Italy: The Italian Medicines Agency – assessment of the environmental impact of medicines

In brief

On 16 November 2023, 50 experts from 19 different European countries met to discuss the environmental impact of medicines for human use that are not derived from genetically modified organisms (GMOs).


Contents

Key takeaways

According to Article 1, para 35, lett. c), of the Proposal of Directive on the Union code relating to medicinal products for human use, one of the potential public health risks associated with the use of medicines for human use that are not derived from GMOs is their release into the environment. Among the instruments to be used to address this issue, the expert panel identified the Environmental Risk Assessment which allows the assessment of the potential risks associated with the release of such medicines into the environment, both during the testing phase and during the phase of actual use and is also an essential element in obtaining new marketing authorizations.

This assessment therefore plays a central role in the protection of human health and ecosystems, to the extent that, as part of the European Green Deal, its strengthening has been placed high on the agenda of the pharmaceutical strategy.

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