Higher-tier testing of veterinary medicinal products to dung fauna - Scientific guideline

This document reflects the need for a further guidance on the design and the evaluation of studies intended to elucidate the effect of veterinary medicinal products to dung organisms at Tier B level.

Keywords: Dung flies, dung beetles, endengered dung species, environmental risk assessment, protection goals, higher tier testing, veterinary medicinal product (VMP)

Current effective version

Draft guideline on the higher-tier testing of veterinary medicinal products to dung fauna

Draft: consultation closed Consultation dates: 25/07/2016 to 31/01/2017 Reference Number: EMA/CVMP/ERA/409350/2010 Summary:

Dung, especially from larger mammals, makes up a complex and highly dynamic ecosystem within a small environmental scale. This guideline is intended to provide guidance on how to investigate the environmental effects of veterinary medicines containing antiparasitic substances in higher tier laboratory tests and field studies, in situations where the initial Tier A risk assessment indicates a risk to dung flies or beetles. The guideline aims to provide harmonisation of the study design for an easier interpretation and comparison of the results.

Document history

Concept paper on higher tier testing of antiparasitics to dung organisms

Reference Number: EMEA/CVMP/ERA/12254/2009