MEB fee rate change as of January 2020
The Medicines Evaluation Board (MEB) is increasing the fee rates for authorisation applications, authorisation changes and the annual fees of human medicinal products. The fees of procedures will be raised by 5%; the annual fees will be increased by 6.5%. Fee rates for consultation procedures will also increase.
The reasons for these regular increases of fee rates are higher prices, salaries and housing costs and processing costs for the reports of drug shortages. Higher housing costs will be settled in all fees, the extra costs for handling of reports of drug shortages will be settled in the annual fees of human medicinal products.
The MEB indexes the fee rates on a yearly basis, to prevent sudden big changes. The fee rates for 2020 will be published on this website on January 1, 2020.
Consultation procedures for medical devices
The current fees for consultation procedures are not cost-effective. More time is needed for these procedures than expected and therefore the costs are higher than the profits. The fee for a consultation procedure for medical devices for a known active substance will be increased from € 4,050.- to € 9,000.-.
The fee for a consultation procedure for a new application will be increased from € 13,500.- to € 14,180.- and for a consultation procedure for an uncomplicated variation of a certified medical device from € 1,350.- to € 1,420.-.
Due to the intended Brexit, a transfer of the medicinal products authority to be consulted is possible. Documents needed by the MEB for a transfer are
- the dossier which received a positive advice
- proof of the CE certificate
- copies of the assessment reports provided by the MHRA
The transfer fee is € 530,-. The request form for a transfer is accessible via the MEB-website.