CASubmissionFee object

Fees for trial submission mandatory



Each Clinical Trial Application (CTA) must be accompanied by payment of a fee.

The fees applicable in 2015 are provided in Circular 616 and are as follows:

• Complete new application file: € 3672,23.-
• Substantial amendment: € 604,63.-
• Annual Safety report: € 655,02.-

Waiver for academic (non-commercial) studies possible


Official guidance on required fees

Circular letter 616: provides the current fees for 2015
A circular letter with the exact amounts and specificities is published each year and is available on the FAMHP website in section: Human medicines > Medicines > Herbal medicinal products > Research and Development > Clinical trials

Additional Information

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