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Results: 1-10 of 214

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


The Council adopts its position on revised medical devices package
  • Hogan Lovells
  • European Union
  • June 23 2015

On 19 June 2015, the Council of the European Union ("Council") came to a common position, during a meeting of the Employment, Social Policy, Health


EU orphan drug exclusivity: the Orphacol case
  • Hogan Lovells
  • European Union
  • June 12 2015

On 11 June 2015, the General Court of the Court of Justice of the European Union issued its judgment in the case between Laboratoires CTRS and the


European Medicines Agency launches consultation on Good Pharmacovigilance Practices for educational materials
  • Hogan Lovells
  • European Union
  • May 13 2015

On 27 April 2015, the European Medicines Agency ("EMA") launched a public consultation on its Good Pharmocoviligance Practices ("GVP") concerning


Revised guideline adopted on core SmPC for plasma-derived fibrin sealant haemostatic products
  • Hogan Lovells
  • European Union
  • July 8 2015

On 25 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a revised Guidance on core SmPC for plasma-derived fibrin


The European Commission adopts two new Directives concerning human tissues and cells
  • Hogan Lovells
  • European Union
  • April 29 2015

On 8 April 2015, the European Commission adopted Directive (EU) 2015565 amending Directive 200686EC as regards certain technical requirements for


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


The European Commission adopts stricter rules concerning notified bodies
  • Hogan Lovells
  • European Union
  • September 30 2013

On Tuesday 24 September 2013, the European Commission adopted a Regulation intended to strengthen the criteria for the designation and supervision of