Profile Comparison between http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi vs http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition
copyright
date	2023-07-26T13:32:34+00:00	2026-05-03T19:07:24+00:00	Values Differ
description	PackagedProductDefinition (ePI)
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	http://unstats.un.org/unsd/methods/m49/m49.htm#001
kind	resource
name	PackagedProductDefinitionUvEpi
publisher	HL7 International - Biomedical Research & Regulation Work Group	HL7 International / Biomedical Research and Regulation	Values Differ
purpose
status	active
title	PackagedProductDefinition (ePI)
type	PackagedProductDefinition
url	http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi
version	1.0.0	1.1.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
id	Σ	0..1	id	Logical id of this artifact	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored	?!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	Σ	1..*	Identifier	A unique identifier for this package as whole - not for the content of the package	Element minimum cardinalities differ: '0' vs '1'
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		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: ?? (required): Identifies the purpose for this identifier, if known .	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (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	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	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	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)	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
name	Σ	1..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc	Σ	0..1	string	A name for this package.	Element minimum cardinalities differ: '1' vs '0'
type	Σ	0..1	CodeableConcept	A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: ?? (example): A high level categorisation of a package.	Σ	0..1	CodeableConcept	A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: ?? (example): A high level categorisation of a package.
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
packageFor	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	The product that this is a pack for	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: ?? (preferred): The lifecycle status of an artifact.	?!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: ?? (preferred): The lifecycle status of an artifact.	Example/preferred bindings differ at PackagedProductDefinition.status using binding from PackagedProductDefinitionUvEpi
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
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	Σ	0..1	dateTime	The date at which the given status became applicable.
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)	Σ	0..*	Quantity	A count of the contained items.
description	Σ	0..1	markdown	Narrative description of the overall pack; e.g., description of a sample pack	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.	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		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!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: ?? (example): The prescription supply types appropriate to a medicinal product	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: ?? (example): The prescription supply types appropriate to a medicinal product
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: ?? (preferred)	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: ?? (example): Jurisdiction codes	Example/preferred bindings differ at PackagedProductDefinition.legalStatusOfSupply.jurisdiction using binding from PackagedProductDefinitionUvEpi
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
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.	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		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		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	?!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	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
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
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: ?? (preferred)	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	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	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
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	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	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	Σ	0..1	boolean	If the drug product is supplied with another item such as a diluent or adjuvant.
manufacturer	Σ	0..*	Reference(Organization (ePI))	Manufacturer of this package type (multiple means these are all possible manufacturers)	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	Σ	0..*	Reference(DocumentReference)	Pack artwork images or other related documents associated with this package.
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	Σ	0..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within.
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier	Σ	1..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier	Σ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier	Element minimum cardinalities differ: '1' vs '0'
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		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: ?? (required): Identifies the purpose for this identifier, if known .	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (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	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	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	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)	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: ?? (example): A high level categorisation of a package.	Σ	0..1	CodeableConcept	The physical type of the container of the items Binding: ?? (example): A high level categorisation of a package.
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
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)	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)	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: ?? (example): A material used in the construction of packages and their components.	Σ	0..*	CodeableConcept	Material type of the package item Binding: ?? (example): A material used in the construction of packages and their components.	Element maximum cardinalities differ: '1' vs '2147483647'
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
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: ?? (example): A material used in the construction of packages and their components.	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: ?? (example): A material used in the construction of packages and their components.
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information.	Σ	0..*	ProductShelfLife	Shelf Life and storage information
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		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	?!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	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
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
Slices for period[x]	Σ	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	Σ	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
specialPrecautionsForStorage	Σ	0..1	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	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	Element maximum cardinalities differ: '1' vs '2147483647'
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
manufacturer	Σ	0..*	Reference(Organization (ePI))	Manufacturer of this packaging item (multiple means these are all potential manufacturers)	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	Σ	0..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	1..1	Coding	Code defined by a terminology system	Added this element
text					Σ	0..1	string	Plain text representation of the concept	Added this element
value[x]	Σ	0..1	CodeableConcept, Quantity, date, boolean, Attachment	A value for the characteristic	Σ	0..1	CodeableConcept, Quantity, date, boolean, Attachment	A value for the characteristic
containedItem	Σ	0..*	BackboneElement	The item(s) within the packaging	Σ	0..*	BackboneElement	The item(s) within the packaging
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!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	Σ	1..1	CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	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)	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	Σ	0..*	See packaging (PackagedProductDefinition)	Nested packaging.
characteristic	Σ	0..*	See property (PackagedProductDefinition)	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"	Σ	0..*	See property (PackagedProductDefinition)	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Documentation for this format