EU Telematics PIM _
 

eSubmission

_

Home

_
Upcoming meetings - NEW
_

Human eSubmission

_
Veterinary esubmission
_

TIGes

_
TIGes Documents
_

Documentation

_

Projects:

_

Common Repository NEW

_
CESP
_

eCTD

_

eAF

_
eASMF
_

EU Module 1

_

eSubmission Gateway and eSubmission Web Client

_

eCTD NMV/RPS

_

eSignatures

_
_

Introduction

For human medicinal products in the context of the International Conference on Harmonisation (“ICH”) , an electronic exchange standard for the submission of regulatory information by applicants for marketing authorisations for medicinal products to the relevant competent authorities has been developed.

Based on the ICH Common Technical Document (CTD), the ICH M2 Expert Working Group has developed the electronic CTD (eCTD) Specification and released version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and completes it with the European Module 1.

In addition to the continued development and maintenance of the electronic submission standards, and in order properly to implement the eCTD from the perspective of the EMA and National Competent Authorities, there are a number of prerequisites. These include development of the necessary business processes to receive and handle electronic submissions (particularly the eCTD); development of policies particularly those with regard to electronic archiving; and development and implementation of an appropriate technical infrastructure and implementation of systems. Most notable here is the requirement for a tool that will enable Competent Authorities that choose to implement it to receive, validate, store and make available for review marketing authorisation applications and supporting documents submitted electronically by applicants using the eCTD (commonly known as the European Review System or EURS).

For veterinary medicinal products, esubmission guidance has also been developed.

These different initiatives can be encompassed within the general term 'electronic submission implementation'.

All comments and feedback on the content of this website should be sent to esubmission@ema.europa.eu.


_

What's New

_

04-04-2014

The following National Competent Authorities are now ready to receive Centralised Procedure submissions via the Common Repository only:

  • Estonia
  • Iceland
  • Liechtenstein
  • Slovenia

The above mentioned agencies will no longer accept Centralised Procedure submissions on CD or DVD or via CESP. This will apply to all types of Centralised Procedure eCTD procedures, including ASMF submissions related to centrally authorised products submitted in eCTD format. More information is available here

05-05-2014

Webinar on the use of the eSubmission Gateway/Web Client for Veterinary submissions

The EMA are hosting a webinar on 24th of March 2014 at 13.30 UK time to provide an overview detailing how Marketing Authorisation Holders can send submissions via the eSubmission Gateway. The webinar will describe the registration process and provide guidance on how to send all types of Veterinary submissions.

Webinar on the use of the eSubmission Gateway/Web Client for Referral procedures and Paediatric submissions

The EMA are hosting a webinar on 24th of March 2014 at 15.00 UK time to provide an overview detailing how Marketing Authorisation Holders can send submissions via the eSubmission Gateway. The webinar will describe the registration process and provide guidance on how to send all Referral and Paediatric submissions.

If you would like to participate in one of these online sessions please email natasha.brown@ext.ema.europa.eu. Places will be allocated on a first come first served basis.

03-03-2014

New Common Repository launched on 28 February 2014.

The introduction of the Common Repository in February 2014 will enable National Competent Authorities (NCAs) to search, browse and download centralised procedure eCTD submissions for human products. The introduction of this solution will reduce significantly the time required for receiving and validating incoming applications and will ensure continuous and immediate access to up-to-date dossiers.

28-02-2014

The eSubmission Gateway and eSubmission Web Client user guidance documents have been updated and are available here

14-02-2014

Regulatory information - Use of eSubmission Gateway and Web Client extended to new procedure types from 1 April 2014

From 1 April 2014, the European Medicines Agency (EMA) will extend the use of the eSubmission Gateway and Web Client to all referral procedures, veterinary medicines submissions and paediatric submissions. This will allow companies to submit these applications to the EMA securely over the internet thereby improving efficiency and decreasing costs for applicants. The Agency launched the electronic submission channel eSubmission Gateway in 2012 for all types of electronic Common Technical Document (eCTD) applications for human medicines. The eSubmission Web Client was launched in January 2013 to complement the Gateway and is aimed at applicants with lower transmission volumes.

