FAQs

After uploading my files via web based file transfer system (status is Completed and verified) the folders do not disappear (Remote Server files and folders) as shown in the demonstration but have to be deleted manually. Is there a problem with the submission?

If the delivery file is still visible your submission has not yet been processed and you should not delete anything from the folder.

Once the delivery file is no longer visible and you have received the confirmation emails the directory structure should be removed automatically. At this point all of the files have been uploaded. There is one known issue however when sometimes the empty directory structure remains visible , this just needs to be removed before you upload you next submission.

Are Clinical Trials received through CESP?

A number of agencies will accept clinical trials through the system. Please check the contacts section of the website for specific national requirements.

Are we required to provide the CESP submission number (the number of the downloaded xml file right?) in the cover letter and on the CD/DVD?

Correct, this will ensure that agencies will duplicate the submission in agency systems. Please refer to the contacts section for specific national requirements

Can the CESP system be used for national submissions?

Yes, it is the intention that the system could be used for all types of submissions. Please refer to the contacts section for specific national requirements.

Can we make submissions of multiple regulatory activities in one single CESP delivery?

While technically possible, this is not recommended. Not only will this make the delivery file metadata incorrect/incomplete, but it might also complicate the agencies’ internal processing of the submitted documentation.

Can we submit scanned hard copy files through CESP. If so, which option should we select as submission type for veterinary dossiers.

Yes, any type of electronic submission can be submitted through CESP which includes scanned PDF files, the "other e submission" option should be selected when creating the delivery file. Please refer to the contacts section of the website for any specific national requirements.

Can you please confirm that we are submitting eCTD or NeeS submissions at the sequence folder level (ie, including the sequence # folder)?

You should submit the submission using the same directory structure that is used on the CD/ DVD. The system places everything uploaded into a designated delivery folder when you upload the submission, the delivery file should not be contained within the folder structure but should be in the root of the remote server after you have uploaded your submission.

Currently electronic applications have to be provided with originally signed paper cover letters and applications forms in most countries. Are these letters still required?

Please refer to the contacts section for specific national requirements.

Do specific national requirements impact CESP submissions more than other national requirements? And how will you manage when several NCA will ask for the same?

The issue of national requirements are currently under review by the group, it is important to note that some agencies have a legal obligation to request a national requirement. Where practice and possible, national requirements will be provided electronically through CESP to meet these obligations. Please refer to the contacts section of the website for specific national requirements.

Do we still need to include the CESP Submission ID on the cover letter ?

Please refer to the contacts tab section for national requirements

Does the web-based option also provide confirmation emails from each agency?

Yes

File and Path name Length

Please note that file names and paths should not exceed 240 characters , in a few submissions users have prefixed the product / substance name to the file and path name , maximum length of file / path name in windows is 256 characters.

When naming your zip file we recommend to keep the name as short as possible. Please use the standard ASCII character set when naming all files and folders inside your zip file and also when naming the zip file.

Do not use any special characters. The following list is an example of the characters that are not permitted by the system: ~ ! @ # $ % ^ & * ( ) ` ; : / \ < > ? , [ ] { } ' " international characters such as ä , Ä , é, ö, Ö, ü, Ü, ß, &, æ, ç, û, are not permitted.

If special characters are used the submission is at risk of rejection by the recipient agency.

File Naming Standards

When naming your zip file we recommend to keep the name as short as possible. Please use the standard ASCII character set when naming all files and folders inside your zip file and also when naming the zip file.

Do not use any special characters. The following list is an example of the characters that are not permitted by the system: ~ ! @ # $ % ^ & * ( ) ` ; : / \ < > ? , [ ] { } ' " international characters such as ä , Ä , é, ö, Ö, ü, Ü, ß, &, æ, ç, û, are not permitted.

If special characters are used the submission is at risk of rejection by the recipient agency.

For NeeS or eCTD submissions, would we be sending the submission at a certain file/folder level, e.g., would submissions be sent at the sequence level or a level above?

This has been discussed within the POC group and agreed to see what companies submitted, we would suggest at sequence level for the POC.

How does NCA’s handle eSubmissions submitted by CESP - i.e. uses CESP data first and if this is invalid, then the posted submitted CD will be used?

Yes, the agreement of the NCA group is that the Cesp submission will be used first, if there are any problems with the submission a CD/DVD will be requested and the applicant will be informed of any issue with the cesp submission by the NCA.

How long does it take to be sent to the correct agency?

Submissions once uploaded to CESP are delivered (depending on size) usually within one hour. This may vary depending on the size of your submission and volume of traffic on the System.

How should we make a submission for a Worksharing procedure, or a Grouping procedure concerning multiple MAs?

Ideally, for a worksharing procedure or grouped variation covering multiple MAs, all eCTD and/or NeeS submissions for the products concerned should be provided in separate folders within one submitted zip file. If there are MAs not approved in all countries concerned by the procedure, this could be clarified in the CESP delivery file (in “Comments”).

If, for whatever reason, you have to make multiple submissions (e.g. for duplicate dossiers having different MAHs) ) for the same procedure, this should be clarified in the same fashion as above, in each CESP delivery file.

