Tag archives: European Commission

Impact of Brexit on marketing authorisation holders – new EMA and CMDh guidance

Health Law PulseBy on Posted in International, Regulatory
The European Commission and European Medicines Agency (EMA) have published a Q&A document (the EMA Q&A) concerning the legal consequences for marketing authorisation holders (MAHs) of centrally authorised medicines if the UK becomes a ‘third country’ after Brexit. The EMA Q&A provides further detail following the European Commission and EMA notice of 2 May 2017. … Continue reading

Recent European developments in mHealth regulation

Health Law PulseBy on Posted in International, Regulatory
In this briefing we cover recent regulatory developments for mobile health (mHealth) in the European Union and set out a summary of the current framework. mHealth is a sub-segment of electronic health (eHealth) and covers medical and public health practice supported by mobile devices. It especially includes the use of mobile devices for health and … Continue reading
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