Changes to fees for human medicinal products and devices as of 1 January 2023

With effect from 1 January 2023, the Medicines Evaluation Board (MEB) will be increasing the fees for authorisation applications, authorisation changes and the annual fees of human medicinal products. Fees for consultation procedures for medical devices will be increased as well.

As in previous years, the MEB is adjusting the fees, because of the salary and price developments. Based on these developments, a cost increase of 6% has been incorporated in the fee rates for 2023.

Based on current insights, the costs of the product group ‘consultation procedures for medical devices’ deviate significantly from revenues. Therefore, the costs for this product group have been further adjusted with effect from 1 January 2023. A new fee has also been introduced for major changes in the use of a medicinal product in a medical device (there is now a different fee for type I and type II changes).