Clinical trials of veterinary medicinal products are regulated by Article 9 of Regulation 2019/6, and Articles 7 and 8 of the Belgian Act of 5 May 2022 on medicinal products for veterinary use.

Prior to initiating a clinical trial, an application must be submitted to receive an authorisation.
The clinical trial can only start after the FAMHP has granted a favourable advice.

An authorisation is granted for a maximum period of one year. If the clinical trial exceeds one year, an extension must be applied for. Such extensions are granted for up to one year, but are renewable.

A new application must be submitted when making (an) amendment(s) to the test protocol, administrative file, or quality file that has been submitted. They can only be implemented upon receipt of a favourable advice of such (an) amendment(s).

Last updated on 29/03/2024