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Re: Bouf post# 320994

Monday, 01/25/2021 6:58:29 PM

Monday, January 25, 2021 6:58:29 PM

Post# of 423561
The vast majority of CHMP positive recommendations are approved. Negative opinions can be challenged, though only a small minority are successful.

If you are interested in a detailed description of the process, the following may be helpful:


Centralised procedure - European Medicines Agency |www.ema.europa.eu › documents › presentation › pres...
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In Europe today, all medicines must have a marketing authorisation before they can be ... Some medicines must come through the EMA to be approved and these include ... The assessment of an application for a new medicine can take up to ... Following a CHMP opinion the European Commission takes usually its decision ...
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