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Results: 1-10 of 57

Important new food labelling and information rules now apply in the EU
  • Sidley Austin LLP
  • European Union
  • December 15 2014

On December 13, 2014, Regulation 11692011 on Food Information to Consumers finally became legally binding across the EU, after many years of


Update on overhaul of EU medical device regime
  • Sidley Austin LLP
  • European Union
  • June 20 2013

An important step in the European Union's review of the two proposed regulations intended to replace the current three directives that form the EU


EU Commission shifts responsibility for pharmaceuticals, medical devices, biotechnology and cosmetics
  • Sidley Austin LLP
  • European Union
  • September 18 2014

On September 10, 2014, European Commission President-elect Juncker issued a press release unveiling his new EU executive team and announcing a


Overhaul of EU medical device and diagnostic legislation faces further delays
  • Sidley Austin LLP
  • European Union
  • December 13 2013

The latest December 10, 2013 discussions between EU Member States on new EU medical device and in vitro diagnostic (IVD) regulations reveal continued


EU publishes new GMP Regulation and guidelines
  • Sidley Austin LLP
  • European Union
  • December 11 2014

The European Commission's long-awaited Delegated Regulation on Good Manufacturing Practice (GMP) principles and guidelines for active substances for


EU continues revision and implementation of strict GMP rules
  • Sidley Austin LLP
  • European Union
  • February 4 2013

In January 2013, three important developments regarding the EU's good manufacturing practice ("GMP") rules for medicinal products were made public:


Sidley Austin LLP global pricing newsletter - volume three 2014
  • Sidley Austin LLP
  • Brazil, Canada, China, European Union, France, Germany, India, United Kingdom, USA
  • April 15 2014

On October 21, 2013, Brazil’s National Agency of Supplemental Health enacted Normative Resolution 388, which mandated that all private healthcare


EU court rejects national requirement for GM crop coexistence measures
  • Sidley Austin LLP
  • European Union
  • September 26 2012

On 6 September 2012, the Court of Justice of the European Union (CJEU) issued an important ruling in a case referred to it by Italy’s highest administrative court, the Consliglio di Stato


Extended scope EU Penalties Regulation enters into force
  • Sidley Austin LLP
  • European Union
  • July 13 2012

As of 2 July 2012, infringements of the EU’s paediatric and new pharmacovigilance rules fall within the scope of the revised EU Penalties Regulation and are now subject to financial penalties of up to 5 percent of the marketing authorization holder’s annual EU turnover


Opportunities to comment on the implementation of the EU Falsified Medicines Directive
  • Sidley Austin LLP
  • European Union
  • January 31 2012

The European Commission is currently taking the necessary steps to implement the provisions of the EU Falsified Medicines Directive (201162EU), published on 1 July 2011 and amending the EU Medicinal Products Directive (200183EC