CESP makes submissions totally electronic

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CESP makes submissions totally electronic

Home/Guidelines | Posted 14/12/2012 0 Post your comment

The Dutch Medicines Evaluation Board (CBG-MEB) announced on 1 November 2012 that starting from 12 November 2012, it will be possible to submit applications for marketing authorizations and deviations in the national, MRP (mutual recognition procedure) or DCP (decentralized procedure) procedures through the improved Common European Submission Platform (CESP).

Common European Submission Platform is a secure platform set up by the Heads of Medicines Agencies (HMA) for the exchange of regulatory submissions and submissions-related information between applicants and agencies. It covers both human and veterinary medicine submissions for national, MRP and DCP application types [1].

A proof of concept for CESP was run during September and October 2011 and following its success an extended proof of concept was started in January 2012. Following the success of this trial it was decided by HMA to accept live applications via CESP starting on 29 October 2012. This was delayed slightly until 12 November 2012, due to several prominent (un-named) authorization authorities not yet being ready to link up to the CESP.

When submitting through the CESP, the parallel sending of CDs or DVDs, including the paper submission letter and/or ‘application form’ to the national authority is no longer necessary. The mandatory original signature is also no longer required. Authentication within the CESP will take place on the basis of the login data (user management system). The intention is that this will make submissions fast, safe and easy. When submitting via CD or DVD, the paper submission letter and ‘application form’ (both containing original signature) are still needed.

The CBG-MEB is advising applicants to submit preferably via the CESP route, and has also announced that in 2013 the agency will consider the extent to which the use of the CESP may be made mandatory.

The CESP is available for all EU Member States and authorization applicants and holders, for both human and veterinary medicinal products. The improved CESP can be accessed via http://cesp.hma.eu. This website contains information, such as frequently asked questions and training videos, as well as an online training session.

Registration for the improved CESP can be done starting now through this new website. It was decided to employ a ‘self-service model for user management’. This means that every company must appoint its own ‘company administrator’, who establishes and maintains the access to CESP for employees of that company. To initiate the registration of the ‘company administrator’, a form must be completed using the registration link on the new website.

Agencies from Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Ireland, Italy, Malta, The Netherlands, Norway, Portugal, Slovenia, Spain, Sweden and UK are all taking part in the CESP.

Reference

1. GaBI Online - Generics and Biosimilars Initiative. The Common European Submission Platform [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Dec 14]. Available from: www.gabionline.net/Guidelines/The-Common-European-Submission-Platform

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Source: CBG-MEB, HMA