The evaluation of medicinal products based on Directives 2001/83 / EC (human medicinal products) and 2001/82 / EC (veterinary medicinal products) requires assessment of the environmental impact of the medicinal product. The aim is to assess the potential harmful effects, which the use of the medicinal product may cause to the environment and to identify the risk of such effects. The assessment shall also identify any mitigation measure which may be necessary to reduce such risk.
This environmental risk assessment must be provided for each new marketing authorisation application (new medicinal products including generics products) and can also be necessary for authorisation renewal (extensions of indications, variations).
For the extension of indications and variations, a specific environmental assessment is needed when the amendment of the marketing authorisation may lead to an increase in the level of environmental exposure.
For veterinary medicinal products, a marketing authorisation should be refused where the estimated ecotoxicological risk is not outweighed by the expected benefit. The stakes are this important!