AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: Ingredient

Defines the strength and composition parts of a medicinal product

Usage:

• This Resource Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Ingredient

Name	Flags	Card.	Type	Description & Constraints
Ingredient		0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product
identifier		1..1	AT_MedicinalProduct_Identifier	An identifier intended for computation
system		1..1	uri	The namespace for the identifier value Required Pattern: https://www.ages.at/fhir/referenceNumber
for		1..1	Reference(Manufactured item definition | Administrable product definition)	The product which this ingredient is a constituent part of
role		1..1	AT_MedicinalProduct_CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive (ingredient role) Binding: The Ingredient Role Value Set (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 100000072072
substance
code
concept		1..1	AT_MedicinalProduct_CodeableConcept	Concept - reference to a terminology or just text
Slices for coding		1..*	AT_MedicinalProduct_Coding	A reference to a code defined by a terminology system Slice: Unordered, Open by value:system
coding:substancePharos		1..1	AT_MedicinalProduct_Coding	Substance
system		1..1	uri	Identity of the terminology system Required Pattern: https://www.ages.at/fhir/GRZ
coding:substanceSMS		0..1	AT_MedicinalProduct_Coding	Active ingredient
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
strength	C	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit) atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
referenceStrength
substance		1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance (reference ingredient)
strength[x]		1..1	Ratio, RatioRange, Quantity	Strength expressed in terms of a reference substance (reference ingredient strength & unit)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet / Code	URI
Ingredient.role	required	Pattern: 100000072072 https://ema.europa.eu/fhir/vs/ingredientRole from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
atLeastOnePresentationOrOneConcentrationInvariant	error	Ingredient.substance.strength	There must be at least one presentation or one concentration. : presentation.count() >=1 or concentration.count() >=1

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product ing-1: 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
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
identifier	C	1..1	AT_MedicinalProduct_Identifier	An identifier intended for computation ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
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 Required Pattern: https://www.ages.at/fhir/referenceNumber
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	1..1	Reference(Manufactured item definition | Administrable product definition)	The product which this ingredient is a constituent part of
role		1..1	AT_MedicinalProduct_CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive (ingredient role) Binding: The Ingredient Role Value Set (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 100000072072
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.
concept		1..1	AT_MedicinalProduct_CodeableConcept	Concept - reference to a terminology or just text
Slices for coding	C	1..*	AT_MedicinalProduct_Coding	A reference to a code defined by a terminology system Slice: Unordered, Open by value:system cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
coding:substancePharos	C	1..1	AT_MedicinalProduct_Coding	Substance cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
Slices for extension				Content/Rules for all slices
codeSystemName		0..1	string	Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.ages.at/fhir/GRZ
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	1..1	string	Representation defined by the system
coding:substanceSMS	C	0..1	AT_MedicinalProduct_Coding	Active ingredient cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
Slices for extension				Content/Rules for all slices
codeSystemName		0..1	string	Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	1..1	string	Representation defined by the system
strength	ΣC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit) atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Ingredient.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Ingredient.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	required	Pattern: 100000072072 https://ema.europa.eu/fhir/vs/ingredientRole from this IG
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
atLeastOnePresentationOrOneConcentrationInvariant	error	Ingredient.substance.strength	There must be at least one presentation or one concentration. : presentation.count() >=1 or concentration.count() >=1
cod-1	warning	Ingredient.substance.code.concept.coding, Ingredient.substance.code.concept.coding:substancePharos, Ingredient.substance.code.concept.coding:substanceSMS	A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text : code.exists().not() implies display.exists().not()
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()
ident-1	warning	Ingredient.identifier	Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason : 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

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product ing-1: 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
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
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	C	1..1	AT_MedicinalProduct_Identifier	An identifier intended for computation ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
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 Required Pattern: https://www.ages.at/fhir/referenceNumber
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	1..1	Reference(Manufactured item definition | Administrable product definition)	The product which this ingredient is a constituent part of
role		1..1	AT_MedicinalProduct_CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive (ingredient role) Binding: The Ingredient Role Value Set (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 100000072072
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		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).
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)	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		1..1	AT_MedicinalProduct_CodeableConcept	Concept - reference to a terminology or just text
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	C	1..*	AT_MedicinalProduct_Coding	A reference to a code defined by a terminology system Slice: Unordered, Open by value:system cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
coding:substancePharos	C	1..1	AT_MedicinalProduct_Coding	Substance cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
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
codeSystemName		0..1	string	Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.ages.at/fhir/GRZ
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
coding:substanceSMS	C	0..1	AT_MedicinalProduct_Coding	Active ingredient cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
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
codeSystemName		0..1	string	Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
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	ΣC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit) atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
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, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
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 (reference ingredient) 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 (reference ingredient strength & unit)
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Ingredient.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Ingredient.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Ingredient.identifier.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Ingredient.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	required	Pattern: 100000072072 https://ema.europa.eu/fhir/vs/ingredientRole from this IG
Ingredient.function	example	IngredientFunction http://hl7.org/fhir/ValueSet/ingredient-function from the FHIR Standard
Ingredient.manufacturer.role	required	IngredientManufacturerRole http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0 from the FHIR Standard
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
atLeastOnePresentationOrOneConcentrationInvariant	error	Ingredient.substance.strength	There must be at least one presentation or one concentration. : presentation.count() >=1 or concentration.count() >=1
cod-1	warning	Ingredient.substance.code.concept.coding, Ingredient.substance.code.concept.coding:substancePharos, Ingredient.substance.code.concept.coding:substanceSMS	A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text : code.exists().not() implies display.exists().not()
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()
ident-1	warning	Ingredient.identifier	Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason : 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

