Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1 International flag

Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12), published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/unicom-project-eu/d4.12/ and changes regularly. See the Directory of published versions

Resource Profile: Administrable/Pharmaceutical Product

Official URL: http://unicom-project.eu/fhir/d4-12/StructureDefinition/AdministrableProductD412 Version: 1.0.0
Draft as of 2024-08-20 Computable Name: AdministrableProductD412

Administrable Product data

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from AdministrableProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..* AdministrableProductDefinition A medicinal product in the final form, suitable for administration - after any mixing of multiple components
... identifier 0..* Identifier An identifier for this particular administrable version of the product (not PhPID)
... formOf 0..* Reference(Medicinal Product) Reference to the Medicinal Product
... administrableDoseForm 0..1 CodeableConcept Dose form of the administrable product (after preparing for administration)
Binding: EMA SPOR Pharmaceutical Dose Form (required)
... producedFrom 0..* Reference(Manufactured Item) References to manufactured items that are used in the preparation of this administrable product
... routeOfAdministration 1..* BackboneElement The path by which the product is taken into or makes contact with the body
.... code 1..1 CodeableConcept Coded expression for the route
Binding: EMA SPOR Routes and Methods of Administration (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs
from this IG
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs
from this IG
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/routes-and-methods-of-administration-vs
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... formOf ΣC 0..* Reference(Medicinal Product) Reference to the Medicinal Product
... administrableDoseForm Σ 0..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(Manufactured Item) 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)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdministrableProductDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs
from this IG
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs
from this IG
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/routes-and-methods-of-administration-vs
from this IG

Constraints

IdGradePath(s)DetailsRequirements
apd-1errorAdministrableProductDefinitionRouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)
: AdministrableProductDefinition.formOf.resolve().route.empty()
dom-2errorAdministrableProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdministrableProductDefinitionIf 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-4errorAdministrableProductDefinitionIf 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-5errorAdministrableProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdministrableProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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 An identifier for this particular administrable version of the product (not PhPID)
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... formOf ΣC 0..* Reference(Medicinal Product) Reference to the Medicinal Product
... administrableDoseForm Σ 0..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(Manufactured Item) 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdministrableProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
AdministrableProductDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs
from this IG
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs
from this IG
AdministrableProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
AdministrableProductDefinition.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
AdministrableProductDefinition.property.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/routes-and-methods-of-administration-vs
from this IG
AdministrableProductDefinition.routeOfAdministration.targetSpecies.codeexampleTargetSpecies
http://hl7.org/fhir/ValueSet/target-species
from the FHIR Standard
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissueexampleAnimalTissueType
http://hl7.org/fhir/ValueSet/animal-tissue-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
apd-1errorAdministrableProductDefinitionRouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)
: AdministrableProductDefinition.formOf.resolve().route.empty()
dom-2errorAdministrableProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdministrableProductDefinitionIf 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-4errorAdministrableProductDefinitionIf 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-5errorAdministrableProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdministrableProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from AdministrableProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..* AdministrableProductDefinition A medicinal product in the final form, suitable for administration - after any mixing of multiple components
... identifier 0..* Identifier An identifier for this particular administrable version of the product (not PhPID)
... formOf 0..* Reference(Medicinal Product) Reference to the Medicinal Product
... administrableDoseForm 0..1 CodeableConcept Dose form of the administrable product (after preparing for administration)
Binding: EMA SPOR Pharmaceutical Dose Form (required)
... producedFrom 0..* Reference(Manufactured Item) References to manufactured items that are used in the preparation of this administrable product
... routeOfAdministration 1..* BackboneElement The path by which the product is taken into or makes contact with the body
.... code 1..1 CodeableConcept Coded expression for the route
Binding: EMA SPOR Routes and Methods of Administration (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs
from this IG
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs
from this IG
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/routes-and-methods-of-administration-vs
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... formOf ΣC 0..* Reference(Medicinal Product) Reference to the Medicinal Product
... administrableDoseForm Σ 0..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(Manufactured Item) 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)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdministrableProductDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs
from this IG
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs
from this IG
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/routes-and-methods-of-administration-vs
from this IG

Constraints

IdGradePath(s)DetailsRequirements
apd-1errorAdministrableProductDefinitionRouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)
: AdministrableProductDefinition.formOf.resolve().route.empty()
dom-2errorAdministrableProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdministrableProductDefinitionIf 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-4errorAdministrableProductDefinitionIf 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-5errorAdministrableProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdministrableProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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 An identifier for this particular administrable version of the product (not PhPID)
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... formOf ΣC 0..* Reference(Medicinal Product) Reference to the Medicinal Product
... administrableDoseForm Σ 0..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(Manufactured Item) 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdministrableProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
AdministrableProductDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs
from this IG
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs
from this IG
AdministrableProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
AdministrableProductDefinition.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
AdministrableProductDefinition.property.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
http://unicom-project.eu/fhir/d4-12/ValueSet/routes-and-methods-of-administration-vs
from this IG
AdministrableProductDefinition.routeOfAdministration.targetSpecies.codeexampleTargetSpecies
http://hl7.org/fhir/ValueSet/target-species
from the FHIR Standard
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissueexampleAnimalTissueType
http://hl7.org/fhir/ValueSet/animal-tissue-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
apd-1errorAdministrableProductDefinitionRouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)
: AdministrableProductDefinition.formOf.resolve().route.empty()
dom-2errorAdministrableProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdministrableProductDefinitionIf 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-4errorAdministrableProductDefinitionIf 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-5errorAdministrableProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdministrableProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

 

Other representations of profile: CSV, Excel, Schematron