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Re: Steady_T post# 458344

Sunday, 05/05/2024 8:27:13 PM

Sunday, May 05, 2024 8:27:13 PM

Post# of 459973
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
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