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15.2 Resource PackagedProductDefinition - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 1

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

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

15.2.1 Scope and Usage

For an overview of this resource and others in the Medication Definition domain, also see the module page

A medically related item or items of any type, in a container or package, representing the unit that has been prepared for sale, supply or similar use. These can include packaged medications, devices and other items such as food, biologicals, raw materials, medical fluids, gases etc. This resource represents the whole package of items, and all the packaging within, rather than the individual items themselves. In some cases a "product" exists at a logically higher level, which has a variety of available packages associated with it, typically of different sizes.

This resource is usually used with MedicinalProductDefinition, via the productFor relationship. For cases where only a subset of PackagedProductDefinition is need in a product, use as a contained resource to MPD may be appropriate. See MedicinalProductDefinition for an example.

Note about recursive relationships in this resource: This resource has two recursive relationships. One is meant to be "internal" to the package - for package layers and contents, and the other for aggregated packages (e.g. for wholesaling) that are made up of other packages.
PackagedProductDefinition.package.package
This recursive relationship is for the inner parts and containers within a package, which is normally indivisible and is marketed or prescribed as a whole entity. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
This recursive route, which is for cases where the whole (indivisible) package is then aggregated into another, divisible, package, for example a warehousing or transport pack. This represents a package of packages. It is not used for the internal parts of a single package. For which see PackagedProductDefinition.package.package.

15.2.2 References

This resource is referenced by itself, PlanDefinition and RegulatedAuthorization.

This resource does not implement any patterns.

Structure

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition	TU		DomainResource	A medically related item or items, in a container or package Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Unique identifier
name	Σ	0..1	string	A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc
type	Σ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping/transport container, etc
packageFor	Σ	0..*	Reference(MedicinalProductDefinition)	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status PublicationStatus (Preferred)
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
containedItemQuantity	Σ	0..*	Quantity	A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource
description	Σ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator
code	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context
marketingStatus	Σ	0..*	MarketingStatus	Marketing information
characteristic	Σ	0..*	CodeableConcept	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
copackagedIndicator	Σ	0..1	boolean	States whether a drug product is supplied with another item such as a diluent or adjuvant
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package type. When there are multiple it means these are all possible manufacturers
package	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 (which is not a device or a medication manufactured item)
identifier	Σ	0..*	Identifier	Including possibly Data Carrier Identifier
type	Σ	0..1	CodeableConcept	The physical type of the container of the items
quantity	Σ	0..1	integer	The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1
material	Σ	0..*	CodeableConcept	Material type of the package item
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for the packaging
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers
property	Σ	0..*	BackboneElement	General characteristics of this item
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic
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
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition \| DeviceDefinition \| PackagedProductDefinition \| BiologicallyDerivedProduct \| NutritionProduct)	The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package)
amount	Σ	0..1	Quantity	The number of this type of item within this packaging
package	Σ	0..*	see package	Allows containers (and parts of containers) within containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
Documentation for this format

UML Diagram (Legend)

XML Template

<PackagedProductDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <name value="[string]"/><!-- 0..1 A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc -->
 <type><!-- 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping/transport container, etc --></type>
 <packageFor><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pack for --></packageFor>
 <status><!-- 0..1 CodeableConcept The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable -->
 <containedItemQuantity><!-- 0..* Quantity A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource --></containedItemQuantity>
 <description value="[markdown]"/><!-- 0..1 Textual description. Note that this is not the name of the package or product -->
 <legalStatusOfSupply>  <!-- 0..* The legal status of supply of the packaged item as classified by the regulator -->
  <code><!-- 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use --></code>
  <jurisdiction><!-- 0..1 CodeableConcept The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context --></jurisdiction>
 </legalStatusOfSupply>
 <marketingStatus><!-- 0..* MarketingStatus Marketing information --></marketingStatus>
 <characteristic><!-- 0..* CodeableConcept Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack" --></characteristic>
 <copackagedIndicator value="[boolean]"/><!-- 0..1 States whether a drug product is supplied with another item such as a diluent or adjuvant -->
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package type. When there are multiple it means these are all possible manufacturers --></manufacturer>
 <package>  <!-- 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item) -->
  <identifier><!-- 0..* Identifier Including possibly Data Carrier Identifier --></identifier>
  <type><!-- 0..1 CodeableConcept The physical type of the container of the items --></type>
  <quantity value="[integer]"/><!-- 0..1 The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1 -->
  <material><!-- 0..* CodeableConcept Material type of the package item --></material>
  <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for the packaging --></alternateMaterial>
  <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers --></manufacturer>
  <property>  <!-- 0..* General characteristics of this item -->
   <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
   <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]>
  </property>
  <containedItem>  <!-- 0..* The item(s) within the packaging -->
   <item><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|
     ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package) --></item>
   <amount><!-- 0..1 Quantity The number of this type of item within this packaging --></amount>
  </containedItem>
  <package><!-- 0..* Content as for PackagedProductDefinition.package Allows containers (and parts of containers) within containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition) --></package>
 </package>
</PackagedProductDefinition>

