Il rafforzamento dei poteri dell’Agenzia europea per i medicinali nel prisma delle competenze UE in materia di sanità pubblica

The paper outlines the main novelties contained in Regulation (EU) 2022/123 that confers an extended mandate to the European Medicines Agency for the purposes of strengthening preparedness and crisis management capacity with regard to medicinal products and medical devices. The new provisions are also examined taking into account the further initiatives adopted (and still under negotiation) towards the building of a European Health Union. Lastly, summary reflections are put forward in the light of the unchanged framework of competences attributed to the Union in the field of public health.