Profile_R5_PackagedProductDefinition_R4B - Extensions for Using Data Elements from FHIR R5 in FHIR R4B v0.1.0

Logical id of this artifact

Meta

Metadata about the resource

implicitRules

?!Σ

0..1

uri

A set of rules under which this content was created

language

0..1

Language of the resource content
Binding: CommonLanguages (preferred): IETF language tag

Additional Bindings

Purpose

AllLanguages

Max Binding

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
Constraints: dom-r4b

0..*

extension:attachedDocument

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

0..*

Reference(Cross-version Profile for R5.DocumentReference for use in FHIR R4B(0.1.0) | Media)

R5: Additional information or supporting documentation about the packaged product (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.attachedDocument
Constraints: ext-1

?!

0..*

Extensions that cannot be ignored
Constraints: ext-1

Σ

0..*

A unique identifier for this package as whole

name

Σ

0..1

A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc

Σ

0..1

Reference(MedicinalProductDefinition)

A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.

packageFor

Σ

0..*

The product that this is a pack for

status

?!Σ

0..1

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..*

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

description

Σ

0..1

markdown

Textual description. Note that this is not the name of the package or product

legalStatusOfSupply

Σ

0..*

The legal status of supply of the packaged item as classified by the regulator

id

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

Σ

0..1

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

The place where the legal status of supply applies
Binding: Jurisdiction ValueSet (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

characteristic

Σ

0..*

Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Binding: PackageCharacteristic (example): A characteristic of a package.

copackagedIndicator

Σ

0..1

If the drug product is supplied with another item such as a diluent or adjuvant

Σ

0..*

Manufacturer of this package type (multiple means these are all possible manufacturers)

Σ

0..1

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

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:componentPart

0..1

R5: 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) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.componentPart
Constraints: ext-1

extension:packaging

0..*

(Complex)

R5: Allows containers (and parts of containers) within containers, still as a part of single packaged product (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

Σ

0..*

An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier

Σ

0..1

The physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.

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

Σ

0..*

Material type of the package item
Binding: PackageMaterial (example): A material used in the construction of packages and their components.

alternateMaterial

Σ

0..*

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

Σ

0..*

Shelf Life and storage information

id

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

Σ

0..1

This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified

period[x]

Σ

0..1

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used

periodDuration

Duration

periodString

specialPrecautionsForStorage

Σ

0..*

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified

Σ

0..*

Manufacturer of this package Item (multiple means these are all possible manufacturers)

property

Σ

0..*

General characteristics of this item

id

0..1

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:value

0..1

CodeableConcept, Quantity, date, boolean, Attachment

R5: A value for the characteristic (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.property.value
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

Σ

1..1

A code expressing the type of characteristic
Binding: product-characteristic-codes (??) (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

valueQuantity

valueDate

valueBoolean

valueAttachment

Σ

0..*

The item(s) within the packaging

id

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

item

Σ

1..1

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

id

0..1

Unique id for inter-element referencing

0..*

CodeableReference(Cross-version Profile for R5.NutritionProduct for use in FHIR R4B(0.1.0) | NutritionProduct)

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:item

1..1

R5: item additional types
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.containedItem.item
Constraints: ext-1

concept

Σ

0..1

Reference to a concept (by class)

reference

Σ

0..1

Reference()

Reference to a resource (by instance)

amount

Σ

0..1

The number of this type of item within this packaging

Documentation for this format

Σ

0..*

See package (PackagedProductDefinition)

Allows containers (and parts of containers) within containers, still a single packaged product

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
PackagedProductDefinition.language	Base	preferred	Common Languages	📍4.3.0	FHIR Std.
PackagedProductDefinition.type	Base	example	PackageType	📍4.3.0	FHIR Std.
PackagedProductDefinition.status	Base	preferred	PublicationStatus	📍4.3.0	FHIR Std.
PackagedProductDefinition.legalStatusOfSupply.code	Base	example	LegalStatusOfSupply	📍4.3.0	FHIR Std.
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	Base	example	Jurisdiction	📍4.3.0	FHIR Std.
PackagedProductDefinition.characteristic	Base	example	PackageCharacteristic	📍4.3.0	FHIR Std.
PackagedProductDefinition.package.type	Base	example	PackagingType	📍4.3.0	FHIR Std.
PackagedProductDefinition.package.material	Base	example	PackageMaterial	📍4.3.0	FHIR Std.
PackagedProductDefinition.package.alternateMaterial	Base	example	PackageMaterial	📍4.3.0	FHIR Std.
PackagedProductDefinition.package.property.type	Base	example	http://hl7.org/fhir/ValueSet/product-characteristic-codes	Not State	Unknown

