Electronic submissions of applications for marketing authorisations for human medicinal use through CESP
Starting on 29 October 2012 it will be possible to submit electronic applications for marketing authorisations in the national procedure, Mutual Recognition Procedure (MRP) or Decentralised procedure (DCP) through the improved Common European Submission Platform (CESP) .
The Common European Submission Platform (CESP) is an electronic platform developed by a group of EU member states and industry representatives and managed by the Heads of Medicines Agencies (HMA), to which applications in the national procedure, MRP and DCP for both human and veterinary medicinal products can be sent.
After a Proof of Concept (PoC) and an ‘extended PoC’, CESP will be transformed into a ‘pre-production pilot’ on 29 October 2012.
The FAMHP accepts only submissions for new applications for marketing authorisations, for human medicinal use.
The use of CSP makes submission fast, safe and easy. Therefore The FAMHP advises all companies to start using the CESP from 29 October 2012 and to register themselves through the website of CESP.