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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
EU court rejects national requirement for GM crop coexistence measures
- Sidley Austin LLP
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- European Union
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- 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
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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
New EMA guidance on pharmacovigilance legislation
- Sidley Austin LLP
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- European Union
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- June 14 2012
The European Medicines Agency (“EMA”) recently published new guidance on the initial phases of operation of the new EU pharmacovigilance (“PV”) legislation which becomes applicable in July 2012
EU adopts list of general function health claims on foods
- Sidley Austin LLP
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- European Union
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- 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
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- European Union
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- 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
New EU data protection regulation to have significant impact on life sciences
- Sidley Austin LLP
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- European Union
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- December 13 2011
A draft EU Regulation on Data Protection was released un-officially last week
Court of Justice affirms primacy of EU in suspending GMO approvals
- Sidley Austin LLP
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- European Union
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- September 27 2011
On September 8, 2011, the Court of Justice of the European Union issued its ruling in Monsanto and Others v French Ministry for Agriculture and Fisheries (joined cases C-5810 to C-6910
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
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
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