News
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
Milestones (Updated 05.06.2019)
CESP dataset Module Milestones
Draft version of the updated DES schema published |
Done |
Webinar on the use of XSD (H+V) |
Done |
Coding of the CESP application dataset module finalised |
Q4 2019 |
Final version of the updated DES schema published |
Q4 2019 |
Approval from the project team to start UAT 3 (User Acceptance Test) |
Q1 2020 |
Call for interest for UAT 3 published |
Q1 2020 |
UAT 3 started |
Q1 2020 |
Draft guidance documents published |
Q1 2020 |
Training for regulators in collaboration with the EUNTC Telematics Curriculum started |
Q1 2020 |
Training for industry users started |
Q1 2020 |
Release candidate of the application dataset module developed |
Q2 2020 |
Pre-registration for CESP Application Dataset Module opened |
Q2 2020 |
Final guidance documents published |
Q2 2020 |
CESP application dataset Go-live / Start of transition phase |
Q2 2020 |
Mandatory use of CESP application dataset module (eAF MAA human and veterinary) |
Q4 2020 |
Contact us:
cesspproject@hma.eu
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