Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products - Scientific guideline
Table of contents
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.
Keywords: PBT criteria, environmental risk assessment, PBT emission, PBT risk management, veterinary medicinal product (VMP)
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Question and answer document in support of the guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012) (PDF/121.83 KB)
First published: 31/01/2020
EMA/593989/2019 -
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Guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (PDF/143.47 KB)
Adopted
First published: 17/09/2015
Last updated: 17/09/2015
EMA/CVMP/ERA/52740/2012 -
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Overview of comments received during the second public consultation on 'Guidance on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinar... (PDF/272.63 KB)
First published: 17/09/2015
Last updated: 17/09/2015
EMA/CVMP/ERA/74265/2015 -
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Overview of comments received during the first public consultation on 'Guidance on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary... (PDF/233.58 KB)
First published: 19/11/2014
Last updated: 19/11/2014
EMA/CVMP/ERA/102239/2013 -
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Draft guidance on the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative substances in veterinary medicine (PDF/186.12 KB)
Draft: consultation closed
First published: 25/07/2012
Last updated: 27/10/2014
Consultation dates: 27/10/2014 to 27/01/2015
EMA/CVMP/ERA/52740/2012 -
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Concept paper on assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicine (PDF/71.82 KB)
Draft: consultation closed
First published: 19/07/2010
Last updated: 19/07/2010
Consultation dates: 15/07/2010 to 01/09/2010
EMA/CVMP/ERAWP/389867/2010