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eCTD baseline sequences

Version 1.0, November 2020
Last updated

This user guide is for sponsors converting their dossier format from paper, Common Technical Document (CTD) or Non eCTD electronic Submission (NeeS) to electronic Common Technical Document (eCTD).

  • About this user guide 
  • Using a baseline
  • What to include in a baseline sequence
  • Submitting a baseline
  • Transitioning without a baseline

Supporting documents

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