From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD. The European Medicines Agency (EMA) strongly recommends using the electronic submission channels (eSubmission Gateway or Web Client) and the electronic Common Technical Document (eCTD) or NeeS (Non-eCTD electronic Submission) formats for submission of referrals. For Referral submissions related to Centrally Authorised products, it is mandatory to use the eCTD format. The EMA’s strategy for the electronic submission of applications aims to improve efficiency and decrease costs for applicants. Applicants who wish to use the eSubmission Gateway or Web Client are encouraged to register to use the eSubmission Gateway/Web Client on the EMA’s eSubmission Gateway website as soon as possible.