The use of the eSubmission Gateway or Web Client will be mandatory for all eCTD submissions through the centralised procedure from 1 March 2014. Applicants who wish to use the eSubmission Gateway or Web Client need to register on the EMA’s eSubmission website. Applicants who have registered and previously used the Gateway or Web Client for eCTD submissions for the centralised procedure or PSUR single assessment (PSUSA) procedure submissions do not need to register again. Submissions on physical media (CD/DVD) for referrals, veterinary submissions and paediatrics will continue to be accepted as an alternative method for the time being. However, it is essential that applicants only use one method of submission and do not submit duplicate submissions with a physical media (CD/DVD) Eudralink as this might lead to negative technical validation and cause a delay in the processing of the application. Applicants are invited to register to use the eSubmission Gateway or Web Client solution as soon as possible.

12-02-2014

eSubmission Gateway Webinar – 24th of Feburary 2014 at 12.00 UK time

In the view of the mandatory use of the eSubmission Gateway/Web Client from 1 March 2014 the EMA are hosting a webinar to provide an overview detailing how Marketing Authorisation Holders can send submissions via the eSubmission Gateway. The webinar will describe the registration process and provide guidance on how to send all  submission types including ASMFs.

And

The 2014 Meetings calendar has now been updated with the dates of the EU Telematics Management Board (EU TMB), Telematics Enterprise Architecture Board (TEAB), and IT Directors Executive Committee (IT DEC) meetings for the whole of 2014.

  • The next CCG meeting is 19th of Feb via teleconference
  • Common Repository implementation group (CRIG) will meet via teleconference on 25th of Feb

Once the reorganisation of esubmission is complete additional meeting dates will be published.

Please note: Occasionally meetings may be cancelled due to unforeseen circumstances. We recommend you check this page on a regular basis which will show if any meetings are cancelled.

06-02-2014

New versions of the electronic application forms and release notes and schemas have been released and can be found here

27-01-2014

New versions of the MAA - Vet electronic application form, release notes, and schemas have been released and can be found here

23-01-2014

The multi media webinar "How to request additional terms in eAF" is now available and can be found here

17-12-2013

Information relating to the electronic submission of Active Substance Master Files to the EMA and to Europe is now  available under eASMF

13-12-2013

The EMA are hosting a series of weekly webinars to assist users of our eSignature solution. Please see the dates of forthcoming webinars for 2014 below. The sessions start at 11am for up to 60 minutes.

 If you would like to participate in these online sessions please email natasha.brown@ext.ema.europa.eu Places will be allocated on a first come first served basis.

Date

Time

5th March

11:00-12:00

29-11-2013

Draft HMA eSubmission Roadmap

The draft HMA eSubmission roadmap (for consultation ) is available here

And

An eAF defects and workaround solutions document is available and can be found here

And

A new Common Repository is set to be launched in January 2014. For more information, click here

11-11-2013

TIGes Harmonised NeeS Guidance

The TIGes Harmonised NeeS guidance document version 4.0 can be found here and Release notes here

05-11-2013

The Slides from the EMA Gateway Webinar on the eSubmission of PSURs have been updated and can be viewed here

01-10-2013

The EU Change Request Tracking table has been updated and is available here

19-09-2013

Webinar on the use of the eSubmission Gateway

This recording of a recent webinar is aimed at all applicants submitting PSUR Single Assessment submissions in eCTD or NeeS format through the eSubmission Gateway and the Web Client. This session covers topics from registration and necessary configurations to the filename convention, and the receipts and acknowledgements the applicant will receive upon submission via the Gateway/Web Client. You can view the webinar by clicking here.

30-08-2013


New versions of the electronic application forms and release notes and schemas have been released and can be found here

And

The eCTD Validation Criteria has been updated, The TIGes Harmonised eCTD guidance version and Release notes have also been updated and can be found here

16-08-2013

Training sessions on the use of the eSubmission Gateway / Web Client for PSUR Single Assessment submissions

These training sessions are meant for all applicants submitting PSUR Single Assessment submissions in eCTD or NeeS format through the eSubmission Gateway and the Web Client. The sessions will cover topics from registration and necessary configurations to the filename convention and the receipts and acknowledgements that the applicant will receive upon submission via the Gateway/Web Client.
 
The places will be allocated on first come first served basis for up to 75 participants.

  • Webinar: 27/09/2013 at 11.00 – 12:30 UK time

Book your place now by emailing  natasha.brown@ext.ema.europa.eu

And

The slides from the eSubmission of PSUR slides via the EMA Gateway Webinar are available and can be found here

25-07-2013

New versions of the electronic application forms Renewal and Variations and Release Notes have been released and can be found here

 

 

 

EMA
©1995-2014 European Medicines Agency | Disclaimer Contact: esubmission@ema.europa.eu