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If you have any questions or require assistance please contact CESP Support.
CESP Support is available Mon - Fri from 9:30 - 17:00 GMT
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 as well as the. For identification purposes, names, member states and procedure number should be included in the cover letter.
For please mention the active substance covered by the workshare procedure, year and month of DLP and the PSUR RMS.
As previously communicated, updates were applied to the CESP portal to support GDPR (General Data Protection Regulations).
As part of these updates you are requested to Opt-In or Opt-Out of email notifications. This is a two step process.
Step 1: For each of the email notification types you wish to subscribe you must select you choice on screen under your My Account, Subscription area.
Step 2: Confirm your subscription from your registered email address. An email will be sent to you whereby you must confirm your Opt-In to receive the notification type. You must confirm your choice via email for the choice to be valid.
If you have not received email you were expecting from the system, please ensure that you have completed step 2 of the above process. You can request confirmation emails to be sent again via your My Account, Subscription area.
Only when you have completed both steps you will receive email for your chosen notification types going forward.
The CESP system will be undergoing routine maintenance outside of core business hours (09:00-17:00GMT Mon-Fri) over the periods Friday 31st August - Saturday 1st Sept, Friday 7th Sept - Saturday 8th Sept.
We do not anticipate major disruption to services during these windows however some short periods of disruption to service may take place.
We apologies for any inconvenience caused.
The CESP Support Team
CESP Live Demonstrations are designed to provide general training for the Common European Submission Portal and will focus on the following.
CESP 2.0 Dashboard
Delivery File Creation
Uploading a Submission
Delivery Tracking & Reporting
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.
Once registered you will receive an email confirming your registration with information you need to join the webinar.
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.
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.
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.