Environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - Scientific guideline
Table of contents
This 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. Read together with questions and answers.
Keywords: Environmental risk assessment, veterinary medicinal product, VICH GL6, VICH GL38
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Questions and answers: implementation of CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 (Phase I) and GL38 (Phase II) (PDF/351.66 KB)
First published: 23/09/2009
Last updated: 20/05/2022
EMEA/CVMP/ERA/172074/2008 Rev.7 -
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Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (PDF/935.27 KB)
Adopted
First published: 17/11/2008
Last updated: 05/07/2016
Legal effective date: 01/03/2009
EMEA/CVMP/ERA/418282/2005-Rev.1 Corr.1 -
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Overview of comments received on guideline on environmental impact assessment for veterinary medicinal products in support of VICH guidelines GL6 and GL 38 - Doc. ref. EMEA/CVMP/ERA/418282/2005-REV.1 post publication (PDF/127.77 KB)
First published: 17/11/2008
Last updated: 17/11/2008
EMEA/CVMP/ERA/571947/2008 -
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Draft revised guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38 (PDF/685.69 KB)
Draft: consultation closed
First published: 23/06/2008
Last updated: 23/06/2008
EMEA/CVMP/ERA/418282/2005-Rev.1
- Safety and residues: pharmaceuticals
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Focus group on implementation of CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 (Phase I) and GL38 (Phase II)
- VICH GL6 Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I
- VICH GL38 Environmental impact assessments for veterinary medicinal products (VMPs) - Phase II
- Volume 6: Notice to applicants and regulatory guidelines for medicinal products for veterinary use