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Results: 1-10 of 57

New EU Guideline facilitates global development of biosimilars
  • Sidley Austin LLP
  • European Union
  • May 4 2015

On April 30, 2015, a new EU Guideline on biosimilar medicines took effect. The new Guideline defines a number of concepts applied by the EMA in its


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


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 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


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


European Commission proposes new rules for novel foods
  • Sidley Austin LLP
  • European Union
  • January 22 2014

The European Commission recently adopted a proposal for a new EU Regulation on novel foods, which - if adopted - will streamline and simplify the


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 detailed criteria for justification of cosmetic claims
  • Sidley Austin LLP
  • European Union
  • July 11 2013

Detailed EU requirements regarding the use of cosmetic product claims were published on 11 July 2013, the same day that the EU Cosmetic Products


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: