Is the "Validation of the application,"* which assures "all essential regulatory elements required for scientific assessment are included in the application," typically announced to the public? If yes, is that done by the EMA or by the submitting company? I've read on this board that companies usually announce the submission of a MAA; do they announce (a) that they've sent in their MAA or (b) that it's been validated, or both? After that, are we left in the dark until such time as the CHMP makes its recommendation (or, for that matter, until even later when the European Commission issues, or declines to issue, the marketing authorisation)?
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