JSON Template

{
  "resourceType" : "PackagedProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "name" : "<string>", // A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc
  "type" : { CodeableConcept }, // A high level category e.g. medicinal product, raw material, shipping/transport container, etc
  "packageFor" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pack for
  "status" : { CodeableConcept }, // The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status
  "statusDate" : "<dateTime>", // The date at which the given status became applicable
  "containedItemQuantity" : [{ Quantity }], // A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource
  "description" : "<markdown>", // Textual description. Note that this is not the name of the package or product
  "legalStatusOfSupply" : [{ // The legal status of supply of the packaged item as classified by the regulator
    "code" : { CodeableConcept }, // The actual status of supply. In what situation this package type may be supplied for use
    "jurisdiction" : { CodeableConcept } // The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context
  }],
  "marketingStatus" : [{ MarketingStatus }], // Marketing information
  "characteristic" : [{ CodeableConcept }], // Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
  "copackagedIndicator" : <boolean>, // States whether a drug product is supplied with another item such as a diluent or adjuvant
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package type. When there are multiple it means these are all possible manufacturers
  "package" : { // A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item)
    "identifier" : [{ Identifier }], // Including possibly Data Carrier Identifier
    "type" : { CodeableConcept }, // The physical type of the container of the items
    "quantity" : <integer>, // The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1
    "material" : [{ CodeableConcept }], // Material type of the package item
    "alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for the packaging
    "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
    "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers
    "property" : [{ // General characteristics of this item
      "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
      // value[x]: A value for the characteristic. One of these 5:
      "valueCodeableConcept" : { CodeableConcept }
      "valueQuantity" : { Quantity }
      "valueDate" : "<date>"
      "valueBoolean" : <boolean>
      "valueAttachment" : { Attachment }
    }],
    "containedItem" : [{ // The item(s) within the packaging
      "item" : { CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|
     ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) }, // R!  The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package)
      "amount" : { Quantity } // The number of this type of item within this packaging
    }],
    "package" : [{ Content as for PackagedProductDefinition.package }] // Allows containers (and parts of containers) within containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:PackagedProductDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:PackagedProductDefinition.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:PackagedProductDefinition.name [ string ]; # 0..1 A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc
  fhir:PackagedProductDefinition.type [ CodeableConcept ]; # 0..1 A high level category e.g. medicinal product, raw material, shipping/transport container, etc
  fhir:PackagedProductDefinition.packageFor [ Reference(MedicinalProductDefinition) ], ... ; # 0..* The product that this is a pack for
  fhir:PackagedProductDefinition.status [ CodeableConcept ]; # 0..1 The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status
  fhir:PackagedProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:PackagedProductDefinition.containedItemQuantity [ Quantity ], ... ; # 0..* A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource
  fhir:PackagedProductDefinition.description [ markdown ]; # 0..1 Textual description. Note that this is not the name of the package or product
  fhir:PackagedProductDefinition.legalStatusOfSupply [ # 0..* The legal status of supply of the packaged item as classified by the regulator
    fhir:PackagedProductDefinition.legalStatusOfSupply.code [ CodeableConcept ]; # 0..1 The actual status of supply. In what situation this package type may be supplied for use
    fhir:PackagedProductDefinition.legalStatusOfSupply.jurisdiction [ CodeableConcept ]; # 0..1 The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context
  ], ...;
  fhir:PackagedProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing information
  fhir:PackagedProductDefinition.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
  fhir:PackagedProductDefinition.copackagedIndicator [ boolean ]; # 0..1 States whether a drug product is supplied with another item such as a diluent or adjuvant
