FAQs

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

At present there is no significant requirements to provide this functionality. The development team received a request to review the possibility of companies creating delivery files internally from within their organizational systems. This can be achieved but would require development work on both the Industry and CESP systems. It was agreed at one of the Industry/ Agency meeting that this requirement be placed on hold until further notice.

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?

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 you create and save the xml file some weeks before submission?

Yes, the xml file can be created any time, however it is important to note that the xml file cannot be reused or renamed. The only time a delivery file can be reused is if a rejection email is received as it is non-compliant with our zip and submission guidelines and you are requested to re-upload your 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

A Delivery file cannot be reused or renamed, they are unique to the submission you are currently uploading. Each submission (even for the same product to the same agency) requires a new delivery file.

If you have incorrectly uploaded a submission and wish to resubmit the submission again , you must create a new delivery file.

For the product information, for eCTD, would it be possible to refer to the eu-regional xml file instead of preparing a .txt document?

Yes, you can indicate the file name in the box provided.

How do I know the Submission has been delivered?

Select deliveries, delivery tracking from the menu on the left. Search for the submission id number. Click on the id number and it will show the time it was delivered to each of the agencies.

Also an email is sent advising the submission has been uploaded to CESP. An email will then be sent once the submission is delivered to each of the Agencies in the delivery file.

How do I know the submission has been rejected by CESP

If a submission is uploaded incorrectly and does not meet our zip and submission guideline, an email will be sent advising it has been rejected and you will be requested to re-upload the submission in accordance with our guidelines.
This can also be seen from our delivery tracking menu when the delivery status tab is selected as Rejected.

How to Create a .zip file

All submissions should be uploaded as a .zip file. Please check our zip and submission guideline to ensure all submission detail is contained in one zip file - https://cespportal.hma.eu/Announcements

Submissions uploaded incorrectly will be rejected and an email will be sent advising to re-upload according to our zip and submission guidelines.

How to Create a delivery file

Please refer to our Training on demand videos available on the CESP Portal

How to Create a Submission to Upload via CESP

A submission is made up of one zip file containing all documentation and one delivery file.

How to Upload the submission

Please refer to our Training on demand videos available on the CESP Portal

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.

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 still mandatory to select a RMS in order to select CMS?

For DCP/ MRP you must select an RMS. If the RMS is currently not participating in CESP you may select the test agency "ZZ" option for the RMS to allow you to proceed with the delivery for the CMS's.

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.

MAA Numbers in the second step of creation of a delivery file: What should be entered in this field in case of initial MAAs where no MAA is yet available?

Please enter "N/A" for this type of submission

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. It does not distinguish between vNeeS and PDF files in a folder.

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

Unless you have clear indications that point to the NCA contacting you having internal problems with the submission, then resubmit to all agencies that received the same submission. In this case, ensure to include a comment stating that this submission is an exact copy of the previous submission (give CESP delivery number), re-submitted by request of [NCA], and that if the NCAs have received the previous submission in full, then this resubmission can be discarded.

If resubmitting only to the NCA with problems, please also give clear information as above.

We have been contacted by an NCA asking us to resubmit because the submission lacked working documents, product information fragments, or other files not part of the eCTD sequence/NeeS/VNeeS and not relevant to all agencies. Should we resubmit to all agencies, or just to the agency contacting us?

Send it only to the agency asking you to resubmit. Include a comment stating that this is an exact copy of the previous submission (give CESP delivery number), now with the requested working documents/PI fragments/missing files.

If the missing documents concerns all NCAs, please resubmit to all and give the same clarifying information as a “comment”.

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 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?

This is similar to delivery tracking, however here we can view delivery files that have been created but not yet uploaded.

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 are a standard user and either created or uploaded the delivery file it will appear on your tracking list

What should an applicant do in case we submit a MRP and one NCA doe not receive/download the sequence correctly.

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.

Why is it necessary to cross the RMS and CMSs, this info should be known?

The CESP system is a delivery system and does not interpret any information in the submission or application form. Indicating the RMS / CMS on the delivery file allows the system to deliver the package to the agency.

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?

The delivery file (cesp_submission_xx.xml) should be the last file to be dropped to the cesp server. 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.

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FAQs / Delivery Files