This
page
is
part
of
the
FHIR
Specification
(v4.3.0:
R4B
(v5.0.0-ballot:
R5
Ballot
-
STU
see
ballot
notes
).
The
current
version
which
supercedes
this
version
is
5.0.0
.
For
a
full
list
of
available
versions,
see
the
Directory
of
published
versions
.
Page
versions:
R5
R4B
Biomedical
Research
and
Regulation
Work
Group
|
Maturity
Level
:
|
Trial Use | Security Category : Anonymous | Compartments : Not linked to any defined compartments |
Detailed Descriptions for the elements in the PackagedProductDefinition resource.
| PackagedProductDefinition | |
| Element Id | PackagedProductDefinition |
| Definition |
A medically related item or items, in a container or package. |
| Short Display | A medically related item or items, in a container or package |
| Cardinality | 0..* |
| Type | DomainResource |
| Summary | false |
| PackagedProductDefinition.identifier | |
| Element Id | PackagedProductDefinition.identifier |
| Definition |
A
unique
identifier
for
this
package
as
|
| Short Display | A unique identifier for this package as whole - not for the content of the package |
| Note | This is a business identifier, not a resource identifier (see discussion ) |
| Cardinality | 0..* |
| Type | Identifier |
| Summary | true |
| PackagedProductDefinition.name | |
| Element Id | PackagedProductDefinition.name |
| Definition |
A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc. |
| Short Display | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
| Cardinality | 0..1 |
| Type | string |
| Summary | true |
| PackagedProductDefinition.type | |
| Element Id | PackagedProductDefinition.type |
| Definition |
A high level category e.g. medicinal product, raw material, shipping/transport container, etc. |
| Short Display | A high level category e.g. medicinal product, raw material, shipping container etc |
| Cardinality | 0..1 |
| Terminology Binding | PackageType ( Example ) |
| Type | CodeableConcept |
| Summary | true |
| PackagedProductDefinition.packageFor | |
| Element Id | PackagedProductDefinition.packageFor |
| Definition |
The product this package model relates to, not the contents of the package (for which see package.containedItem). |
| Short Display |
The
product
that
this
is
a
pack
|
| Cardinality | 0..* |
| Type | Reference ( MedicinalProductDefinition ) |
| Summary | true |
| PackagedProductDefinition.status | |
| Element Id | PackagedProductDefinition.status |
| Definition |
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. |
| Short Display | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status |
| Cardinality | 0..1 |
| Terminology Binding | PublicationStatus ( Preferred ) |
| Type | CodeableConcept |
| Is Modifier | true (Reason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid) |
| Summary | true |
| PackagedProductDefinition.statusDate | |
| Element Id | PackagedProductDefinition.statusDate |
| Definition |
The date at which the given status became applicable. |
| Short Display | The date at which the given status became applicable |
| Cardinality | 0..1 |
| Type | dateTime |
| Summary | true |
| PackagedProductDefinition.containedItemQuantity | |
| Element Id | PackagedProductDefinition.containedItemQuantity |
| Definition |
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. 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. |
| Short Display | 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 |
| Cardinality | 0..* |
| Type | Quantity |
| Summary | true |
| PackagedProductDefinition.description | |
| Element Id | PackagedProductDefinition.description |
| Definition |
Textual description. Note that this is not the name of the package or product. |
| Short Display | Textual description. Note that this is not the name of the package or product |
| Cardinality | 0..1 |
| Type | markdown |
| Summary | true |
| PackagedProductDefinition.legalStatusOfSupply | |
| Element Id | PackagedProductDefinition.legalStatusOfSupply |
| Definition |
The legal status of supply of the packaged item as classified by the regulator. |
| Short Display | The legal status of supply of the packaged item as classified by the regulator |
| Cardinality | 0..* |
| Summary | true |
| PackagedProductDefinition.legalStatusOfSupply.code | |
| Element Id | PackagedProductDefinition.legalStatusOfSupply.code |
| Definition |
The actual status of supply. Conveys in what situation this package type may be supplied for use. |
| Short Display | The actual status of supply. In what situation this package type may be supplied for use |
| Cardinality | 0..1 |
| Terminology Binding | LegalStatusOfSupply ( Example ) |
| Type | CodeableConcept |
| Summary | true |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | |
| Element Id | PackagedProductDefinition.legalStatusOfSupply.jurisdiction |
| Definition |
The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context. |
| Short Display | The place where the legal status of supply applies |
| Cardinality | 0..1 |
| Terminology Binding | Jurisdiction ( Example ) |
| Type | CodeableConcept |
| Summary | true |
| PackagedProductDefinition.marketingStatus | |
| Element Id | PackagedProductDefinition.marketingStatus |
| Definition |
Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. |
| Short Display | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
