Registration of Novel Parasiticides under the New 2022 EU Regulation

Abstract

Twenty-one years after Directive 2001/82/EC regulating veterinary medicinal products (VMPs) came into force, a new veterinary regulation will apply from 28 January 2022. Future applicants will have to follow the requirements of Regulation (EU) 2019/6. This regulation defines different products, non-biologicals (equivalent to formerly defined pharmaceuticals), and biological products. Biological VMPs belong either to the new class, non-immunological VMPs or immunologicals, including those known as vaccines. This new regulation also defines novel therapies covering innovative medicinal therapeutic approaches. Antiparasitic products will always be VMPs, and additional requirements for environmental safety and potential risks for the development of resistance are enforced.