EMA: Reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal

This reflection paper provides a critical review of the adequacy/appropriateness of risk mitigation measures included in current marketing authorisations of veterinary medicinal products. These risk mitigation measures are included on the SPCs and product literature of products for which a potential risk to the environment was identified with the intended purpose of reducing the risk, as required by the Directive. This reflection paper takes into account the current legislation and existing guidelines, as well as the experience gained formulating risk mitigation measures in line with the criteria specified in the VICH-TGD (EMA 2008)