UK Explains Approach To Renewing Converted EU Drug Approvals in 2021
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.
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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.
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.