Regulatory information – Mandatory use of common repository for human centralised procedures as of today

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01/07/2015

Regulatory information – Mandatory use of common repository for human centralised procedures as of today

Companies now to submit their applications to the European Medicines Agency only

As of today, 1 July 2015, companies should no longer send their centralised procedure applications for human medicines to individual Member States on CDs/DVDs or via the Common European Submission Platform (CESP).

Instead, companies should send these applications to the European Medicines Agency’s (EMA) via eSubmission Gateway/Web Client only. These applications will automatically be made available to all national competent authorities via a common online repository.

This applies to all human centralised procedure applications in the electronic Common Technical Document (eCTD) format. The CESP remains in use for other procedure types as previously.

The common repository has been available since February 2014. It enables national competent authorities to safely search, browse and download centralised procedure eCTD submissions for human medicines. The system is expected to accelerate the validation of incoming applications and will ensure continuous and immediate access to up-to-date dossiers by all national competent authorities.

For further information, please see the eSubmission website.

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