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European Commission Permits Member State COVID-19 Aid Measures

European Union - March 19 2020 On March 19, 2020, the European Commission adopted a State Aid Temporary Framework (the 2020 Temporary Framework), which will remain in place until...

Tom Bainbridge, Ken Daly, Kristina Nordlander.

Replacement Compounding: A Major Threat to the Marketing Authorization System

Switzerland, European Union - December 12 2019 Pharmaceutical laws in the EU, as well as in Switzerland, provide that no...

Andreas Balsiger Betts.

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.