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.

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?

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 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

Brexit Update - 27th March 2019

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.

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.

Could you please remind us why the EMA are not involved in the CESP more formally?

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? And how will you manage when several NCA will ask for the same?

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.
Please refer to the contacts section of the website for any specific national requirements.

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.

Do you expect all agencies to implement CESP when it ‘goes live’ and is there going to be any mandate so that all of them do use it.

No, it will be optional for agencies to participate in CESP.

Glossary of Terms

CESP	Common European Submission Portal
EDQM	European Dictorate for the Quality of Medicines & Healthcare
GxP	GxP is a general term for Good (Anything...) Practice quality guidelines and regulations.
PSUR	Periodic Safety Update Report
CEP	Certificate of Suitability to the monographs of the European Pharmacopoia
OCABR	Official Control Authority Batch Release
CTA	Clinical Trials Application
CAP	Centrally Authorised Products
CHMP	Committee for Medicinal Products for Human Use
PRAC	Pharmacovigilance Risk Assessment Committee
CCC	Clinical Competency Committee
WHO	World Health Organisation
GMP	Good Manufacturing Practices
MAs	Marketing Authorisation
MP	Manufacturing Procedure
COEN	Centre of Exceellence in Neurodegeneration
NBOG	Notified Body Operations Group
IVMP	Immunological Veterinary Medicineal Products
MRP	Mutual Recognition Procedure
DCP	Decentralised Procedure
CP	Centralised Procedure
eCTD	Electronic Common Technical Document
NeeS	Non-eCTD electronic Submissions for Human Medicinal Products
vNeeS	Non-ectd electronic Submissions for Veterinary Medicinal Products
MAA Number	Marketing Authorisation Application Number
RMS	Reference Member State
CMS	Concerned Member State

How do I submit in case of a "RMS- only" DCP with no CMS?

You can select the ZZ agency which is a test agency that can be used for this purpose.

How do you deal with Agencies not involved currently?

You can provide submissions on cd/dvd to those agencies not currently participating. If you are submitting a DCP/MRP and the rms is not listed, you can select the test agency (ZZ) to allow you to submit the dossier to the CMS participating in CESP.

How many characters can a username have?

A username is made up of the last name and first letter of the users first name.

This should not be more than 14 characters in length.

How to Contact CESP Support

Please contact CESP Support for any information in relation to CESP via the Online Support desk. This is monitored daily (Monday-Friday). 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.

How will issues be handled, via CESP email or NCA contact?

Through the standard NCA contact point , CESP email should NOT be used for ongoing communication with an individual NCA. Technical issues can be directed to cesp@hma.eu or through the online suuport desk for registered users.

How will the implementation of CESP impact other national portals such as the MHRAs and the IMBs? Will the national portals be replaced or will CESP be used in addition to these?

It is envisaged that for agencies participating in CESP with national portal that each agency will review their requirement for a national system once the system is fully operational.

If a user inadvertently brings over the sequence folder twice, would they be able to delete the duplicate files?

Yes, as long as the delivery file has not been moved to the cesp server.

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 another mechanism to deliver submisisons. The use of CD/ DVD or CESP is at the discretion of the MAH / Agency.

Is there a limit of upload size?

No, we have tested this system up to submissions with a size of 10gb. Speed of uploading is the main issue but this is dependent on your available bandwidth.

Where bandwidth is limited a suggestion would be to start the upload of the submission out of normal working hours and once uploaded you can then upload the delivery file the following day to initiate the transfer to the agencies.

Is there any thought of implementing an API to allow systems to automate creation of the XML file and transmission?

We have looked at the possibility of proving and API / web service, however it was agreed at the last Industry/ Agency meeting that this requirement be placed on hold until further notice.

It is experienced that new Agencies have made their own preferences regarding CESP. But the decisions from the CESP team has to be followed right?

The participating agencies in the CESP project have a monthly online meeting to discuss areas and topics that require clarification. The consensus view is always taken with the exception where the consensus contradicts national legislation.

Login details not working

If you cut and paste your username and password from the email sent when you register, the paste function adds a space at the end of both the username and password , delete these spaces which will allow you log into the system.

Please note you should always reset your password on a regular basis.

