2. Electronic Application forms (eAF), eSubmission-Gateway and -Web Client and Common European Submission Platform (CESP)

2.2. eSubmission Gateway and eSubmission Web Client

The eSubmission Gateway and the eSubmission Gateway Web Client are electronic submission channels that allow to submit documents supporting all types of applications related to the authorisation and maintenance of medicinal products to the EMA securely over the internet in structured and non-structured formats. They are based on the ESTRI (Electronic Standards for the Transfer of Regulatory Information) gateway standard, which defines a secure data exchange service for regulatory information. The web-based Gateway Web Client, available for all applicants, may be particularly relevant for Small and Medium sized Enterprises (SMEs) and companies with lower IT budgets and low submission volumes. The Gateway and the Web Client provide an automated confirmation of the technical validation feedback and an automated upload to the EMA’s eCTD review system. The use of the eSubmission Gateway and the Web Client is mandatory for all submissions.