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Results: 1-10 of 23

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

EU court rejects national requirement for GM crop coexistence measures

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • September 26 2012

On 6 September 2012, the Court of Justice of the European Union (CJEU) issued an important ruling in a case referred to it by Italy’s highest administrative court, the Consliglio di Stato

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 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

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

Extended scope EU Penalties Regulation enters into force

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • July 13 2012

As of 2 July 2012, infringements of the EU’s paediatric and new pharmacovigilance rules fall within the scope of the revised EU Penalties Regulation and are now subject to financial penalties of up to 5 percent of the marketing authorization holder’s annual EU turnover

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

European Commission proposes overhaul of dietetic foods regime

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • August 1 2011

The European Commission adopted a proposal for a Regulation on Food Intended for Infants and Young Children and on Food for Special Medical Purposes (the “Proposed Regulation”) on June 20, 2011