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Results: 1-10 of 237

EU close to deal on foods for particular nutritional uses?
  • Hogan Lovells
  • European Union
  • December 4 2012

The European Parliament and the Council appear to have reached agreement, in principle, on the text of a draft Regulation on food intended for infants and young children and food for special medical purposes


Directive 201226EU of the European Parliament and the Council of 25 October 2012 amending directive 200183EC as regards pharmacovigilance
  • Hogan Lovells
  • European Union
  • October 31 2012

The directive of 25 October 2012 amending directive 200183EC as regards pharmacovigilance was published in the Official Journal of the European Union on 29 October 2012


English court asks the CJEU to try again on supplementary protection certificates
  • Hogan Lovells
  • European Union, United Kingdom
  • October 25 2012

Following two recent decisions of the English High Court, preliminary references have been made to the European Court of Justice seeking clarity on when a supplementary protection certificate can be granted for pharmaceutical products comprising combinations of active ingredients


EMA publishes a questions & answers document on the practical implementation of Article 31 Pharmacovigilance Referral procedure
  • Hogan Lovells
  • European Union
  • January 29 2014

On 20 January 2014, the European Medicines Agency ("EMA") published a Questions & Answers document discussing the practical implementation of the


U.S. and EU authorities focus attention on competition in pharmaceutical industry
  • Hogan Lovells
  • USA, European Union
  • March 25 2008

During the past several years, there has been an increase in antitrust enforcement directed at the pharmaceutical industry, both in the United States and in Europe, primarily focused on conduct by branded pharmaceutical companies that might affect the timing and effectiveness of entry by less costly generic drugs


European Commission inspections in the pharmaceutical sector antitrust scrutiny continues
  • Hogan Lovells
  • European Union
  • November 23 2009

Surprise inspections announced by the European Commission on 6 October 2009 came just over a week after European Competition Commissioner Kroes warned of further antitrust cases in the pharmaceutical sector and three months after publication of the Commission’s Final Report in the Pharmaceutical Sector Inquiry


Uncertainty remains as to the practical impact of revision of the EU Medical Devices Directive on existing certificates of conformity as the deadline for enforcement of the revision approaches
  • Hogan Lovells
  • European Union
  • May 27 2009

On March 21, 2010, the modifications to the EU legislation governing medical devices that were introduced by Directive 200747EC (the Directive) will enter into force in the 27 EU Member States


European Food Safety Authority publishes first batch of health claim opinions
  • Hogan Lovells
  • European Union
  • October 6 2009

On October 1, 2009, the European Food Safety Authority (EFSA) issued a first batch of opinions on health claims that are based on generally established scientific evidence


The Court of Justice of the European Union declares that the prohibition in the Community Code on provision of inducements to healthcare professionals to prescribe medicinal products does not apply to national health authority policies
  • Hogan Lovells
  • European Union
  • April 29 2010

The Court held that the provisions of the European Union (hereafter the "EU") legislation imposing restrictions on the promotion and advertising of medicinal products apply only to pharmaceutical companies and independent third parties


The European Court of Justice adopts stricter approach to the promotion of medicinal products and the scope of the term “advertising”
  • Hogan Lovells
  • European Union
  • May 11 2009

A recent decision of the European Court of Justice suggests that the Court is beginning to adopt a strict interpretation as to what could constitute the "promotion" of medicinal products in the European Union