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

• CMDh Best Practice Guide on the use of eCTD in the MRP/DCP (November 2011) [Track version]
  
  The aim of this guidance is to encourage the submission of eCTD applications in the MRP and DCP and, therefore, to enable all parties to gain more experience.
  Any comments about this guidance in relation to experience from its use in application procedures should be sent to eCTD@ema.europa.eu, coordinated where possible by trade associations.

• Technical validation of eCTD submissions for new MAAs in DCP - start of pilot phase (voluntary) [Track version] (March 2013)

• Requirements on submissions (eCTD and NeeS) for New Applications within MRP, DCP or National procedures (November 2012)

• Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for Variations and Renewals within MRP or National procedures (March 2013)

Questions & Answers on eSubmissions

• Further Q&As covering issues of eCTD dossier submission and handling under the new variations regulation