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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
Phone: +353-1-634-3801
Email: cesp@hma.eu
The CESP Portal will be offline this Wednesday 14th May for maintenance from 17:00 to 22:00 GMT+1.
Apologies in advance for any inconvenience.
Kind regards,
CESP Support
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.
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
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