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eSubmissions

Further guidance on eSubmissions can be found on the EMA website under eSubmission

  • Information related to the CESSP project is available on the CESSP eSubmission website and on the EMAwebsite. (November 2016)

  • CMDh Best Practice Guide on the use of eCTD in the MRP/DCP (April 2020) [Track version]
  • Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures (February 2022) [Track version]
  • Requirements on submissions for Variations and Renewals within MRP and National Procedures (February 2022) [Track version]

Questions & Answers on eSubmissions

  • Questions and answers
  • Question and answer document covering practical issues for variations in eCTD format
  • Q&A on how to handle ongoing procedures in relation to mandatory eCTD format
  • Q&A on mandatory eCTD in National Procedures (NP)

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