Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

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Resource Profile: PackagedProductDefinition (ePI)

PackagedProductDefinition (ePI)

Usage:

• Use this Resource Profile: Bundle - ePI
• Refer to this Resource Profile: RegulatedAuthorization (ePI)
• Examples for this Resource Profile: DrugX 75 mg tablet blister x28 tablets

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			PackagedProductDefinition
identifier
system		1..1	uri	The namespace for the identifier value
value		1..1	string	The value that is unique
type		0..1	CodeableConcept	A high level category e.g., medicinal product pack, sample pack, shipping container.
packageFor		0..*	Reference(MedicinalProductDefinition (ePI))	The product that this is a pack for
statusDate		0..1	dateTime	The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z
description		0..1	markdown	Narrative description of the overall pack; e.g., description of a sample pack
legalStatusOfSupply		0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator.
jurisdiction		0..1	CodeableConcept	The place where the legal status of supply applies Binding: ISO Country two letter code (preferred)
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.
jurisdiction		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 Binding: ISO Country two letter code (preferred)
copackagedIndicator		0..1	boolean	If the drug product is supplied with another item such as a diluent
manufacturer		0..*	Reference(Organization (ePI))	Manufacturer of this package type (multiple means these are all possible manufacturers)
packaging
identifier
system		1..1	uri	The namespace for the identifier value
value		1..1	string	The value that is unique
material		0..1	CodeableConcept	Material type of the package item
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information.
Slices for period[x]		0..1	Duration, string	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 Slice: Unordered, Open by type:$this
period[x]:periodDuration		0..1	Duration	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
manufacturer		0..*	Reference(Organization (ePI))	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
containedItem
item		1..1	CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition)	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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG
PackagedProductDefinition.marketingStatus.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country 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
type	Σ	0..1	CodeableConcept	A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package.
packageFor	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	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 Example Example of a status date: 2015-02-07T13:28:17Z
description	Σ	0..1	markdown	Narrative description of the overall pack; e.g., description of a sample pack
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: ISO Country two letter code (preferred)
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
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 Binding: ISO Country two letter code (preferred)
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
copackagedIndicator	Σ	0..1	boolean	If the drug product is supplied with another item such as a diluent
manufacturer	Σ	0..*	Reference(Organization (ePI))	Manufacturer of this package type (multiple means these are all possible manufacturers)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
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.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG
PackagedProductDefinition.marketingStatus.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country 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
identifier	Σ	0..*	Identifier	A unique identifier for this package as whole - not for the content of the 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
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 Example General: http://www.acme.com/identifiers/patient
value	ΣC	1..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 pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package.
packageFor	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	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 Example Example of a status date: 2015-02-07T13:28:17Z
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
description	Σ	0..1	markdown	Narrative description of the overall pack; e.g., description of a sample pack
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: ISO Country two letter code (preferred)
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
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 Binding: ISO Country two letter code (preferred)
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
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	If the drug product is supplied with another item such as a diluent
manufacturer	Σ	0..*	Reference(Organization (ePI))	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
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 Example General: http://www.acme.com/identifiers/patient
value	ΣC	1..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)
type	Σ	0..1	CodeableConcept	The physical type of the container of the items 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..1	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.
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
type	Σ	0..1	CodeableConcept	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
Slices for 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 Slice: Unordered, Open by type:$this
periodDuration			Duration
periodString			string
period[x]:periodDuration	Σ	0..1	Duration	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
specialPrecautionsForStorage	Σ	0..*	CodeableConcept	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
manufacturer	Σ	0..*	Reference(Organization (ePI))	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	The item(s) within the packaging
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition)	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	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	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.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
PackagedProductDefinition.identifier.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	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG
PackagedProductDefinition.marketingStatus.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG
PackagedProductDefinition.packaging.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
PackagedProductDefinition.packaging.identifier.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type 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

Summary

Mandatory: 0 element(4 nested mandatory elements)

Structures

This structure refers to these other structures:

• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)
• Organization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi)
• ManufacturedItemDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi)

