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Results: 1-10 of 14

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:

European Commission publishes guidelines on use of food-related health claims

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • January 28 2013

On 25 January 2013, the European Commission's new guidelines regarding the use of food-related health claims ("Guidelines") were published in the

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

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

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

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

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

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

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

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