We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 237

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


EMA publishes draft guidance on medication errors for public consultation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On 14 April 2015, the European Medicines Agency ("EMA") published three draft guidance documents concerning medication errors for consultation.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


European Medicines Agency adopts policy on publication of clinical data for medicinal products
  • Hogan Lovells
  • European Union
  • October 3 2014

On 2 October 2014, the European Medicines Agency (EMA) adopted its long awaited policy on the publication of clinical data for medicinal products


EDQM publishes draft guidelines on endotoxins, pyrogens and sterile products
  • Hogan Lovells
  • European Union
  • October 23 2014

The European Directorate for the Quality of Medicines ("EDQM") has published draft revisions to its Guidelines for Using the Test for Bacterial


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


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"


EU orphan drug exclusivity
  • Hogan Lovells
  • European Union
  • January 26 2015

On 22 January 2015, the General Court of the Court of Justice of the European Union issued its judgment in the case between Teva and the European


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


EMA publishes Guide on access to unpublished documents
  • Hogan Lovells
  • European Union
  • November 29 2014

The European Medicines Agency (“EMA”) has published its Guide on access to unpublished documents (the “Guide“). In accordance with European Union


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