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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

EU pharma sector report pushes regulatory reform

Sidley Austin LLP
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European Union
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July 8 2009

Earlier today, the European Commissioner for Competition, Neelie Kroes, presented the Final Report on the Commission’s Pharmaceutical Sector Inquiry

New EU cosmetics regulation published

Sidley Austin LLP
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European Union
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December 22 2009

A new EU law on cosmetic products, the Cosmetics Regulation (the Regulation), was published in the EU’s Official Journal today

European Commission allows submission of new data in support of probiotic health claims

Sidley Austin LLP
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European Union
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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

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

Sidley Austin LLP
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European Union
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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

European Medicines Agency publishes new electronic submission format of information on medicines

Sidley Austin LLP
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European Union
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August 22 2011

The European Medicines Agency (“EMA”) has published the new electronic format in which pharmaceutical companies will need to submit information on medicinal products for human use authorized or registered in the European Union

European Commission proposes overhaul of dietetic foods regime

Sidley Austin LLP
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European Union
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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 Union adopts falsified medicines directive

Sidley Austin LLP
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European Union
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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 publishes new guidance on clinical trials safety reporting

Sidley Austin LLP
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European Union
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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 safety reporting guideline enters into force

Sidley Austin LLP
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European Union
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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

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