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eSubmission

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Human eSubmission

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Veterinary esubmission
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eSubmission CMB

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Documentation

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Projects:

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Common Repository

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CESP
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eAF

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CESSP

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eASMF
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ePMF
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eSubmission Gateway & eSubmission Web Client

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Delivery file UI

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eSubmission Gateway

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PSUR Repository
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Industry access

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NCA access
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eCTD

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eCTD v4.0

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EU Module 1

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eSignatures

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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'.

 

RSS news feed


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What's New in eSubmission Today?

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11-01-2017

Version 1.21 of the eAFs will become available on 7 February 2017. The release v1.21 will provide mainly technical defect fixes and usability improvements.
We are organising a User Acceptance Testing (UAT) to support the release of this next version of the forms:

  • The testing by Industry and NCAs will take place
    • Industry: from Mon 16/01/17 to Thu 19/01/17
    • NCAs*: from Tue 23/01/17 to Fri 27/01/17   (*Based on the eAFs received from Industry)

If you wish to participate, please email Beatriz.Calvo@ema.europa.eu.  A feedback form for consolidated comments will be provided to you following your registration.

Please use the Service Desk portal https://servicedesk.ema.europa.eu to raise any queries related to the eAFs. Procedural queries related to MRP, DCP and National procedures should be directed to the relevant National Competent Authority.

13-12-2016

New versions of the VNeeS Guideline v2.5 and the related Validation checklist v2.5 have been published under the Current Guidance section on the Vet eSubmission website. The new VNeeS Guideline and the checklist will enter into force on 1 June 2017. Rules for technical validation remain unchanged and therefore the current VNeeS Checker v.2.4b (validation tool) will remain valid from 1 June 2017.

The release schedule for the update of the electronic Application Forms (eAFs) is now available and can be found here. The next release, version 1.21 will deliver defect fixes and usability improvements and is planned for user acceptance testing in January 2017 and for deployment in February 2017.

The User guide to the XML delivery file creation has been updated and is available here.

Support to eSubmissions during EMA holidays: Please note that all EMA eSubmission systems are running as per normal during the EMA holiday. Submissions received via the eSubmission Gateway during the EMA closure are automatically uploaded to the Common Repository and the PSUR Repository as relevant. In case of technical issues, the EMA IT service desk is open until 6:30pm UK time on 22nd of December 2016. The service desk will reopen for external users for 4 half days between 27th and 30th December 2016, please note that if the queries are complex or require specific expertise they may not be solved until the service desk returns to normal service on Tuesday 3rd January 2017. There will be no procedural support available during the EMA closure from 23rd December until 2nd of January 2017 inclusive.

05-12-2016

An updated version of the eSubmission Gateway XML delivery file web UI is now available. This version delivers new functionality to create delivery files for MRL and veterinary PSUR submissions as well as functionality to create delivery files for human PASS 107o submissions, PASS 107n, PASS 107o and PASS 107q submissions for Nationally Authorised Products and submissions for Ancillary Medicinal Products in medical devices.  

The User guide to the XML delivery file creation and the Release notes have been updated and are now available here.

The use of eSubmission Gateway / Web Client will become mandatory for all Veterinary submissions on 1 January 2017. The procedural announcement and presentation from the training held on 1 December 2016 are available here.

The use of XML delivery files for all Veterinary submissions will become mandatory on 1 April 2017. The Statement of Intent is available here.

The Common Repository will be extended to all veterinary submissions in the centralised procedure. The Statement of Intent is available here.

The use of VNeeS format for all veterinary submissions in European procedures (CP, DCP and MRP) will become mandatory as of 1 January 2017. Details are available in the Annex to the eSubmission roadmap.

01-12-2016

Essential maintenance to computer systems during the weekend

Please note that the following computer systems will be unavailable on Sunday, 4th December 2016 between 9.00hrs and 19.00hrs (UK Time) due to essential maintenance:

  • PSUR and eSubmission Web User Interface – affecting parts of DREAM*
  • Axway Gateway – affecting EudraVigilance and eSubmissions

(* Due to essential folder re-structuring, colleagues working in the cabinet 01 /H-PUSA area might receive warning messages. Please avoid working in this area on Sunday 4th Dec, if possible. All other areas of DREAM will be available as usual.)

22-11-2016

A statement of intent is published regarding the replacement of electronic Application Forms by CESSP. More information on the CESSP project is available here.

11-11-2016

As of 1 January 2017 it will be mandatory for applicants to make all veterinary procedural submission to EMA via the eSubmission Gateway/Web Client portal. In preparation, a training Webinar for Industry – Mandatory Use of eSub Gateway for veterinary submissions to EMA will be held on 1 December 2016 from 13:00 to 15:00 UK time. For details see the Veterinary esubmission website.

09-11-2016

An updated version of the Common Repository is now available for the NCAs. The Common Repository contains all Centralised Procedure eCTD format submissions and is accessible to all NCAs. The update user guide is now available for NCAs. The updated Q&A document is now available here.

And

The Practical User Guide for Electronic Application Forms (eAF) for human and veterinary medicinal products in the EU has been updated and is available here.  

 

Previous news is available here

 

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