  fhir:PackagedProductDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this package type. When there are multiple it means these are all possible manufacturers
  fhir:PackagedProductDefinition.package [ # 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item)
    fhir:PackagedProductDefinition.package.identifier [ Identifier ], ... ; # 0..* Including possibly Data Carrier Identifier
    fhir:PackagedProductDefinition.package.type [ CodeableConcept ]; # 0..1 The physical type of the container of the items
    fhir:PackagedProductDefinition.package.quantity [ integer ]; # 0..1 The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1
    fhir:PackagedProductDefinition.package.material [ CodeableConcept ], ... ; # 0..* Material type of the package item
    fhir:PackagedProductDefinition.package.alternateMaterial [ CodeableConcept ], ... ; # 0..* A possible alternate material for the packaging
    fhir:PackagedProductDefinition.package.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
    fhir:PackagedProductDefinition.package.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers
    fhir:PackagedProductDefinition.package.property [ # 0..* General characteristics of this item
      fhir:PackagedProductDefinition.package.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
      # PackagedProductDefinition.package.property.value[x] : 0..1 A value for the characteristic. One of these 5
        fhir:PackagedProductDefinition.package.property.valueCodeableConcept [ CodeableConcept ]
        fhir:PackagedProductDefinition.package.property.valueQuantity [ Quantity ]
        fhir:PackagedProductDefinition.package.property.valueDate [ date ]
        fhir:PackagedProductDefinition.package.property.valueBoolean [ boolean ]
        fhir:PackagedProductDefinition.package.property.valueAttachment [ Attachment ]
    ], ...;
    fhir:PackagedProductDefinition.package.containedItem [ # 0..* The item(s) within the packaging
      fhir:PackagedProductDefinition.package.containedItem.item [ CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|ManufacturedItemDefinition|
  NutritionProduct|PackagedProductDefinition) ]; # 1..1 The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package)
      fhir:PackagedProductDefinition.package.containedItem.amount [ Quantity ]; # 0..1 The number of this type of item within this packaging
    ], ...;
    fhir:PackagedProductDefinition.package.package [ See PackagedProductDefinition.package ], ... ; # 0..* Allows containers (and parts of containers) within containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
  ];
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition	TU		DomainResource	A medically related item or items, in a container or package Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Unique identifier
name	Σ	0..1	string	A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc
type	Σ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping/transport container, etc
packageFor	Σ	0..*	Reference(MedicinalProductDefinition)	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status PublicationStatus (Preferred)
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
containedItemQuantity	Σ	0..*	Quantity	A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource
description	Σ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator
code	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context
marketingStatus	Σ	0..*	MarketingStatus	Marketing information
characteristic	Σ	0..*	CodeableConcept	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
copackagedIndicator	Σ	0..1	boolean	States whether a drug product is supplied with another item such as a diluent or adjuvant
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package type. When there are multiple it means these are all possible manufacturers
package	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 (which is not a device or a medication manufactured item)
identifier	Σ	0..*	Identifier	Including possibly Data Carrier Identifier
type	Σ	0..1	CodeableConcept	The physical type of the container of the items
quantity	Σ	0..1	integer	The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1
material	Σ	0..*	CodeableConcept	Material type of the package item
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for the packaging
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers
property	Σ	0..*	BackboneElement	General characteristics of this item
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic
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
item	Σ	1..1	CodeableReference(ManufacturedItemDefinition \| DeviceDefinition \| PackagedProductDefinition \| BiologicallyDerivedProduct \| NutritionProduct)	The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package)
amount	Σ	0..1	Quantity	The number of this type of item within this packaging
package	Σ	0..*	see package	Allows containers (and parts of containers) within containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
Documentation for this format

UML Diagram (Legend)

