It is mandatory for a marketing authorisation application (MAA) for a medicinal product for human use (HMP) to include an environmental risk assessment (ERA). This ERA is based on the use of the product and the physico-chemical, ecotoxicological, and fate properties of its active substance(s). This guideline describes how to perform this ERA and how to evaluate potential risks to the environment arising from the use of the medicinal product, with the aim of protecting aquatic and terrestrial ecosystems including surface water, groundwater, soil, species at risk of secondary poisoning and the risk for the microbial processes in sewage treatment plants (STPs). Furthermore, the identification of potential hazards of the active substance of a medicinal product is described. The guideline also includes consideration of potential precautionary and risk mitigation measures and provides guidance on how to report the findings in an Environmental Risk Assessment Report…
