The Heads of Medicines Agencies (HMA) is currently carrying out an ‘extended proof of concept’ for the Common European Submission Platform (CESP) project aimed at establishing a single portal for electronic submissions to multiple competent authorities in the context of European registration and post-approval procedures in the European Economic Area.

The CESP is an initiative of a group of EU Member States and industry representatives, managed by HMA, and is available for all EU Member States and authorisation applicants and holders, for both human and veterinary medicinal products. Current agency participants include, Austria, Croatia, Cyprus, Denmark, Estonia, Finland, France (Anses), Germany (BfArM, PEI), Iceland, Ireland, Malta, The Netherlands, Portugal, Slovenia, Spain, Sweden and UK (MHRA, VMD).

The CESP Project for Human and Veterinary Electronic Submissions provides a simple and secure mechanism for exchange of submission information between applicants and agencies, covering the following:

• National, Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) application types
• Initial, variation and renewal submissions

The aim of the system is to:

• Provide a secure method of communicating with the regulatory agencies via one platform
• Allow submission of an application once to reach all required agencies
• Reduce the burden for both industry and regulators of submitting/handling applications on CD-Rom and DVD

At the moment CESP submissions need to be made in addition to the current method of submission. However, the intention is that once the project has proven to be workable and effective it will replace the current system of CD/DVDs and paper submissions. This means that in most EU countries a legally valid submission needs to be made on CD/DVD, including certain paper documents signed by hand, in addition to the identical eSubmission uploaded via the CESP.

The ‘extended CESP’ is expected to go live in October 2012, and the Dutch Medicines Evaluation Board (CBG-MEB) has already announced that, starting on 29 October 2012, the agency will allow applications for marketing authorisations and deviations in the national, MRP or DCP procedures to be submitted through the improved CESP. When submitting through the CESP, the parallel sending of CDs or DVDs to the MEB is no longer necessary, thus making submission fast, safe and easy.

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Source: www.gabionline.net