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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.
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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.
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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.
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Politics of France protecting the supply of critical medicines and medical devices
German requirements protecting the supply of critical medicinal products and medical devices
Advertising medicines, foods and food supplements and medical devices to consumers in the UK
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.
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Preliminary injunctions in the UPC – lessons learnt
Two years in, the UPC has become a key forum for patent enforcement, offering swift preliminary injunctions across many EU states. Courts assess both infringement and patent validity rigorously, requiring applicants to act quickly and prepare thoroughly.
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UPC litigation in life sciences: seven early takeaways for the pharma, biotech and medical devices sectors
The Unified Patent Court (UPC) has become a crucial forum for life sciences patent litigation. Early rulings show strict claim interpretation, careful review of European Patent Office oppositions, and limits on the Bolar exemption. The UPC has clarified infringement tests for second medical use claims and considers patient interests in injunctions. These developments emphasise precise patent strategy, regulatory alignment, and proactive risk management for pharma, biotech, and medical device sectors.
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