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/ and changes regularly. See the Directory of published versions
| Official URL: http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition | Version: 0.1.0 | |||
| Draft as of 2024-06-21 | Computable Name: PPLAdministrableProductDefinition | |||
Administrable product profile defines the ISO IDMP Pharmaceutical Product concept
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from AdministrableProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  AdministrableProductDefinition |
0..* | AdministrableProductDefinition | A medicinal product in the final form, suitable for administration - after any mixing of multiple components | |
  identifier |
0..* | Identifier | Business identifier for the administrable version of this particular product. This should not be the official PhPID. | |
 formOf |
1..* | Reference(PPL Medicinal Product profile) | Reference to the Medicinal Product | |
| administrableDoseForm |
1..1 | CodeableConcept | Dose form of the administrable product (after preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required) | |
| unitOfPresentation |
0..1 | CodeableConcept | Unit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging. Binding: EMA SPOR Unit of Presentation (required) | |
| producedFrom |
0..* | Reference(PPL Manufactured Item profile) | References to manufactured items that are used in the preparation of this administrable product | |
 routeOfAdministration |
||||
  code |
1..1 | CodeableConcept | Coded expression for the route Binding: EMA SPOR Routes and Methods of Administration (required) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdministrableProductDefinition.administrableDoseForm | required | PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vsfrom this IG | |
| AdministrableProductDefinition.unitOfPresentation | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vsfrom this IG | |
| AdministrableProductDefinition.routeOfAdministration.code | required | RoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)http://unicom-project.eu/fhir/ValueSet/routes-and-methods-of-administration-vsfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdministrableProductDefinition |
C | 0..* | AdministrableProductDefinition | A medicinal product in the final form, suitable for administration - after any mixing of multiple components apd-1: RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
 identifier |
Σ | 0..* | Identifier | Business identifier for the administrable version of this particular product. This should not be the official PhPID. |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
| formOf |
ΣC | 1..* | Reference(PPL Medicinal Product profile) | Reference to the Medicinal Product |
| administrableDoseForm |
Σ | 1..1 | CodeableConcept | Dose form of the administrable product (after preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required) |
| unitOfPresentation |
Σ | 0..1 | CodeableConcept | Unit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging. Binding: EMA SPOR Unit of Presentation (required) |
| producedFrom |
Σ | 0..* | Reference(PPL Manufactured Item profile) | References to manufactured items that are used in the preparation of this administrable product |
| routeOfAdministration |
Σ | 1..* | BackboneElement | The path by which the product is taken into or makes contact with the body |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code |
Σ | 1..1 | CodeableConcept | Coded expression for the route Binding: EMA SPOR Routes and Methods of Administration (required) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdministrableProductDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| AdministrableProductDefinition.administrableDoseForm | required | PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vsfrom this IG | |
| AdministrableProductDefinition.unitOfPresentation | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vsfrom this IG | |
| AdministrableProductDefinition.routeOfAdministration.code | required | RoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)http://unicom-project.eu/fhir/ValueSet/routes-and-methods-of-administration-vsfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| apd-1 | error | AdministrableProductDefinition | RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) : AdministrableProductDefinition.formOf.resolve().route.empty() | |
| dom-2 | error | AdministrableProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdministrableProductDefinition | 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 | AdministrableProductDefinition | 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 | AdministrableProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdministrableProductDefinition | 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() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| AdministrableProductDefinition |
C | 0..* | AdministrableProductDefinition | A medicinal product in the final form, suitable for administration - after any mixing of multiple components apd-1: RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) | ||||
| 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..* | Identifier | Business identifier for the administrable version of this particular product. This should not be the official PhPID. | ||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
