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Snapshot of Sunshine rules in EU countries for the pharmaceutical industry part 1 - June 2014
  • McDermott Will & Emery
  • European Union, United Kingdom
  • June 12 2014

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. In 2013


Paying Royalties for Technology that Competitors Can Use for Free - AG Wathelet’s Genentech Opinion
  • McDermott Will & Emery
  • European Union
  • April 28 2016

The Court of Justice of the European Union (CJEU) recently issued its opinion on a question referred to it by the Paris Court of Appeal regarding the


Repackaging and parallel import of pharmaceutical products
  • McDermott Will & Emery
  • European Union
  • May 22 2007

On 27 April 2007, the European Court of Justice (the “ECJ”) handed down yet another decision in the case of Boehringer Ingelheim & others v Swingward Ltd and Dowelhurst Ltd, Case C-34804 (“Boehringer II”


Brexit Update: What’s Next for the Global Marketplace
  • McDermott Will & Emery
  • European Union, OECD, United Kingdom
  • June 28 2016

The United Kingdom’s vote to leave the European Union is expected to have complex legal implications for the United Kingdom, the European Union and


Controlling and processing data in EU clinical trials
  • McDermott Will & Emery
  • European Union
  • November 22 2010

The legal regime for the conduct of clinical trials of medicinal products for human use in the European Union is set out in Directive 200120EC (the Clinical Trials Directive


EMEA and FDA focus on clinical research safety and enforcement
  • McDermott Will & Emery
  • USA, European Union
  • August 20 2009

Recent policy changes emphasize the need for sponsoring organizations to be even more vigilant in establishing, updating and monitoring their systems for compliance with clinical research requirements, whether conducted domestically or in a foreign locale


EC introduces major changes to medical device regulation
  • McDermott Will & Emery
  • European Union
  • December 17 2012

The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics


European Commission fines pharmaceutical companies for Citalopram pay-for-delay agreements
  • McDermott Will & Emery
  • European Union
  • June 30 2013

On 19 June 2013, the European Commission announced a fine of 93.8 million for H. Lundbeck AS (Lundbeck) and a further 52.2 million of fines levied


The new EU clinical trials regulation aims at harmonization and transparency
  • McDermott Will & Emery
  • European Union
  • October 20 2014

On June 16, 2014, Reg. (EU) No. 5362014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes


CJEU actavis and Eli Lilly SPC judgments
  • McDermott Will & Emery
  • European Union
  • January 22 2014

In addition to giving its decision in Georgetown University C-48412, the Court of Justice of the European Union (CJEU) handed down two other