XML Template

<PackagedProductDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <name value="[string]"/><!-- 0..1 A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc -->
 <type><!-- 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping/transport container, etc --></type>
 <packageFor><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pack for --></packageFor>
 <status><!-- 0..1 CodeableConcept The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable -->
 <containedItemQuantity><!-- 0..* Quantity A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource --></containedItemQuantity>
 <description value="[markdown]"/><!-- 0..1 Textual description. Note that this is not the name of the package or product -->
 <legalStatusOfSupply>  <!-- 0..* The legal status of supply of the packaged item as classified by the regulator -->
  <code><!-- 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use --></code>
  <jurisdiction><!-- 0..1 CodeableConcept The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context --></jurisdiction>
 </legalStatusOfSupply>
 <marketingStatus><!-- 0..* MarketingStatus Marketing information --></marketingStatus>
 <characteristic><!-- 0..* CodeableConcept Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack" --></characteristic>
 <copackagedIndicator value="[boolean]"/><!-- 0..1 States whether a drug product is supplied with another item such as a diluent or adjuvant -->
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package type. When there are multiple it means these are all possible manufacturers --></manufacturer>
 <package>  <!-- 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item) -->
  <identifier><!-- 0..* Identifier Including possibly Data Carrier Identifier --></identifier>
  <type><!-- 0..1 CodeableConcept The physical type of the container of the items --></type>
  <quantity value="[integer]"/><!-- 0..1 The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1 -->
  <material><!-- 0..* CodeableConcept Material type of the package item --></material>
  <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for the packaging --></alternateMaterial>
  <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers --></manufacturer>
  <property>  <!-- 0..* General characteristics of this item -->
   <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
   <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]>
  </property>
  <containedItem>  <!-- 0..* The item(s) within the packaging -->
   <item><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|
     ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package) --></item>
   <amount><!-- 0..1 Quantity The number of this type of item within this packaging --></amount>
  </containedItem>
  <package><!-- 0..* Content as for PackagedProductDefinition.package Allows containers (and parts of containers) within containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition) --></package>
 </package>
</PackagedProductDefinition>

