Terms & Conditions

Accessing the Portal

To register please complete the registration form available by selecting the  “Register” option on this registration page, once approved your account will be set up and an automated email will be sent to your email account with connection details.  Each Company must have a least one company administrator set up by the CESP support team, once this company administrator is setup they are responsible for setting up additional users for that company on the system. There is no charge to use the system, if you wish to participate please complete the registration process.  The portal can be accessed using two methods either though an sFTP client  (preferred option) or through a web based interface. In order to connect to the  portal you will need:

• A  PC with broadband access
• FTP client that has sFTP capability currently tested clients are Filezilla V3.4 + (free ftp client) or CuteFTP V8.3+ professional additional configuration may be required please see FAQ section
• Standard web browser with java enabled

National Requirements 

Some agencies have indicated National Requirements for using CESP, these requirements are indicated on the Contacts Page and should be reviewed prior to submission. 

Online Training Material

A training presentation is available to download , this presentation will be updated on an on-going basis

CESP Demonstration Presentation - Published 17/02/2014

Guidance on Zip Files , Folder and File Names - Published 27/10/2013

Support

The CESP Group shall provide support in respect of the Portal to authorised users during normal working hours on Monday to Friday (other than public holidays listed below). Contact details for accessing CESP Group support are available on the Portal. 

All support calls should be logged either through the online support system available to registered users of the system or by emailing cesp@hma.eu.

eSubmission Guidance 

Guidance has been published on the structure and format of electronic submissions for both human a veterinary medicinal product submissions and can be access at : 

http://esubmission.ema.europa.eu

Electronic Application Forms

The Electronic Application Forms offer an alternative, convenient, online version of the currently used paper forms, which are published and maintained on the European Commission’s EudraLex website. These electronic forms are designed to reflect and capture the same content as the paper-based application forms. These forms can be accessed at EU Electronic  Application Forms eSubmission website 

eSubmission Gateway for Centralised Applications 

The European Medicines Agency eSubmission Gateway for electronic submissions is located at eSubmissions Gateway website.