Q&As

Q&As

These Q&As seek to briefly address common questions faced when dealing with Life Sciences matters.

The Q&As supplement and link to other more detailed content within Lexis®+ UK, but are intentionally short. It is anticipated that a brief Q&A will be most helpful when you need a quick overview of an issue and its likely impact. This might arise, for example, for lawyers needing to provide advice, provide business development or training at short notice. The Q&A content on Lexis®+ UK Practical Guidance is date stamped. This date is the publish date and

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Latest Life Sciences News

MHRA launches consultation on indefinite recognition of CE-marked medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposals for the indefinite recognition of Conformité Européenne (CE)-marked medical devices in Great Britain (GB), aimed at protecting patient access and ensuring the continued supply of safe and effective medical technologies. The consultation closes on 10 April 2026.

MHRA updates guidance on defective medicinal products reporting procedure

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on defective medicinal products and on substances used in their manufacture or packaging that may be defective. The revised guidance reflects the introduction of an online reporting form for industry stakeholders to notify the Defective Medicines Report Centre (DMRC) of suspected defective products and includes minor editorial amendments.

MHRA reports seizure of 4.4 million unlicensed erectile dysfunction pills in 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has reported the seizure of approximately 4.4 million doses of unlicensed erectile dysfunction pills in 2025, bringing the total seized between 2021 and 2025 to 19.5 million doses. The seizures were carried out by the MHRA's Criminal Enforcement Unit in collaboration with Border Force to intercept shipments and disrupt organised criminal networks. The pills contained the active ingredients sildenafil, tadalafil, vardenafil and avanafil and were being illegally sold online. Annual seizures have more than doubled since 2022, with erectile dysfunction pills remaining among the most frequently seized illegally traded medicines in the UK. The MHRA has advised the public to avoid purchasing medicines from social media, messaging apps or unknown websites, to use only UK-registered pharmacies displaying the official green cross logo and to consult GPs or pharmacists for safe treatment options.

EU Commission sets out priorities for AI Act implementation

MLex: The European Commission has identified its 2026 priorities for implementing the EU AI Act, focusing on procedural rules for general-purpose AI models, regulatory sandboxes and the AI Office’s market surveillance role. Several rules implementing the AI law, including the criteria for designating a model ‘with systemic risk’ and the methodology to estimate energy consumption, have been de-prioritised, according to an internal document seen by MLex.