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Results: 1-10 of 266

European Medicines Agency updates guidelines on good pharmacovigilance practices
  • Hogan Lovells
  • European Union
  • May 9 2014

On 25 April 2014, the European Medicines Agency ("EMA") updated its guidelines on Good Pharmacovigilance Practices ("GVP Guidelines"). The update


European Commission clarifies position on post-authorisation efficacy studies
  • Hogan Lovells
  • European Union
  • May 8 2014

On 10 April 2014, the European Commission ("Commission") adopted Commission Delegated Regulation (EU) No 3572014 as regards situations in which


The European Medicines Agency publishes draft guideline on process validation for biologics
  • Hogan Lovells
  • European Union
  • May 9 2014

On 25 April 2014, the European Medicines Agency ("EMA") published a Draft Guideline on process validation for the manufacture of


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


Entry in force of the new amendments to the EU pharmacovigilance rules
  • Hogan Lovells
  • European Union
  • November 7 2013

Obligations related to pharmacovigilance in the EU are governed by the Community Code on medicinal products. Amendments to the pharmacovigilance


European Commission publishes report on external reference pricing for medicinal products
  • Hogan Lovells
  • European Union
  • March 18 2014

On 10 March 2014, the European Commission ("Commission") published a report which details the results of an assessment of external reference pricing


French legal and regulatory update - April 2014
  • Hogan Lovells
  • European Union, France
  • May 1 2014

Draft law granting amnesty for acts committed in the course of social movements and trade unions' protesting activities Filed on November 28, 2012


EU daily update: other developments - 211107
  • Hogan Lovells
  • European Union
  • November 21 2007

On November 20, 2007, EU Commissioner for Internal Market and Services Charlie McCreevy has called on national supervisors of financial markets in the EU to become more accountable to authorities and incorporate a European dimension into their mandate


EU daily update: foodconsumer policypharmaceuticals - 201107
  • Hogan Lovells
  • European Union
  • November 20 2007

Decision No 13502007EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the field of health


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