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

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• CMDh Best Practice Guide on the use of eCTD in the MRP/DCP (June 2010)
  Click here

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 the CMDh Secretariat (H-CMDhSecretariat@ema.europa.eu), coordinated where possible by trade associations.

The changes in this revision 2 compared to revision 1 is in the Sequence Tracking Table examples (page 20) that now also include examples on how a change of RMS should be handled.

• Requirements on electronic submissions for New Applications within MRP, DCP or National procedures (Latest update: June 2010)
  Click here

• Requirements on electronic submissions for Renewals & Variations within MRP, DCP or National procedures (Latest update: July 2009)
  **Table to be updated soon** Click here

• Questions & Answers - The use of eCTD on MRP/DCP
  Click here

New Variation Regulation and eCTD

Questions & Answers covering issues of eCTD dossier submission and handling under the new variations regulation HERE