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Results: 1-10 of 234

The EMA publishes new biosimilars guideline on non-clinical and clinical issues
  • Hogan Lovells
  • European Union
  • January 15 2015

Following its adoption by the Committee for Medicinal Products for Human Use ("CHMP") on 18 December 2014, the European Medicines Agency ("EMA"


TEAM-NB releases a new version of its Code of Conduct for notified bodies
  • Hogan Lovells
  • European Union
  • August 7 2014

On 29 July 2014, the European Association for Medical Devices of Notified Bodies (TEAM-NB) issued a press release on its website to announce the


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


EMA publishes a draft Q&A document for consultation on the environmental risk assessment guidelines
  • Hogan Lovells
  • European Union
  • April 13 2015

On 26 March 2015, the European Medicines Agency (“EMA”) published a draft Questions and Answers Document (“Q&A Document“) for consultation concerning


EMA confirms that access to clinical study reports for preparation of health technology dossiers will be permitted within the new EMA Disclosure Policy
  • Hogan Lovells
  • European Union
  • April 13 2015

According to the minutes of a meeting between the European Medicines Agency ("EMA") and the European Network for Health Technology Assessment


EMA permits the use of a comparator product authorised outside the EEA in clinical studies for biosimilars
  • Hogan Lovells
  • European Union
  • April 13 2015

The European Medicines Agency's ("EMA") revised overarching guideline on biosimilars("Guideline"), which was published on 23 October 2014, will come


General Court examines the introduction of new pleas in law during the course of proceedings before the court
  • Hogan Lovells
  • European Union
  • January 28 2015

On 22 January 2015, the Sixth Chamber of the General Court of the Court of Justice of the European Union (“General Court”) issued its judgement in


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 launches public consultation on draft guideline concerning the development of GTMPs
  • Hogan Lovells
  • European Union
  • June 1 2015

On 20 May 2015, the European Medicines Agency ("EMA") launched a three month consultation on a revised Guideline on the quality, non-clinical and