BioCentury
ARTICLE | Politics & Policy

Brexit deal smooths transition for MAAs, IP protections

November 15, 2018 1:09 AM UTC

Details of a draft Brexit deal reveal that the U.K.'s MHRA and EMA will be able to share MAA dossiers and both sides will honor IP protections during a transition period set to run until the end of 2020.

Article 45 of the Withdrawal Agreement allows for the U.K. to request from EMA or any EU member state an MAA dossier for a medicinal product approved in the EU to facilitate the MHRA's own review of the same product, or vice versa, during the post-Brexit transition period, which is set to begin March 30...