Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 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.