| formOf |
ΣC | 1..* | Reference(PPL Medicinal Product profile) | Reference to the Medicinal Product | ||||
| administrableDoseForm |
Σ | 1..1 | CodeableConcept | Dose form of the administrable product (after preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required) | ||||
| unitOfPresentation |
Σ | 0..1 | CodeableConcept | Unit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging. Binding: EMA SPOR Unit of Presentation (required) | ||||
| producedFrom |
Σ | 0..* | Reference(PPL Manufactured Item profile) | References to manufactured items that are used in the preparation of this administrable product | ||||
| ingredient |
Σ | 0..* | CodeableConcept | The ingredients of this administrable medicinal product. This is only needed if the ingredients are not specified either using ManufacturedItemDefiniton, or using by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| device |
Σ | 0..1 | Reference(DeviceDefinition) | A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product | ||||
| description |
0..1 | markdown | A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed | |||||
 property |
Σ | 0..* | BackboneElement | Characteristics e.g. a product's onset of action | ||||
 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 | ||||
| type |
Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
 value[x] |
Σ | 0..1 | A value for the characteristic | |||||
| valueCodeableConcept |
CodeableConcept | |||||||
| valueQuantity |
Quantity | |||||||
| valueDate |
date | |||||||
| valueBoolean |
boolean | |||||||
| valueMarkdown |
markdown | |||||||
| valueAttachment |
Attachment | |||||||
| valueReference |
Reference(Binary) | |||||||
| status |
Σ | 0..1 | CodeableConcept | The status of characteristic e.g. assigned or pending Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
| routeOfAdministration |
Σ | 1..* | BackboneElement | The path by which the product is taken into or makes contact with the body | ||||
| 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 | CodeableConcept | Coded expression for the route Binding: EMA SPOR Routes and Methods of Administration (required) | ||||
| firstDose |
Σ | 0..1 | Quantity | The first dose (dose quantity) administered can be specified for the product | ||||
| maxSingleDose |
Σ | 0..1 | Quantity | The maximum single dose that can be administered | ||||
| maxDosePerDay |
Σ | 0..1 | Quantity | The maximum dose quantity to be administered in any one 24-h period | ||||
| maxDosePerTreatmentPeriod |
Σ | 0..1 | Ratio | The maximum dose per treatment period that can be administered | ||||
| maxTreatmentPeriod |
Σ | 0..1 | Duration | The maximum treatment period during which the product can be administered | ||||
| targetSpecies |
Σ | 0..* | BackboneElement | A species for which this route applies | ||||
| 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 | CodeableConcept | Coded expression for the species Binding: TargetSpecies (example): A tissue type of an animal. | ||||
| withdrawalPeriod |
Σ | 0..* | BackboneElement | A species specific time during which consumption of animal product is not appropriate | ||||
| 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 | ||||
| tissue |
Σ | 1..1 | CodeableConcept | The type of tissue for which the withdrawal period applies, e.g. meat, milk Binding: AnimalTissueType (example): A tissue type of an animal. | ||||
| value |
Σ | 1..1 | Quantity | A value for the time | ||||
| supportingInformation |
Σ | 0..1 | string | Extra information about the withdrawal period | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| AdministrableProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| AdministrableProductDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| AdministrableProductDefinition.administrableDoseForm | required | PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vsfrom this IG | |
| AdministrableProductDefinition.unitOfPresentation | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vsfrom this IG | |
| AdministrableProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| AdministrableProductDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard | |
| AdministrableProductDefinition.property.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| AdministrableProductDefinition.routeOfAdministration.code | required | RoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)http://unicom-project.eu/fhir/ValueSet/routes-and-methods-of-administration-vsfrom this IG | |
| AdministrableProductDefinition.routeOfAdministration.targetSpecies.code | example | TargetSpecieshttp://hl7.org/fhir/ValueSet/target-speciesfrom the FHIR Standard | |
| AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue | example | AnimalTissueTypehttp://hl7.org/fhir/ValueSet/animal-tissue-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| apd-1 | error | AdministrableProductDefinition | RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) : AdministrableProductDefinition.formOf.resolve().route.empty() | |
| dom-2 | error | AdministrableProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdministrableProductDefinition | 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 | AdministrableProductDefinition | 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 | AdministrableProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdministrableProductDefinition | 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() |
