Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product strength-required: If product is active, then strength MUST be populated
for		1..*	Reference(PPL Medicinal Product profile | PPL Administrable Product profile | PPL Manufactured Item profile)	Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used
role		1..1	CodeableConcept	Role of the ingredient. Default is 100000072072|Active as PPL data normally only includes active ingredients.
coding
system		0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072050
substance		1..1	BackboneElement	Substance code from EMA SMS
code		1..1	CodeableReference(SubstanceDefinition)	A code or full resource that represents the ingredient substance Binding: EMA SPOR SMS Substances (required)
strength		0..*	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for presentation[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this
presentation[x]:presentationRatio		0..1	Ratio	Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial)
numerator		0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator		1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationRatio		0..1	Ratio	Strength per unit of measurement (20mg/1ml)
numerator		0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator		1..1	SimpleQuantity	Denominator value Binding: EMA SPOR Unit of Measurement (required)
referenceStrength		0..*	BackboneElement	Strenth expressed in terms of a reference substance; reference strength type not distinguished. According to EMA IG, all products need to have reference strentgh (repeating the strentgh, if needed)
substance		1..1	CodeableReference(SubstanceDefinition)	Substance code from EMA SMS Binding: EMA SPOR SMS Substances (required)
Slices for strength[x]		1..1	Ratio, RatioRange, Quantity	Strength expressed in terms of a reference substance Slice: Unordered, Open by type:$this
strength[x]:strengthRatio		0..1	Ratio	Strength expressed in terms of a reference substance
numerator		1..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator		1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
Documentation for this format

Terminology Bindings (Differential)

Constraints

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 strength-required: If product is active, then strength MUST be populated
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
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for	Σ	1..*	Reference(PPL Medicinal Product profile | PPL Administrable Product profile | PPL Manufactured Item profile)	Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used
role	Σ	1..1	CodeableConcept	Role of the ingredient. Default is 100000072072|Active as PPL data normally only includes active ingredients. Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
substance	ΣC	1..1	BackboneElement	Substance code from EMA SMS
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: EMA SPOR SMS Substances (required)
strength	Σ	0..*	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this
presentationRatio			Ratio
presentationRatioRange			RatioRange
presentationCodeableConcept			CodeableConcept
presentationQuantity			Quantity
presentation[x]:presentationRatio	Σ	0..1	Ratio	Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial)
numerator	ΣC	0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationRatio	Σ	0..1	Ratio	Strength per unit of measurement (20mg/1ml)
numerator	ΣC	0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Denominator value Binding: EMA SPOR Unit of Measurement (required)
referenceStrength	Σ	0..*	BackboneElement	Strenth expressed in terms of a reference substance; reference strength type not distinguished. According to EMA IG, all products need to have reference strentgh (repeating the strentgh, if needed)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Substance code from EMA SMS Binding: EMA SPOR SMS Substances (required)
Slices for strength[x]	Σ	1..1		Strength expressed in terms of a reference substance Slice: Unordered, Open by type:$this
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
strength[x]:strengthRatio	Σ	0..1	Ratio	Strength expressed in terms of a reference substance
numerator	ΣC	1..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
Documentation for this format

Terminology Bindings

Constraints

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 strength-required: If product is active, then strength MUST be populated
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	Σ	0..1	Identifier	An identifier or code by which the ingredient can be referenced
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for	Σ	1..*	Reference(PPL Medicinal Product profile | PPL Administrable Product profile | PPL Manufactured Item profile)	Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used
role	Σ	1..1	CodeableConcept	Role of the ingredient. Default is 100000072072|Active as PPL data normally only includes active ingredients. 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	0..*	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	0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072050
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..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).
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	Substance code from EMA SMS
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: EMA SPOR SMS Substances (required)
strength	Σ	0..*	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
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
Slices for presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this
presentationRatio			Ratio
presentationRatioRange			RatioRange
presentationCodeableConcept			CodeableConcept
presentationQuantity			Quantity
presentation[x]:presentationRatio	Σ	0..1	Ratio	Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
numerator	ΣC	0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
textPresentation	Σ	0..1	string	Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationRatio	Σ	0..1	Ratio	Strength per unit of measurement (20mg/1ml)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
numerator	ΣC	0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Denominator value Binding: EMA SPOR Unit of Measurement (required)
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	Strenth expressed in terms of a reference substance; reference strength type not distinguished. According to EMA IG, all products need to have reference strentgh (repeating the strentgh, if needed)
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)	Substance code from EMA SMS Binding: EMA SPOR SMS Substances (required)
Slices for strength[x]	Σ	1..1		Strength expressed in terms of a reference substance Slice: Unordered, Open by type:$this
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
strength[x]:strengthRatio	Σ	0..1	Ratio	Strength expressed in terms of a reference substance
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
numerator	ΣC	1..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
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

Constraints

Summary

Mandatory: 1 element(4 nested mandatory elements)

Structures

This structure refers to these other structures:

• PPL Medicinal Product profile (http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition)
• PPL Administrable Product profile (http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition)
• PPL Manufactured Item profile (http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Ingredient.substance.strength.presentation[x]
• The element 1 is sliced based on the value of Ingredient.substance.strength.concentration[x]
• The element 1 is sliced based on the value of Ingredient.substance.strength.referenceStrength.strength[x]