MHRA Clinical Trial Submission Guidelines

If you are a first time CESP user and wish to setup up an Organisation/University or Trust to manage multiple users on the system, register here

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.

Please view the MHRA Clinical Trials Guidelines document here

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.

What will happen with the other Portals such as MHRA?

Each agency participating in CESP will be reviewing the functionality of their portals.

When do files begin to officially transfer via CESP (to the health authorities)? We notice that the bottom pane reflects files processing – we are unclear as to whether these files are actually transferring or whether the actual transfer begins after the XML delivery files is dragged over?

Files begin to transfer as soon as the xml delivery file is uploaded to the CESP server. This is why it is important to copy your ZIP file first. Once the XML is uploaded the files immediately begin to distribute to the required recipients.

Why is it necessary to indicate the RMS and CMSs?

The delivery file and system are not currently integrated with any other system that provides that information.

Will agencies be able to use CESP to communicate with Applicants i.e. sending approval documents?

No, currently the system provides one way communication but it has been raised as a possible requirement for a later stage of the project.

Will files be received by MAHs as well as sent?

Currently the system only provides MAHs the ability to upload information , no download capbaility is currently enabled.

Are security certificates required to send submissions?

Security certiificates are not a requirement at present.

As administrator you fill in the password, can a user change this themselves later on?

Passwords can be changed by the user by selecting the "forgotten password" option from the main screen.

Does the Company Administrator see the User password in plain text and is it possible to modify it?

The Company Administrator can reset the password if required , but the best approach changing a password for a user is for the user to submit a "forgotten password" request from the main screen and they can then set their own password which is then encrypted in the database.

How to change a password?

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.

I have noted that service runs on http protocol. Are there any plans to use SSL (https) to encrypt password from client to the server?

CESP 1.0

The website itself runs on HTTP, but the web based upload runs over secure HTTPS and sFTP

CESP 2.0

CESP 2.0 runs over Secure HTTPS and file uploads run over secure HTTPS and sFTP

Regarding Firewall set-up, we must open port 22?

Port 22 must be available when using the sFTP client.

Regarding the FTP client setup are there any requirements or set up instructions for our IT department?

The ftp client software must have secure FTP capability and your firewall must allow traffic over port 22.

Will the FTP that is set up be secure (SFTP)?

The protocol for the system is SFTP.

Can a specific configuration be set up for my company to allow access to the system?

Due to the short timeframe it would not be feasible to set up a specific configuration for your company outside of what is currently available. You can use the web interface for ftp transfer, when the system goes into full production we can work with your IT department to put in place a solution that meets your specific requirement.

Can you define the difference between an Administrator and a Company Administrator again?

There are three roles - CESP Support Desk Administrator, Company Administrator and User. The company administrator and user are specific roles to the company configured on the system, with the company administrator having permission to setup and manage users for their company.

The CESP Support Desk Administrator is responsible for approving a company registration request and setting up the company administrator on the system.

How do satellite offices get set up as company administrators?

If the main office has a company administrator set up, it is possible for this company administrator to create additional company administrators in satellite offices.

Is it possible to carry out a Test Submission?

Yes, to test the system I would recommend creating a delivery file for a National Submission and indicating “ZZ” as the target agency, we can then confirm the delivery of the package.

Is there a limit to the number of Company Administrators? We have colleagues in each country and they would need their own Administrator?

A company can have one or more company administrators. The support desk will validate the first company and the first company administrator. Once set up the company administrator can set up any additional company administrators and standard users.

Is there a limit to the number of users from a company?

No there is no limit.

Should the client FTP software, CuteFTP or Filezilla, be installed in-before-hand prior to the Training?

It is not necessary for the Training, however, we recommend to do the installation as soon as possible in order to solve any issues you might run into during installation.

What are Company Codes?

CESP 1.0

A company code in CESP is a unique code generated by the system to allow a company administrator set up additional users for that company. This code is provided to each user that they wish to set up on the system and when entered places the request in the company administrator request folder.

CESP 2.0

Company Codes do not exist in CESP 2.0. All Users must be created by a Company Administrator.

Do we need to install both CuteFTP or a Filezilla alternative? Which one is recommended ?

