Pharma: The Impact of Brexit on Pharma Drug Regulations
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Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.
There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.
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.
Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.
From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.
Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.
With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.
The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year.
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