If the procedure is MRP, tick the RMS for the Grouping/Worksharing procedure. Tick the dummy RMS “ZZ” if you intend to submit something only to one or more CMS agency (e.g. when the RMS does not yet accept CESP submissions, or if you are sending a NeeS submission to a CMS agency only).

How to upload correctly through CESP

The correct steps to upload through CESP are as follows:

Create and download your delivery file
Log on to the CESP server using either the Web Transfer Client or using Sftp Client Software
Upload your Zip file first ensuring that the upload is fully complete before going to the next step, verify that the zip file is completely uploaded using the status panel of the Web Transfer Client or using the panel in the sFTP client.
Upload your delivery file.
An email will be received advising it has been received on the CESP Server and delivery receipts from each agency indicated by you in the delivery file will be emailed to the email address indicated on the delivery file.

If the Reference Member State is not particitpating in CESP but the Concerend Memeber States are. How do i submit ?

You can select the test agency indicated as "ZZ" in the RMS section, this will allow you to send the submission to the participating CMS agenies.

If we are to submit several sequences/submissions from different eCTD and/or NeeS/VNeeSs dossiers at the same time (e.g. submissions for different MAs or for an MA for which separate eCTD/NeeS/VNeeS dossier is used for different dosage forms or strengths), should we submit them in one or several CESP submissions?

If the documentation is relevant for the same regulatory activity, please submit all documentation in the same CESP submission even if it is in several NeeSs/VNeeSs/eCTD sequences. Inside the zip file you should create a separate folder for each dossier.

If the documentation concerns different regulatory activities, please make a separate CESP submission for each regulatory activity.

Is it necessary to inform authorities that sequences are uploaded via CESP upfront? Could you switch between CESP upload the sending CDs between sequences?

CESP is just another mechanism to deliver submissions, you can alternate sending of submissions either through CESP or on CD/ DVD if required, but participating agencies may require that all submissions be uploaded through CESP at some point in time.

Is there a recommendation for use like for FDA gateway when the size of the dossier is over a certain limit (e.g. example over 45 GB, USB drive is recommended for use)?

We have tested the system with uploads of up to 10GB. We do understand that it is possible for submissions to exceed this size. For large submissions the key issue I would assume would be the time that it takes to upload , from the user side , some organisations may have time out controls on browsers and other types of ftp clients.

Once the dossier is uploaded can it be viewed by the company?

No, CESP is purely a delivery system

Some agencies have a portal with electronic databases to fulfill when a variation for a national procedure is submitted. Is there a requirement for a parallel submission.

This is currently under review but the consensus so far is that if CESP is used for delivery with a correctly structured dossier including a electronic application form then no other action would be required

Some agencies have a portal with electronic databases to fulfill when a varitaion for a national procedure is submitted. In this situation are parallel submissions required?

CESP is purely a submission platform, tracking and electronic application form are provided either through national or EU systems.

We have been contacted by an NCA asking us to resubmit because the submission was technically invalid. No other recipient agency has reported this. Should we resubmit to all agencies, or just to the agency contacting us?

If the submission needs to be corrected, resubmit the corrected submission to all agencies that have received the invalid submission. Ensure to include a comment stating that this submission is a technically revised version of the previous submission (give CESP delivery number), submitted after technical invalidation by [agency]. Do not re-use the same CESP delivery file.

If the submission is technically invalid due to errors during transmission or previous sequences missing from the eCTD lifecycle, please contact the other agencies involved to determine if they are experiencing the same issues, and then resubmit only to the relevant agencies. Please inform the RMS or rapporteur of the issues experienced.

We want to make a CESP submission for an MRP dossier, but only to one or more CMS(s) and not to the RMS. For MR procedures, ticking an RMS is mandatory in the CESP. How should we handle this situation?

Tick the CMS in question in the CMS section and tick the dummy RMS “ZZ” in the RMS section.

If the submission is intended only to be delivered to the CMS (and not to the RMS), just tick the CMS in question in the CMS grid and tick the dummy RMS “ZZ” in the RMS section.

What should be entered into the procedure number field?

If you are submitting an actual submission you would enter the MR / DCP procedure number or in the case of a national submission the unique identifier for the product on the market e.g. license number.

What should you do if you have more agencies related to your submission than those involved in the current system ?

You can send in the submission via CESP for those agencies participating in the system as indicated on the CESP website, and you will need to send on a cd/dvd to all agencies who are not using CESP and are involved in the procedure.

Will parallel CD submission still be required?

In the event of a issue with a submission through CESP, the agency may request a cd/dvd copy.Please refer to the contacts section of the website for specific national requirements.

Will the validation of the application be by the system? Will the agency still do a validation? Won't this increase timelines if another submission needs to be submitted?

The system will not carry out validation, the agency will still validate the submission on receipt, but companies should carry out validation prior to submission. CESP is purely a delivery system. It provides a fast and efficient method of sending and receiving company applications. It is hoped that by providing a faster system than cd/dvd, errors in submissions can be identified and fixed in shorter time frames.

ZIP and Submission Guidelines

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

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FAQs / eSubmissions