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UK Explains Approach To Renewing Converted EU Drug Approvals in 2021

 
• By Vibha Sharma

The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.

Broken chain
MHRA will be the UK’s standalone medicines regulator From 1 January 2021 • Source: Shutterstock

The UK medicines regulator has issued guidance explaining how companies can renew their drug marketing authorizations (MAs), initially evaluated through various EU procedures, when the transition period after Brexit comes to an end this year.

Under arrangements being put in place by the Medicines and Healthcare products Regulatory Agency, all medicines approved under the EU’s centrallized procedure will be automatically converted into UK MAs effective...

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