ENVIRONMENTAL RISK ASSESSMENT (ERA)
It is mandatory that the dossier for the marketing authorization of human medicinal products (HMP) includes an environmental risk assessment (ERA). This ERA is based on the use of the product and on the physicochemical, ecotoxicological, and fate properties of the active substance. This report includes an assessment of the potential risks to the environment arising from the use of the product, with the aim of protecting aquatic and terrestrial ecosystems, including surface water, groundwater, and soil.