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Results: 1-10 of 357

European Commission fines for delaying market entry of generic medicines
  • Hogan Lovells
  • European Union
  • June 20 2013

The European Commission yesterday imposed a fine of Euro 93.8 million on Danish pharmaceutical company Lundbeck and fines totalling Euro 52.2 million


EMA opens public consultation on ICH E11(R1) Guideline
  • Hogan Lovells
  • European Union
  • October 28 2016

On 13 October 2016, the European Medicines Agency ("EMA") opened for public consultation the Guideline concerning clinical investigation of medicinal


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


European Court rules that products can be classified as both medical devices and medicinal products in the EU
  • Hogan Lovells
  • European Union
  • October 11 2013

On 3 October 2013, the Court of Justice of the European Union issued a judgment in Case C-10912, which concerned the implications of


EMA revises biosimilars guideline on quality issues
  • Hogan Lovells
  • European Union
  • June 9 2014

On 22 May 2014, the European Medicines Agency ("EMA") published a finalised version of its Guideline on similar biological medicinal products


German Federal Court: Permission granted - HIVAIDS drug distribution continued
  • Hogan Lovells
  • European Union, Germany
  • July 17 2017

The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a


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 publishes draft guideline on process validation for biologics
  • Hogan Lovells
  • European Union
  • May 9 2014

On 25 April 2014, the European Medicines Agency ("EMA") published a Draft Guideline on process validation for the manufacture of


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