MHRA Advocates Use of Online Submissions Platform by Applicants

Posted 07 January 2013 | By Alexander Gaffney, RAC 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is "strongly" encouraging all applicants to participate in its pilot participation in the Central European Submissions Platform (CESP), an online-based secure submissions system.

Currently, applicants are permitted to submit applications to MHRA using data contained on CDs or DVDs, depending on the size of the submission. However, this submission style necessitates manual handing of media, storage space, and can also lead to delays in being able to submit time-critical submissions, which often must be delivered by courier. In particular situations, these delays could be sufficient to affect the marketing protections given to a product.

The CESP platform avoids these issues by providing a secure online submission system that also allows sponsors to submit a single document to multiple EU agencies. The medicines agencies of 23 EU countries, including the UK's Veterinary Medicines Directorate (VMD), are currently participating in the CESP, though regional requirements still apply to each application.

More information on the CESP may be found on the Heads of Medicines Agencies (HMA) website.

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