Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0-ballot. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi | Version: 1.0.0-ballot | |||
| Active as of 2022-12-04 | Computable Name: IngredientUvEpi | |||
Ingredient (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
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 | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced. | |
| status | 1..1 | code | draft|active|retired|unknown | |
 for | 0..* | Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI)) | The product which this ingredient is a constituent part of | |
| role | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (preferred) | |
| 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 | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance Binding: Substances (preferred) | |
| strength | 0..* | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity. | |
| textPresentation | 0..1 | string | Text of either the whole presentation strength or a part of it | |
| textConcentration | 0..1 | string | Text of either the whole concentration strength or a part of it | |
| basis | 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) Binding: Ingredient Role; e.g., inactive, active base, active moiety (preferred) | |
| referenceStrength | ||||
| substance | 0..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: Substances (preferred) | |
| strength[x] | 1..1 | Ratio, RatioRange, Quantity | Strength of the reference substance. | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Ingredient.role | preferred | RoleClassIngredientEntity |
| Ingredient.substance.code | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) |
| Ingredient.substance.strength.basis | preferred | VsRoleClassIngredientEntity |
| Ingredient.substance.strength.referenceStrength.substance | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 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 | 0..* | Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | 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: RoleClassIngredientEntity (preferred) |
| allergenicIndicator | Σ | 0..1 | boolean | If the ingredient is a known or suspected allergen. |
| substance | Σ | 1..1 | BackboneElement | The substance that comprises this ingredient |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code | Σ | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance Binding: Substances (preferred) |
| 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 |
| textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it |
| textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it |
| 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) Binding: Ingredient Role; e.g., inactive, active base, active moiety (preferred) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Ingredient.status | required | PublicationStatus |
| Ingredient.role | preferred | RoleClassIngredientEntity |
| Ingredient.substance.code | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) |
| Ingredient.substance.strength.basis | preferred | VsRoleClassIngredientEntity |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| 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 | 0..* | Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | 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: RoleClassIngredientEntity (preferred) | ||||
| 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 | Σ | 0..1 | boolean | If the ingredient is a known or suspected allergen. | ||||
| 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 | Σ | 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 | Σ | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance Binding: Substances (preferred) | ||||
| 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 | ||||
 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 | ||||
| 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 | ||||
| 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) Binding: Ingredient Role; e.g., inactive, active base, active moiety (preferred) | ||||
| 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: Country ValueSet (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 | 0..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: Substances (preferred) | ||||
| strength[x] | Σ | 1..1 | Strength of the 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: Country ValueSet (example): Jurisdiction codes | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | ||||
| Ingredient.language | preferred | CommonLanguages
| ||||
| Ingredient.status | required | PublicationStatus | ||||
| Ingredient.role | preferred | RoleClassIngredientEntity | ||||
| Ingredient.function | example | IngredientFunction | ||||
| Ingredient.manufacturer.role | required | IngredientManufacturerRole | ||||
| Ingredient.substance.code | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) | ||||
| Ingredient.substance.strength.basis | preferred | VsRoleClassIngredientEntity | ||||
| Ingredient.substance.strength.country | example | Country ValueSet | ||||
| Ingredient.substance.strength.referenceStrength.substance | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) | ||||
| Ingredient.substance.strength.referenceStrength.country | example | Country ValueSet |
This structure is derived from Ingredient
Summary
Structures
This structure refers to these other structures:
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 | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced. | |
| status | 1..1 | code | draft|active|retired|unknown | |
| for | 0..* | Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI)) | The product which this ingredient is a constituent part of | |
| role | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (preferred) | |
| 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 | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance Binding: Substances (preferred) | |
| strength | 0..* | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity. | |
| textPresentation | 0..1 | string | Text of either the whole presentation strength or a part of it | |
| textConcentration | 0..1 | string | Text of either the whole concentration strength or a part of it | |
| basis | 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) Binding: Ingredient Role; e.g., inactive, active base, active moiety (preferred) | |
| referenceStrength | ||||
| substance | 0..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: Substances (preferred) | |
| strength[x] | 1..1 | Ratio, RatioRange, Quantity | Strength of the reference substance. | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Ingredient.role | preferred | RoleClassIngredientEntity |
| Ingredient.substance.code | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) |
| Ingredient.substance.strength.basis | preferred | VsRoleClassIngredientEntity |
| Ingredient.substance.strength.referenceStrength.substance | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| 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 | 0..* | Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | 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: RoleClassIngredientEntity (preferred) |
| allergenicIndicator | Σ | 0..1 | boolean | If the ingredient is a known or suspected allergen. |
| substance | Σ | 1..1 | BackboneElement | The substance that comprises this ingredient |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code | Σ | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance Binding: Substances (preferred) |
| 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 |
| textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it |
| textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it |
| 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) Binding: Ingredient Role; e.g., inactive, active base, active moiety (preferred) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Ingredient.status | required | PublicationStatus |
| Ingredient.role | preferred | RoleClassIngredientEntity |
| Ingredient.substance.code | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) |
| Ingredient.substance.strength.basis | preferred | VsRoleClassIngredientEntity |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| 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 | 0..* | Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | 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: RoleClassIngredientEntity (preferred) | ||||
| 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 | Σ | 0..1 | boolean | If the ingredient is a known or suspected allergen. | ||||
| 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 | Σ | 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 | Σ | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance Binding: Substances (preferred) | ||||
| 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 | ||||
| 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 | ||||
| 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 | ||||
| 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) Binding: Ingredient Role; e.g., inactive, active base, active moiety (preferred) | ||||
| 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: Country ValueSet (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 | 0..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance Binding: Substances (preferred) | ||||
| strength[x] | Σ | 1..1 | Strength of the 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: Country ValueSet (example): Jurisdiction codes | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | ||||
| Ingredient.language | preferred | CommonLanguages
| ||||
| Ingredient.status | required | PublicationStatus | ||||
| Ingredient.role | preferred | RoleClassIngredientEntity | ||||
| Ingredient.function | example | IngredientFunction | ||||
| Ingredient.manufacturer.role | required | IngredientManufacturerRole | ||||
| Ingredient.substance.code | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) | ||||
| Ingredient.substance.strength.basis | preferred | VsRoleClassIngredientEntity | ||||
| Ingredient.substance.strength.country | example | Country ValueSet | ||||
| Ingredient.substance.strength.referenceStrength.substance | preferred | VsSubstance (a valid code from https://gsrs.ncats.nih.gov/ginas/app/beta) | ||||
| Ingredient.substance.strength.referenceStrength.country | example | Country ValueSet |
This structure is derived from Ingredient
Summary
Structures
This structure refers to these other structures:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ . Package hl7.fhir.uv.emedicinal-product-info#1.0.0-ballot based on FHIR 5.0.0-ballot. Generated 2022-12-04
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