CASubmissionFee object
Fees for trial submission mandatory
Yes
Fees
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
Yes
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.
