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EU’s Highest Court Rules on the Regulatory Framework Applicable to GMOs Developed Through New Mutagenesis Techniques

European Union - August 7 2018 On July 25, 2018, the Court of Justice of the European Union (CJEU) issued an important ruling clarifying that the EU's 2001 GMO Directive1 and its...

Kristina Nordlander, Yohan Benizri.

New EMA Guidance to Help Pharmaceutical Companies Prepare for Brexit

United Kingdom, European Union - January 9 2018 As of March 30, 2019, the United Kingdom will become a “third country.” Applicants and marketing authorization holders (MAHs) of...

Maurits J.F. Lugard.

CJEU Rules on EU-Canadian Passenger Name Record Agreement; Data Retention Possible; Detailed Court Scrutiny to Ensure Proportionality

Canada, European Union - August 1 2017 On 26 July 2017, the Court of Justice of the EU ("Court") issued its Opinion on the proposed EU-Canada Agreement on the transfer and processing of...

Cameron F. Kerry, Jacques Bourgeois.

European Commission Launches 'Excessive Pricing' Investigation in Pharma Sector

United Kingdom, European Union, Italy - May 16 2017 The European Commission announced yesterday that it has launched a formal investigation into Aspen Pharma's pricing of five cancer drugs. The...

Patrick J. Harrison, Kristina Nordlander.

New EU Medical Device Regulations - Immediate Impact and Moving Targets

European Union - May 5 2017 The new EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) were published on May 5, 2017...

Josefine Sommer, Anna-Shari Melin, Maurits J.F. Lugard.