FAQs

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 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.

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FAQs / General