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Re: Guzzi62 post# 476217

Saturday, 12/07/2024 8:27:15 AM

Saturday, December 07, 2024 8:27:15 AM

Post# of 518944
I don't this so Guzzie. It has to be applied for using a somewhat rigorous process: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment

Applying for it prior to submitting your application is important because then the rapporteurs, who are essentially your coaches and mentors who ensure your application meets the requirements of your application and application type prior to submission, can be sure that the type of application you submitted will be accepted.

I don't know of any examples of MAA applications that were declared AA by the EMA without AA having been applied for - do you?
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