| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
CrossBorderProduct
|
Base |
DRAFT: Medicinal Product in crossborder eP/eD This logical model cannot be the target of a reference |
||
medicinalProductIdentifier
|
0..* | Element |
MPID or national identifier |
|
|
packagedProductIdentifier
|
0..* | Element |
PCID or national |
|
|
pharmaceuticalProductIdentifier
|
0..* | Element |
PhPID |
|
|
atc
|
1..1 | Element | ATC code | |
|
packSize
|
1..* | Element |
Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries) |
|
|
fullName
|
0..* | Element |
Name of the product |
|
|
doseForm
|
1..1 | Element | Authorised dose form for eD; authorised or pharmaceutical for eP | |
|
constitution
|
1..* | BackboneElement |
Content of the product - defines ingredients, manufactured items, or device |
|
ingredient
|
0..* | BackboneElement |
Ingredients, by default only active ingredients |
|
|
role
|
1..1 | Element | (might not be needed if only active ingredients are expected) | |
|
substance
|
1..1 | Element | Substance | |
strengthInfo
|
1..* | BackboneElement |
Concentration or presentation strength |
|
strength
|
1..1 | Element | Concentration or presentation strength of the precise active ingredient | |
|
referenceStrength
|
0..* | BackboneElement |
Reference strength; according to the substance+strength type above |
|
|
referenceSubstance
|
1..1 | Element | Substance for reference strength | |
|
strength
|
1..1 | Element | Reference strength | |
|
manufacturedItem
|
0..* | BackboneElement |
Manufactured item if the prescription contains more than one type of items |
|
|
doseForm
|
1..1 | Element | Manufactured item dose form | |
|
unitOfPresentation
|
0..* | Element |
Unit of presentation for the manufactured item |
|
|
containedQuantity
|
0..1 | Element | Manufactured item quantity for liquids (3ml/vial) | |
|
manufacturedItemQuantity
|
1..1 | Element | Number of such manufactured items in this product (5 vials) | |
|
device
|
0..* | BackboneElement |
Administrative device included in the product |
|
|
deviceQuantity
|
1..1 | Element | Number of such devices | |
|
device
|
1..1 | Element | Device coded | |
|
marketingAuthorisationHolder
|
0..1 | Element | MAH name - do we need more? | |
|
routeOfAdministration
|
1..* | Element |
Route of Administration - if we need it on product level |
|
|
Documentation for this format
|
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