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Results: 1-10 of 61

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


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


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


New EU rules recognize tolerance level for traces of GM material in feed
  • Sidley Austin LLP
  • European Union
  • July 21 2011

On 15 July, new rules entered into force in the EU that for the first time recognize a de facto tolerance level for traces of certain unauthorized genetically modified (“GM”) material in feed


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


Significant overhaul of EU medical devices regime planned
  • Sidley Austin LLP
  • European Union
  • October 29 2012

On 26 September 2012, the European Commission published the proposals for two new Regulations intended to replace the EU directives that govern medical devices intended to be placed on the EU market


Sidley Austin LLP global pricing newsletter - volume three 2014
  • Sidley Austin LLP
  • Brazil, Canada, USA, China, European Union, France, Germany, India, United Kingdom
  • 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 rules on classification of certain borderline products as medical devices
  • Sidley Austin LLP
  • European Union
  • December 3 2012

In a judgment published on November 22, 2012, the Court of Justice of the European Union (CJEU) confirmed that products intended for the investigation of physiological processes only fall within the scope of the EU Medical Device Directive (9342EEC), as implemented into EU Member State legislation, if the products are intended for a medical purpose


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 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: