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Common European Single Submission Portal (CESSP)

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Introduction

CESSP is a programme contained in the eSubmission programme which will eventually result in the implementation of the Common European Single Submission Portal.

The ongoing project CESSP Phase 1 is the first milestone which will deliver a new tool for creation of Marketing Authorisation Application forms with the goal to replace the relevant PDF forms with a web based interface and to enhance the current PDF based electronic application form. This will cover human and veterinary application forms for new marketing authorisations and extension applications. The system was earlier referred to as the CESSP but will be implemented within the current CESP as a new module called CESP Application Dataset Management Module (CESP Dataset Module). However, the project is referred to as CESSP Phase 1.

The main objective of CESSP Phase 1 is to provide a modern user interface with a flexible technical platform for the future. This step will enable future enhancements which would not be possible using the current PDF technology.

CESSP Phase 1 is planned to be followed by the addition of the Variation and Renewal form to the CESP Dataset Module.

It is expected that the first version of the system will be available for use by end of June 2020. The main reason for this delay is related to additional requirements to be implemented, resources having been diverted to other projects and limitations within the project budget.

Contact us: cesspproject@hma.eu

News

06-10-2020

The eSubmission Roadmap describes an initiative called Common European Single submission Portal which was due to deliver a single submission channel for all European submissions with integrated application forms. The delivery was planned in multiple phases. The first phase was to deliver web-based application forms for initial Marketing Authorisations for Human and Veterinary domains. These forms were to be followed by subsequent releases of variation and renewal forms and finally, an integration of the eSubmission Gateway and the CESP Delivery Portal.

The CESSP Phase 1 project was expected to deliver the application forms for initial Marketing Authorisations for Human and Veterinary as a replacement of the EMA hosted PDF format electronic Application Forms (eAFs). However, the project has faced implementation challenges and budgetary constraints and a decision has been taken to close this project. Please notice that stopping CESSP Phase 1 does not affect operation and maintenance of the CESP delivery portal.

More details on the next steps will be provided on the eSubmission website as soon they are approved by the relevant governance bodies.

The project team would like to thank everyone who has participated in this project throughout the years, with dedication and great input, and we would like to assure you that we will pass on the results already achieved to see how they can be useful in the future approach.

11-03-2020

The milestones for the CESSP phase 1 project have been updated and can be found below.

05-06-2019

The milestones for the CESSP phase 1 project have been updated and can be found below.

03-06-2019

A webinar providing an update of the CESSP phase 1 project (converting the current eAFs MAA human and veterinary into web based forms) will be held on 5 June 2019. This webinar is aimed for Regulators and instructions on how to connect have been sent out by email to representatives of National Competent Authorities.

23-05-2019

The presentation and recording from the webinar providing an update to Industry about the CESSP phase 1 project held on 7th May 2019 is now available. Questions and answers from the webinar will be added to the CESSP Q&A document.

15-04-2019

A webinar providing an update of the CESSP phase 1 project (converting the current eAFs into web based forms) will be held on 7 May 2019 from 10:00 to 11:30 CET. This webinar is aimed for applicants (from pharmaceutical industry). A separate session aimed for regulators will be be organised in near future.

Please note that participation in this webinar is on first come first serve basis as the maximum capacity of the virtual meeting room is limited to 200 participants. If multiple users from your organisation are attending, please share the connection with your colleagues.

The webinar will be recorded and the recording will be made available on the CESSP webpage after the webinar.

How to login is availble here.

10-04-2019

The slides from the CESSP XML schema training held by the Network Training Centre are now available.

15-03-2019

The final draft versions of the new XML schemas for the human and veterinary MAA forms that will be used in CESSP phase 1 are now available. Please provide your comments on the XSDs to cesspproject@hma.eu by 30th of April 2019.

And

The Network Training Centre is organising a webinar on utilising the upgraded XML schema of the initial application forms (eAF MAA human and Vet) to automate application data import into IT systems. The session will be held on 27th March 2019 at 10.30am CET. All relevant NCA staff is encouraged to register for the training on the NTC platform here.


Relevant documentation

Contact us: cesspproject@hma.eu

 

 

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