Synapse

Politics of European countries protecting the supply of critical medicines 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.

1 de 5 Publications

EU and medicines supply issues (part one): Current measures

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.

par Alison Dennis

2 de 5 Publications

EU and medicines supply issues (part two): Proposals for future measures

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.

par Alison Dennis et Alice Matthews

3 de 5 Publications

Guidance to manufacturers withdrawing a medical device from the EU market

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.

par Bartosz Świdrak

4 de 5 Publications

Comparison of national measures to protect the supply of medicines and medical devices

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.

par plusieurs auteurs

5 de 5 Publications

Medical devices: additional regulatory considerations from the new liability frameworks

In this article we examine why this burden is particularly difficult for multi-national life sciences businesses and explain the steps you should be taking now to mitigate against potential court sanctions for failure to disclose relevant evidence.

par plusieurs auteurs

4 de 6 Publications

Corrective actions: dos and don’ts

This article sets out a summary of the key dos and don’ts for preparing for and managing corrective action in the life sciences sector.

par plusieurs auteurs

5 de 6 Publications

A new era for product liability in the EU

This article outlines the key changes introduced by the new PLD. It explores the expanded scope of liability and the broader pool of potentially liable parties, as well as the new rules on the burden of proof and disclosure of evidence.

par plusieurs auteurs

1 de 6 Publications

Drafting PMS and vigilance obligations into medical device distribution agreements

In this article we discuss here how manufacturers might ensure, through appropriate contractual provisions, that distributors (and importers) will provide all necessary support to allow a manufacturer to comply with its PMS obligations.

par Alison Dennis

6 de 6 Publications