Authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances - Scientific guideline
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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
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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... (PDF/805 KB)
First published: 23/05/2017
Last updated: 23/05/2017
EMA/CVMP/401418/2016 -
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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 (PDF/200.13 KB)
Draft: consultation closed
First published: 26/02/2016
Last updated: 26/02/2016
Consultation dates: 26/02/2016 to 31/05/2016
EMA/CVMP/448211/2015