Name	Flags	Card.	Type	Description & Constraints
Ingredient	C	0..*	Ingredient	An ingredient of a manufactured item or pharmaceutical product strength-required: If product is active, then strength MUST be populated
for		1..*	Reference(PPL Medicinal Product profile | PPL Administrable Product profile | PPL Manufactured Item profile)	Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used
role		1..1	CodeableConcept	Role of the ingredient. Default is 100000072072|Active as PPL data normally only includes active ingredients.
coding
system		0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072050
substance		1..1	BackboneElement	Substance code from EMA SMS
code		1..1	CodeableReference(SubstanceDefinition)	A code or full resource that represents the ingredient substance Binding: EMA SPOR SMS Substances (required)
strength		0..*	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
Slices for presentation[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this
presentation[x]:presentationRatio		0..1	Ratio	Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial)
numerator		0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator		1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
Slices for concentration[x]		0..1	Ratio, RatioRange, CodeableConcept, Quantity	The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentration[x]:concentrationRatio		0..1	Ratio	Strength per unit of measurement (20mg/1ml)
numerator		0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator		1..1	SimpleQuantity	Denominator value Binding: EMA SPOR Unit of Measurement (required)
referenceStrength		0..*	BackboneElement	Strenth expressed in terms of a reference substance; reference strength type not distinguished. According to EMA IG, all products need to have reference strentgh (repeating the strentgh, if needed)
substance		1..1	CodeableReference(SubstanceDefinition)	Substance code from EMA SMS Binding: EMA SPOR SMS Substances (required)
Slices for strength[x]		1..1	Ratio, RatioRange, Quantity	Strength expressed in terms of a reference substance Slice: Unordered, Open by type:$this
strength[x]:strengthRatio		0..1	Ratio	Strength expressed in terms of a reference substance
numerator		1..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator		1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
Documentation for this format

Terminology Bindings (Differential)

Constraints

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 strength-required: If product is active, then strength MUST be populated
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
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for	Σ	1..*	Reference(PPL Medicinal Product profile | PPL Administrable Product profile | PPL Manufactured Item profile)	Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used
role	Σ	1..1	CodeableConcept	Role of the ingredient. Default is 100000072072|Active as PPL data normally only includes active ingredients. Binding: IngredientRole (example): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
substance	ΣC	1..1	BackboneElement	Substance code from EMA SMS
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: EMA SPOR SMS Substances (required)
strength	Σ	0..*	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Slices for presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this
presentationRatio			Ratio
presentationRatioRange			RatioRange
presentationCodeableConcept			CodeableConcept
presentationQuantity			Quantity
presentation[x]:presentationRatio	Σ	0..1	Ratio	Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial)
numerator	ΣC	0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationRatio	Σ	0..1	Ratio	Strength per unit of measurement (20mg/1ml)
numerator	ΣC	0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Denominator value Binding: EMA SPOR Unit of Measurement (required)
referenceStrength	Σ	0..*	BackboneElement	Strenth expressed in terms of a reference substance; reference strength type not distinguished. According to EMA IG, all products need to have reference strentgh (repeating the strentgh, if needed)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Substance code from EMA SMS Binding: EMA SPOR SMS Substances (required)
Slices for strength[x]	Σ	1..1		Strength expressed in terms of a reference substance Slice: Unordered, Open by type:$this
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
strength[x]:strengthRatio	Σ	0..1	Ratio	Strength expressed in terms of a reference substance
numerator	ΣC	1..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
Documentation for this format

Terminology Bindings

Constraints

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 strength-required: If product is active, then strength MUST be populated
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	Σ	0..1	Identifier	An identifier or code by which the ingredient can be referenced
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
for	Σ	1..*	Reference(PPL Medicinal Product profile | PPL Administrable Product profile | PPL Manufactured Item profile)	Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used
role	Σ	1..1	CodeableConcept	Role of the ingredient. Default is 100000072072|Active as PPL data normally only includes active ingredients. 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	0..*	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	0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072050
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..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).
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	Substance code from EMA SMS
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: EMA SPOR SMS Substances (required)
strength	Σ	0..*	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
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
Slices for presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this
presentationRatio			Ratio
presentationRatioRange			RatioRange
presentationCodeableConcept			CodeableConcept
presentationQuantity			Quantity
presentation[x]:presentationRatio	Σ	0..1	Ratio	Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
numerator	ΣC	0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
textPresentation	Σ	0..1	string	Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
Slices for concentration[x]	Σ	0..1		The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
concentration[x]:concentrationRatio	Σ	0..1	Ratio	Strength per unit of measurement (20mg/1ml)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
numerator	ΣC	0..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Denominator value Binding: EMA SPOR Unit of Measurement (required)
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	Strenth expressed in terms of a reference substance; reference strength type not distinguished. According to EMA IG, all products need to have reference strentgh (repeating the strentgh, if needed)
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)	Substance code from EMA SMS Binding: EMA SPOR SMS Substances (required)
Slices for strength[x]	Σ	1..1		Strength expressed in terms of a reference substance Slice: Unordered, Open by type:$this
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
strength[x]:strengthRatio	Σ	0..1	Ratio	Strength expressed in terms of a reference substance
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
numerator	ΣC	1..1	Quantity	Numerator value Binding: EMA SPOR Unit of Measurement (required)
denominator	ΣC	1..1	SimpleQuantity	Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined (required)
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

Constraints

Summary

Mandatory: 1 element(4 nested mandatory elements)

Structures

This structure refers to these other structures:

• PPL Medicinal Product profile (http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition)
• PPL Administrable Product profile (http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition)
• PPL Manufactured Item profile (http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Ingredient.substance.strength.presentation[x]
• The element 1 is sliced based on the value of Ingredient.substance.strength.concentration[x]
• The element 1 is sliced based on the value of Ingredient.substance.strength.referenceStrength.strength[x]