Regulatory review of the environmental risk assessment of veterinary medicinal products in the European Union, with particular focus on the centralised authorisation procedure

In the EU, the requirement for a two-tier-based environmental risk assessment for a veterinary medicinal product applies for marketing authorisations submitted since 1993. This article outlines the framework for conducting environmental risk assessments and provides information about the outcomes and type of substances that often require a higher tier assessment due to environmental concerns, and the tools available within the relevant...