Istituzione di un quadro volto a rafforzare la disponibilità e la sicurezza dell'approvvigionamento di medicinali critici, nonché la disponibilità e l'accessibilità dei medicinali di interesse comune, e modifica del regolamento (UE) 2024/795

This regulation seeks to enhance the security of supply and availability of critical medicines across the EU. It establishes a framework to diversify supply chains and incentivize investments in local manufacturing capacities. Special focus is placed on older, off-patent drugs through targeted financial support and streamlined approval processes. Coordination among member states aims to reduce market fragmentation and strengthen the internal market. The goal is to bolster the EU’s strategic autonomy in the healthcare sector.