JSON Template

{
  "resourceType" : "PackagedProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "name" : "<string>", // A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc
  "type" : { CodeableConcept }, // A high level category e.g. medicinal product, raw material, shipping/transport container, etc
  "packageFor" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pack for
  "status" : { CodeableConcept }, // The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status
  "statusDate" : "<dateTime>", // The date at which the given status became applicable
  "containedItemQuantity" : [{ Quantity }], // A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource
  "description" : "<markdown>", // Textual description. Note that this is not the name of the package or product
  "legalStatusOfSupply" : [{ // The legal status of supply of the packaged item as classified by the regulator
    "code" : { CodeableConcept }, // The actual status of supply. In what situation this package type may be supplied for use
    "jurisdiction" : { CodeableConcept } // The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context
  }],
  "marketingStatus" : [{ MarketingStatus }], // Marketing information
  "characteristic" : [{ CodeableConcept }], // Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
  "copackagedIndicator" : <boolean>, // States whether a drug product is supplied with another item such as a diluent or adjuvant
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package type. When there are multiple it means these are all possible manufacturers
  "package" : { // A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item)
    "identifier" : [{ Identifier }], // Including possibly Data Carrier Identifier
    "type" : { CodeableConcept }, // The physical type of the container of the items
    "quantity" : <integer>, // The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1
    "material" : [{ CodeableConcept }], // Material type of the package item
    "alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for the packaging
    "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
    "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers
    "property" : [{ // General characteristics of this item
      "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
      // value[x]: A value for the characteristic. One of these 5:
      "valueCodeableConcept" : { CodeableConcept }
      "valueQuantity" : { Quantity }
      "valueDate" : "<date>"
      "valueBoolean" : <boolean>
      "valueAttachment" : { Attachment }
    }],
    "containedItem" : [{ // The item(s) within the packaging
      "item" : { CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|
     ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) }, // R!  The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package)
      "amount" : { Quantity } // The number of this type of item within this packaging
    }],
    "package" : [{ Content as for PackagedProductDefinition.package }] // Allows containers (and parts of containers) within containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:PackagedProductDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:PackagedProductDefinition.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:PackagedProductDefinition.name [ string ]; # 0..1 A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc
  fhir:PackagedProductDefinition.type [ CodeableConcept ]; # 0..1 A high level category e.g. medicinal product, raw material, shipping/transport container, etc
  fhir:PackagedProductDefinition.packageFor [ Reference(MedicinalProductDefinition) ], ... ; # 0..* The product that this is a pack for
  fhir:PackagedProductDefinition.status [ CodeableConcept ]; # 0..1 The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status
  fhir:PackagedProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:PackagedProductDefinition.containedItemQuantity [ Quantity ], ... ; # 0..* A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource
  fhir:PackagedProductDefinition.description [ markdown ]; # 0..1 Textual description. Note that this is not the name of the package or product
  fhir:PackagedProductDefinition.legalStatusOfSupply [ # 0..* The legal status of supply of the packaged item as classified by the regulator
    fhir:PackagedProductDefinition.legalStatusOfSupply.code [ CodeableConcept ]; # 0..1 The actual status of supply. In what situation this package type may be supplied for use
    fhir:PackagedProductDefinition.legalStatusOfSupply.jurisdiction [ CodeableConcept ]; # 0..1 The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context
  ], ...;
  fhir:PackagedProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing information
  fhir:PackagedProductDefinition.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
  fhir:PackagedProductDefinition.copackagedIndicator [ boolean ]; # 0..1 States whether a drug product is supplied with another item such as a diluent or adjuvant
  fhir:PackagedProductDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this package type. When there are multiple it means these are all possible manufacturers
  fhir:PackagedProductDefinition.package [ # 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item)
    fhir:PackagedProductDefinition.package.identifier [ Identifier ], ... ; # 0..* Including possibly Data Carrier Identifier
    fhir:PackagedProductDefinition.package.type [ CodeableConcept ]; # 0..1 The physical type of the container of the items
    fhir:PackagedProductDefinition.package.quantity [ integer ]; # 0..1 The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1
    fhir:PackagedProductDefinition.package.material [ CodeableConcept ], ... ; # 0..* Material type of the package item
    fhir:PackagedProductDefinition.package.alternateMaterial [ CodeableConcept ], ... ; # 0..* A possible alternate material for the packaging
    fhir:PackagedProductDefinition.package.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
    fhir:PackagedProductDefinition.package.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers
    fhir:PackagedProductDefinition.package.property [ # 0..* General characteristics of this item
      fhir:PackagedProductDefinition.package.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
      # PackagedProductDefinition.package.property.value[x] : 0..1 A value for the characteristic. One of these 5
        fhir:PackagedProductDefinition.package.property.valueCodeableConcept [ CodeableConcept ]
        fhir:PackagedProductDefinition.package.property.valueQuantity [ Quantity ]
        fhir:PackagedProductDefinition.package.property.valueDate [ date ]
        fhir:PackagedProductDefinition.package.property.valueBoolean [ boolean ]
        fhir:PackagedProductDefinition.package.property.valueAttachment [ Attachment ]
    ], ...;
    fhir:PackagedProductDefinition.package.containedItem [ # 0..* The item(s) within the packaging
      fhir:PackagedProductDefinition.package.containedItem.item [ CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|ManufacturedItemDefinition|
  NutritionProduct|PackagedProductDefinition) ]; # 1..1 The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package)
      fhir:PackagedProductDefinition.package.containedItem.amount [ Quantity ]; # 0..1 The number of this type of item within this packaging
    ], ...;
    fhir:PackagedProductDefinition.package.package [ See PackagedProductDefinition.package ], ... ; # 0..* Allows containers (and parts of containers) within containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
  ];
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

15.2.3.1 Terminology Bindings

Path	Definition	Type	Reference
PackagedProductDefinition.status		Preferred	PublicationStatus

Path

Definition

Type

Reference

PackagedProductDefinition.status

Preferred

PublicationStatus

15.2.4 Search Parameters

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name	Type	Description	Expression	In Common
biological D	reference	A biologically derived product within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
contained-item D	reference	Any of the contained items within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
device D	reference	A device within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
identifier	token	Unique identifier	PackagedProductDefinition.identifier
manufactured-item D	reference	A manufactured item of medication within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
medication D	reference	A manufactured item of medication within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
name N	token	A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc	PackagedProductDefinition.name
nutrition D	reference	A nutrition product within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
package D	reference	A complete packaged product within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
package-for	reference	The product that this is a pack for	PackagedProductDefinition.packageFor (MedicinalProductDefinition)
status	token	The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status	PackagedProductDefinition.status