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.exists() and ('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	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()
dom-r4b	warning	PackagedProductDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems	($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1	error	PackagedProductDefinition.meta, PackagedProductDefinition.implicitRules, PackagedProductDefinition.language, PackagedProductDefinition.text, PackagedProductDefinition.extension, PackagedProductDefinition.extension:attachedDocument, PackagedProductDefinition.modifierExtension, PackagedProductDefinition.identifier, PackagedProductDefinition.name, PackagedProductDefinition.type, PackagedProductDefinition.packageFor, PackagedProductDefinition.status, PackagedProductDefinition.statusDate, PackagedProductDefinition.containedItemQuantity, PackagedProductDefinition.description, PackagedProductDefinition.legalStatusOfSupply, PackagedProductDefinition.legalStatusOfSupply.extension, PackagedProductDefinition.legalStatusOfSupply.modifierExtension, PackagedProductDefinition.legalStatusOfSupply.code, PackagedProductDefinition.legalStatusOfSupply.jurisdiction, PackagedProductDefinition.marketingStatus, PackagedProductDefinition.characteristic, PackagedProductDefinition.copackagedIndicator, PackagedProductDefinition.manufacturer, PackagedProductDefinition.package, PackagedProductDefinition.package.extension, PackagedProductDefinition.package.extension:componentPart, PackagedProductDefinition.package.extension:packaging, PackagedProductDefinition.package.modifierExtension, PackagedProductDefinition.package.identifier, PackagedProductDefinition.package.type, PackagedProductDefinition.package.quantity, PackagedProductDefinition.package.material, PackagedProductDefinition.package.alternateMaterial, PackagedProductDefinition.package.shelfLifeStorage, PackagedProductDefinition.package.shelfLifeStorage.extension, PackagedProductDefinition.package.shelfLifeStorage.modifierExtension, PackagedProductDefinition.package.shelfLifeStorage.type, PackagedProductDefinition.package.shelfLifeStorage.period[x], PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage, PackagedProductDefinition.package.manufacturer, PackagedProductDefinition.package.property, PackagedProductDefinition.package.property.extension, PackagedProductDefinition.package.property.extension:value, PackagedProductDefinition.package.property.modifierExtension, PackagedProductDefinition.package.property.type, PackagedProductDefinition.package.property.value[x], PackagedProductDefinition.package.containedItem, PackagedProductDefinition.package.containedItem.extension, PackagedProductDefinition.package.containedItem.modifierExtension, PackagedProductDefinition.package.containedItem.item, PackagedProductDefinition.package.containedItem.item.extension, PackagedProductDefinition.package.containedItem.item.extension:item, PackagedProductDefinition.package.containedItem.item.concept, PackagedProductDefinition.package.containedItem.item.reference, PackagedProductDefinition.package.containedItem.amount, PackagedProductDefinition.package.package	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
ext-1	error	PackagedProductDefinition.extension, PackagedProductDefinition.extension:attachedDocument, PackagedProductDefinition.modifierExtension, PackagedProductDefinition.legalStatusOfSupply.extension, PackagedProductDefinition.legalStatusOfSupply.modifierExtension, PackagedProductDefinition.package.extension, PackagedProductDefinition.package.extension:componentPart, PackagedProductDefinition.package.extension:packaging, PackagedProductDefinition.package.modifierExtension, PackagedProductDefinition.package.shelfLifeStorage.extension, PackagedProductDefinition.package.shelfLifeStorage.modifierExtension, PackagedProductDefinition.package.property.extension, PackagedProductDefinition.package.property.extension:value, PackagedProductDefinition.package.property.modifierExtension, PackagedProductDefinition.package.containedItem.extension, PackagedProductDefinition.package.containedItem.modifierExtension, PackagedProductDefinition.package.containedItem.item.extension, PackagedProductDefinition.package.containedItem.item.extension:item	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`

This structure is derived from PackagedProductDefinition

Summary

Extensions

This structure refers to these extensions:

Maturity: 0

Key Elements View

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
PackagedProductDefinition		0..*	PackagedProductDefinition(4.3.0)	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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:attachedDocument		0..*	Reference(Cross-version Profile for R5.DocumentReference for use in FHIR R4B(0.1.0) \| Media)	R5: Additional information or supporting documentation about the packaged product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.attachedDocument Constraints: ext-1
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
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.
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
PackagedProductDefinition.status	Base	preferred	PublicationStatus	📍4.3.0	FHIR Std.

