The European Medicines Agency hereby announces plans to implement the eSubmission Gateway. The eSubmission Gateway will allow the electronic-only submission of all centralised procedure eCTD applications.
In this context, the European Medicines Agency is pleased to announce that a pilot phase for the eSubmission Gateway is starting on 9th of January 2012.
During the pilot phase the Gateway will be available to a limited number of applicants as a new submission channel through which all types of centralised procedure eCTD applications can be submitted to a limited number of applicants (e.g. new applications, supplementary information, variations and renewals).
The pilot phase will run for three months and the Agency would like to welcome all interested applicants to register for the pilot. To register, please follow the steps described in the Pilot Guidance document.
To find more information and download the document please click here: EMA: Sending electronic submissions (Human) via the eSubmission Gateway - Statement of Intent
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