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Lykiri

07/09/23 3:49 AM

#607963 RE: scotty3371 #607823

Application has been submitted for at least 30 days. August is approval month imo.


So, scotty, you think submission around June1?
Not in the UK, IMO.

The guidance recommends a pre-submission meeting with the MHRA approximately 90 days before the intended submission for the final phase.

Doesn't make sense to have a pre-submission meeting with the MHRA before you can provide certificates for all manufacturing functions IMO.