Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition			PackagedProductDefinition
Slices for identifier		0..*	Identifier	Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:pcid		0..1	Identifier	PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid
packageFor		0..*	Reference(Medicinal Product)	The product that this is a pack for
containedItemQuantity		0..*	Quantity	Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required)
description		0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply		0..1	BackboneElement	Legal status of supply on the packaged product level.
code		0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: EMA SPOR Legal Status for the Supply (required)
jurisdiction		0..1	CodeableConcept	The place where the legal status of supply applies Binding: EMA SPOR Country (required)
marketingStatus		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
country		0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: EMA SPOR Country (required)
status
coding
system		0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052
packaging
type		0..1	CodeableConcept	Container type
coding
system		0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346
quantity		0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
material		0..*	CodeableConcept	Material type of the package item
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
containedItem		0..*	BackboneElement	An item (inner package or manufactured item) within the packaging
item		1..1	CodeableReference(Packaged Product | Manufactured Item)	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		0..1	Quantity	Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PackagedProductDefinition.containedItemQuantity	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
PackagedProductDefinition.legalStatusOfSupply.code	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG
PackagedProductDefinition.marketingStatus.country	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG

Name	Flags	Card.	Type	Description & Constraints
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
Slices for identifier	Σ	0..*	Identifier	Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:pcid	Σ	0..1	Identifier	PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid
packageFor	Σ	0..*	Reference(Medicinal Product)	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.
containedItemQuantity	Σ	0..*	Quantity	Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required)
description	Σ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..1	BackboneElement	Legal status of supply on the packaged product level.
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: EMA SPOR Legal Status for the Supply (required)
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: EMA SPOR Country (required)
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: EMA SPOR Country (required)
status	Σ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PackagedProductDefinition.identifier:pcid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.containedItemQuantity	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
PackagedProductDefinition.legalStatusOfSupply.code	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG
PackagedProductDefinition.marketingStatus.country	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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
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 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
Slices for identifier	Σ	0..*	Identifier	Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:pcid	Σ	0..1	Identifier	PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
name	Σ	0..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
type	Σ	0..1	CodeableConcept	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..*	Reference(Medicinal Product)	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	Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required)
description	Σ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..1	BackboneElement	Legal status of supply on the packaged product level.
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: EMA SPOR Legal Status for the Supply (required)
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: EMA SPOR Country (required)
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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: EMA SPOR Country (required)
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
status	Σ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
dateRange	Σ	0..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
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	Σ	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	Σ	0..1	CodeableConcept	Container type Binding: PackagingType (example): A high level categorisation of a package.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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	Σ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (example): 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	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	Σ	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	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
valueAttachment			Attachment
containedItem	Σ	0..*	BackboneElement	An item (inner package or manufactured item) 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(Packaged Product | Manufactured Item)	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	Σ	0..1	Quantity	Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
packaging	Σ	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	Conformance	ValueSet	URI
PackagedProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PackagedProductDefinition.identifier:pcid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
PackagedProductDefinition.identifier:pcid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
PackagedProductDefinition.type	example	PackageType http://hl7.org/fhir/ValueSet/package-type from the FHIR Standard
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.containedItemQuantity	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
PackagedProductDefinition.legalStatusOfSupply.code	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG
PackagedProductDefinition.marketingStatus.country	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG
PackagedProductDefinition.packaging.type	example	PackagingType http://hl7.org/fhir/ValueSet/packaging-type from the FHIR Standard
PackagedProductDefinition.packaging.material	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterial	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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

Mandatory: 0 element(1 nested mandatory element)

Structures

This structure refers to these other structures:

• Medicinal Product (http://unicom-project.eu/fhir/d4-12/StructureDefinition/MedicinalProductD412)
• Packaged Product (http://unicom-project.eu/fhir/d4-12/StructureDefinition/PackagedProductD412)
• Manufactured Item (http://unicom-project.eu/fhir/d4-12/StructureDefinition/ManufacturedItemD412)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of PackagedProductDefinition.identifier

