REMINDER: EMA gateway made mandatory

As of the 1st of March 2014, the use of the eSubmission Gateway or web client will become mandatory for all eCTD submissions through the centralised procedure to the EMA.

After this date, the Agency will no longer accept submissions saved onto CD or DVD.

The EMA's strategy for electronic submissions aims to improve efficiency and decrease costs for applicants. The major benefits include a quicker and easier way to send submissions securely over the Internet, a speedy confirmation of the outcome of the eCTD technical validation and subsequent upload to the EMA's eCTD review system and lastly, there will no longer be a need to submit physical copies of dossiers or hard copy cover letters to the EMA.

 

 

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