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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
Routine maintenance of CESP to support important IT security upgrades has been scheduled between 17:00GMT and 19:00GMT Tuesday the 16th of April.
We do not anticipate major disruption to services during this window; however, some short periods of disruption to service may take place.
We apologise for any inconvenience caused.
The CESP Support Team
Due to the Easter holiday in Ireland, the online support desk will be monitored on Friday 19th April and Monday 22nd April 2019.
Please log all support calls via the online support desk which is available to all registered users.
Please find an update on the United Kingdom's withdrawal from the European Union ('Brexit') and how this relates to CESP.
Following the European Council meeting on 22 March 2019, the date for UK's withdrawal from the EU has been extended beyond 30 March 2019.
Based on the European Council decision, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood to be replaced by 12 April 2019 until further notice.
The decision makes clear that the UK remains a Member State for the duration of the extension and will retain access to CESP alongside other EU telematics systems.
Companies are advised to continue their preparedness for the UK’s withdrawal as per previous guidance.
Due to a public holiday in Ireland, please log all new support calls via the online support desk which is available to all registered users.
CESP will be online and available for deliveries.
The EU Telematics Group and the European Commission are working on the assumption that the UK will leave the EU as of 30 March 2019 and will become a third country thereafter. Therefore, as of 30 March 2019, the UK will no longer be able to access a number of EU Telematic systems and applications supporting the approval and safety monitoring of medicines.
This includes access to the Common European Single Submission Portal (CESP) which will be closed to National Agencies in the UK.
Please be advised that delivery files generated prior to the 30 March 2019 and, include National Agency’s from the UK as a recipient and, then submitted for delivery after the 30 March 2019 will fail. Such submissions after the 30 March 2019 must be resubmitted with a valid EU delivery file, i.e. does not include a National Agency from the UK as a recipient.
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.
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.