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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 case of ophthalmic drugs in Italy and France: a lesson to learn - parallel antitrust investigations and cooperation between national competition authorities
  • McDermott Will & Emery
  • European Union, France, Italy
  • May 7 2014

The recent investigations into two pharmaceutical companies active in the ophthalmic drugs market in Italy and France serve as a reminder of the


Pharma patents: the EU court rules in favor of functional claiming
  • Nctm Studio Legale
  • European Union, United Kingdom
  • January 9 2014

On December 12, 2013, in case C-49312, the European Court of Justice stated that the grant of a supplementary Protection Certificate (SPC) can be


La Commissione Europea sanziona Johnson & Johnson e Novartis per aver ritardato l’ingresso dei generici
  • Martini Manna Avvocati
  • European Union
  • January 9 2014

Con comunicato dello scorso 10 dicembre, la Commissione Europea ("CE") ha dichiarato di avere comminato due sanzioni da 10.798.000 ed 5


EMA publishes new Union procedure on the management of pharmacovigilance inspection findings
  • Hogan Lovells
  • European Union
  • July 1 2014

On 20 June 2014, the European Medicines Agency (hereafter "EMA") published a new European Union procedure on the management of pharmacovigilance


EU General Court Rules on Pay-for-Delay Agreements in Patent Disputes
  • Jones Day
  • European Union
  • November 7 2016

In a series of judgments, the European Union General Court ("General Court") on September 8, 2016, upheld a 2013 Commission decision (including 146


European Commission fines Lundbeck and generic companies EUR 146 million, accusing them of delaying market entry of generic medicines
  • Baker Botts LLP
  • European Union
  • June 24 2013

On 19 June 2013, the European Commission ("Commission") fined Lundbeck and several producers of generic medicines - including Alpharma, Merck


EU Commission Proposes mHealth App Assessment Guidelines
  • William Fry
  • European Union
  • November 17 2016

'In 2016 users will trust health apps more than their doctors'. So predicted Forbes Magazine in 2015 in reference to Mobile Health ("mHealth") apps


Disclosure of clinical trial and other information: recent developments in Canada and the EU
  • Norton Rose Fulbright LLP
  • Canada, European Union
  • November 10 2014

Bill C-17, An Act to Amend the Food and Drugs Act, reported in our earlier Pharma In Brief has now passed through Parliament and was given Royal