The MHRA has been piloting CESP since the end of October 2012 and up until April 2013 we have received 664 submissions via this submission platform. The response from applicants who have used CESP has been extremely positive. It is recognised as a significant step towards reducing the use of CD/DVDs and improving data security.

 

CESP is currently being piloted by a number of Member States. It offers a faster, more reliable means of submission than CD/DVD, and reduces the administrative burden of handling and storing these types of media for both agencies and applicants. The MHRA strongly encourages the use of CESP. If you are interested in using CESP please see the Heads of Medicines Agency (HMA) website for details. Common European Submission Platform (external link)

 

The MHRA is able to accept the following types of submission via CESP:

  • Centralised – CESP is the our preferred method of submission for Centralised Procedures
  • National
  • Mutually Recognised and Decentralised Procedures
  • Active Substance Master files

 

For further details on making a submission to the MHRA, please consult the submissions web pages on the MHRA website: Submitting an application to the MHRA

 

Posted on the UK MHRA website on 13 May 2013