IAHJ: EMA/CVMP proposals for the requirements for limited markets and minor species: an update in 2021

Read Klifovet's Q2 article published in the IAHJ


In less than a year, on January 28, 2022, Regulation (EU) 2019/6 will become applicable. The CVMP has now issued different guidance documents how the new Regulation impacts the registration for limited markets including minor species. While article 23 provides an abbreviated pathway for such products to obtain a marketing authorisation with a reduced dataset on safety and efficacy, resulting in a 5 years period for marketing authorisation, an unlimited authorisation is achieved with an adapted amount of data for such limited market products according to Article 8. CVMP reflects on the approach for classification of such products, and provides guidance for efficacy and safety data requirements in the target species for both, biological and non-biological products. Further guidance is given for safety and residue data requirements to establish an MRL.