This structure is derived from AdministrableProductDefinition
Differential View
This structure is derived from AdministrableProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdministrableProductDefinition |
0..* | AdministrableProductDefinition | A medicinal product in the final form, suitable for administration - after any mixing of multiple components | |
| identifier |
0..* | Identifier | Business identifier for the administrable version of this particular product. This should not be the official PhPID. | |
| formOf |
1..* | Reference(PPL Medicinal Product profile) | Reference to the Medicinal Product | |
| administrableDoseForm |
1..1 | CodeableConcept | Dose form of the administrable product (after preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required) | |
| unitOfPresentation |
0..1 | CodeableConcept | Unit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging. Binding: EMA SPOR Unit of Presentation (required) | |
| producedFrom |
0..* | Reference(PPL Manufactured Item profile) | References to manufactured items that are used in the preparation of this administrable product | |
| routeOfAdministration |
||||
| code |
1..1 | CodeableConcept | Coded expression for the route Binding: EMA SPOR Routes and Methods of Administration (required) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdministrableProductDefinition.administrableDoseForm | required | PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vsfrom this IG | |
| AdministrableProductDefinition.unitOfPresentation | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vsfrom this IG | |
| AdministrableProductDefinition.routeOfAdministration.code | required | RoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)http://unicom-project.eu/fhir/ValueSet/routes-and-methods-of-administration-vsfrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdministrableProductDefinition |
C | 0..* | AdministrableProductDefinition | A medicinal product in the final form, suitable for administration - after any mixing of multiple components apd-1: RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier |
Σ | 0..* | Identifier | Business identifier for the administrable version of this particular product. This should not be the official PhPID. |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
| formOf |
ΣC | 1..* | Reference(PPL Medicinal Product profile) | Reference to the Medicinal Product |
| administrableDoseForm |
Σ | 1..1 | CodeableConcept | Dose form of the administrable product (after preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required) |
| unitOfPresentation |
Σ | 0..1 | CodeableConcept | Unit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging. Binding: EMA SPOR Unit of Presentation (required) |
| producedFrom |
Σ | 0..* | Reference(PPL Manufactured Item profile) | References to manufactured items that are used in the preparation of this administrable product |
| routeOfAdministration |
Σ | 1..* | BackboneElement | The path by which the product is taken into or makes contact with the body |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code |
Σ | 1..1 | CodeableConcept | Coded expression for the route Binding: EMA SPOR Routes and Methods of Administration (required) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdministrableProductDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| AdministrableProductDefinition.administrableDoseForm | required | PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vsfrom this IG | |
| AdministrableProductDefinition.unitOfPresentation | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vsfrom this IG | |
| AdministrableProductDefinition.routeOfAdministration.code | required | RoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)http://unicom-project.eu/fhir/ValueSet/routes-and-methods-of-administration-vsfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| apd-1 | error | AdministrableProductDefinition | RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) : AdministrableProductDefinition.formOf.resolve().route.empty() | |
| dom-2 | error | AdministrableProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdministrableProductDefinition | 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 | AdministrableProductDefinition | 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 | AdministrableProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdministrableProductDefinition | 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| AdministrableProductDefinition |
C | 0..* | AdministrableProductDefinition | A medicinal product in the final form, suitable for administration - after any mixing of multiple components apd-1: RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) | ||||
| 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..* | Identifier | Business identifier for the administrable version of this particular product. This should not be the official PhPID. | ||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
| formOf |
ΣC | 1..* | Reference(PPL Medicinal Product profile) | Reference to the Medicinal Product | ||||
| administrableDoseForm |
Σ | 1..1 | CodeableConcept | Dose form of the administrable product (after preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required) | ||||
| unitOfPresentation |
