Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.
The current requirements and procedures for granting a marketing authorisation for veterinary medicinal products are laid down primarily in Directive 2001/82/EC and in Regulation (EC) No 726/2004. The new Regulation (EU) 2019/6 on veterinary medicinal products (VMPs) has been published on January 7th, 2019, to come into force on January 28th, 2022. The main aim of the new legislation is to increase the availability of VMPs in the EU, to improve the function of the EU market, to reduce the administrative burdens, and to strengthen innovation. This new Regulation has a new short Article 9 dedicated to veterinary clinical trials.