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EU court rules on classification of certain borderline products as medical devices

Sidley Austin LLP
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European Union
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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

Amendments to proposed EU clinical trials regulation could have significant impact

Sidley Austin LLP
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European Union
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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 proposes significant reform of clinical trial rules

Sidley Austin LLP
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European Union
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July 18 2012

On 17 July 2012, the European Commission adopted its long-awaited proposal to reform the much-criticized rules on clinical trials conducted in the EU that have applied since May 2004

Implementation of EU API import restriction

Sidley Austin LLP
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European Union
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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

Significant overhaul of EU medical devices regime planned

Sidley Austin LLP
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European Union
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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
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European Union
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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 continues revision and implementation of strict GMP rules

Sidley Austin LLP
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European Union
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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
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European Union
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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

European Parliament calls for additional medical device safety measures

Sidley Austin LLP
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European Union
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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 'special' authorization for wholesale distribution of medicines applies to pharmacists

Sidley Austin LLP
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European Union
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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