Marketing Authorization Holders

Registration and fees

As per the delegated regulation marketing authorization holders are required to fund the medicines verification system.

When the fee for participants in the Norwegian NMVS was first agreed between the organisations representing MAHs in Norway it was agreed to share the costs of establishing and operating the NMVS on an equal basis, so that every MAH received an equal share of the total cost.

This model was evaluated in 2019 with input from several companies of various size and product structure. The feedback was that the current model was predictable and easy to understand, but also that a flat fee per. MAH did not truly reflect the activity generated on the system. We saw that some of the largest companies in the market are only represented by one or two MAHs, whilst many niche providers are represented by five or more MAHs and start-up’s with minimal sales pay as much as the largest companies per. MAH, creating an uneven share of the cost burden for operating the NMVS.

A change in the fee model was broadly supported provided that a new model would be predictable, easy to calculate and consistent over time. The revised model was presented and accepted by LMI and Parallellimportørforeningen. At that time no MFE was not represented in Norway. Based on the consultation with companies and the organisation Nomvec adapted a revised fee-model which will evaluated again in 2023.

New entrants will be charged a new-entrant fee in addition to an annual fee.

New entrants need to register with Nomvec if they have a marketing licence and have active sales in the market.

Already registered companies will be charged a fee will that split between a flat fee and a sales-based fee.

The 2023 fees are announced here.

Note that small companies and new entrants can apply for a reduced fee the first year. This application is evaluated individually based on time of registration, sales and other relevant circumstances. Contact us for more information if you want to be considered.