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exwannabe

05/08/24 2:23 PM

#689708 RE: mike00h #689701

I think calendar is correct, but it is definitely from submission of a valid MAA.

UK Human Medicens Regulations 2022

58.—(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a UK marketing authorisation before the end of 210 days beginning immediately after the day on which the application for the authorisation is submitted in accordance with regulations 49 to 55.



That is the standard 210, but I wold be certain the 150 day is the same language wrt initial clock on day.

newman2021

05/08/24 2:28 PM

#689709 RE: mike00h #689701

So, they can squeeze the shorts in 10 days, if the 150 calendar days guidance is good.