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Results: 1-10 of 97

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


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”


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


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


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


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


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


Advocate General Jääskinen gives Georgetown University SPC opinion
  • McDermott Will & Emery
  • European Union, Netherlands, United Kingdom
  • December 16 2013

On 14 November 2013, Advocate General (AG) Jääskinen's opinion in the Dutch supplementary protection certificate (SPC) referral, Georgetown


Focus on regulatory law - June 2014
  • McDermott Will & Emery
  • European Union, France
  • June 3 2014

If an appeal is lodged against an AMF decision to levy a financial penalty, the appeal judge has to verify that the penalty is proportionate in


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