EU Telematics PIM _
 

Common European Single Submission Portal (CESSP)

_

Home

_

Human eSubmission

_
Veterinary esubmission
_

eSubmission CMB

_
CMB Documents
_

Documentation

_

Projects:

_

Common Repository

_
CESP
_

eAF

_
eASMF
_
ePMF
_

eSubmission Gateway & eSubmission Web Client

_

Delivery file UI

_

eSubmission Gateway

_
PSUR Repository
_

Industry access

_
NCA access
_

eCTD

_

eCTD v4.0

_

EU Module 1

_

eSignatures

_
_

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. 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

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.

 

 

EMA
©1995-2016 European Medicines Agency | Disclaimer | For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu