Act Quickly On Converted EU Product Approvals, GB Firms Urged
Companies Can Opt Out Of “Grandfathering” Process
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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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 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.
A European Parliament committee says that some aspects of the EU’s proposed unitary supplementary protection certificate scheme could promote access to cheaper off-patent medicines while others could delay generic competition.