CASubmissionFee object
Fees for trial submission mandatory
Yes
Fees
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
Yes
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).
