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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


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 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


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


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 Court issues landmark ruling on article versus component under REACH
  • Sidley Austin LLP
  • European Union
  • September 16 2015

On September 10, 2015, the Court of Justice of the European Union (Court) adopted a landmark ruling resolving a dispute between the European


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


Sidley Global Pricing newsletter - V4 2016
  • Sidley Austin LLP
  • Spain, Sweden, United Kingdom, USA, China, European Union, France, Germany, India, Netherlands, Australia, Belgium, Canada
  • January 27 2016

The Australian Pharmaceutical Benefits Pricing Authority (PBPA) ceased operations on April 1, 2014, in a move by the government to improve drug