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.exists() and ('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	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	PackagedProductDefinition.implicitRules, PackagedProductDefinition.extension, PackagedProductDefinition.extension:attachedDocument, PackagedProductDefinition.modifierExtension, PackagedProductDefinition.status	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
ext-1	error	PackagedProductDefinition.extension, PackagedProductDefinition.extension:attachedDocument, PackagedProductDefinition.modifierExtension	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`

Differential View

This structure is derived from PackagedProductDefinition

Name	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
PackagedProductDefinition	0..*	PackagedProductDefinition(4.3.0)	A medically related item or items, in a container or package
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:attachedDocument	0..*	Reference(Cross-version Profile for R5.DocumentReference for use in FHIR R4B(0.1.0) \| Media)	R5: Additional information or supporting documentation about the packaged product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.attachedDocument
package
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:componentPart	0..1	boolean	R5: 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) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.componentPart
extension:packaging	0..*	(Complex)	R5: Allows containers (and parts of containers) within containers, still as a part of single packaged product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging
property
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:value	0..1	CodeableConcept, Quantity, date, boolean, Attachment	R5: A value for the characteristic (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.property.value
containedItem
item
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:item	0..1	CodeableReference(Cross-version Profile for R5.NutritionProduct for use in FHIR R4B(0.1.0) \| NutritionProduct)	R5: item additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.containedItem.item
Documentation for this format

Snapshot View

Description & Constraints Filter: Filters

PackagedProductDefinition

0..*

PackagedProductDefinition(4.3.0)

A medically related item or items, in a container or package

id

Σ

0..1

Logical id of this artifact

Meta

Metadata about the resource

implicitRules

?!Σ

0..1

uri

A set of rules under which this content was created

language

0..1

Language of the resource content
Binding: CommonLanguages (preferred): IETF language tag

Additional Bindings

Purpose

AllLanguages

Max Binding

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
Constraints: dom-r4b

0..*

extension:attachedDocument

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

0..*

Reference(Cross-version Profile for R5.DocumentReference for use in FHIR R4B(0.1.0) | Media)

R5: Additional information or supporting documentation about the packaged product (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.attachedDocument
Constraints: ext-1

?!

0..*

Extensions that cannot be ignored
Constraints: ext-1

Σ

0..*

A unique identifier for this package as whole

name

Σ

0..1

A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc

Σ

0..1

Reference(MedicinalProductDefinition)

A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.

packageFor

Σ

0..*

The product that this is a pack for

status

?!Σ

0..1

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..*

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

description

Σ

0..1

markdown

Textual description. Note that this is not the name of the package or product

legalStatusOfSupply

Σ

0..*

The legal status of supply of the packaged item as classified by the regulator

id

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

Σ

0..1

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

The place where the legal status of supply applies
Binding: Jurisdiction ValueSet (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

characteristic

Σ

0..*

Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Binding: PackageCharacteristic (example): A characteristic of a package.

copackagedIndicator

Σ

0..1

If the drug product is supplied with another item such as a diluent or adjuvant

Σ

0..*

Manufacturer of this package type (multiple means these are all possible manufacturers)

Σ

0..1

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

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:componentPart

0..1

R5: 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) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.componentPart
Constraints: ext-1

extension:packaging

0..*

(Complex)

R5: Allows containers (and parts of containers) within containers, still as a part of single packaged product (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

Σ

0..*

An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier

Σ

0..1

The physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.

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

Σ

0..*

Material type of the package item
Binding: PackageMaterial (example): A material used in the construction of packages and their components.

alternateMaterial

Σ

0..*

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

Σ

0..*

Shelf Life and storage information

id

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

Σ

0..1

This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified

period[x]

Σ

0..1

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used

periodDuration

Duration

periodString

specialPrecautionsForStorage

Σ

0..*

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified

Σ

0..*

Manufacturer of this package Item (multiple means these are all possible manufacturers)

property

Σ

0..*

General characteristics of this item

id

0..1

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:value

0..1

CodeableConcept, Quantity, date, boolean, Attachment

R5: A value for the characteristic (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.property.value
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

Σ

1..1

A code expressing the type of characteristic
Binding: product-characteristic-codes (??) (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

valueQuantity

valueDate

valueBoolean

valueAttachment

Σ

0..*

The item(s) within the packaging

id

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

item

Σ

1..1

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

id

0..1

Unique id for inter-element referencing

0..*

CodeableReference(Cross-version Profile for R5.NutritionProduct for use in FHIR R4B(0.1.0) | NutritionProduct)

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:item

1..1

R5: item additional types
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-PackagedProductDefinition.packaging.containedItem.item
Constraints: ext-1

concept

Σ

0..1

Reference to a concept (by class)

reference

Σ

0..1

Reference()

Reference to a resource (by instance)

amount

Σ

0..1

The number of this type of item within this packaging