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition			PackagedProductDefinition
Slices for identifier		0..*	Identifier	Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:pcid		0..1	Identifier	PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
system		1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid
packageFor		0..*	Reference(Medicinal Product)	The product that this is a pack for
containedItemQuantity		0..*	Quantity	Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required)
description		0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply		0..1	BackboneElement	Legal status of supply on the packaged product level.
code		0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: EMA SPOR Legal Status for the Supply (required)
jurisdiction		0..1	CodeableConcept	The place where the legal status of supply applies Binding: EMA SPOR Country (required)
marketingStatus		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
country		0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: EMA SPOR Country (required)
status
coding
system		0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052
packaging
type		0..1	CodeableConcept	Container type
coding
system		0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346
quantity		0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
material		0..*	CodeableConcept	Material type of the package item
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
containedItem		0..*	BackboneElement	An item (inner package or manufactured item) within the packaging
item		1..1	CodeableReference(Packaged Product | Manufactured Item)	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		0..1	Quantity	Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PackagedProductDefinition.containedItemQuantity	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
PackagedProductDefinition.legalStatusOfSupply.code	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG
PackagedProductDefinition.marketingStatus.country	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG

Name	Flags	Card.	Type	Description & Constraints
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
Slices for identifier	Σ	0..*	Identifier	Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:pcid	Σ	0..1	Identifier	PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid
packageFor	Σ	0..*	Reference(Medicinal Product)	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.
containedItemQuantity	Σ	0..*	Quantity	Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required)
description	Σ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..1	BackboneElement	Legal status of supply on the packaged product level.
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: EMA SPOR Legal Status for the Supply (required)
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: EMA SPOR Country (required)
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: EMA SPOR Country (required)
status	Σ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PackagedProductDefinition.identifier:pcid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.containedItemQuantity	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
PackagedProductDefinition.legalStatusOfSupply.code	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG
PackagedProductDefinition.marketingStatus.country	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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
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 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
Slices for identifier	Σ	0..*	Identifier	Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system
identifier:pcid	Σ	0..1	Identifier	PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
name	Σ	0..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
type	Σ	0..1	CodeableConcept	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..*	Reference(Medicinal Product)	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	Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required)
description	Σ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..1	BackboneElement	Legal status of supply on the packaged product level.
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: EMA SPOR Legal Status for the Supply (required)
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: EMA SPOR Country (required)
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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: EMA SPOR Country (required)
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
status	Σ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
dateRange	Σ	0..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
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	Σ	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	Σ	0..1	CodeableConcept	Container type Binding: PackagingType (example): A high level categorisation of a package.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	0..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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	Σ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (example): 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	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	Σ	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	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
valueAttachment			Attachment
containedItem	Σ	0..*	BackboneElement	An item (inner package or manufactured item) 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(Packaged Product | Manufactured Item)	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	Σ	0..1	Quantity	Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
packaging	Σ	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	Conformance	ValueSet	URI
PackagedProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PackagedProductDefinition.identifier:pcid.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
PackagedProductDefinition.identifier:pcid.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
PackagedProductDefinition.type	example	PackageType http://hl7.org/fhir/ValueSet/package-type from the FHIR Standard
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.containedItemQuantity	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
PackagedProductDefinition.legalStatusOfSupply.code	required	LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG
PackagedProductDefinition.marketingStatus.country	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG
PackagedProductDefinition.packaging.type	example	PackagingType http://hl7.org/fhir/ValueSet/packaging-type from the FHIR Standard
PackagedProductDefinition.packaging.material	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterial	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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

Mandatory: 0 element(1 nested mandatory element)

Structures

This structure refers to these other structures:

• Medicinal Product (http://unicom-project.eu/fhir/d4-12/StructureDefinition/MedicinalProductD412)
• Packaged Product (http://unicom-project.eu/fhir/d4-12/StructureDefinition/PackagedProductD412)
• Manufactured Item (http://unicom-project.eu/fhir/d4-12/StructureDefinition/ManufacturedItemD412)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of PackagedProductDefinition.identifier