UK Regulator Explains Data Requirements For Converted EU Approvals

New Portal Planned For Information Submission

09 Sep 2020

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.

PS1712_Piles of Paper_448000054_1200.jpg — The MHRA has issued a range of post-Brexit regulatory guidances • Source: Shutterstock

Updated guidance issued by the UK regulator, the MHRA, explains the “essential baseline data” that pharmaceutical companies will have to provide for products with EU centralized approvals that are converted into Great Britain marketing authorizations at the beginning of next year.

The data will need to be submitted within a one-year period starting on 1 January 2021, through a new “national...