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.
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
What is the difference between an appeal and a review?What is an appeal?An appeal in insolvency proceedings is no different to an appeal in normal litigation. An appeal will be allowed only if the appeal court is satisfied that the decision of the lower court was 'wrong' or 'unjust because of a
If a beneficiary signs a deed of disclaimer of their share of an estate and the estate pays their legal fees, will that count as a PET against their estate?A disclaimer is the refusal of a gift prior to acceptance. The refusal of the gift must take place before the beneficiary accepts any benefit
Strike out—making an application to strike out a statement of caseA strike out order can be made either following an application by the parties or on the court's own initiative. This Practice Note deals with the scenario of the order being made following a party's application.Making an application
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