General Information

Accessing the Portal

To register please complete the registration form available by selecting the  “Register” option on the 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 which will be setup during the registration process by the CESP support team. Once the company registration has been approved, the nominated company administrator will receive connection details to their registered email address.  The company administrator is then responsible for setting up additional companies/users on the system as required. There is no charge to use the system, if you wish to participate please complete the registration process. 

In order to connect to the  portal you will need:

  • Internet Access with a recommended upload speed of 2mbps or greater.
  • Modern Web Browser such as:
    • Chrome v8+
    • Firefox v25+
    • Internet Explorer v10+
    • Safari v5 (PC) v6+ (Mac)

File uploads can be completed by using one of two methods, integrated web transfer client or by using a local sFTP client.

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

Training videos are available to watch and training guides are available to download from our Training On Demand section once logged in to the Portal.

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 through the online support desk when logged into the system or by emailing cesp@hma.eu.

Business hours are:

Monday to Friday, 09:30hrs to 17:00hrs (GMT)

Main contact details Telephone: +35316343801

Email Address: cesp@hma.eu

 

The list of public holidays each year is as follows:

  • New Year's Day (1 January)
  • First Monday in February
  • St. Patrick's Day (17 March)
  • Easter Monday
  • First Monday in May, June, August
  • Last Monday in October
  • Christmas Day (25 December)
  • St. Stephen's Day (26 December) 

eSubmission Guidance 

Guidance has been published on the structure and format of electronic submissions for both human & 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 is are pleased to announce that the eSubmission Gateway for electronic submissions is in full production. Further information is located at eSubmissions Gateway website.