CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6

The Committee adopted the scientific advice on the establishment of a list of antimicrobials which shall not be used in accordance with Articles 112, 113 and 114 of Regulation (EU) 2019/6 or which shall be used in accordance with these articles subject to certain conditions. This advice relates to the implementing act referred to in Article 107(6) of the same regulation (EMA/CVMP/151584/2021). The purpose of this list, together with the list of antimicrobials reserved for human use established under Article 37(5) and enacted under Commission Implementing Regulation (EU) 2022/1255, is to help preserve the efficacy of certain antimicrobials for humans and/or animals by promoting prudent antimicrobial use and thereby reducing the risk from antimicrobial resistance (AMR).

The Committee adopted by consensus positive opinions for variation requiring assessment applications concerning quality-related changes…