In less than a year, on January 28, 2022, Regulation (EU) 2019/6 will become applicable. The CVMP has now issued different guidance documents on how the new Regulation impacts the registration for limited markets including minor species. CVMP reflects on the approach for classification of such products and guides efficacy and safety data requirements in the target species for both biological and non-biological products. Klaus Hellmann and Cornelia Hüttinger at Klifovet give you an update on the requirements for limited markets and minor species.