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Results: 1-10 of 256

EU orphan drug exclusivity
  • Hogan Lovells
  • European Union
  • January 26 2015

On 22 January 2015, the General Court of the Court of Justice of the European Union issued its judgment in the case between Teva and the European


EU, UK: CJEU opinion delivered on the Specific Mechanism
  • Hogan Lovells
  • European Union, United Kingdom
  • October 23 2014

Advocate General Niilo Jääskinen’s opinion on the interpretation of the Specific Mechanism (in the case of Merck v Sigma (Case C-53913) was


EU: relatively high level of attention in the field of pharmaceutical products
  • Hogan Lovells
  • European Union
  • October 23 2014

Once more the General Court has confirmed that the relevant public in the field of pharmaceutical products - consisting both of medical professionals


European Commission Action Plan on Antimicrobial Resistance
  • Hogan Lovells
  • European Union
  • March 3 2015

On 26 February 2015, the European Commission published a progress report concerning the Commission's five year Action Plan on Antimicrobial


EMA begins publishing the outcome of safety reports concerning nationally authorised medicinal products
  • Hogan Lovells
  • European Union
  • July 20 2015

On 6 July 2015, the European Medicines Agency ("EMA") announced that it would begin publishing the outcome of single assessments of period safety


Commission supplements the health and nutrition claims Regulation by adopting rules on generic descriptors
  • Hogan Lovells
  • European Union
  • October 16 2013

On 20 September 2013, the European Commission adopted implementing rules for so-called generic descriptors under Article 1(4) of the Regulation (EC


European Commission revises Blue Guide on the implementation of EU product rules
  • Hogan Lovells
  • European Union
  • March 31 2014

The European Commission has published a revised Blue Guide on the implementation of European Union product rules ("Blue Guide"). The Blue Guide aims


EPO patent examination guidelines to reflect stem cells ruling
  • Hogan Lovells
  • European Union
  • July 20 2012

The European Patent Office (EPO)'s latest revisions to the Guidelines for Examination (in force on 20 June 2012) now reflect the Brüstle ruling of the Court of Justice (CJEU) on the patentability of stem cell inventions using human embryos


Entry in force of the new amendments to the EU pharmacovigilance rules
  • Hogan Lovells
  • European Union
  • November 7 2013

Obligations related to pharmacovigilance in the EU are governed by the Community Code on medicinal products. Amendments to the pharmacovigilance


The EFPIA and PhRMA principles for responsible sharing of clinical trial data enter into force on 1 January 2014
  • Hogan Lovells
  • European Union, USA
  • January 7 2014

On 1 January 2014, the joint Principles for Responsible Clinical Trial Data Sharing ("the Principles") endorsed by the European Federation of