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Common European Single Submission Portal (CESSP)

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Systems:

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eAF

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CESSP

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eASMF
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ePMF
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eSubmission Gateway & eSubmission Web Client

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Delivery file UI

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eCTD

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eCTD v4.0

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EU Module 1

Paediatric submissions

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SPOR

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eSignatures

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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 Q1 2019. Detailed announcements of the project milestones, training and any additional support information will be provided on this webpage.

 

News

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

 

 

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