Improving environmental protection in EU pharmaceutical legislation | Umweltbundesamt

In preparation of the revision of Directive 2001/83/ EC and Regulation (EC) No 726/2004, the German Environment Agency (⁠UBA⁠) proposes legal changes to reduce pharmaceutical residues in the environment. The proposals are based on UBA’s experiences as competent authority for the environmental risk assessment (ERA) of pharmaceuticals. Our overall aim is to ensure a comprehensive risk management system without compromising availability of medicines for patients. In this context we consider the recent EU strategy on pharmaceuticals and initiatives in connection with EU`s Green Deal particularly the Zero Pollution Ambition and the one substance one assessment approach.