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MHRA PMS and Vigilance reporting – Updated UK requirements

Last week, MHRA updated the PMS and Vigilance guidance page. They intend to continue to accept reporting for NI using the EU MIR and will transition to using 7.3.1 as per the EU deadline, however for GB reporting there is a new GB Schema that will be introduced and will need to be used from the date of application of…
Ben Kemp
May 19, 2025