Brian Kelly

Brian Kelly


Brian Kelly’s practice focuses on food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law and product liability and safety. Mr. Kelly’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, product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice.

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Commission publishes draft rules on country of origin/place of provenance indications for primary ingredients

On 4 January 2018, the European Commission published a draft implementing regulation laying down rules for the application of Article 26(3) of Regulation (EU) N° 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (“FIC”), as regards the rules for indicating the country of origin or place … Continue Reading

French Pilot on Mandatory Country of Origin Labelling (COOL) for Dairy and Meat in Processed Foods

On 19 August 2016, France adopted Decree No 2016-1137 introducing mandatory country of origin labelling (COOL) for dairy and meat in processed foods.  The national measures strengthen the regulatory framework that exists at the EU level, which already imposes COOL requirements on specific foodstuffs, such as unprocessed and pre-packed swine, poultry, sheep and goat meat … Continue Reading

B2B or not B2B: Application of the NHCR to Business-to-Business Commercial Communications

On 14 July 2016, the Court of Justice of the European Union (CJEU) issued its decision in Case C-19/15 Verband Sozialer Wettbewerb v Innova Vital GmbH on the application of the Nutrition and Health Claims Regulation 1924/2006 (“NHCR”) to business-to-business (“B2B”) commercial communications.  The CJEU ruled that B2B communications that were promotional in nature came … Continue Reading

The Psychoactive Substances Act 2016: An Example of Poor Drafting and Unintended Consequences for Food?

The UK has enacted new legislation to address the issue of so-called ‘legal highs’ following a number of cases of paranoia, seizures, hospitalisation and even death after consumption of certain psychoactive substances.  The Psychoactive Substances Act 2016 (the “Act”) was granted Royal Assent on 28 January 2016.  It is expected to come into force on … Continue Reading

New Novel Foods Regulation: A Step Towards a Simpler and Faster Procedure?

A new Novel Food Regulation (EU) 2015/2283 (“Regulation”) was published in the Official Journal of the European Union on 11 December 2015. The Regulation aims to make it easier for food business operators to place novel foods and food ingredients on the EU market, while ensuring high level of consumer protection. Under the Regulation, novel … Continue Reading

General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case

Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post. On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation … Continue Reading

Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

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 … Continue Reading

PARNUTS: Out with the Old and in with the New

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 … Continue Reading

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

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 — particularly software-based devices … Continue Reading

European Commission Adopts List of General Health Claims

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 … Continue Reading

Nice Powers May Be Clipped In UK Pharmaceutical Pricing Overhaul

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 … Continue Reading

No More Red Tape: MHRA Awaits Tougher Sanctioning Powers in the UK

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 … Continue Reading

Product Liability and Reuse of Medical Devices

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 … Continue Reading

Global Harmonization Is Not All That Global: Divergent Approaches in Drug Safety

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 … Continue Reading

Medical Nanotechnology in Europe

 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 and size … Continue Reading