Σ | 0..1 | CodeableConcept | Unit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging. Binding: EMA SPOR Unit of Presentation (required) | ||||
| producedFrom |
Σ | 0..* | Reference(PPL Manufactured Item profile) | References to manufactured items that are used in the preparation of this administrable product | ||||
| ingredient |
Σ | 0..* | CodeableConcept | The ingredients of this administrable medicinal product. This is only needed if the ingredients are not specified either using ManufacturedItemDefiniton, or using by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| device |
Σ | 0..1 | Reference(DeviceDefinition) | A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product | ||||
| description |
0..1 | markdown | A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed | |||||
| property |
Σ | 0..* | BackboneElement | Characteristics e.g. a product's onset of action | ||||
| 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 | ||||
| type |
Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
| value[x] |
Σ | 0..1 | A value for the characteristic | |||||
| valueCodeableConcept |
CodeableConcept | |||||||
| valueQuantity |
Quantity | |||||||
| valueDate |
date | |||||||
| valueBoolean |
boolean | |||||||
| valueMarkdown |
markdown | |||||||
| valueAttachment |
Attachment | |||||||
| valueReference |
Reference(Binary) | |||||||
| status |
Σ | 0..1 | CodeableConcept | The status of characteristic e.g. assigned or pending Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
| routeOfAdministration |
Σ | 1..* | BackboneElement | The path by which the product is taken into or makes contact with the body | ||||
| 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 | CodeableConcept | Coded expression for the route Binding: EMA SPOR Routes and Methods of Administration (required) | ||||
| firstDose |
Σ | 0..1 | Quantity | The first dose (dose quantity) administered can be specified for the product | ||||
| maxSingleDose |
Σ | 0..1 | Quantity | The maximum single dose that can be administered | ||||
| maxDosePerDay |
Σ | 0..1 | Quantity | The maximum dose quantity to be administered in any one 24-h period | ||||
| maxDosePerTreatmentPeriod |
Σ | 0..1 | Ratio | The maximum dose per treatment period that can be administered | ||||
| maxTreatmentPeriod |
Σ | 0..1 | Duration | The maximum treatment period during which the product can be administered | ||||
| targetSpecies |
Σ | 0..* | BackboneElement | A species for which this route applies | ||||
| 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 | CodeableConcept | Coded expression for the species Binding: TargetSpecies (example): A tissue type of an animal. | ||||
| withdrawalPeriod |
Σ | 0..* | BackboneElement | A species specific time during which consumption of animal product is not appropriate | ||||
| 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 | ||||
| tissue |
Σ | 1..1 | CodeableConcept | The type of tissue for which the withdrawal period applies, e.g. meat, milk Binding: AnimalTissueType (example): A tissue type of an animal. | ||||
| value |
Σ | 1..1 | Quantity | A value for the time | ||||
| supportingInformation |
Σ | 0..1 | string | Extra information about the withdrawal period | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| AdministrableProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| AdministrableProductDefinition.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| AdministrableProductDefinition.administrableDoseForm | required | PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vsfrom this IG | |
| AdministrableProductDefinition.unitOfPresentation | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vsfrom this IG | |
| AdministrableProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| AdministrableProductDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard | |
| AdministrableProductDefinition.property.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| AdministrableProductDefinition.routeOfAdministration.code | required | RoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)http://unicom-project.eu/fhir/ValueSet/routes-and-methods-of-administration-vsfrom this IG | |
| AdministrableProductDefinition.routeOfAdministration.targetSpecies.code | example | TargetSpecieshttp://hl7.org/fhir/ValueSet/target-speciesfrom the FHIR Standard | |
| AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue | example | AnimalTissueTypehttp://hl7.org/fhir/ValueSet/animal-tissue-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| apd-1 | error | AdministrableProductDefinition | RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) : AdministrableProductDefinition.formOf.resolve().route.empty() | |
| dom-2 | error | AdministrableProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdministrableProductDefinition | 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 | AdministrableProductDefinition | 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 | AdministrableProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdministrableProductDefinition | 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() |
This structure is derived from AdministrableProductDefinition
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 2024-06-21
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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.
