EU Telematics PIM _
 

Common European Single Submission Portal (CESSP)

_

Home

_

Human eSubmission
eCTD v3.2
eCTD EU M1 specification

_
Veterinary esubmission
_
eSubmission expert group
_

eSubmission expert group documents

_

External Links

_

Systems:

_

Common Repository

_

eAF

_

CESSP

_
eASMF
_
ePMF
_
CESP
_

eSubmission Gateway & eSubmission Web Client

_

Delivery file UI

_

eSubmission Gateway

_

PAM submission form

_
PSUR Repository
_

Industry access

_
NCA access
_

eCTD

_

eCTD v4.0

_

EU Module 1

Paediatric submissions

_

SPOR

_

eSignatures

_
_
_

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 Q4 2019. Detailed announcements of the project milestones, training and any additional support information will be provided on this webpage.

 

News

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.

Please join the webinar in the virtual meeting room on 7th of May at 10:00 CET: https://connect.ema.europa.eu/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.

05-02-2019

The CESP dataset Module Milestones have been published and can be found, below.

19-12-2018

The CESSP essentials project information has been updated and can be found below.

22-06-2018

Updated documentation related to CESSP Phase 1 - i.e. Q&A, CESSP essentials project information and UAT2 results summary - have been published.

Relevant documentation

Milestones

Contact us:

cesspproject@hma.eu

 

 

EMA
©1995-2019 European Medicines Agency | Disclaimer | For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here