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Posted On: 10/27/2020 5:35:26 PM
Post# of 148908
According to my sources, MHRA has two weeks to determine if the BLA/MIA application has been property filled out, contains proper data, etc. This is not a review of data but a review of the application form so to speak. MHRA then has up to 90 working days to determine if the drug is authorized in the UK. From a diplomatic agreement standpoint the question also becomes since U.K. has received the application while a member of the EEA and are then processing on that entities behalf what would be the impact of any decision by MHRA on approval if after January 1. My suspicion is that other EU states would be bound by acceptance of the application as worthy of evaluation. But determination of approval would be up to the EU medical body as a final agreement by the EU and U.K. on this subject is not ratified.
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