UnicomIG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/unicom-ig/ and changes regularly. See the Directory of published versions

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

Resource Profile: Processing Profile - Packaged Product

Intermediate profile for processing PPL Packaged Product data

Usage:

• Refer to this Resource Profile: Processing Profile - Packaged Product and Processing Profile - Marketing Authorisation

Formal Views of Profile Content

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

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

This structure is derived from PackagedProductDefinition

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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(Processing Profile - Medicinal Product)	The product that this is a pack for
containedItemQuantity		0..*	Quantity	Pack size. Repeated for combination packages.
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.
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
packaging
type		0..1	CodeableConcept	Container type
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
containedItem		0..*	BackboneElement	An item (inner package or manufactured item) within the packaging
item		1..1	CodeableReference(Processing Profile - Packaged Product | Processing Profile - 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

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(Processing Profile - 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.
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
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
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

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(Processing Profile - 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.
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: 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	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.
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(Processing Profile - Packaged Product | Processing Profile - 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.legalStatusOfSupply.code	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
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()

This structure is derived from PackagedProductDefinition

Differential View

This structure is derived from PackagedProductDefinition

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
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(Processing Profile - Medicinal Product)	The product that this is a pack for
containedItemQuantity		0..*	Quantity	Pack size. Repeated for combination packages.
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.
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
packaging
type		0..1	CodeableConcept	Container type
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
containedItem		0..*	BackboneElement	An item (inner package or manufactured item) within the packaging
item		1..1	CodeableReference(Processing Profile - Packaged Product | Processing Profile - 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

Key Elements View

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(Processing Profile - 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.
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
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
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

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()

Snapshot View

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(Processing Profile - 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.
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: 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	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.
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(Processing Profile - Packaged Product | Processing Profile - 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.legalStatusOfSupply.code	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
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()

This structure is derived from PackagedProductDefinition

Other representations of profile: CSV, Excel, Schematron