Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. 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/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

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Resource Profile: PackagedProductDefinition - Drug PQ

This PackagedProductDefinition profile represents information about the packaging for a drug product or drug substance.

Usages:

• Use this Profile: Bundle – Container Closure System PQ and Bundle – Drug Product Composition PQ
• Examples for this Profile: PackagedProductDefinition/packagedproductdefinition-drug-pq-ex1

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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
type	SΣ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (preferred)
packageFor	SΣ	0..*	Reference(MedicinalProductDefinition)	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
description	SΣ	0..1	markdown	Textual description. Note that this is not the name of the package or product
packaging	SΣ	0..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	0..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package.
material	SΣ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.
shelfLifeStorage	SΣ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	SΣ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	SΣ	0..*	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Package Property (preferred)
Slices for value[x]	SΣ	0..1		A value for the characteristic Slice: Unordered, Open by type:$this
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
value[x]:valueCodeableConcept	SΣ	0..1	CodeableConcept	A value for the characteristic Binding: Grades (preferred) Additional Bindings Purpose Colors Extensible
value[x]:valueQuantity	SΣ	0..1	Quantity	A value for the characteristic
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
system	ΣC	0..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	ΣC	0..1	code	Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueBoolean	SΣ	0..1	boolean	A value for the characteristic
containedItem	SΣ	0..*	BackboneElement	The item(s) within the packaging
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	SΣ	0..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
PackagedProductDefinition.​type	Base	preferred	Package Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.type	Base	preferred	Packaging Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.material	Base	preferred	Package Material	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.type	Base	preferred	Package Property	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueCodeableConcept	Base	preferred	Grades	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​code	Base	required	UnitsOfMeasureCaseSensitive	📦3.0.0	THO v7.1

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	PackagedProductDefinition	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	PackagedProductDefinition	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	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	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    Filter: Bindings Constraints Obligations
PackagedProductDefinition			PackagedProductDefinition
type	S	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (preferred)
packageFor	S	0..*	Reference(MedicinalProductDefinition)	The product that this is a pack for
description	S	0..1	markdown	Textual description. Note that this is not the name of the package or product
packaging	S	0..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
type	S	0..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package.
material	S	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.
shelfLifeStorage	S	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	S	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	S	0..*	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Package Property (preferred)
Slices for value[x]	S	0..1	CodeableConcept, Quantity, date, boolean, Attachment	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	0..1	CodeableConcept	A value for the characteristic Binding: Grades (preferred) Additional Bindings Purpose Colors Extensible
value[x]:valueQuantity	S	0..1	Quantity	A value for the characteristic
system		0..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code		0..1	code	Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueBoolean	S	0..1	boolean	A value for the characteristic
containedItem	S	0..*	BackboneElement	The item(s) within the packaging
amount	S	0..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	S	0..*		Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
PackagedProductDefinition.​type	Base	preferred	Package Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.type	Base	preferred	Packaging Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.material	Base	preferred	Package Material	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.type	Base	preferred	Package Property	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueCodeableConcept	Base	preferred	Grades	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​code	Base	required	UnitsOfMeasureCaseSensitive	📦3.0.0	THO v7.1

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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	A unique identifier for this package as whole - not for the content of the package
name	Σ	0..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
type	SΣ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (preferred)
packageFor	SΣ	0..*	Reference(MedicinalProductDefinition)	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
description	SΣ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator
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	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
copackagedIndicator	Σ	0..1	boolean	Identifies if the drug product is supplied with another item such as a diluent or adjuvant
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package type (multiple means these are all possible manufacturers)
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the packaged product
packaging	SΣ	0..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
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
identifier	Σ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
type	SΣ	0..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package.
componentPart	Σ	0..1	boolean	Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
quantity	Σ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
material	SΣ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components.
shelfLifeStorage	SΣ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	SΣ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	SΣ	0..*	BackboneElement	General characteristics of this item
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	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Package Property (preferred)
Slices for value[x]	SΣ	0..1		A value for the characteristic Slice: Unordered, Open by type:$this
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
value[x]:valueCodeableConcept	SΣ	0..1	CodeableConcept	A value for the characteristic Binding: Grades (preferred) Additional Bindings Purpose Colors Extensible
value[x]:valueQuantity	SΣ	0..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	ΣC	0..1	code	Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueBoolean	SΣ	0..1	boolean	A value for the characteristic
containedItem	SΣ	0..*	BackboneElement	The item(s) within the packaging
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
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	SΣ	0..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
characteristic	Σ	0..*	See property (PackagedProductDefinition)	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
PackagedProductDefinition.​language	Base	required	All Languages	📍5.0.0	FHIR Std.
PackagedProductDefinition.​type	Base	preferred	Package Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
PackagedProductDefinition.​legalStatusOfSupply.​code	Base	example	Legal Status Of Supply	📍5.0.0	FHIR Std.
PackagedProductDefinition.​legalStatusOfSupply.​jurisdiction	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.type	Base	preferred	Packaging Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.material	Base	preferred	Package Material	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.alternateMaterial	Base	example	Package Material	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.type	Base	preferred	Package Property	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueCodeableConcept	Base	preferred	Grades	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​code	Base	required	UnitsOfMeasureCaseSensitive	📦3.0.0	THO v7.1

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	PackagedProductDefinition	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	PackagedProductDefinition	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	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	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()

