ERA reports

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In order to prevent the toxic effects of pharmaceuticals in the environment, ERA reports (Environmental Risk Assessment) are required for all new drug applications (NDA) of human medicinal products.

ERA report is focused on the use of the product and its physicochemical and ecotoxicological properties and defines the fate and effects of pharmaceuticals in the environment. This report aims to define the potential risks to the environment derived from use of medicinal products, in order to protect aquatic and terrestrial ecosystems, including surface water, groundwater and ground.

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