Authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances - Scientific guideline

This document reflects the need for a strategic approach to the assessment of the risks posed by veterinary medicinal products containing potential persistent, bioaccumulative substances.

Keywords: PBT criteria, PBT emission, PBT risk management, veterinary medicinal product (VMP), aquatic, terrestrial

Current effective version

Reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances

Adopted Reference Number: EMA/CVMP/448211/2015

Document history

Overview of comments received on 'Reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPv...

Reference Number: EMA/CVMP/401418/2016

Draft reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances

Draft: consultation closed Consultation dates: 26/02/2016 to 31/05/2016 Reference Number: EMA/CVMP/448211/2015 Summary:

Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances are associated with specific concerns because of their persistence, their ability to accumulate in the environment and in living organisms and their toxicity.