Assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwater - Scientific guideline

This document reflects the need for a guideline on the methodology to perform a risk assessment of veterinary medicinal products for both human health and the environment. The proposed guideline shall provide technical support to the implementation of the VICH GL6 and GL 38.

Keywords: Higher tier assessment, environmenal risk assessment, human health, VICH GL6, VICH GL38

Current effective version

Concept paper on assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwater

Draft: consultation closedConsultation dates: 19/04/2013 to 30/06/2013Reference Number: EMA/CVMP/ERA/718229/2012Summary:

This intended guideline should provide further technical support to the implementation of the VICH 19 guidelines GL6 and GL38 on the environmental risk assessment (ERA) of veterinary medicinal products (VMPs).