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Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington's Global Food Industry Group. Brian's practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our "world-class [regulatory and public affairs] team and describes him as a notable practitioner who is "very ambitious, thorough with a sharp intellect". The Chambers UK Guide quotes clients saying: "his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases."

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European "Brexit" related issues including tariffs.

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Brian is an honorary lecturer at University College London.

A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer protection in relation to food information whilst ensuring smooth functioning of the EU market.

The FIC Regulation governs all food information provided to the consumer through any commercial communication, including in particular labeling and websites. The Regulation affects all food business operators along the whole supply chain as it changes the existing provisions and introduces new ones:
Continue Reading Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, was published in the Official Journal of the European Union on 12 June 2013.  The new Regulation allows the Commission to create specific compositional and information requirements and update the list of categories of allowed nutrient ingredients in these foods from 19th July 2013.  
Continue Reading PARNUTS: Out with the Old and in with the New

This post originally appeared on our sister blog, InsideMedicalDevices.

The General Medical Council in the UK has issued new prescribing guidance for doctors that includes detailed provisions on prescribing medical devices and managing patients using medical devices. The GMC’s previous guidance was focused almost exclusively on medicines.  The new guidance recognizes that medical devices

This post originally appeared on our sister blog, InsideMedicalDevices.

The Court of Justice of the European Union (CJEU) has recently ruled that products which fall within the definition of a medical device, but are not intended by their manufacturer to be used for a “medical purpose,” do not fall within the scope of the Medical Devices Directive 93/42/EEC (MDD).

Case C-219/11 Brain Products GmbH V BioSemi VOF and Others, concerned the product ActiveTwo, a “biopotential measurement system” that records electrical signals from the brain, heart and muscles, manufactured and is marketed by Dutch company BioSemi. ActiveTwo is not designed for use in any medical diagnosis or treatment, but is used by researchers for clinical investigation of cognitive sciences. BioSemi’s website and promotional material state that the product is “not designed or intended to be used for diagnosis or treatment of disease.” As such, BioSemi argued that the ActiveTwo was not a medical device and so did not require CE-marking.
Continue Reading CJEU Clarifies Medical Device Borderline

Originally published as Covinton E-Alert on May 25, 2012

On 16 May 2012, the European Commission adopted the much delayed list of permitted general health claims (Permitted List) for foods after scrutiny of the list by the European Parliament and the Council ended on 27 April 2012. The Permitted List contains just 222 health claims

Originally published as Covington E-Alert on November 10, 2010

The UK government will consult in the coming year on proposals to move the UK’s National Health Service (NHS) towards a value-based system of pricing medicines from 2014. While official details are yet to be published, it is expected that doctors will be given powers to

Article originally published in RAJ Devices, September/October 2009

The UK government in 2004 asked Philip Hampton, a leading businessman, to lead a review of regulatory inspection and enforcement across a number of the country’s regulatory agencies. The report of the review, called the Hampton Report, was published in March 2005 and set out an ambitious

Article originally published in EURALex in October 2008

The reprocessing of medical devices has been an increasing industrial practice since the late 1970s. While reprocessing of some medical devices has taken place within hospitals for many years, the market for professional third-party reprocessing service providers has developed during the last decade due to financial pressures

Article originally published in the Food and Drug Law Journal (with permission from FDLI), August 2008

I. INTRODUCTION

Pharmacovigilance is a global public health activity that is currently undergoing a considerable amount of regulatory, social and political change. The standards expected by society have been raised following high-profile product withdrawals. Industry, regulatory authorities and consumers are now focusing on a more proactive, risk management based approach to drug safety monitoring. There has been a shift from the formulaic collection, classification and reporting of adverse event reports to a more holistic focus on any information suggesting a change in a product’s risk benefit profile.

There has also been a realization that effective pharmacovigilance must be global. Companies and regulatory authorities must receive and react to information suggesting a change in risk-benefit profile wherever it arises. The past 20 years has therefore seen a steady drive towards global harmonization of safety reporting definitions and standards.
Continue Reading Global Harmonization Is Not All That Global: Divergent Approaches in Drug Safety

 Article originally published in RAJ Pharma in July 2008

By 2015 nanotechnology-based medicines and medical devices are expected to flood the global market. Brian Kelly and Peter Bogaert discuss the regulatory and legal implications of medical nanotechnology in Europe.

Nanotechnologies are the design, characterisation, production and application of structures, devices and systems by controlling shape