Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CVMP/ERA/52740/2012
Published17/09/2015
Effective from01/04/2016
KeywordsPBT criteria, environmental risk assessment, PBT emmission, PBT risk management, veterinary medicinal product (VMP)
DescriptionThis document provides guidance on the scientific data/information, parameters, test conditions and default values that should be used for the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative veterinary medicinal products.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments (2nd public consultation)


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/04/2016–present


Published: 17/09/2015


Published: 19/11/2014


Published: 27/10/2014


Published: 19/07/2010


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