EMA: eSubmission Gateway for Centralised Authorisations - Questions and answers
For some time now, the EMA has only been accepting the submission of documents in electronic form for the centralised procedure. So far, there have been 2 possibilities to submit documents: either by sending a CD or DVD (in duplicate); or by using the EMA\'s eSubmission gateway (in the pilot phase) with a limited number of users and restricted functionality. On 23 April, the EMA announced the end of the pilot phase - meaning the release of the complete eSubmission gateway and its unrestricted functionality.
The source of the news: http://esubmission.ema.europa.eu/gateway/Q%20&%20A%20for%20EMA%20eSubmission%20Gateway.pdf