Summary

Must-Support: 17 elements

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of PackagedProductDefinition.packaging.property.value[x]

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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
type	SΣ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (preferred)
packageFor	SΣ	0..*	Reference(MedicinalProductDefinition)	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
description	SΣ	0..1	markdown	Textual description. Note that this is not the name of the package or product
packaging	SΣ	0..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	0..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package.
material	SΣ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.
shelfLifeStorage	SΣ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	SΣ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	SΣ	0..*	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Package Property (preferred)
Slices for value[x]	SΣ	0..1		A value for the characteristic Slice: Unordered, Open by type:$this
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
value[x]:valueCodeableConcept	SΣ	0..1	CodeableConcept	A value for the characteristic Binding: Grades (preferred) Additional Bindings Purpose Colors Extensible
value[x]:valueQuantity	SΣ	0..1	Quantity	A value for the characteristic
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
system	ΣC	0..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	ΣC	0..1	code	Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueBoolean	SΣ	0..1	boolean	A value for the characteristic
containedItem	SΣ	0..*	BackboneElement	The item(s) within the packaging
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	SΣ	0..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
PackagedProductDefinition.​type	Base	preferred	Package Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.type	Base	preferred	Packaging Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.material	Base	preferred	Package Material	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.type	Base	preferred	Package Property	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueCodeableConcept	Base	preferred	Grades	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​code	Base	required	UnitsOfMeasureCaseSensitive	📦3.0.0	THO v7.1

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	PackagedProductDefinition	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	PackagedProductDefinition	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	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	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()

Differential View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
PackagedProductDefinition			PackagedProductDefinition
type	S	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (preferred)
packageFor	S	0..*	Reference(MedicinalProductDefinition)	The product that this is a pack for
description	S	0..1	markdown	Textual description. Note that this is not the name of the package or product
packaging	S	0..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
type	S	0..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package.
material	S	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.
shelfLifeStorage	S	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	S	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	S	0..*	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Package Property (preferred)
Slices for value[x]	S	0..1	CodeableConcept, Quantity, date, boolean, Attachment	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	0..1	CodeableConcept	A value for the characteristic Binding: Grades (preferred) Additional Bindings Purpose Colors Extensible
value[x]:valueQuantity	S	0..1	Quantity	A value for the characteristic
system		0..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code		0..1	code	Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueBoolean	S	0..1	boolean	A value for the characteristic
containedItem	S	0..*	BackboneElement	The item(s) within the packaging
amount	S	0..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	S	0..*		Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
PackagedProductDefinition.​type	Base	preferred	Package Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.type	Base	preferred	Packaging Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.material	Base	preferred	Package Material	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.type	Base	preferred	Package Property	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueCodeableConcept	Base	preferred	Grades	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​code	Base	required	UnitsOfMeasureCaseSensitive	📦3.0.0	THO v7.1

Snapshot ViewView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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	A unique identifier for this package as whole - not for the content of the package
name	Σ	0..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
type	SΣ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (preferred)
packageFor	SΣ	0..*	Reference(MedicinalProductDefinition)	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
description	SΣ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator
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	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
copackagedIndicator	Σ	0..1	boolean	Identifies if the drug product is supplied with another item such as a diluent or adjuvant
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package type (multiple means these are all possible manufacturers)
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the packaged product
packaging	SΣ	0..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
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
identifier	Σ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
type	SΣ	0..1	CodeableConcept	The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package.
componentPart	Σ	0..1	boolean	Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
quantity	Σ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
material	SΣ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components.
shelfLifeStorage	SΣ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	SΣ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	SΣ	0..*	BackboneElement	General characteristics of this item
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	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Package Property (preferred)
Slices for value[x]	SΣ	0..1		A value for the characteristic Slice: Unordered, Open by type:$this
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
value[x]:valueCodeableConcept	SΣ	0..1	CodeableConcept	A value for the characteristic Binding: Grades (preferred) Additional Bindings Purpose Colors Extensible
value[x]:valueQuantity	SΣ	0..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code	ΣC	0..1	code	Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueBoolean	SΣ	0..1	boolean	A value for the characteristic
containedItem	SΣ	0..*	BackboneElement	The item(s) within the packaging
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
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	SΣ	0..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
characteristic	Σ	0..*	See property (PackagedProductDefinition)	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
PackagedProductDefinition.​language	Base	required	All Languages	📍5.0.0	FHIR Std.
PackagedProductDefinition.​type	Base	preferred	Package Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
PackagedProductDefinition.​legalStatusOfSupply.​code	Base	example	Legal Status Of Supply	📍5.0.0	FHIR Std.
PackagedProductDefinition.​legalStatusOfSupply.​jurisdiction	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.type	Base	preferred	Packaging Type	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.material	Base	preferred	Package Material	📦5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.alternateMaterial	Base	example	Package Material	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.type	Base	preferred	Package Property	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueCodeableConcept	Base	preferred	Grades	📦1.0.0	This IG
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍5.0.0	FHIR Std.
PackagedProductDefinition.​packaging.property.value[x]:valueQuantity.​code	Base	required	UnitsOfMeasureCaseSensitive	📦3.0.0	THO v7.1

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	PackagedProductDefinition	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	PackagedProductDefinition	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	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	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()

Summary

Must-Support: 17 elements

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of PackagedProductDefinition.packaging.property.value[x]

Other representations of profile: CSV, Excel, Schematron