EU Telematics PIM � _
 

Paediatric submissions

_

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

eASMF
ePMF
CESP Portal
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

_
PSUR Repository

Industry access

NCA access
_

Projects:

eCTD v4.0

DADI (eAF)

Paediatric submissions

SPOR

eSignatures

_
_

Previous news

19-11-2020

A new version of the eSubmission Gateway XML delivery file is now available

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced multiple changes for Paediatric submissions by completely transforming the delivery files for these types of submissions as we are preparing to extend the Common Repository to contain Paediatric submissions.

Users should note that the delivery files created prior to the new release will not work after the go live.

 

 

 

EMA
European Medicines Agency ©1995-2024 | Disclaimer | For technical support, please visit the EMA Service Desk (ServiceNow) 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