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Results: 1-10 of 285

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


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


EMA publishes draft guidance on medication errors for public consultation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On 14 April 2015, the European Medicines Agency ("EMA") published three draft guidance documents concerning medication errors for consultation.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


Revised guideline adopted on core SmPC for plasma-derived fibrin sealant haemostatic products
  • Hogan Lovells
  • European Union
  • July 8 2015

On 25 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a revised Guidance on core SmPC for plasma-derived fibrin


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


European Medicines Agency updates guidelines on good pharmacovigilance practices
  • Hogan Lovells
  • European Union
  • May 9 2014

On 25 April 2014, the European Medicines Agency ("EMA") updated its guidelines on Good Pharmacovigilance Practices ("GVP Guidelines"). The update


European Commission clarifies position on post-authorisation efficacy studies
  • Hogan Lovells
  • European Union
  • May 8 2014

On 10 April 2014, the European Commission ("Commission") adopted Commission Delegated Regulation (EU) No 3572014 as regards situations in which


The European Medicines Agency issues an opinion on the principal mode of action of proanthocyanidins present in cranberry extracts
  • Hogan Lovells
  • European Union
  • November 10 2016

On 8 November 2016, the European Commission published the opinion of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human


Commission authorised three proprietary general function health claims
  • Hogan Lovells
  • European Union
  • September 5 2013

On 3 September 2013, the European Commission adopted Regulation (EU) No 8512013 authorising three general function health claims based on