... status 1..1 code draft|active|retired|unknown
... for 0..* Reference(ManufacturedItemDefinition (ePI)) The product which this ingredient is a constituent part of
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... function
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... allergenicIndicator 0..1 boolean If the ingredient is a known or suspected allergen.
... manufacturer
.... manufacturer 1..1 Reference(Organization (ePI)) An organization that manufactures this ingredient
... substance
.... code
..... concept
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
.... strength 0..* BackboneElement The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item.
..... basis 0..1 CodeableConcept A code that indicates if the strength is reckoned based on the substance or the moiety.

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
Constraints: ing-1
... 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..1 Identifier An identifier or code by which the ingredient can be referenced.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... status ?!Σ 1..1 code draft|active|retired|unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... for Σ 0..* Reference(ManufacturedItemDefinition (ePI)) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen.
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this 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
.... role Σ 0..1 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
.... manufacturer Σ 1..1 Reference(Organization (ePI)) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this 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
.... code ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ 0..1 CodeableConcept Reference to a concept (by class)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
.... strength Σ 0..* BackboneElement The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured 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
..... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
...... presentationRatio Ratio
...... presentationRatioRange RatioRange
...... presentationCodeableConcept CodeableConcept
...... presentationQuantity Quantity
..... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
..... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
...... concentrationRatio Ratio
...... concentrationRatioRange RatioRange
...... concentrationCodeableConcept CodeableConcept
...... concentrationQuantity Quantity
..... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
..... basis Σ 0..1 CodeableConcept A code that indicates if the strength is reckoned based on the substance or the moiety.
..... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
..... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
..... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
...... 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
...... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
...... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
....... strengthRatio Ratio
....... strengthRatioRange RatioRange
....... strengthQuantity Quantity
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Ingredient.language Base required All Languages 📍5.0.0 FHIR Std.
Ingredient.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Ingredient.identifier.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Ingredient.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Ingredient.role Base example Ingredient Role 📍5.0.0 FHIR Std.
Ingredient.function Base example Ingredient Function 📍5.0.0 FHIR Std.
Ingredient.manufacturer.​role Base required Ingredient Manufacturer Role 📍5.0.0 FHIR Std.
Ingredient.substance.​code Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.country Base example Country ValueSet 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​substance Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​country Base example Country ValueSet 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Ingredient If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Ingredient 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 Ingredient 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 Ingredient If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Ingredient 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()
ing-1 error Ingredient If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
Constraints: ing-1
... 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
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... status ?!Σ 1..1 code draft|active|retired|unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... for Σ 0..* Reference(ManufacturedItemDefinition (ePI)) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen.
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
.... strength Σ 0..* BackboneElement The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... basis Σ 0..1 CodeableConcept A code that indicates if the strength is reckoned based on the substance or the moiety.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Ingredient.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Ingredient.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Ingredient.role Base example Ingredient Role 📍5.0.0 FHIR Std.
Ingredient.substance.​code Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Ingredient If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Ingredient 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 Ingredient 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 Ingredient If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Ingredient 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()
ing-1 error Ingredient If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
... identifier 0..1 Identifier An identifier or code by which the ingredient can be referenced.
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... status 1..1 code draft|active|retired|unknown
... for 0..* Reference(ManufacturedItemDefinition (ePI)) The product which this ingredient is a constituent part of
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... function
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... allergenicIndicator 0..1 boolean If the ingredient is a known or suspected allergen.
... manufacturer
.... manufacturer 1..1 Reference(Organization (ePI)) An organization that manufactures this ingredient
... substance
.... code
..... concept
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
.... strength 0..* BackboneElement The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item.
..... basis 0..1 CodeableConcept A code that indicates if the strength is reckoned based on the substance or the moiety.

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
Constraints: ing-1
... 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..1 Identifier An identifier or code by which the ingredient can be referenced.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... status ?!Σ 1..1 code draft|active|retired|unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... for Σ 0..* Reference(ManufacturedItemDefinition (ePI)) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen.
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this 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
.... role Σ 0..1 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.
.... manufacturer Σ 1..1 Reference(Organization (ePI)) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this 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
.... code ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ 0..1 CodeableConcept Reference to a concept (by class)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
.... strength Σ 0..* BackboneElement The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured 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
..... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
...... presentationRatio Ratio
...... presentationRatioRange RatioRange
...... presentationCodeableConcept CodeableConcept
...... presentationQuantity Quantity
..... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
..... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
...... concentrationRatio Ratio
...... concentrationRatioRange RatioRange
...... concentrationCodeableConcept CodeableConcept
...... concentrationQuantity Quantity
..... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
..... basis Σ 0..1 CodeableConcept A code that indicates if the strength is reckoned based on the substance or the moiety.
..... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
..... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes
..... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance
...... 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
...... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
...... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
....... strengthRatio Ratio
....... strengthRatioRange RatioRange
....... strengthQuantity Quantity
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Ingredient.language Base required All Languages 📍5.0.0 FHIR Std.
Ingredient.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Ingredient.identifier.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Ingredient.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Ingredient.role Base example Ingredient Role 📍5.0.0 FHIR Std.
Ingredient.function Base example Ingredient Function 📍5.0.0 FHIR Std.
Ingredient.manufacturer.​role Base required Ingredient Manufacturer Role 📍5.0.0 FHIR Std.
Ingredient.substance.​code Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.country Base example Country ValueSet 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​substance Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
Ingredient.substance.​strength.referenceStrength.​country Base example Country ValueSet 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Ingredient If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Ingredient 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 Ingredient 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 Ingredient If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Ingredient 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()
ing-1 error Ingredient If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

 

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