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Results: 1-10 of 336

European Medicines Agency adopts policy on publication of clinical data for medicinal products
  • Hogan Lovells
  • European Union
  • October 3 2014

On 2 October 2014, the European Medicines Agency (EMA) adopted its long awaited policy on the publication of clinical data for medicinal products


ANSM on the de-notification or termination of notified bodies’ activities
  • Hogan Lovells
  • European Union, France
  • November 21 2016

On 14 November 2016, the French National Agency for Medicines and Health Products Safety (“ANSM”) issued the English version of an information


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 adopts new guideline on modified release dosage forms
  • Hogan Lovells
  • European Union
  • December 5 2014

On 27 November 2014, the European Medicines Agency (“EMA”) published its new guideline on the pharmacokinetic and clinical evaluation of modified


EMA revises Guideline on First-in-Human Trials
  • Hogan Lovells
  • European Union
  • November 25 2016

On 15 November 2016, the European Medicines Agency (“EMA”) opened for public consultation its updated Guideline on strategies to identify and mitigate


EMA publishes draft guidance on medication errors for public consultation
  • Hogan Lovells
  • European Union
  • April 20 2015

On 14 April 2015, the European Medicines Agency ("EMA") published three draft guidance documents concerning medication errors for consultation. The


Global Media and Communications Quarterly - Autumn 2016
  • Hogan Lovells
  • European Union, Global, USA
  • November 23 2016

Digital has been one very powerful manifestation of globalization, but like other globalization trends, policymakers are divided on who should govern


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


The treatment of health data under the EU Data Protection Regulation cause for hope?
  • Hogan Lovells
  • European Union
  • April 30 2015

On 9 March, the Council of the EU issued a partial general approach on a key chapter (Chapter II) of the EU Data Protection Regulation which has


CJEU judgment on Merck Canada Inc. & Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc, case C-53913, 12 February 2015
  • Hogan Lovells
  • European Union
  • February 16 2015

The CJEU has recently clarified when patent and SPC rights can be relied on under the Specific Mechanism to prevent parallel imports within the EU