Helen Kerr

Hogan Lovells

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European court invalidates transfer of clinical data from the EU to the U.S through the Safe Harbor Framework

European Union, USA - October 7 2015 On 6 October 2015, the Court of Justice of the European Union ("CJEU") ruled that the European Commission Decision on the adequacy of the EU-U.S Safe…

Ciara Farrell.

MHRA publishes guidance relating to DEHP phthalates in medical devices

European Union - September 28 2015 On 10 September 2015, the Medicines and Healthcare Products Regulatory Agency ("MHRA") published guidance in relation to medical devices which…

European Commission launches public consultation on New Implementing Act on GMP

European Union - September 23 2015 On 28 August 2015, the European Commission launched a public consultation on a new Implementing Act on principles and guidelines on good…

Notification of draft Commission Delegated Regulation on the implementation of obligatory safety features for medicinal products

European Union - August 25 2015 On 12 August 2015, the European Commission notified the World Trade Organisation ("WTO") of its draft Delegated Regulation supplementing Directive…

Public consultation process launched on draft revised Guideline concerning accelerated assessment of medicinal products

European Union - August 4 2015 On 27 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) launched a two month public consultation process on a revised draft…