| Cardinality | 0..* |
| Type | MarketingStatus |
| Summary | true |
| PackagedProductDefinition.characteristic | |
| Element Id | PackagedProductDefinition.characteristic |
| Definition |
Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack". |
| Short Display | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" |
| Cardinality | 0..* |
| Terminology Binding | PackageCharacteristic ( Example ) |
| Type | CodeableConcept |
| Summary | true |
| PackagedProductDefinition.copackagedIndicator | |
| Element Id | PackagedProductDefinition.copackagedIndicator |
| Definition |
|
| Short Display | Identifies if the drug product is supplied with another item such as a diluent or adjuvant |
| Cardinality | 0..1 |
| Type | boolean |
| Meaning if Missing | If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made |
| Summary | true |
| PackagedProductDefinition.manufacturer | |
| Element Id | PackagedProductDefinition.manufacturer |
| Definition |
Manufacturer of this package type. When there are multiple it means these are all possible manufacturers. |
| Short Display | Manufacturer of this package type (multiple means these are all possible manufacturers) |
| Cardinality | 0..* |
| Type | Reference ( Organization ) |
| Summary | true |
|
|
|
| Element Id |
|
| Definition | Additional information or supporting documentation about the packaged product. |
| Short Display | Additional information or supporting documentation about the packaged product |
| Cardinality | 0..* |
| Type | Reference ( DocumentReference ) |
| Summary | true |
| PackagedProductDefinition.packaging | |
| Element Id | PackagedProductDefinition.packaging |
| Definition |
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). |
| Short Display | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| Cardinality | 0..1 |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
|
| Short Display | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
| Note | This is a business identifier, not a resource identifier (see discussion ) |
| Cardinality | 0..* |
| Type | Identifier |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
The physical type of the container of the items. |
| Short Display | The physical type of the container of the items |
| Cardinality | 0..1 |
| Terminology Binding | PackagingType ( Example ) |
| Type | CodeableConcept |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
The quantity of packaging items contained at this layer of the package. This does not relate to the number of contained items but relates solely to the number of packaging items. When looking at the outermost layer it is always 1. If there are two boxes within, at the next layer it would be 2. |
| Short Display |
The
quantity
of
this
level
of
packaging
in
the
package
that
contains
|
| Cardinality | 0..1 |
| Type | integer |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
Material type of the package item. |
| Short Display | Material type of the package item |
| Cardinality | 0..* |
| Terminology Binding | PackageMaterial ( Example ) |
| Type | CodeableConcept |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve). |
| Short Display | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material |
| Cardinality | 0..* |
| Terminology Binding | PackageMaterial ( Example ) |
| Type | CodeableConcept |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
Shelf Life and storage information. |
|
|
|
| Cardinality |
|
| Type |
|
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
|
|
|
Manufacturer
of
this
|
| Cardinality | 0..* |
| Type | Reference ( Organization ) |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
General characteristics of this item. |
| Short Display | General characteristics of this item |
| Cardinality | 0..* |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
A code expressing the type of characteristic. |
| Short Display | A code expressing the type of characteristic |
| Cardinality | 1..1 |
| Terminology Binding |
ProductCharacteristic
|
| Type | CodeableConcept |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
A value for the characteristic. |
| Short Display | A value for the characteristic |
| Cardinality | 0..1 |
| Type | CodeableConcept | Quantity | date | boolean | Attachment |
| [x] Note |
See
Choice
of
|
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
The item(s) within the packaging. |
| Short Display | The item(s) within the packaging |
| Cardinality | 0..* |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
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
|
| Short Display | 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 |
| Cardinality | 1..1 |
| Type | CodeableReference ( ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct ) |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
The number of this type of item within this packaging. |
| Short Display | The number of this type of item within this packaging |
| Cardinality | 0..1 |
| Type | Quantity |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
Allows
containers
(and
parts
of
containers)
parwithin
containers,
still
a
single
packaged
product.
See
also
|
| Short Display | Allows containers (and parts of containers) within containers, still a single packaged product |
| Cardinality | 0..* |
| Type |
See
|
| Summary | true |