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The materials published on http://esubmission.ema.europa.eu/ are documents produced and/or adopted by the TIGes. They are published for consultation with interested parties and may be removed, updated or replaced at any time. Documents related to eCTD that have been adopted by other regulatory instances may be removed from this site, and only links to their actual location will be maintained (e.g. eCTD standards on the Notice to Applicants web site). It is inappropriate to use any working drafts published on this site as reference material or to cite them other than work in progress .

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