The European Medicines Agency (EMA) has issued guidelines for the environmental risk/impact assessment (ERA or EIA) of veterinary medicinal products (VMPs). The ERA is tier-based and comprises two phases described in two different guidelines.
VICH GL6 Environmental Impact Assessment (EIAS) for Veterinary Medicinal Products - Phase I [CVMP/VICH/592/98-FINAL]
This guideline recommends that the assessment of the environmental impact of VMPs should be conducted in a stepwise manner through questions that allow the applicant to conclude first if their product qualifies for a Phase I Report and then if the compound should be assessed in a Phase II studies.