| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
PackagedProductDefinition
|
PackagedProductDefinition | |||
Slices for identifier
|
1 .. |
Identifier for the packaged product: PCID, national ID, or other
Slice: Unordered, Open by pattern:system |
||
identifier:pcid
|
1..1 | PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different. | ||
system
|
1.. | Required Pattern: http://ema.europa.eu/example/pcid | ||
packageFor
|
1.. | Reference (PPL Medicinal Product profile) | ||
|
containedItemQuantity
|
1.. | Pack size. Repeated for combination packages. | ||
code
|
Binding: EMA SPOR Unit of Presentation ( required ) | |||
|
description
|
1.. | |||
|
legalStatusOfSupply
|
..1 | Legal status of supply on the packaged product level. | ||
|
code
|
Binding: EMA SPOR Legal Status for the Supply ( required ) | |||
|
jurisdiction
|
||||
|
coding
|
Binding: EMA SPOR Country ( required ) | |||
|
marketingStatus
|
||||
|
country
|
1.. | |||
|
coding
|
Binding: EMA SPOR Country ( required ) | |||
|
status
|
||||
|
coding
|
||||
|
system
|
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052 | |||
|
packaging
|
1.. | |||
|
type
|
1.. | Container type | ||
|
coding
|
||||
|
system
|
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346 | |||
|
quantity
|
1.. | |||
|
material
|
Binding: EMA SPOR Material ( required ) | |||
|
shelfLifeStorage
|
||||
|
type
|
1.. | |||
|
coding
|
||||
|
system
|
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073343 | |||
|
period[x]
|
1.. | |||
|
containedItem
|
An item (inner package or manufactured item) within the packaging | |||
|
item
|
CodeableReference (PPL Packaged Product profile | PPL Manufactured Item profile) | |||
|
amount
|
Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition | |||
|
code
|
Binding: EMA SPOR All Units Combined ( required ) | |||
|
Documentation for this format
|
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