The new veterinary medicines regulation (Regulation (EU) 2019/6) will come into force in January 2022. It will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union. The new regulation seeks to simplify the regulatory environment and reduce the administrative burden for pharmaceutical companies developing veterinary medicines.
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, reduce the administrative burdens, and strengthen innovation. It contains new measures for increasing the availability and safety of veterinary medicines and enhances EU action against antimicrobial resistance. This new Regulation has a new short Article 9 dedicated to veterinary clinical trials.