| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
MedicinalProduct
|
Base |
Medicinal Product Logical Model This logical model cannot be the target of a reference |
||
identifier
|
1..* | BackboneElement |
Identifiers of different types |
|
mpId
|
1..1 | Element | Medicinal Product Identifier (MPID) | |
|
pmsId
|
0..1 | Element | EMA PMS Identifier | |
nationalId
|
0..* | Element |
National/other identifier. Virtual/nonbranded product identifier should be here, unless it's administrable product related. |
|
|
domain
|
1..1 | Element | Domain (human/veterinary) | |
|
legalStatusOfSupply
|
1..1 | Element | Legal status of supply | |
|
authorisedDoseForm
|
1..1 | Element | Authorised dose form | |
|
classification
|
1..* | BackboneElement |
Classifications |
|
|
ATC
|
1..1 | Element | ATC classification | |
|
narcotic
|
0..1 | Element | Narcotic, psychotropic | |
|
classificationOther
|
0..* | Element |
Other classification |
|
|
orphanDrug
|
1..1 | Element | Orphan drug | |
|
additionalMonitoring
|
1..1 | Element | Black Triangle, a.k.a additional monitoring indicator | |
|
indication
|
0..1 | BackboneElement | Indications for the product | |
|
indicationText
|
0..1 | Element | Indication in text format | |
|
indicationStructured
|
0..* | Element |
Indications as a structured and coded list |
|
|
name
|
1..* | BackboneElement |
Name of the product - variety of different types of names and languages allowed |
|
|
fullName
|
1..1 | Element | Full name as registered and readable in SPC. | |
|
commonName
|
0..1 | Element | Commonly used name, which would appear in product catalogue searches, etc. | |
|
otherName
|
0..* | Element |
Other type of name that may be relevant on national level. |
|
|
nameUsage
|
0..* | BackboneElement |
Countries and languages where the name is used |
|
jurisdiction
|
1..1 | Element | Country | |
|
language
|
1..1 | Element | Language | |
|
marketingAuthorisation
|
0..* | BackboneElement |
Marketing Authorisation for the product |
|
|
marketingAuthorisationNumber
|
1..* | Element |
Marketing authorisation number |
|
|
region
|
1..1 | Element | Region | |
|
marketingAuthorisationStatus
|
1..1 | Element | Marketing authorisation status | |
|
date
|
0..1 | Element | Status date | |
|
marketingAuthorisationHolder
|
1..1 | BackboneElement | Marketing authorisation holder | |
|
locationId
|
1..1 | Element | Location identifier | |
|
organisationId
|
0..1 | Element | Organization identifier | |
|
mahName
|
1..1 | Element | Marketing authorisation holder's name | |
|
localMAHrepresentative
|
0..1 | BackboneElement | Local representative of marketing authorisation holder | |
|
documents
|
0..* | BackboneElement |
Documents of different types, linked or enclosed, related to product definition |
|
|
smpc
|
0..1 | BackboneElement | Summary of Product Characteristics | |
|
pil
|
0..1 | BackboneElement | Package Information Leaflet | |
|
labelling
|
0..1 | BackboneElement | Labelling information | |
|
par
|
0..1 | BackboneElement | Public assessment report | |
|
other
|
0..* | BackboneElement |
Other document |
|
|
packagedProductDefinition
|
1..* | BackboneElement |
Packaged product |
|
|
identifier
|
0..* | BackboneElement |
Package identifier |
|
|
pcid
|
1..1 | Element | Packaged medicinal product ID (PCID) | |
|
nationalId
|
0..* | Element |
National package identifier |
|
|
packageName
|
0..* | BackboneElement |
Short name for describing the package, includes pack size. May have different types and languages? |
|
|
name
|
1..1 | Element | Name | |
|
language
|
0..1 | Element | Language of the name | |
|
description
|
0..1 | BackboneElement | Package description | |
|
descriptionText
|
1..1 | Element | Package description text | |
|
language
|
0..1 | Element | Description language | |
|
packSize
|
1..* | Element |
Pack size, repeatable for different manufactured items |
|
|
legalStatusOfSupply
|
0..1 | Element | Legal status of supply on package level | |
|
marketingStatus
|
0..* | BackboneElement |
Marketing status |
|
|
country
|
1..1 | Element | Country | |
|
status
|
1..1 | Element | Status | |
|
packaging
|
1..1 | BackboneElement | Package | |
|
packageType
|
1..1 | Element | Package type | |
|
quantity
|
1..1 | Element | Package quantity (number of this type of items) | |
|
material
|
0..* | Element |
Package material |
|
|
innerPackage
|
0..* | BackboneElement |
Inner Package |
|
|
containedItem
|
C | 0..* | BackboneElement |
The content of the inner package itemcontent-1: containedItem.containedPackage or containedItem.manufacturedItem SHALL be present, but not both |
|
amount
|
1..1 | Element | Amount of manufacturedItems (solid) or size of the manufactured item (liquid) | |
|
manufacturedItem
|
1..* | BackboneElement |
Manufactured item |
|
|
manufacturedDoseForm
|
1..1 | Element | Manufactured dose form | |
|
unitOfPresentation
|
1..1 | Element | Unit of presentation | |
|
ingredient
|
1..* | BackboneElement |
Ingredient |
|
|
role
|
1..1 | Element | Ingredient role | |
|
substance
|
1..1 | Element | Substance | |
|
strength
|
1..* | BackboneElement |
Strength of active or other ingredient |
|
|
strengthType
|
1..1 | Element | Strength type (concentration or presentation strength) | |
|
strength
|
1..1 | Element | Strength | |
|
numerator
|
1..1 | Element | Numerator | |
|
denominator
|
1..1 | Element | Denominator | |
|
referenceStrength
|
1..* | BackboneElement |
Reference strength |
|
|
substance
|
1..1 | Element | Substance of reference strength | |
|
strength
|
1..1 | Element | Strength | |
|
numerator
|
1..1 | BackboneElement | Numerator | |
|
denominator
|
1..1 | BackboneElement | Denominator | |
|
pharmaceuticalProduct
|
1..* | BackboneElement |
Pharmaceutical/administrable product |
|
|
identifier
|
0..* | BackboneElement |
Identifier |
|
|
phpid
|
0..* | Element |
Pharmaceutical Product ID (PhPID) |
|
|
nationalId
|
0..* | Element |
National identifier for a pharmaceutical/administrable product |
|
|
administrableDoseForm
|
1..1 | Element | Administrable Dose Form | |
|
unitOfPresentation
|
0..1 | Element | Unit of presentation | |
|
routeOfAdministration
|
0..* | Element |
Route of administration |
|
|
ingredientPhP
|
1..* | BackboneElement |
Ingredient of the pharmaceutical/administrable product |
|
|
role
|
1..1 | Element | Ingredient role | |
|
substance
|
1..1 | Element | Substance | |
|
strength
|
1..* | BackboneElement |
Strength of active or other ingredient |
|
|
strengthType
|
1..1 | Element | Strength type (concentration or presentation strength) | |
|
strength
|
1..1 | Element | Strength | |
|
numerator
|
1..1 | Element | Numerator | |
|
denominator
|
1..1 | Element | Denominator | |
|
referenceStrength
|
1..* | BackboneElement |
Reference strength |
|
|
substance
|
1..1 | Element | Substance | |
|
strength
|
1..1 | Element | Strength | |
|
numerator
|
1..1 | Element | Numerator | |
|
denominator
|
1..1 | Element | Denominator | |
|
Documentation for this format
|
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