Only one is required to be installed. We do not recommend one over the other.

Does CESP work on a MAC?

Yes CESP is compatible with MAC.

Web Browser : Safari v6 or higher is supported.

FTP: FTP client (MAC OS X Version 10.6.8 or higher).

Zip Software: When users create their zip files on a MAC queries are often raised regarding the .DS_Store file and __Mac_OSX folder which the MAC OS saves inside zip files.

These MAC files and folders inside the zip can cause confusion to PC users. It is recommend that MAC users create zip files without these proprietary MAC files. This can be done natively from the MAC command line or by using Third Party Zip Applications such as "YEMU Zip" or similar zip software available from the App Store.

I001 - WinSCP issue and Invalid Checksums on eCTD submissions

Issue: An agency reported that the checksum on validation of an eCTD submission was incorrect when received. On investigation it was found that the index.xml and the e-regional.xml files had been modified during transfer by the client transfer software in this case WinSCP by placing spaces and soft carriage returns into the files, this was due to the configuration of the client software and not the CESP system. The software was set to automatic and specific file types were set to transfer in plain text mode.

Resolution: Open WInSCP software and select the Options>>Preferences window and then select Transfer and edit. Set the transfer mode to Automatic and remove the files types from the “Transfer following files in text mode” box that you wish to be transferred in their normal format e.g. “*.xml”, this will resolved this issue.

This issue could also be in other client software packages please review the configuration of the client software that you are using.

Is it possible to use Core FTP Lite?

Yes we have tested connectivity with the tool from a default install and it has operated with the test files. Some client software packages require additional configuration to ensure that they transfer files correctly.

Is the use of the FTP client for performance reason for large dossiers?

Yes, users have more control and visibility over the upload

We would like to access CESP via a Web Browsers with Java enabled. Is there a specific Java version required?

CESP will operate best on most recent versions of Java

What are the requirements for using CESP

A user account with login details is required to access the Portal.

Browser Requirements are:

Firefox v25+, Chrome v8+, Safari V5, Apple v6+ or Internet Explorer V10+

What FTP client can be used?

Any ftp client that supports Secure FTP can be used on the system.Some client software packages require additional configuration to ensure that they transfer files correctly.

What Internet browsers are compatible with CESP?

CESP 1.0 Requirements

Internet Exploere 8+, Google Chrome and Mozilla Firefox.

CESP 2.0 Requirements

Internet explorer 10+, Firefox v25+,Chrome v8, safari v5, apple v6+ (we support all of these however we recommend you install the latest version available)

Note:If using CESP 2.0 please do not run your browser in Compatibiltiy Mode.

What settings are required for Java when using CESP

CESP 1.0 Requirements

To allow CESP web transfer client to run effectively please apply the following security settings to your Java client.

In the Java control panel, set the security level to High and add https://cesp.hma.eu/ to the exception site list.

In Internet Explorer add https://cesp.hma.eu/ to the trusted sites.

If using Internet Explorer 11 add https://cesp.hma.eu in the compatibility view settings.

CESP 2.0 Requirements

CESP 2.0 Does not require Java. If making the transition from CESP 1.0 to CESP 2.0 and are an Internet Explorer 11 user, remove https://cesp.hma.eu from compatibility view settings.

What Zip File Software is supported?

All well supported zip software packages that can create a .zip file can be used to create a CESP submission.

Please note CESP only accepts .zip files and not proprietary zip formats. (please refer to our zip and submission guidelines available under the FAQ's)

Windows Users: Most common software packages include

Windows Compressed Folders.
WinZip
WinRaR
7-Zip

MAC Users: When users create their zip files on a MAC queries are often raised regarding the .DS_Store file and __Mac_OSX folder which the MAC OS saves inside zip files.

These MAC files and folders inside the zip can cause confusion to PC users. It is recommend that MAC users create zip files without these proprietary MAC files. This can be done natively from the MAC command line or by using Third Party Zip Applications such as "YEMU Zip" or similar zip software available from the App Store.

Online Training Guide

CESP 2.0
An On Demand Training module is available to all CESP 2.0 users, this contains the Latest Video Guides and Training documentation and will be updated on an on-going basis.

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FAQs