UK To Have Own Conditional Drug Approval Scheme in 2021
Companies Must Register To Make Submissions
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.
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In another of the many guidances it has issued on medicines regulation in the post-Brexit UK, the MHRA explains the additional information it will need from companies whose EU marketing authorizations are converted into national MAs in January 2021, and the new labeling requirements for those products.
The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.
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.