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

By on June 7, 2017 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

The UK Government’s Brexit White Paper and its impact on the life sciences sector

By on February 7, 2017 Posted in International

On February 2, 2017, the Government published a White Paper on its plan for exiting and achieving a new partnership with the EU. The White Paper expands upon Prime Minister Theresa May’s speech on January 17, 2017. We have previously written about the speech and earlier developments (The UK government’s Brexit plan and its implications for Life Sciences). See … Continue reading

The UK Government’s Brexit plan and its implications for life sciences

By Huw Evans (UK) on January 19, 2017 Posted in International

On January 17, 2017, Prime Minister Theresa May delivered her much anticipated speech on the UK Government’s plan for exiting the EU. Continued membership of the EU’s single market and full membership of the customs union have both been explicitly ruled out. The plan for achieving a new partnership between the UK and the EU … Continue reading