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 regulation to reassess potential risks from products already authorised (i.e., referral procedures (under Article 33(4), Article 35 of Directive 2001/82/EC and Article 30(3) of Regulation (EC) No 726/2004)). The majority of pharmaceutical veterinary medicinal products (> 95%) are considered to have a limited environmental release, and their risk assessment ends in the lowest tier (Phase I). To date, 19 referrals have been triggered as a result of environmental concerns, with the outcome from two out of the 19 concluding with an overall benefit/risk balance being negative, and resulting in the withdrawal of products from the market. The way environmental risk assessment for veterinary products will be addressed when the new veterinary regulation (Regulation (EU) 2019/6) comes into force on 28 January 2022 is also presented, and ongoing initiatives and published reports are discussed. The latter recommending policy actions to address water pollution by pharmaceutical residues and advocating a robust international cooperation and the establishment of a 'One Health' approach.