eSubmission web client for electronic submissions now available for registration

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18/12/2012

eSubmission web client for electronic submissions now available for registration

The European Medicines Agency’s eSubmission web client is now open for registration to all applicants. Registered applicants can start submitting centralised procedure Electronic Common Technical Document (eCTD) applications through the web client starting on 15 January 2013.

The eSubmission web client is a free, web-based tool which is aimed for applicants with lower transmission volumes. It complements the existing Gateway by offering all applicants the possibility to submit eCTD applications securely over the internet to the Agency. The Agency strongly recommends using the Gateway or the web client for all eCTD submissions. Submissions on physical media (CD or DVD) will however continue to be accepted as an alternative method for the time being. It is essential that applicants only use one method of submission.

The eSubmission Gateway and web client both include new and improved functionality such as an automated confirmation of the technical validation feedback to the applicant and an automated upload to the Agency’s eCTD review system.

The introduction of the improved functionality for the eSubmission Gateway and the introduction of the web client are important milestones in the Agency’s long-term eSubmission strategy, which is aimed to provide efficiency gains and cost reductions for all stakeholders.

A further step in the eSubmission strategy is the implementation of secure access to the Agency’s central repository for online reviewing and downloading of applications by national competent authorities. The Agency anticipates that this will give simultaneous access to dossiers and address the burden related to the distribution of multiple physical copies. It expects early testing of the prototype to start by the end of second quarter of 2013. More detailed implementation timelines will be subject to a dedicated central repository announcement.

Applicants who have registered and used the web client during the user acceptance testing can continue submitting their applications without further registration in the production environment after 15 January 2013.

Applicants who use the eSubmission Gateway or the web client must not submit duplicate submissions with physical media (CD or DVD) as this might lead to negative technical validation and cause a delay in the processing of the application.

The Gateway does not cover applications for veterinary medicines at this stage.

The necessary registration process is detailed at eSubmission Gateway and eSubmission web client.

Related information

Contact point:

info@ema.europa.eu