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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
The CESP portal will be offline for 4 hours from midnight IST Friday the 29th of June until 04:00am on Saturday 30th June.
As previously communicated some key points to note once the GDPR updates are applied.
Further details regarding the GDPR changes can be found in the FAQ and training areas of the CESP portal. In addition, several webinars will be held over the coming weeks to provide an overview of GDPR changes. REGISTER HERE to attend a scheduled webinar.
Please contact CESP support via the portal or email firstname.lastname@example.org if you have any questions or concerns.
Due to a public holiday in Ireland on Monday 4th June 2018, please log all support calls via the online support desk which is available to all registered users.
CESP will be online and available for deliveries.
As you are probably aware on the 25th of May 2018 the Data Protection laws are changing, your rights under the GDPR regulations are important to us and we would like to take this opportunity to inform you of the updates we are rolling out to comply with the regulation.
The General Data Protection Regulation (GDPR) requires that where CESP processes your personal data you are informed of the lawful grounds on which CESP will continue to process your personal data.
All active CESP users will be asked to review and agree to the updated privacy notice, terms and conditions and confirm subscriptions to email notifications.
By accepting these updates, you are consenting to the processing of your personal data by the CESP portal in the manner outlined in the updated privacy notice.
By rejecting these updates, you are opting out of use of the CESP portal and your personal data will be deleted from the CESP portal in line with GDPR. This will terminate your user account and future access to the CESP portal under the named user account logged in when taking this action.
If you have any quesetions please contact the CESP support team.
The CESP Support Team
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.
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.
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.