Submission of Documentation via the CESP Portal

The State Institute for Drug Control (hereinafter referred to as the "Institute") hereby informs about the possibility to submit authorisation applications and related documents through the CESP Portal starting from 1 July 2014.  

CESP (Common European Submission Platform) is a portal for mass submission of applications within the EU as well as a platform technologically independent on the type of application that allows the Institute to receive applications and related documents fully in electronic form. 

From 1 July 2014, the Institute accepts all types of authorisation applications and related documents, submitted through the CESP and such submission will be considered valid. The Institute will also allow submission of applications and related documents via CESP without the need to sign such submissions using the certified electronic signature. However, the application form must contain at least a scanned signature of the authorized representative (see Zápis ze schůzky se zástupci Asociací ze dne 5. 6. 2014).   

In addition to the documentation sent via CESP as described above, it is required to deliver powers of attorney containing an authorisation for an unspecified number of a particular subject - related proceedings that will be initiated in future, with the original signature by post or courier, the grantor’s signature must be officially certified.

Information regarding the submission of applications via the CESP portal, including ensuring access to the portal, is available on the HMA website.

The procedure for submitting applications via CESP is demonstrated in the presentation published in the section Training after registration. The documentation submitted via the CESP portal shall be provided in one compressed ZIP file. No other compressed files may be placed in this ZIP file.

National requirements of individual member states for documentation submitted via CESP are available here. We strongly recommend you study these requirements before starting the submission via the CESP portal.

Frequently asked questions and answers regarding the CESP portal are published on the HMA website.

All types of authorisation applications and related documents may still be submitted using the current options for the submission of applications in accordance with the Institute Regulation REG-84. It is also essential that electronic formats set out in this regulation are followed in all options of submission.

Information regarding the possibility of submitting an amendment within national and MR/DC procedures are available on the website of the Institute.

 

Marketing Authorisation Branch

25th June 2014 (update 19th January 2018)