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Results: 1-7 of 7

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 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

European Parliament calls for additional medical device safety measures

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • June 18 2012

On 14 June 2012, the European Parliament (“EP”) adopted a Resolution calling on EU Member States and the European Commission to introduce and implement new measures aimed at ensuring the safety of medical devices

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

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

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

New EU rules recognize tolerance level for traces of GM material in feed

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • July 21 2011

On 15 July, new rules entered into force in the EU that for the first time recognize a de facto tolerance level for traces of certain unauthorized genetically modified (“GM”) material in feed