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

• Content
• Detailed Descriptions
• Mappings
• XML
• JSON
• TTL

Resource Profile: Administrable/Pharmaceutical Product

Administrable Product data

Usage:

• Refer to this Resource Profile: Ingredient

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

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	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)
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(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)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AdministrableProductDefinition.administrableDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs from this IG
AdministrableProductDefinition.unitOfPresentation	required	UnitOfPresentation (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.code	required	RoutesAndMethodsOfAdministration (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

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	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
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

Terminology Bindings

Path	Conformance	ValueSet	URI
AdministrableProductDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
AdministrableProductDefinition.administrableDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs from this IG
AdministrableProductDefinition.unitOfPresentation	required	UnitOfPresentation (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.code	required	RoutesAndMethodsOfAdministration (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

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 Additional Bindings Purpose CommonLanguages Starter Set
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdministrableProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
AdministrableProductDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
AdministrableProductDefinition.administrableDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs from this IG
AdministrableProductDefinition.unitOfPresentation	required	UnitOfPresentation (a valid code from Unit of Presentation EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs from this IG
AdministrableProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
AdministrableProductDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
AdministrableProductDefinition.property.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
AdministrableProductDefinition.routeOfAdministration.code	required	RoutesAndMethodsOfAdministration (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.code	example	TargetSpecies http://hl7.org/fhir/ValueSet/target-species from the FHIR Standard
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue	example	AnimalTissueType http://hl7.org/fhir/ValueSet/animal-tissue-type from the FHIR Standard

Constraints

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

Summary

Structures

This structure refers to these other structures:

• Medicinal Product (http://unicom-project.eu/fhir/d4-12/StructureDefinition/MedicinalProductD412)
• Manufactured Item (http://unicom-project.eu/fhir/d4-12/StructureDefinition/ManufacturedItemD412)

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	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)
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(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)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AdministrableProductDefinition.administrableDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs from this IG
AdministrableProductDefinition.unitOfPresentation	required	UnitOfPresentation (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.code	required	RoutesAndMethodsOfAdministration (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

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	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
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

Terminology Bindings

Path	Conformance	ValueSet	URI
AdministrableProductDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
AdministrableProductDefinition.administrableDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs from this IG
AdministrableProductDefinition.unitOfPresentation	required	UnitOfPresentation (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.code	required	RoutesAndMethodsOfAdministration (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

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 Additional Bindings Purpose CommonLanguages Starter Set
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdministrableProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
AdministrableProductDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
AdministrableProductDefinition.administrableDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/pharmaceutical-doseform-vs from this IG
AdministrableProductDefinition.unitOfPresentation	required	UnitOfPresentation (a valid code from Unit of Presentation EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs from this IG
AdministrableProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
AdministrableProductDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
AdministrableProductDefinition.property.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
AdministrableProductDefinition.routeOfAdministration.code	required	RoutesAndMethodsOfAdministration (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.code	example	TargetSpecies http://hl7.org/fhir/ValueSet/target-species from the FHIR Standard
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue	example	AnimalTissueType http://hl7.org/fhir/ValueSet/animal-tissue-type from the FHIR Standard

Constraints

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

Summary

Structures

This structure refers to these other structures:

• Medicinal Product (http://unicom-project.eu/fhir/d4-12/StructureDefinition/MedicinalProductD412)
• Manufactured Item (http://unicom-project.eu/fhir/d4-12/StructureDefinition/ManufacturedItemD412)

Other representations of profile: CSV, Excel, Schematron