Ensuring compliance within post-market frameworks is essential for maintaining product integrity and meeting regulatory standards. Our practical guidance equips legal professionals with the tools needed to navigate ongoing obligations, manage product recalls, and handle post-approval variations effectively. Stay updated on evolving regulations and safeguard the lifecycle of life sciences products with our expert insights.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on its Phase 1, 14-Day Pilot Programme, which is intended to...
This week's edition of Life Sciences weekly highlights includes news that the International Medical Device Regulators Forum (IMDRF) has published...
The Department of Health and Social Care (DHSC) has published a collection of new and updated guidance on sales, promotion and enforcement...
The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare organisations and distributors to stop using or supplying six...
Introduction to technology transfer agreements in the Life Sciences industryWhat is a technology transfer agreement?The term ‘technology transfer...
Regulation of cosmetic products in the UKThis Practice Note provides an overview of the UK regulatory framework for cosmetics. It sets out the legal...
Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
Second and subsequent medical use patent claimsBackground to medical use claimsSecond (and subsequent) medical use patent claims are specific to the...
PharmacovigilanceSTOP PRESS—Impact of the Retained EU Law (Revocation and Reform) Act 2023: This document contains references to retained EU law (REUL) and associated terms introduced by the European Union (Withdrawal) Act 2018 in connection with Brexit. From 1 January 2024, REUL that remains in
Priority between loss reliefs in loss making companiesWhy does it matter?A company that is a member of a group and has incurred any of the types of losses available for surrender by way of group relief may, without any further rules, have more than one way in which to use the loss. There are a
If a rentcharge is shown as being informally exonerated on title information, does this apply to the current registered owner? Or does the informal exoneration only apply to the parties to the document which informally exonerated the rentcharge?This Q&A considers the situation where, at some point
Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a
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