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How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1

 
• By Ian Schofield

Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.

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No-deal Brexit medicines regulations have been published • Source: Shutterstock

The UK government has published draft regulations that would allow the Medicines and Healthcare products Regulatory Agency to function as a standalone regulator and take on roles currently conducted by the European Medicines Agency if the country were to leave the EU without a Brexit deal in place.

The regulations would introduce “a large number of changes to make sure that the MHRA can operate in a...

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