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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

International news: focus on compliance - winter 2014

  • McDermott Will & Emery
  • -
  • China, European Union, Germany, Global, USA
  • -
  • December 2 2014

As regulatory oversight of companiesfrom Sarbanes Oxley and the Dodd-Frank Act to the Foreign Corrupt Practices Act (FCPA) and the UK Bribery

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

EU Japan agreement on information exchange concerning medicines

  • McDermott Will & Emery
  • -
  • European Union, Japan
  • -
  • February 9 2007

After lengthy discussions, the European Union and Japan have reached an agreement on the exchange of confidential information about the authorisation and safety of medicines

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

Commission investigates pharmaceutical sector for anti-competitive practices

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • January 18 2008

The European Commission has launched a sector inquiry with a series of on-the-spot competition investigations into pharmaceutical companies

EMEA and FDA focus on clinical research safety and enforcement

  • McDermott Will & Emery
  • -
  • European Union, USA
  • -
  • 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

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

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”

Mergers: Commission approves Nestlé’s acquisition of Novartis' Medical Nutrition business

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • July 6 2007

The European Commission has cleared the merger of Nestlé S.A. and Novartis' Medical Nutrition business (NMN) following a first phase investigation