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EMA: eSubmission Gateway for Centralised Authorisations - Questions and answers

17.05.2012
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.