UnicomIG
0.1.0 - ci-build
UnicomIG
0.1.0 - ci-build
UnicomIG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/unicom-ig/tree/master and changes regularly. See the Directory of published versions
| Official URL: http://unicom-project.eu/fhir/StructureDefinition/TransitionIngredient | Version: 0.1.0 | |||
| Draft as of 2024-10-11 | Computable Name: TransitionIngredient | |||
Intermediate profile for processing PPL Ingredient data
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 | |
  for |
0..* | Reference(Processing Profile - Medicinal Product | Processing Profile - Administrable Product | Processing Profile - Manufactured Item) | Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used | |
 role |
1..1 | CodeableConcept | Role of the ingredient. PPL data normally only includes active ingredients. | |
 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 (example) | |
| 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:$this | |
   presentation[x]:presentationRatio |
0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | |
| Slices for concentration[x] |
0..1 | Ratio, RatioRange, CodeableConcept, Quantity | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this | |
| concentration[x]:concentrationRatio |
0..1 | Ratio | Strength per unit of measurement (20mg/1ml) | |
| 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 (example) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG | |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG |
| 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 |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
| for |
Σ | 0..* | Reference(Processing Profile - Medicinal Product | Processing Profile - Administrable Product | Processing Profile - Manufactured Item) | 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. 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 (example) |
| 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:$this | |
 presentationRatio |
Ratio | |||
| presentationRatioRange |
RatioRange | |||
| presentationCodeableConcept |
CodeableConcept | |||
| presentationQuantity |
Quantity | |||
| presentation[x]:presentationRatio |
Σ | 0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) |
| Slices for concentration[x] |
Σ | 0..1 | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this | |
| concentrationRatio |
Ratio | |||
| concentrationRatioRange |
RatioRange | |||
| concentrationCodeableConcept |
CodeableConcept | |||
| concentrationQuantity |
Quantity | |||
| concentration[x]:concentrationRatio |
Σ | 0..1 | Ratio | Strength per unit of measurement (20mg/1ml) |
| 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 (example) |
 strength[x] |
Σ | 1..1 | Strength expressed in terms of a reference substance | |
| strengthRatio |
Ratio | |||
| strengthRatioRange |
RatioRange | |||
| strengthQuantity |
Quantity | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | example | IngredientRolehttp://hl7.org/fhir/ValueSet/ingredient-rolefrom the FHIR Standard | |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG | |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ing-1 | error | Ingredient | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
| 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
| |||||
| 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(Processing Profile - Medicinal Product | Processing Profile - Administrable Product | Processing Profile - Manufactured Item) | 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. 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. | ||||
| 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 (example) | ||||
| 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:$this | |||||
| presentationRatio |
Ratio | |||||||
| presentationRatioRange |
RatioRange | |||||||
| presentationCodeableConcept |
CodeableConcept | |||||||
| presentationQuantity |
Quantity | |||||||
| presentation[x]:presentationRatio |
Σ | 0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | ||||
| textPresentation |
Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
| Slices for concentration[x] |
Σ | 0..1 | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this | |||||
| concentrationRatio |
Ratio | |||||||
| concentrationRatioRange |
RatioRange | |||||||
| concentrationCodeableConcept |
CodeableConcept | |||||||
| concentrationQuantity |
Quantity | |||||||
| concentration[x]:concentrationRatio |
Σ | 0..1 | Ratio | Strength per unit of measurement (20mg/1ml) | ||||
| 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 (example) | ||||
| strength[x] |
Σ | 1..1 | Strength expressed in terms of a reference substance | |||||
| strengthRatio |
Ratio | |||||||
| strengthRatioRange |
RatioRange | |||||||
| strengthQuantity |
Quantity | |||||||
| measurementPoint |
Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
| country |
Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| Ingredient.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | example | IngredientRolehttp://hl7.org/fhir/ValueSet/ingredient-rolefrom the FHIR Standard | |
| Ingredient.function | example | IngredientFunctionhttp://hl7.org/fhir/ValueSet/ingredient-functionfrom the FHIR Standard | |
| Ingredient.manufacturer.role | required | IngredientManufacturerRolehttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0from the FHIR Standard | |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG | |
| Ingredient.substance.strength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG | |
| Ingredient.substance.strength.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ing-1 | error | Ingredient | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
This structure is derived from Ingredient
Summary
