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

How The UK Regulatory System Would Work In A No-Deal Brexit – Part 2

In this second article on the regulations published by the government on how the UK would regulate medicines in a “no-deal” Brexit scenario, we look at what is being proposed for areas such as pediatric investigation plans, orphan medicines, pharmacovigilance, parallel trade, generics approvals, and good manufacturing and distribution practices.

EUFlagPills — New medicines rules would kick in if the UK left the EU without a deal • Source: Shutterstock

If the UK were to leave the EU without a Brexit deal, the UK would set up its own systems to duplicate the current EU provisions on pediatric and orphan medicines, including pediatric investigation plans and data and market exclusivity periods, according to regulations laid before parliament on Jan. 24.

It would also have its own procedures for approving generics complete with the current data and market exclusivity periods, and a freestanding pharmacovigilance system. In addition, the UK would allow...

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