Legislation

Legislation

Clinical trials involving the use of medicinal products for veterinary user are regulated by Article 6(5) of the Belgian Medicinal Products Act of 25 March 1964.

Before a clinical trial starts, you must submit an application for an authorisation. You may start the clinical trial only after you have received a favourable opinion.

Authorisation is granted for a maximum period of one year. If your clinical trial lasts longer than one year, you must apply for an extension. Such extensions are granted for up to one year, but they are renewable.

You must also submit a new application if you wish to make any amendments to the test protocol, administrative file, or quality file that you have submitted and they may be implemented only after you have received a favourable opinion on such (an) amendment(s).

Last updated on 23/10/2017