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New EU approach to medicines for children
  • Hogan Lovells
  • European Union
  • February 9 2007

It has been estimated that more than 50 of medicines used to treat children in Europe have not been tested for use in children, neither have they been authorised for use in the care of children


European Commission signals new approach to relevant product market definition in pharmaceutical merger cases
  • Hogan Lovells
  • European Union
  • March 29 2009

On February 4, 2009, the European Commission approved Sanofi-Aventis’s acquisition of Czech generics pharmaceutical manufacturer Zentiva


Commission presents preliminary report on potential areas for antitrust investigation in the pharmaceutical sector
  • Hogan Lovells
  • European Union
  • March 29 2009

On November 28, 2008, the European Commission’s Directorate for Competition published the preliminary findings from its ongoing inquiry into the pharmaceutical sector


The EC pharmaceutical inquiry: state of play and next steps
  • Hogan Lovells
  • European Union
  • August 12 2008

On January 15, 2008, the European Commission’s (EC) Competition Directorate launched a sector inquiry in the pharmaceutical industry and dawn-raided several companies in various EU Member States


ECJ delivers long-awaited judgment in Glaxo ‘Greek’ Case on parallel imports
  • Hogan Lovells
  • European Union, Greece
  • September 22 2008

On September 16, 2008, the European Court of Justice (ECJ) handed down a long-awaited judgment in Sot Lélos kai Sia EE and Others v. GlaxoSmithKline AEVE Farmakeftikon Proïonton1 (the Greek Glaxo Case


Commission presents preliminary report on potential areas for antitrust investigation in the pharmaceutical sector
  • Hogan Lovells
  • European Union
  • December 1 2008

The European Commission's Directorate for Competition (the Commission) has published the preliminary findings from its ongoing inquiry into the pharmaceutical sector


The European Commission proposes a much anticipated “pharmaceutical package” governing information for patients, pharmacovigilance and anti-counterfeit measures
  • Hogan Lovells
  • European Union
  • December 18 2008

On December 10, 2008 the European Commission published its long-awaited “pharmaceutical package."


Updated EMA guidance on maintenance of information requirements
  • Hogan Lovells
  • European Union
  • February 17 2014

The European Medicines Agency ("EMA") has updated its guidance documents to reflect new European Union ("EU") requirements which require Marketing


EFSA publishes second batch of opinions on health claims - 98 rejected due to poor evidence.
  • Hogan Lovells
  • European Union
  • February 26 2010

The European Food Safety Authority (EFSA) published its second batch of opinions on Article 13.1 claims (based on generally accepted scientific evidence) on February 25, 2010


Blocking or delaying generic versions of drugs: the General Court ruling in the AstraZeneca appeal
  • Hogan Lovells
  • European Union
  • July 1 2010

The General Court of the European Union (the "General Court") has today handed down its eagerly awaited judgment in relation to AstraZeneca's appeal against a 2005 decision of the European Commission (the "Commission") finding that AstraZeneca had abused its dominant position by blocking or delaying generic versions of its drug Losec