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
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 | |
| for |
0..* | Reference(Processing Profile - Medicinal Product | Processing Profile - Administrable Product | Processing Profile - Manufactured Item) | Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used | |
| role |
1..1 | CodeableConcept | Role of the ingredient. PPL data normally only includes active ingredients. | |
| 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 (example) | |
| 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:$this | |
| presentation[x]:presentationRatio |
0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | |
| Slices for concentration[x] |
0..1 | Ratio, RatioRange, CodeableConcept, Quantity | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this | |
| concentration[x]:concentrationRatio |
0..1 | Ratio | Strength per unit of measurement (20mg/1ml) | |
| 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 (example) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG | |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG |
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 |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
| for |
Σ | 0..* | Reference(Processing Profile - Medicinal Product | Processing Profile - Administrable Product | Processing Profile - Manufactured Item) | 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. 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 (example) |
| 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:$this | |
| presentationRatio |
Ratio | |||
| presentationRatioRange |
RatioRange | |||
| presentationCodeableConcept |
CodeableConcept | |||
| presentationQuantity |
Quantity | |||
| presentation[x]:presentationRatio |
Σ | 0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) |
| Slices for concentration[x] |
Σ | 0..1 | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this | |
| concentrationRatio |
Ratio | |||
| concentrationRatioRange |
RatioRange | |||
| concentrationCodeableConcept |
CodeableConcept | |||
| concentrationQuantity |
Quantity | |||
| concentration[x]:concentrationRatio |
Σ | 0..1 | Ratio | Strength per unit of measurement (20mg/1ml) |
| 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 (example) |
| strength[x] |
Σ | 1..1 | Strength expressed in terms of a reference substance | |
| strengthRatio |
Ratio | |||
| strengthRatioRange |
RatioRange | |||
| strengthQuantity |
Quantity | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | example | IngredientRolehttp://hl7.org/fhir/ValueSet/ingredient-rolefrom the FHIR Standard | |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG | |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ing-1 | error | Ingredient | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
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
| |||||
| 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(Processing Profile - Medicinal Product | Processing Profile - Administrable Product | Processing Profile - Manufactured Item) | 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. 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. | ||||
| 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 (example) | ||||
| 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:$this | |||||
| presentationRatio |
Ratio | |||||||
| presentationRatioRange |
RatioRange | |||||||
| presentationCodeableConcept |
CodeableConcept | |||||||
| presentationQuantity |
Quantity | |||||||
| presentation[x]:presentationRatio |
Σ | 0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | ||||
| textPresentation |
Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
| Slices for concentration[x] |
Σ | 0..1 | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this | |||||
| concentrationRatio |
Ratio | |||||||
| concentrationRatioRange |
RatioRange | |||||||
| concentrationCodeableConcept |
CodeableConcept | |||||||
| concentrationQuantity |
Quantity | |||||||
| concentration[x]:concentrationRatio |
Σ | 0..1 | Ratio | Strength per unit of measurement (20mg/1ml) | ||||
| 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 (example) | ||||
| strength[x] |
Σ | 1..1 | Strength expressed in terms of a reference substance | |||||
| strengthRatio |
Ratio | |||||||
| strengthRatioRange |
RatioRange | |||||||
| strengthQuantity |
Quantity | |||||||
| measurementPoint |
Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
| country |
Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| Ingredient.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Ingredient.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | example | IngredientRolehttp://hl7.org/fhir/ValueSet/ingredient-rolefrom the FHIR Standard | |
| Ingredient.function | example | IngredientFunctionhttp://hl7.org/fhir/ValueSet/ingredient-functionfrom the FHIR Standard | |
| Ingredient.manufacturer.role | required | IngredientManufacturerRolehttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0from the FHIR Standard | |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG | |
| Ingredient.substance.strength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS)http://unicom-project.eu/fhir/ValueSet/substances-vsfrom this IG | |
| Ingredient.substance.strength.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ing-1 | error | Ingredient | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
This structure is derived from Ingredient
Summary
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ UNICOM. Package hl7.eu.fhir.unicom#0.1.0 based on FHIR 5.0.0. Generated 2024-10-11
Links: Table of Contents |
QA Report
The UNICOM Innovation Action has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No. 875299.
