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Results: 1-10 of 66

Falsified Medicines Directive public consultation on “safety features”
  • Sidley Austin LLP
  • European Union
  • December 22 2011

The EU’s Falsified Medicines Directive (Directive 201162EU) forms part of the Pharma Package, a series of measures proposed by the European Commission in December 2008


European Union adopts falsified medicines directive
  • Sidley Austin LLP
  • European Union
  • June 7 2011

On May 27, 2011 the Council of the European Union (Council) adopted a directive aimed at preventing falsified medicines from entering into the legal supply chain


EU and ISO deliberating on nanotechnology labeling guidance
  • Sidley Austin LLP
  • European Union, Global
  • November 8 2010

The European Committee For Standardization (CEN) and the International Organization For Standardization (ISO) have jointly distributed for ballot and comment a document titled "Guidance on the labeling of manufactured nano-objects and products containing manufactured nano-objects," ISOTS 13830:2010


New EU safety reporting guideline enters into force
  • Sidley Austin LLP
  • European Union
  • September 1 2011

As of 1 September 2011, sponsors of clinical trials must comply with the new clinical trial safety reporting requirements set out in the International Conference on Harmonisation E2F Guideline on Development Safety Update Reports


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


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


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


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 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 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: