EU Telematics PIM _
 

Common European Single Submission Portal (CESSP)

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Home

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Human eSubmission

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Veterinary esubmission
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eSubmission CMB

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CMB Documents
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External Links

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Systems:

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Common Repository

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eAF

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CESSP

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eASMF
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ePMF
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CESP
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eSubmission Gateway & eSubmission Web Client

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Delivery file UI

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eSubmission Gateway

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PAM submission form

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PSUR Repository
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Industry access

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NCA access
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eCTD

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eCTD v4.0

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EU Module 1

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Introduction

The eSubmission Roadmap describes the concept of Single Submission Portal which will be created by integration of the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway. The EU Telematics Management Board has agreed that this single portal shall be built using the current CESP portal. This future system is currently referred to as the Common European Single Submission Portal (CESSP).

The first implementation project step, CESSP Phase 1, will deliver integrated human and veterinary Marketing Authorisation Application datasets for new marketing authorisation and extension applications. Following feedback from the UAT 1, a number of changes to the system have been proposed and to meet these additional requirements, the anticipated release date has now changed. It is expected that the first version of the system will be available for use by Q4 2018. Detailed announcements of the project milestones, training and any additional support information will be provided on this webpage.

News

25-10-2017

CESSP Q&A Document is now available. This document answers to your questions on the project and what the CESSP system actually is.

21-06-2017

A presentation on the outcome of the first ‘proof of concept’ UAT on CESSP is now available. This is a summary of the findings from the testing.

06-04-2017

CESSP Essentials presentation is now available. This presentation provides information on the CESSP project.

Statement of Intent on implementation of the CESSP project is now available. The CESSP will replace electronic Application Forms (eAF) for human and veterinary Initial and extension applications in 2018.

 

 

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