Criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6

The purpose of this reflection paper is to establish criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6.

Keywords: environmental risk assessment, essential, new veterinary regulation, persistent bioaccumulative toxic (PBT), very persistent and very bioaccumulative (vPvB), veterinary medicinal product (VMP)

Current version

Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6

Adopted Reference Number: EMA/CVMP/116512/2021

Document history

Draft reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6

Draft: consultation closed Consultation dates: 25/02/2022 to 31/05/2022 Reference Number: EMA/CVMP/116512/2021