eSubmissions

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

• CMDh Best Practice Guide on the use of eCTD in the MRP/DCP (June 2015) [Track version]
  
  Any change requests for the document should be handled in accordance with the change request instructions given on the EMA eSubmissions website.

• Release notes to the CMDh Best Practise Guide on the use of eCTD in the MRP/DCP (June 2015)

• Technical validation of eCTD submissions for new MAAs in DCP - voluntary pilot
  The pilot phase ended on 31 December 2013.
  A more efficient process for the technical validation is currently being discussed. The objectives as set up in the EMRN eSubmission Roadmap will be taken into account. The draft Roadmap is published on the HMA CESP website  (http://cesp.hma.eu/Home).

• Transitioning to a compulsory usage of the eAFs for Human and Veterinary procedures -  Status and next steps (Annex to the HMA eSubmission Roadmap detailing the status and next steps of outlined strategy relating to eAFs)

• Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures (May 2017) [Track version]

• Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedures (May 2017) [Track version]

Questions & Answers on eSubmissions

• Question and answer document covering practical issues for variations in eCTD format