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Guideline on the use of the CTD format in the preparation ...
www.ema.europa.euThe table below describes the CTD structure and provides additional guidance to that included in the Volume 2B of the Notice to Applicants (Presentation and format of the dossier C TD). For the purpose of this guideline, the term ‘Applicable’ means that the guidance provide d in Notice to Applicants, Volume 2B - CTD should apply.