Europe's approach to supply chain issues for medicines and medical devices

Medicine and device shortages are rising across Europe, threatening patient care and exposing gaps in healthcare systems. With access to treatment considered a fundamental right, governments are under pressure to respond. While some countries have implemented reporting and mitigation strategies, broader EU-level reforms like the proposed Critical Medicines Act aim to strengthen supply chain resilience amid growing global uncertainty.

Marketing Authorisation Holders (MAHs) in the EU are legally required to report medicine supply shortages to the European Medicines Agency and national authorities. This article explores the central role of Marketing Authorisation Holders (MAHs) in identifying and managing medicine supply shortages in the EU as well as the role of EMA committees and working groups in coordinating responses and maintaining the Critical Medicines List to safeguard public health.

In part two of our article on EU and medicine supply issues we explore the key proposals outlined in pharmaceutical reform and their impact on marketing authorisation holders across the region.

Medical product availability and healthcare safety are becoming increasingly important talking points. This is also reflected in the EU regulations on medical devices. Although the provisions may seem straightforward their vagueness may give rise to significant doubts as to which situations they will apply to in practice.

Our international team has developed a practical guide that allows users to navigate different European jurisdictions, identifying medicines subject to supply restrictions, and understand manufacturers' obligations during shortages or product withdrawals.