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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 opens consultation on guidelines for core SmPC for human plasma derived products
  • Hogan Lovells
  • European Union
  • October 7 2014

On 1 October 2014 the European Medicines Agency ("EMA") opened a consultation on revisions to its guideline on core summary of product


CHMP adopts new guidelines on the treatment of IBS
  • Hogan Lovells
  • European Union
  • October 1 2014

On 25 September 2014, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") adopted new guidelines on


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"


EMA publishes Guide on access to unpublished documents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The European Medicines Agency (“EMA”) has published its Guide on access to unpublished documents (the “Guide“).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


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


EU, UK: CJEU opinion delivered on the Specific Mechanism
  • Hogan Lovells
  • United Kingdom, European Union
  • October 23 2014

Advocate General Niilo Jääskinen’s opinion on the interpretation of the Specific Mechanism (in the case of Merck v Sigma (Case C-53913) was


EU: relatively high level of attention in the field of pharmaceutical products
  • Hogan Lovells
  • European Union
  • October 23 2014

Once more the General Court has confirmed that the relevant public in the field of pharmaceutical products - consisting both of medical professionals


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


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