Slices

This structure defines the following Slices:

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

Maturity: 2

Differential View

This structure is derived from PackagedProductDefinition

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition			PackagedProductDefinition
identifier
system		1..1	uri	The namespace for the identifier value
value		1..1	string	The value that is unique
type		0..1	CodeableConcept	A high level category e.g., medicinal product pack, sample pack, shipping container.
packageFor		0..*	Reference(MedicinalProductDefinition (ePI))	The product that this is a pack for
statusDate		0..1	dateTime	The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z
description		0..1	markdown	Narrative description of the overall pack; e.g., description of a sample pack
legalStatusOfSupply		0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator.
jurisdiction		0..1	CodeableConcept	The place where the legal status of supply applies Binding: ISO Country two letter code (preferred)
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.
jurisdiction		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 Binding: ISO Country two letter code (preferred)
copackagedIndicator		0..1	boolean	If the drug product is supplied with another item such as a diluent
manufacturer		0..*	Reference(Organization (ePI))	Manufacturer of this package type (multiple means these are all possible manufacturers)
packaging
identifier
system		1..1	uri	The namespace for the identifier value
value		1..1	string	The value that is unique
material		0..1	CodeableConcept	Material type of the package item
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information.
Slices for period[x]		0..1	Duration, string	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 Slice: Unordered, Open by type:$this
period[x]:periodDuration		0..1	Duration	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
manufacturer		0..*	Reference(Organization (ePI))	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
containedItem
item		1..1	CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition)	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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG
PackagedProductDefinition.marketingStatus.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG

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
type	Σ	0..1	CodeableConcept	A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package.
packageFor	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	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 Example Example of a status date: 2015-02-07T13:28:17Z
description	Σ	0..1	markdown	Narrative description of the overall pack; e.g., description of a sample pack
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: ISO Country two letter code (preferred)
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
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 Binding: ISO Country two letter code (preferred)
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
copackagedIndicator	Σ	0..1	boolean	If the drug product is supplied with another item such as a diluent
manufacturer	Σ	0..*	Reference(Organization (ePI))	Manufacturer of this package type (multiple means these are all possible manufacturers)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
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.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG
PackagedProductDefinition.marketingStatus.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country 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()

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
identifier	Σ	0..*	Identifier	A unique identifier for this package as whole - not for the content of the 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
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 Example General: http://www.acme.com/identifiers/patient
value	ΣC	1..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 pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package.
packageFor	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	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 Example Example of a status date: 2015-02-07T13:28:17Z
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
description	Σ	0..1	markdown	Narrative description of the overall pack; e.g., description of a sample pack
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: ISO Country two letter code (preferred)
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
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 Binding: ISO Country two letter code (preferred)
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
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	If the drug product is supplied with another item such as a diluent
manufacturer	Σ	0..*	Reference(Organization (ePI))	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
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 Example General: http://www.acme.com/identifiers/patient
value	ΣC	1..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)
type	Σ	0..1	CodeableConcept	The physical type of the container of the items 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..1	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.
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
type	Σ	0..1	CodeableConcept	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
Slices for 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 Slice: Unordered, Open by type:$this
periodDuration			Duration
periodString			string
period[x]:periodDuration	Σ	0..1	Duration	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
specialPrecautionsForStorage	Σ	0..*	CodeableConcept	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
manufacturer	Σ	0..*	Reference(Organization (ePI))	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	The item(s) within the packaging
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition)	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	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	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.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
PackagedProductDefinition.identifier.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	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG
PackagedProductDefinition.marketingStatus.jurisdiction	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country from this IG
PackagedProductDefinition.packaging.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
PackagedProductDefinition.packaging.identifier.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type 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

Summary

Mandatory: 0 element(4 nested mandatory elements)

Structures

This structure refers to these other structures:

• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)
• Organization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi)
• ManufacturedItemDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi)

Slices

This structure defines the following Slices:

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

Maturity: 2

Other representations of profile: CSV, Excel, Schematron