Announcements

CESP Live Demonstrations are designed to provide general training for the Common European Submission Portal and will focus on the following.

CESP Overview
CESP 2.0 Dashboard
Delivery File Creation
Uploading a Submission
Delivery Tracking & Reporting
Company Management
User Management

Attendees will have the opportunity to ask questions using the integrated Questions and Answers. These questions will be answered during the session where possible or will be followed up via email after the session.

We can host up to 100 users per session.

Register for a session now by clicking the "Register Now" Link below and select your preferred date from the drop down list. 

REGISTER NOW

Once registered you will receive an email confirming your registration with information you need to join the webinar.

For the submission of periodic safety update reports (PSUR) for MR/DC veterinary medicinal products, the CESP delivery file shall, in addition to all other relevant information, include all national product names with corresponding member state(s) as well as the procedure number. For identification purposes, names, member states and procedure number should be included in the cover letter.

For Workshare PSURs please mention the active substance covered by the workshare procedure, year and month of DLP and the PSUR RMS.

Introduction

The eSubmission Roadmap describes the concept of Single Submission Portal which will be created by integration of the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway. The EU Telematics Management Board has agreed that this single portal shall be built using the current CESP portal. This future system is currently referred to as the Common European Single Submission Portal (CESSP). 

The first implementation project step, CESSP Phase 1, will deliver integrated human and veterinary Marketing Authorisation Application datasets for new marketing authorisation and extension applications. Following feedback from the UAT 1, a number of changes to the system have been proposed and to meet these additional requirements, the anticipated release date has now changed. It is expected that the first version of the system will be available for use by Q4 2018. Detailed announcements of the project milestones, training and any additional support information will be provided on this webpage.

News

Statement of Intent on implementation of the CESSP project is now available. The CESSP will replace electronic Application Forms (eAF) for human and veterinary Initial and extension applications in 2018.

Statement of Intent

CESSP eSubmission 

Dear All

In line with the changes to the CESP System announced earlier this year. It is now required that all stakeholders upload submissions in a single .zip file per the following guideline

 .Zip and Submission Guidelines

One CESP Delivery Per Application.

One .zip file per delivery containing the full documentation required including.. cover letters, validation reports etc... 

Related sequences may be sent within the same zip file once they are in separate subfolders.

The procedure to upload your submission via CESP has not changed. 

The correct process for uploading a submission is:

A. Create a unique submission folder on the remote server.
B. Copy the .zip file into the submission folder.(wait until 100% transferred)
C. Copy your delivery file into the submission folder. 

Please leave both files in the submission folder until you receive the notification email from CESP. This will be sent once the submission has been received by the CESP server. If uploading multiple submissions please ensure a separate submission folder and delivery file are created for each submission. 

We have included documentation below to show how to create your CESP Submission .zip file using the four most commonly used software packages for creating .zip files. We don't recommend any specific software to be used but it is a requirement that all zipped files end in .zip  

Any zipped file with an extension of “.7z” , “.rar” “.zipx”  or anything other than .zip will be rejected by the system.

Please click the link below to see how to set .zip as the default in your software package and how to zip your submissions so all the submission detail is contained in one .zip file.

Windows
WinZip 
WinRAR
7-ZIP