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Hosai

05/05/24 8:27 PM

#458345 RE: Steady_T #458344

The CHMP is involved in both the application eligiblty and the actual submission. The CHMP involvement is mentioned in section 2.2 here - https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance

frrol

05/06/24 6:37 AM

#458361 RE: Steady_T #458344

CMA = "Conditional Marketing Authorization"