Regulatory information - use of eSubmission Gateway and web client extended to new procedure types from 1 April 2014
NewsCorporate
From 1 April 2014, the European Medicines Agency (EMA) will extend the use of the eSubmission Gateway and web client to all referral procedures, veterinary medicine submissions and paediatric submissions.
This will allow companies to submit their documentation to the EMA securely over the internet, thereby improving efficiency and reducing costs for applicants.
Applicants who wish to use the eSubmission Gateway or web client need to register on the EMA's eSubmission website. Applicants who have already registered and used the eSubmission Gateway or web client for electronic Common Technical Document (eCTD) submissions for the centralised procedure or PSUR single assessment (PSUSA) procedure submissions do not need to register again.
Submissions on physical media (CD/DVD) for referrals, veterinary submissions and paediatrics will continue to be accepted as an alternative method for the time being. However, it is essential that applicants only use one submission method and do not submit duplicate submissions on physical media or Eudralink as this might lead to a negative technical validation and cause a delay in processing the application.
Applicants are invited to register to use the eSubmission Gateway or web client solution as soon as possible.
The Agency launched the eSubmission Gateway in 2012 as an electronic submission channel for all types of eCTD applications for human medicines. The eSubmission web client was launched in January 2013 to complement the Gateway and is aimed at applicants with lower transmission volumes.
The use of the eSubmission Gateway or web client will be mandatory for all eCTD submissions through the centralised procedure from 1 March 2014.