Plant testing strategy in the risk assessment for veterinary medicinal products - Scientific guideline

This document addresses the recommended testing strategy and risk assessment for plants in the phase II assessment.

Keywords: Higher tier testing, species sensitivity distribution (SSD), soil risk assessment, OECD 208

Current effective version

Guideline on the plant testing strategy for veterinary medicinal products

Adopted Reference Number: EMA/CVMP/ERA/689041/2015 Rev.1 Legal effective date: 01/10/2017

Document history - Current version

Guideline on the plant testing strategy for veterinary medicinal products

Adopted Reference Number: EMA/CVMP/ERA/689041/2015 Rev.1 Legal effective date: 01/10/2017

Overview of comments received on 'Guideline on the plant testing strategy for veterinary medicinal products' (EMA/CVMP/ERA/689041/2015)

Reference Number: EMA/CVMP/ERA/8138/2017

Draft guideline on the plant testing strategy for veterinary medicinal products

Draft: consultation closed Consultation dates: 27/05/2016 to 30/11/2016 Reference Number: EMA/CVMP/ERA/689041/2015 Summary:

Plant toxicity tests are used in the terrestrial environmental risk assessment of veterinary medicinal products (VMPs) as described in the VICH guideline on environmental impact assessment for veterinary medicinal products Phase II (CVMP/VICH/790/2003) (CVMP/VICH, 2005).

Concept paper on the testing strategy and risk assessment for plants in the Phase II of the environmental risk assessment for veterinary medicinal products

Draft: consultation closed Consultation dates: 18/06/2015 to 30/09/2015 Reference Number: EMA/CVMP/ERA/698394/2014 Summary:

This concept paper has been prepared to address the need to develop a guideline on the testing strategy and risk assessment for plants in the Phase II assessment, as explained in the existing reflection paper, as well as including how to conduct a tier based assessment for plants for those substances that form high amounts of non-extractable residues or transformation products in manure.

Document history - First version

Reflection paper on testing strategy and risk assessment for plants

Adopted Reference Number: EMA/CVMP/ERA/147844/2011

Overview of comments received on 'Reflection paper on testing strategy and risk assessment for plants - draft' (EMA/CVMP/ERA/147844/2011)

Reference Number: EMA/CVMP/ERA/521952/2011

Draft reflection paper on testing strategy and risk assessment for plants

Draft: consultation closed Consultation dates: 09/03/2011 to 30/06/2011 Reference Number: EMA/CVMP/ERA/147844/2011 Summary:

The objective of this reflection paper is to address the recommended testing strategy and risk assessment for plants in the Phase II assessment.