Stay ahead in the ever-evolving landscape of pharmaceutical regulation with our expert guidance. From compliance with stringent UK and EU directives to navigating global market entry requirements, we provide the essential tools and insights legal professionals need to advise clients confidently. We delve into the critical aspects of drug approval processes, marketing authorisations, and post-market surveillance, ensuring you stay informed on the latest regulatory updates and best practices. Equip yourself with the knowledge to tackle regulatory challenges head-on and deliver exceptional legal advice within the life sciences sector.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have published...
This week's edition of Life Sciences weekly highlights includes news that the European Parliament adopted its position on the Digital Omnibus...
The Association of the British Pharmaceutical Industry (ABPI) has published a report examining how improved access to rare disease medicines could...
The European Commission has updated its Q&A on Article 10a of Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU)...
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...
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
Late payment penalties—inheritance taxWhile interest often accrues on overdue tax, the late payment of certain taxes may also attract a penalty. For information on the interest accruing on overdue tax, see Practice Notes: IHT—payment deadlines on death—Interest on IHT and Interest on late paid
Can shares in a limited company that have not been paid-up at all be cancelled?A limited company having a share capital may not alter that share capital, except in the ways listed in section 617 of the Companies Act 2006 (CA 2006). Shares in a company cannot simply be cancelled without following an
Template for regulatory references given by SMCR firms and disclosure requirements[Insert addressee details]Dear [insert name][It is our understanding that [insert name of prospective employee] [was an employee of yours between the dates of [insert dates as appropriate] OR is a current employee of
0330 161 1234