Criteria for Vnr
A Nordic Article Number can be approved to cover one, several, or even all Nordic countries.
Six basic criteria are mandatory and need to be met equally in all countries concerned if a Vnr is to be used in more than one country.
- Trade name
- Marketing authorisation holder (MAH)
- Pharmaceutical dosage form
- Pack size
- Type of package
The trade name of the article must be exactly the same in all countries where a Vnr will be used. Even small differences in trade name are not permitted.
For example: Alvedon vs. Alvedone
Marketing authorisation holder (MAH)
The marketing authorisation holder does not necessarily have to be the same in all concerned countries where a Vnr is used, but the MAH must belong to the same group of companies (same consolidated corporation) or be an official representative for the MAH.
|Company under concern group||Finland: Company name Oy|
|Sweden: Company name AB|
|Denmark: Company name A/S|
|Norway: Company name AS|
|Iceland: Company name hf|
Pharmaceutical dosage form
The pharmaceutical dosage form must be the same in all concerned Nordic countries where the same Vnr is used. However, linguistic differences in presenting the pharmaceutical dosage form can be approved as long as the composition of the product is the same and the term used complies with the EU Standard Terms.
European standard term: Tablet
This means, for example, that it is not permitted to use the same Nordic Article Number for tablets in one country and capsules in another, or tablet in one country and film coated tablet in another.
The strength must be the same in all concerned Nordic countries where the same Vnr is used. However, some differences in presenting the strength might be approved after discussion with NNC.
The pack size must be the same in all Nordic countries where the same Vnr is used for an article, for instance number of tablets or ml.
Type of package
The type of package must be the same in all Nordic countries where the same Vnr is used for an article, for instance blister, jar or bottle.
The package material must also be the same in all countries. It is not allowed to have a glass jar in one country and a plastic jar in another, or a glass vial in one country and a plastic vial in another.
Package appearance and/or package information leaflet
If the six criteria above are fully met, but the text on the package and/or the appearance of the package and/or the package information leaflet differs within the Nordic countries, an unlocked common Vnr can still be approved. However, in this case the packages with the same Vnr should be separated with different GTINs.