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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