As per the delegated regulation marketing authorization holders are required to fund the medicines verification system.
Since 2021 the Norwegian fee has been split between a fixed fee per MAH and a sales base fee. The introduction of this model was broadly supported when it was introduced.
Nomvec has since then reduced its’ reserves and operated at a loss to reflect the reduced need as the system moves from a project phase to an operational phase. A more appropriate level has now been reached and the fee is now aiming for a neutral result.
New entrants will be charged a new-entrant fee in addition to an annual fee.
Already registered companies will be charged a fee will that split between a flat fee and a sales-based fee.
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.