Discount from User fee for Marketing authorisation holders with very low revenue
Based on the NOOL Board’s proposal a reduction of the User fee for 2019 for MAHs with very small or zero revenues was approved by General Meeting on 23rd August 2018. The reduced user fee was set at € 2,000 *.
A lower user fee should allow newly emerging companies or marketing authorization holders with very low revenues to enter or continue to operate on the market of medicinal products in the Czech Republic.
The Marketing Authorization Holder (MAH), which in the previous year achieved sales for all medicinal products on the Czech market of up to 500,000. EUR * (or CZK 13 million, the rate of 26 CZK / EUR was used when determining the amount of the discount and terms of its application) is entitled to request a reduced fee, provided that the MAH asks for a discount by sending no later than by 15th October of this year a written request to NOOL; a request can also be send by e-mail to email@example.com .
The amount of sales receipted by the MAH in the application for a discount should be expressed for regulated products at the producer's price for which the product was actually marketed, unregulated at purchasers' prices, in accordance with DIS-13, without any surcharges, and without VAT. Due to the expected date of issuing the invoice, judged revenues should be for 2017. NOOL is entitled to request additional documentation to verify compliance with the condition to obtain a reduced fee.
In the first year of operation, a MAH without previous history, it may request a reduction in the annual user fee; does not concern newly created MAHs related to over registration (due to Brexit).
The approval of the NOOL user fee discount will then be accompanied by the signature of an addendum to the current cooperation agreement between the MAH and NOOL (the wording of the contract addendum is currently being prepared).
If it is discovered additionally that the discount was obtained in violation of the conditions set, NOOL will demand payment of the full amount of the annual user fee.
The amount of this fee will be revised each year along with the NOOL budget planning for the next period, and its size will be published at least 4 months before the end of the current year.
* The amount of the fee and the revenue to be assessed for its approval has been approved in EUR; to determine the equivalent in CZK, the CNB exchange rate is decisive at the time of the application (in the case of sales in CZK), respectively 1st day of the month when the invoice will be issued (at the amount of user fee in CZK).