eSubmission of the marketing authorisation (MA) dossiers for medicines

The update of the document « eSubmission guideline » (version 2.8) includes in particular the folllowing:

  • change in the maximum size of the mail sent to the FAMHP « mail size limit » : 5MB
  • clear statement that the WORD-documents are to be introduced outside of the CTD tree.

















Last updated on 24/06/2009