MAA Pre-submission meeting is not a mandatory meeting, however, it is strongly recommended as it is the final meeting before the registration (MAA submission) where the developer address product- specific legal, regulatory and scientific issues
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EMA pre-submission meeting (Pre-MAA meetings)
Published by IRDiRC
Regulatory AffairsMarketing AuthorisationEU Marketing Authorisation Road MapMAA Pre-SubmissionRegulatoryMAA Submission