The use of the Common Repository for Human Centralised Procedure submissions is now mandatory for all National Competent Authorities. Submissions sent to EMA via eSubmission Gateway/Web Client will be considered delivered to all National Competent Authorities’ representatives and alternates. Submissions for Centralised Procedure should be made via EMA eSubmission Gateway/Web Client only. Additional copies should not be submitted directly to the NCAs on CD/DVD or via CESP as this might lead to validation issues and cause delays. The use of the electronic Application Forms (eAF) is now mandatory for all Human and Veterinary Centralised Procedure submissions. The forms for Initial, variation and renewal applications as well as the User Guidance document and the updated Q and A document are also available on the eAF webpage.