This structure is derived from Ingredient

Differential View

This structure is derived from Ingredient

Name	Flags	Card.	Type	Description & Constraints
Ingredient		0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product
identifier		1..1	AT_MedicinalProduct_Identifier	An identifier intended for computation
system		1..1	uri	The namespace for the identifier value Required Pattern: https://www.ages.at/fhir/referenceNumber
for		1..1	Reference(Manufactured item definition | Administrable product definition)	The product which this ingredient is a constituent part of
role		1..1	AT_MedicinalProduct_CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive (ingredient role) Binding: The Ingredient Role Value Set (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 100000072072
substance
code
concept		1..1	AT_MedicinalProduct_CodeableConcept	Concept - reference to a terminology or just text
Slices for coding		1..*	AT_MedicinalProduct_Coding	A reference to a code defined by a terminology system Slice: Unordered, Open by value:system
coding:substancePharos		1..1	AT_MedicinalProduct_Coding	Substance
system		1..1	uri	Identity of the terminology system Required Pattern: https://www.ages.at/fhir/GRZ
coding:substanceSMS		0..1	AT_MedicinalProduct_Coding	Active ingredient
system		1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
strength	C	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit) atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
referenceStrength
substance		1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance (reference ingredient)
strength[x]		1..1	Ratio, RatioRange, Quantity	Strength expressed in terms of a reference substance (reference ingredient strength & unit)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet / Code	URI
Ingredient.role	required	Pattern: 100000072072 https://ema.europa.eu/fhir/vs/ingredientRole from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
atLeastOnePresentationOrOneConcentrationInvariant	error	Ingredient.substance.strength	There must be at least one presentation or one concentration. : presentation.count() >=1 or concentration.count() >=1

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product ing-1: 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
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
identifier	C	1..1	AT_MedicinalProduct_Identifier	An identifier intended for computation ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
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 Required Pattern: https://www.ages.at/fhir/referenceNumber
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	1..1	Reference(Manufactured item definition | Administrable product definition)	The product which this ingredient is a constituent part of
role		1..1	AT_MedicinalProduct_CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive (ingredient role) Binding: The Ingredient Role Value Set (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 100000072072
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.
concept		1..1	AT_MedicinalProduct_CodeableConcept	Concept - reference to a terminology or just text
Slices for coding	C	1..*	AT_MedicinalProduct_Coding	A reference to a code defined by a terminology system Slice: Unordered, Open by value:system cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
coding:substancePharos	C	1..1	AT_MedicinalProduct_Coding	Substance cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
Slices for extension				Content/Rules for all slices
codeSystemName		0..1	string	Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.ages.at/fhir/GRZ
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	1..1	string	Representation defined by the system
coding:substanceSMS	C	0..1	AT_MedicinalProduct_Coding	Active ingredient cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
Slices for extension				Content/Rules for all slices
codeSystemName		0..1	string	Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	1..1	string	Representation defined by the system
strength	ΣC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit) atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Ingredient.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Ingredient.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	required	Pattern: 100000072072 https://ema.europa.eu/fhir/vs/ingredientRole from this IG
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
atLeastOnePresentationOrOneConcentrationInvariant	error	Ingredient.substance.strength	There must be at least one presentation or one concentration. : presentation.count() >=1 or concentration.count() >=1
cod-1	warning	Ingredient.substance.code.concept.coding, Ingredient.substance.code.concept.coding:substancePharos, Ingredient.substance.code.concept.coding:substanceSMS	A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text : code.exists().not() implies display.exists().not()
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()
ident-1	warning	Ingredient.identifier	Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason : 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

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product ing-1: 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
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
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	C	1..1	AT_MedicinalProduct_Identifier	An identifier intended for computation ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
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 Required Pattern: https://www.ages.at/fhir/referenceNumber
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	1..1	Reference(Manufactured item definition | Administrable product definition)	The product which this ingredient is a constituent part of
role		1..1	AT_MedicinalProduct_CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive (ingredient role) Binding: The Ingredient Role Value Set (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 100000072072
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		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).
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)	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		1..1	AT_MedicinalProduct_CodeableConcept	Concept - reference to a terminology or just text
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	C	1..*	AT_MedicinalProduct_Coding	A reference to a code defined by a terminology system Slice: Unordered, Open by value:system cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
coding:substancePharos	C	1..1	AT_MedicinalProduct_Coding	Substance cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
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
codeSystemName		0..1	string	Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://www.ages.at/fhir/GRZ
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
coding:substanceSMS	C	0..1	AT_MedicinalProduct_Coding	Active ingredient cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
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
codeSystemName		0..1	string	Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
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	ΣC	1..1	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit) atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
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, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
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 (reference ingredient) 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 (reference ingredient strength & unit)
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Ingredient.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Ingredient.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Ingredient.identifier.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Ingredient.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
Ingredient.role	required	Pattern: 100000072072 https://ema.europa.eu/fhir/vs/ingredientRole from this IG
Ingredient.function	example	IngredientFunction http://hl7.org/fhir/ValueSet/ingredient-function from the FHIR Standard
Ingredient.manufacturer.role	required	IngredientManufacturerRole http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0 from the FHIR Standard
Ingredient.substance.code	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substance	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
Ingredient.substance.strength.referenceStrength.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
atLeastOnePresentationOrOneConcentrationInvariant	error	Ingredient.substance.strength	There must be at least one presentation or one concentration. : presentation.count() >=1 or concentration.count() >=1
cod-1	warning	Ingredient.substance.code.concept.coding, Ingredient.substance.code.concept.coding:substancePharos, Ingredient.substance.code.concept.coding:substanceSMS	A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text : code.exists().not() implies display.exists().not()
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()
ident-1	warning	Ingredient.identifier	Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason : 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

This structure is derived from Ingredient

Other representations of profile: CSV, Excel, Schematron