As of 1st January 2021, the Medicines Evaluation Board (MEB) will increase the fees for marketing authorization applications and changes the annual fee for medicines for human use and the fees for consultation procedures. The fees for veterinary medicines will remain the same.
The fees for applying for a marketing authorization for medicines for human use, as well as the annual fees for the registration of medicines for human use, are both increased by 4.1%.
New development of medical devices
In addition to the general indexation, the MEB will introduce a fee on requests from the Notified Bodies for advice on the quality, safety and usefulness of substances that are processed in medical devices, also known as ‘substance-based medical devices’. These are substances that have no medical effect, but can be found or absorbed on or in the body and act on a specific place in the body. In connection with the new Regulation (EU 2017/745 Medical Devices Regulation – MDR), an advisory procedure for these substances has become mandatory. Notified bodies must therefore first request mandatory advice from a medicine authority (MEB for the Netherlands) for approval of medical devices containing such substances.