NO: Changes to a marketed Vnr

For the common Nordic regulatory framework on changes, see Nordic Instructions. On the topics of changes in the Nordic Instructions, please note the following elaborations:

Change to the trade name

A change to the trade name normally requires a new Vnr. Adjustments or minor changes in the name may be allowed if the product appears principally unchanged.

Change of package type

Change of package type, e.g. from blister to container, requires a new Vnr. For changes to package materials with no impact on pricing, the Vnr can be kept. The register distinguishes between ordinary blisterpack and unitdose blisterpack to facilitate handling in hospitals and hospital pharmacies.

Change of prescription group for medicines with marketing authorisation

A new Vnr is required when a product changes from prescription-only (C) to non-prescription (F). The package must be approved by the NOMA if the prescription group is to be changed from C to F.

When changing the prescription group from F to C, a new Vnr is normally required due to logistics and medicine statistic requirements. This distinction is required for medicine statistics purposes, as prescription and non-prescription sales must be recorded separately.

Notification of change

The pharmaceutical company/supplier must notify Farmalogg on changes to information elements maintained by Farmalogg. A guideline on what information the company must report is available on farmalogg.no after logging in.

There is no direct link between the NNC and Farmalogg. Therefore, any relevant changes relating to a Vnr must be reported to both the NNC and Farmalogg.

Please note that a new Vnr must always be registered and processed as a new product in the article register. Once a product has been marketed, its Vnr cannot be changed.