Environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - Scientific guideline

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

Current effective version

Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38

Adopted Reference Number: EMEA/CVMP/ERA/418282/2005-Rev.1 Corr.1 Legal effective date: 01/03/2009

Document history

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)

Reference Number: EMEA/CVMP/ERA/172074/2008 Rev.7

Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38

Adopted Reference Number: EMEA/CVMP/ERA/418282/2005-Rev.1 Corr.1 Legal effective date: 01/03/2009

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

Reference Number: EMEA/CVMP/ERA/571947/2008

Draft revised guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38

Draft: consultation closed Reference Number: EMEA/CVMP/ERA/418282/2005-Rev.1