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Results: 1-10 of 12

Amendments to proposed EU clinical trials regulation could have significant impact

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • February 20 2013

Recently published amendments prepared by the Rapporteur of the European Parliament's responsible committee on the Commission's proposal to reform

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

Implementation of EU API import restriction

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • October 12 2012

The European Commission recently sent a letter to EU pharmaceutical trade associations requesting information on how the pharmaceutical industry will adapt to the new EU import rules for Active Pharmaceutical Ingredients (“API”) that will apply as of 2 July 2013

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 'special' authorization for wholesale distribution of medicines applies to pharmacists

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • July 10 2012

On 28 June 2012, the Court of Justice of the European Union (CJEU) issued a ruling in a case referred to by an Italian court (Case C-711 Criminal proceedings against Fabio Caronna), regarding an Italian pharmacist who was licensed to retail medicinal products to the public in Italy, and who also engaged in wholesale distribution of these products

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

EU adopts list of general function health claims on foods

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • May 22 2012

On 16 May 2012, the European Commission adopted its long-anticipated Commission Regulation listing permitted “general function” health claims (the “Permitted List”), as well as their conditions of use, under Article 13.1 of Regulation 19242006 on nutrition and health claims made on foods (the “Health Claims Regulation”

Proposed new EU Transparency Directive on pricing and reimbursement of medicinal products

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

On 1 March 2012, the European Commission published its long-awaited proposal to update Directive 89105EEC (the “Transparency Directive”), the key piece of legislation that limits the powers of EU Member States to set prices and reimbursement conditions of medicinal products

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