UnicomIG
0.1.0 - ci-build
UnicomIG
0.1.0 - ci-build
UnicomIG, published by UNICOM. This is not an authorized publication; it is the continuous build for version 0.1.0). This version is based on the current content of https://github.com/hl7-eu/unicom-ig and changes regularly. See the Directory of published versions
| Official URL: http://unicom-project.eu/fhir/StructureDefinition/TransitionIngredient | Version: 0.1.0 | |||
| Active as of 2023-02-03 | 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 | |
 presentationRatio | 0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | |
| 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 | 0..1 | CodeableReference(SubstanceDefinition) | Substance code from EMA SMS Binding: EMA SPOR SMS Substances (example) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) |
| 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 | ?! | 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 | Σ | 1..1 | BackboneElement | Substance code from EMA SMS |
| 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: 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:$this | |
  presentationRatio | Ratio | |||
| presentationRatioRange | RatioRange | |||
  presentation[x]:presentationRatio | Σ | 0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) |
| Slices for concentration[x] | Σ | 0..1 | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this | |
| concentrationRatio | Ratio | |||
| concentrationRatioRange | RatioRange | |||
| 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 | 0..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 | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Ingredient.status | required | PublicationStatus |
| Ingredient.role | example | IngredientRole |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) |
| 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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.allergenicIndicator.where(value='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 | ||||
| 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 | ?! | 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). | ||||
| 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) | An organization that manufactures this ingredient | ||||
| substance | Σ | 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 | Σ | 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:$this | |||||
| presentationRatio | Ratio | |||||||
| presentationRatioRange | RatioRange | |||||||
| presentation[x]:presentationRatio | Σ | 0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | ||||
| textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
| Slices for concentration[x] | Σ | 0..1 | The strength per unitary volume (or mass) Slice: Unordered, Open by type:$this | |||||
| concentrationRatio | Ratio | |||||||
| concentrationRatioRange | RatioRange | |||||||
| 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) | ||||
| 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 | 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 | 0..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 | |||||||
| 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 | example | IngredientRole | ||||
| Ingredient.function | example | IngredientFunction | ||||
| Ingredient.manufacturer.role | required | IngredientManufacturerRole | ||||
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) | ||||
| Ingredient.substance.strength.country | example | Country ValueSet | ||||
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) | ||||
| Ingredient.substance.strength.referenceStrength.country | example | Country ValueSet |
| Id | Grade | Path(s) | Details | Requirements |
| dom-r4b | warning | Ingredient.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| 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() |
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 | |
| 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 | |
| presentationRatio | 0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | |
| 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 | 0..1 | CodeableReference(SubstanceDefinition) | Substance code from EMA SMS Binding: EMA SPOR SMS Substances (example) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) |
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 | ?! | 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 | Σ | 1..1 | BackboneElement | Substance code from EMA SMS |
| 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: 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 | |||
| 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 | |||
| 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 | 0..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 | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Ingredient.status | required | PublicationStatus |
| Ingredient.role | example | IngredientRole |
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) |
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) |
| 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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.allergenicIndicator.where(value='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 | ||||
| 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 | ?! | 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). | ||||
| 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) | An organization that manufactures this ingredient | ||||
| substance | Σ | 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 | Σ | 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 | |||||||
| 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 | |||||||
| 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) | ||||
| 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 | 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 | 0..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 | |||||||
| 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 | example | IngredientRole | ||||
| Ingredient.function | example | IngredientFunction | ||||
| Ingredient.manufacturer.role | required | IngredientManufacturerRole | ||||
| Ingredient.substance.code | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) | ||||
| Ingredient.substance.strength.country | example | Country ValueSet | ||||
| Ingredient.substance.strength.referenceStrength.substance | example | SubstancesSMS (a valid code from Substances EMA SPOR SMS) | ||||
| Ingredient.substance.strength.referenceStrength.country | example | Country ValueSet |
| Id | Grade | Path(s) | Details | Requirements |
| dom-r4b | warning | Ingredient.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| 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() |
This structure is derived from Ingredient
Summary
Structures
This structure refers to these other structures:
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ UNICOM. Package hl7.eu.fhir.unicom#0.1.0 based on FHIR 4.3.0. Generated 2023-02-03
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.
