Environmental Risk Assessments in medicines

All marketing authorisations (MAs) require an evaluation of the potential environmental risks posed by the medicinal product, as specified in Schedule 8 of the Human Medicines Regulations (HMR). This includes an assessment of the product’s potential environmental impact and a description of the proposed arrangements for limiting that impact.

An ERA evaluates the risk to the environment arising from use of the product, taking into account the physicochemical and ecotoxicological properties, as well as the environmental fate, of the active substance. Where the possibility of environmental risk cannot be excluded, specific measures to limit environmental impact should be proposed. Appropriate precautionary and safety measures should be included in the Summary of Product Characteristics (SmPC) and patient information leaflet (PIL), where applicable.