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

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• CMD(h) Best Practice Guide on the use of eCTD in the MRP/DCP (January 2010)
  Click here
  
  

  Further to experience gained both by Industry and National Competent Authorities, the CMD(h) has reviewed the Best Practice Guide on the use of eCTD in the MRP and DCP. This guidance is available for immediate use by applicants using these two submission procedures. It is highly recommended.

  
  Its aim 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 and experience from its use in application procedures should be sent to the CMD(h) Secretariat (H-CMDhSecretariat@ema.europa.eu), coordinated where possible by trade associations.

• Requirements on electronic submissions for New Applications within MRP, DCP or National procedures (Latest update: February 2010)
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• Requirements on electronic submissions for Renewals & Variations within MRP, DCP or National procedures (Latest update: July 2009)
  Click here

New Variation Regulation and eCTD

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