CASubmissionFee object

Fees for trial submission mandatory



Medical Devices: € 2267,02.-
Active implantable medical devices: € 2373,65.-
Clinical trial on Medicinal Products: € 3672,23.-

When there is a submission for both medical device & drug, the fees are to be paid twice (for commercial trials)
e.g € 2267,02.-/ € 2373,65.- + 3672.23.-
(Status: Nov 2015)

Waiver for academic (non-commercial) studies possible


Official guidance on required fees

The current submission rates for clinical trials with MDs are provided on the FAMHP website in section: Human medicines > Health Products > Medical devices and their accessories >Clinical evaluation > Dossier content

Additional Information

NB: No fees are charged for non-commercial, academic studies (pursuant to Chapter XIX Art 31 (5) Law 7/2004.