Cesccra2 zip

We ask that once the issue has been resolved that the user closes the call. To Add a new support call select new support call, provide some brief details.

Please make sure to provide the Delivery file Number and submit the support call. If you are a standalone User and wish to upload for Non Commercial Use on your own behalf, register here. Once registered you will receive credentials to access the portal to your registered email address. General CESP Training is available to all registered users via our training menu once logged into the system. Training on demand videos are available and you can also sign up to our free online weekly live demonstrations.

We encourage all users to attend training before using the system. Use the 'forgot password' option on the main website screen , enter in your username, select 'send instructions' and an email will be sent with details on how to change your password.

CESP 1. CESP 2. To allow CESP web transfer client to run effectively please apply the following security settings to your Java client. All well supported zip software packages that can create a. Please note CESP only accepts. Your browser is no longer supported.

Please upgrade your browser. Can a delivery file be created outside of the system in an internal company system and be used to upload information?

Can I change the name of the Delivery File? No, the delivery file name is unique to that delivery and is used by the system to track and send submissions to agencies. Any change to the name of the file will result in a failed transfer, delivery files should also not be reused or renamed. Can the delivery file be edited?

No, the delivery file is unique to that delivery and should not be editied. Can we make submissions of multiple regulatory activities in one single CESP delivery? Can you create and save the xml file some weeks before submission? Concerning the MAA Numbers in the second step of creation of the delivery xml file. Is it possible to add here multiple MA numbers? Yes, the section allows the entry of multiple MAA numbers, using a semi-colon ; to separate them.

This section is non mandatory. Delivery Files. For the product information, for eCTD, would it be possible to refer to the eu-regional xml file instead of preparing a. Yes, you can indicate the file name in the box provided. How do I know the Submission has been delivered? How to Create a. How to Create a delivery file. How to Upload the submission. If the delivery file is prepared in advance can it be viewed before it is submitted to ensure it is correct?

You can view the delivery file at any time by downloading and opening the file in a browser, or through an editing tool such as notepad. It is important to note that a delivery file should NOT be edited by the user and the file name should NOT be renamed.

On the delivery file, can we submit paper dossiers as well. If so, which option should we select as submission type for veterinary dossiers? CESP allows all types of electronic submissions to be uploaded. No other recipient agency has reported this. Should we resubmit to all agencies, or just to the agency contacting us? If resubmitting only to the NCA with problems, please also give clear information as above.

How should we handle this situation? What happens if you rename the delivery file? Your submisison will not be delivered if the delivery file name has been modified. What is the Delivery Log Feature? What should a Company Administrator see in Delivery Tracking?

If you are a Company administrator you will see all deliveries for your companies and users. What should a Standard User see in Delivery Tracking. If you wish to resubmit through CESP you would need to create a new delivery file and indicate through the comments section the reason for the submission. You can select the test agency on step two and the agency that you wish to deliver the submission into.

You should also raise a support call through the online support desk to allow us to investigate this issue. The CESP system is a delivery system and does not interpret any information in the submission or application form.

XML Delivery file — Is this considered the submission file? Can you confirm that it is the last folder to be dragged into the Remote Server Files and Folder pane? If a user inadvertently brings over the XML file first, what are the implications? If you drop this over before the submission, the submisison will sit on the server until the next delivery file is dropped on to the cesp server and it would then deliver the previous submission with that delivery file.

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.

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?

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. 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? 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? 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. Please refer to the contacts tab section for national requirements.

Does the web-based option also provide confirmation emails from each agency? File and Path name Length. 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. If special characters are used the submission is at risk of rejection by the recipient agency. File Naming Standards. 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 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?

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. How do i submit? Is it necessary to inform authorities that sequences are uploaded via CESP upfront?

Is there a recommendation for use like for FDA gateway when the size of the dossier is over a certain limit e. 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.

What should be entered into the procedure number field? What should you do if you have more agencies related to your submission than those involved in the current system? Will parallel CD submission still be required? 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. ZIP and Submission Guidelines.

Is a new account required when a user returns from leave after more than 12 months? Brexit Update - 27th March Can we log out of CESP even if files are still in the process of transferring — or should we wait for everything to transfer before closing the CESP application? If you are delivering files through the browser or ftp client you can minimise the windows but the connection must remain active during the transmission, It is important to make sure all files are transferred completely before copying over the delivery file, otherwise the complete submission will not be delivered.

EMA are currently active in a number of projects and due to resource limitations are not actively participating in the project. Do these specific national requirements really impact CESP submission more than other national requirements?

Some agencies are legally bound to request additional information in respect of applications. We are looking at each of these requirements to see if they can be incorporated or delivered through CESP on a case by case basis. Do we get an acknowledgement for successful sending? Yes, an email is sent to acknowledge it has been uploaded to the CESP server and a confirmation email from each agency that the submission was delivered. Please note, the questions might be different from that of your examiner Only some words has been changed from the original one.

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