Innovation in animal health under Regulation (EU) 2019/6: Review and recommendations

Date: April 13, 2026

Authors: Klaus Hellmann 1, Helen Jukes 1, Matthias Hofer 2, Jens Peters 3, Ivo Schmerold 4, Gabriel Beechinor 5, Raffaele Bruno 6, Rory Cooney 7, Gabriele Braun 1, Charley Cull 8, Sven Bergmann 9, Michael Walkenhorst 10, Theresa Schlittenlacher 10, Dejan Cvejic 1, Juliane Straube 1 and Cornelia Huettinger 1 — 1 Klifovet GmbH, Munich, Germany, 2 Stonehaven Cozmix Group, Frauenfeld, Switzerland, 3 BPIvet, Berlin, Germany, 4 European Federation for Pharmaceutical Sciences (EUFEPS), Mannheim, Germany, 5 Health Products Regulatory Authority (HPRA), Dublin, Ireland, 6 Zoetis, Zaventem, Belgium, 7 Veterinary Medicines Directorate (VMD), Addlestone, United Kingdom, 8 Midwest Veterinary Services Inc., Manhattan, KS, United States, 9 City University of Hong Kong, Hong Kong, Hong Kong SAR, China, 10 Research Institute of Organic Agriculture (FiBL), Frick, Switzerland

Published: frontiers in Veterinary Science

Access publication: link

Translating scientific innovation into approved veterinary medicines remains challenging under evolving regulatory frameworks. This article examines how Regulation (EU) 2019/6 is shaping the development, authorization, and availability of innovative veterinary medicinal products in Europe – highlighting regulatory bottlenecks, practical experiences three years post-implementation, and recommendations to better enable novel therapies and limited-market products.