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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.


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What's New

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01-09-2014

Regulatory information - Referral Procedures to be sent via eSubmission Gateway / Web Client from 1st of November 2014

From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD.

The European Medicines Agency (EMA) strongly recommends using the electronic submission channels (eSubmission Gateway or Web Client) and the electronic Common Technical Document (eCTD) or NeeS (Non-eCTD electronic Submission) formats for submission of referrals. For Referral submissions related to Centrally Authorised products, it is mandatory to use the eCTD format.

The EMA's strategy for the electronic submission of applications aims to improve efficiency and decrease costs for applicants. Applicants who wish to use the eSubmission Gateway or Web Client need to register on the EMA’s eSubmission Gateway website.

22-08-2014

Norway has now joined the use the Common Repository to receive Centralised Procedure submissions. There are currently 13 NCAs that are using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated.

And

New versions of the eAF DES and schemas have been released and can be found here

14-08-2014

Bulgaria, Czech Republic and Luxembourg have now joined the use the Common Repository to receive Centralised Procedure submissions. There are currently 12 NCAs that are using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated

01-08-2014

Belgium, Greece and Slovakia have now joined the Common Repository to receive Centralised Procedure submissions. There are currently 9 NCAs using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. Please see details on the Common Repository page. Additionally the CAP Dossier Requirements document has been updated.

And

A further draft of the eSubmission Roadmap v.1.0 has now been endorsed by the IT Directors Executive Committee on 24 July 14 and will be on the agenda for the next EUTMB for further endorsement. More details on the implementation of the Roadmap will also be published at a later stage by the eSubmission CMB.

And

The European Medicines Agency has moved. Our new address is:
30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom

09-07-2014

Croatia is now using the Common Repository to receive Centralised Procedure submissions. The CAP Dossier Requirements document has been updated

25-06-2014

The European Medicines Agency is moving
Please note that from 1 August 2014 our new address will be:


30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom

10-06-2014

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

27-05-2014

Lithuania is now using the Common Repository to receive Centralised Procedure submissions. The CAP Dossier Requirements document has been updated

07-05-2014

eAF Data Exchange Standard version 1.15 (effective June 10, 2014) can be found here

23-04-2014

The eAF hot fix version 1.14.1.0 has been released and latest forms can be found here

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.

 

 

 

 

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