NO: The changes to an Vnr introduced to the market

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 of trade name

Any change of trade name should be followed by a new Vnr. Adjustments or minor changes in the name may be allowed as long as 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 blisterpacks to facilitate handling in hospitals and hospital pharmacies.

Change of prescription group for medicines with MA

When changing the prescription group from C (prescription) to F (non-prescription), a new Vnr is required. 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 logistic and medicine statistic requirements. With respect to medicine statistics, it is required to differentiate between prescription and non-prescription sales.

Notification of change

The pharmaceutical company must notify Farmalogg on changes to information elements maintained by Farmalogg. A guideline on what information the company must communicate is available at after logging in.

There is no link between the systems for NNC and Vareregisteret. Thus, any relevant changes concerning the Vnr must be communicated to both Farmalogg and NNC.

Please note that new Vnrs always must be registered and processed as new products in Vareregisteret. It is not possible to change the Vnr on an already marketed Vnr.