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UK To Have Own Conditional Drug Approval Scheme in 2021

Companies Must Register To Make Submissions

 
• By Ian Schofield

New UK guidance on the post-Brexit regulation of medicines says the Medicines and Healthcare products Regulatory Agency will be able to issue its own conditional marketing authorizations next year. The agency has also outlined how drug safety reports should be submitted.

Brexit
The UK will take over responsibility for conditional approvals next year • Source: Shutterstock

The UK government has confirmed that mechanisms will be in place from 1 January 2021 allowing the medicines regulator, the MHRA, to issue national conditional marketing authorizations (CMAs) and to approve products under exceptional circumstances, based on the same eligibility criteria as the existing EU schemes.

The UK is having to change its regulations because when the Brexit transition period ends on 31 December, the MHRA...

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