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Results: 1-10 of 25

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

Updates on international pricing issues for pharmaceutical and biologic products

  • Sidley Austin LLP
  • -
  • China, European Union, France, Germany, United Kingdom, USA
  • -
  • May 18 2012

Sidley Austin LLP’s Global Life Sciences Team is pleased to provide you with this Global Pricing Newsletter, the first in a periodic series updating clients and friends of the firm on pricing issues around the world that may have an impact on pharmaceutical and biologic manufacturers’ legal and business strategies

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:

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 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

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

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

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

European Commission publishes new guidance on clinical trials safety reporting

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • July 25 2011

The European Commission’s new detailed guidance on the collection, verification and presentation of adverse eventreaction reports arising from clinical trials on medicinal products for human use (“CT-3”) was published on 11 June 2011 in the European Union’s Official Journal

European Commission allows submission of new data in support of probiotic health claims

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • June 20 2011

The European Commission has opened a four-month window, starting on June 1 and closing on September 30, 2011, during which stakeholders can submit new data to Member States in support of certain probiotic health claims rejected by the European Food Safety Authority