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Human eSubmission

eSubmission CMB

Documentation

Projects:

Common Repository

eAF

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

eCTD

eCTD v4.0

EU Module 1

SPOR

eSignatures

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. It is expected that the first version of the system will be available for use by the end of Q1 2018.
Detailed announcements of the project milestones, training and any additional support information will be provided on this webpage.

News

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.

• CESSP UAT1 Result summary

06-04-2017

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

• CESSP Essentials

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.

• Statement of Intent (22-11-2016)