Grant Castle

Grant Castle

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products. He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, the former Soviet Union, Africa, the Near East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Subscribe to all posts by Grant Castle

Regulatory Watch: How has recent Law No 2019-774 of 24 July 2019 on the organization and transformation of the health system changed the anti-gift rules?

French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them.  This includes a general prohibition against offering such benefits. To strengthen the … Continue Reading

European Commission publishes Letter on Exemption allowing for UK Batch Testing post-Brexit

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here).  The letter seeks to address concerns that a number of pharmaceutical companies will not have been able … 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

Mandatory registration and logo for UK online sales of medicines

By Colin Warriner Since 1 July 2015, anyone in the UK selling medicines online to the general public must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), and be on the MHRA’s list of UK registered online retail sellers.  In addition, those retailers now need to display, on every relevant page of … Continue Reading

New Medical Devices Regulations in the EU – Significant Changes But No Big Bang

Originally published as Covington E-Alert on September 26, 2012 Today the European Commission published its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices (IVD) will … Continue Reading

New Rules for Clinical Trials Proposed in Europe

Originally published as Covington E-Alert on August 1st, 2012 On 17 July, the European Commission released the long-awaited proposal for a Regulation on clinical trials on medicinal products for human use (the Proposal). The future regulation will replace the Clinical Trials Directive 2001/20/EC, the revision of which has been advocated by the pharmaceutical industry, academia, … 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

Agency Workers Regulations: Issues for Life Sciences Companies

Originally published as Covington E-Alert on June 15, 2011 The U.K. Department for Business, Innovation and Skills (BIS) has recently issued the final version of its guidance on the Agency Workers Regulations 2010, which implement Directive 2008/104/EC. The Regulations come into force on 1 October 2011, and will entitle agency workers (or “temps”) to the … Continue Reading

Advertising of Medical Products and Summary of Product Characteristics (Smpc) before the European Court Of Justice

Originally published as Covington E-Alert on May 9, 2011 The EU Court of Justice just issued two long awaited rulings on the interpretation of the rules governing advertising of medicines in Europe. They address (i) the requirement that all advertising must comply with the prescribing information (SmPC) for the product and (ii) the distinction between … 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

Pharma Buy

Article originally published in The Lawyer on October 14, 2010 Despite global economic conditions, deal-making by large pharmaceutical companies has remained relatively buoyant, say Daniel Pavin, Grant Castle and Alexandra Pygall. Acquisitions in the pharmaceuticals sector are being driven by factors such as the need to replenish shrinking product pipelines, the need to maintain revenues … Continue Reading

European Union Regulation of In Vitro Diagnostic Medical Devices

Article originally published in the In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI), 2010 I. Introduction This chapter discusses the European Union (EU) regulation of in vitro diagnostic (IVD) medical devices, covering both pre- and postmarket regulatory requirements. In order to understand these rules and the manner in which they … 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

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

European Commission’s Public Consultation on the EU Pharmacovigilance System

Article originally published in EURALex, issue 192, in March 2008 The European Commission has launched a consultation on proposed amendments to strengthen and rationalise the European Community (EC) pharmacovigilance rules and systems established by Directive 2001/83/EC and Regulation (EC) No 726/2004. Comments were sought from stakeholders by 1 February 2008. Grant Castle and Robin Blaney … Continue Reading
LexBlog