An Environmental Risk  Assessment (ERA) is mandatory for all Marketing Authorization Applications  (MAA) of medicinal products in the European Union, regardless of the legal  basis. The ERA aims to assess the potential environmental risks arising from  the use of a medicinal product and to identify appropriate precautionary and  risk mitigation measures, with the objective of protecting aquatic and terrestrial  ecosystems, as well as microbial processes occurring in wastewater treatment  plants.

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The new European  Medicines Agency (EMA) guideline on ERA entered into force on 1 September 2024 and introduced a range of new orientations and specific requirements for  the assessment of the environmental risk of medicinal products. Understanding  the implications of this new guideline is therefore essential for the  successful submission of MAAs and, most importantly, for ensuring the proper  use and disposal of medicinal products.  

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