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 that might introduce any doubts about the identity of the product, 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

A change of package type, eg from blister to container, is not acceptable and a new Vnr is required. Package materials has not been a Vnr-issue in Norway. If change of package materials has is no impact on pricing, and the Vnr can be kept. The register distinguishes between ordinary blisterpack and unitdose blisterpacks to facilitate handling in hospitals and hospitals pharmacies.

Change of prescription group for medicines with MA

When changing the prescription group from C (prescription) to F (non-prescription), a new Nordic article number is required on the package. The package must be approved by the NoMA if the prescription group is to be changed from C to F to ensure correct patient information.

The need for separate Vnrs on packs intended for prescription- and non-prescription sales is an issue in relation to logistics. The wholesaler and the retailer need separate Vnrs to differentiate these packages. With respect to medicine statistics, it is required to differentiate between prescription and non-prescription sales. This is also an issue because of the non-pharmacy sales of some OTC medicines.  On this basis, a new article number is necessary when changing from prescription group F to C.

Change of product code

If a GTIN is changed without a corresponding change of Vnr, the new product code may be added to the Vnr at Farmalogg’s website.  The change situations for VNR respectively GTIN is presented at http://wiki.vnr.fi/

Notification of change

Farmalogg is the entry point for maintaining the information linked to the identity of a Vnr. It is important to note that there is no link between the systems for NNC and Vareregisteret. Any change concerning the Vnr in the NNC-system must be communicated to Farmalogg by the responsible pharmaceutical company.

The pharmaceutical company must also notify Farmalogg on changes to other information elements maintained by Farmalogg. A guideline on what information the company must communicate is available at www.farmalogg.no after logging in.

Please note that any change in a product which entails a change of Vnr, the new Vnr must be registered and processed as any new product in Vareregisteret.