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Notwithstanding the exit of the UK from the EU on 31 January, the Withdrawal Agreement (the ‘WA’) provides that EU law will continue to apply until 31 December 2020, the so called ‘Implementation Period (IP) completion day’. During this transition period the nature of the future EU-UK relationship will be determined, however for the most part it should be ‘business as usual’ for the UK life sciences sector. After IP completion day it is likely that the UK's life sciences regulatory framework will become increasingly de-harmonised from that of the EU.
The European Union (Withdrawal) Act 2018 as amended by European Union (Withdrawal Agreement) Act 2020 contains provisions whereby directly applicable EU legislation as at IP completion day is converted into UK domestic law. This will provide an initial period of certainty for UK life sciences organisations until the end of the transition period. Subject to any agreed deal, post-IP completion day de-harmonisation between UK and EU regulatory frameworks will have a significant impact for the UK life sciences sector.
After IP completion day the UK will no longer be subject to EU law. A new system for independent MA approval through the MHRA will be established to carry out all functions currently done at the EU level. Pharmaceutical companies whose presence and activities are principally in the UK risk losing their MAs granted through the centralised, EU wide procedure,
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