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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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CMB Documents
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External Links

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Systems:

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Common Repository

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eAF

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CESSP

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eASMF
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ePMF
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CESP
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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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PAM submission form

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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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Paediatric submissions

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SPOR

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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'.

For technical support, please visit the EMA Service Desk 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

eSubmission eAFRSS news feed


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What's New in eSubmission Today?

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15-12-2017

New versions of the 4 electronic Application Forms (eAF v. 1.22) and the related release notes are now available here.
This release includes integration with OMS for organisation data and RMS for reference data.

OMS will provide standardised organisation and location data. (For information, eAF has been integrated with RMS since June 2017.)
This new version, 1.22 of the forms can be used as of today (15th December 2017) and will fully replace the version 1.21 after transitional period, on 15 February 2018.

The version of the form should not be changed during an ongoing procedure.

13-12-2017

Please see below the summary of post User Acceptance Testing for eAF v1.22 outcome.
In total 247 comments were received.

We have fixed 62 defects (remaining defects will be assessed and prioritised in future releases).
All submitted change requests will be analysed and prioritised.

    Change Requests Defects Defects Addressed
eAF MAA(Human)
19
38
33
  MAA(Vet)
2
6
5
  Renewal
9
16
11
  Variation
27
22
13
   
57
82
62

08-12-2017

From 1 December 2017, the use of Common Repository for Referral submissions replaces the use of CESP and CD/DVD for sending Referral submissions to the National Competent Authorities (NCAs). All human referral submissions sent to the EMA will be considered delivered to all NCAs representatives and alternates.

Submissions for all referrals should only be made using the EMA eSubmission Gateway/Web Client.. Additional copies should not be submitted directly to the NCAs on CD/DVD or via CESP as this might lead to validation issues and cause delays. More information on the Common Repository can be found here.

Formatted Cover Letter Template - Survey
The use of the XML delivery files is now mandatory for all Human and Veterinary submissions via the eSubmission Gateway and the Web Client.
Release of XML delivery file was introduced in anticipation of future replacement and use of the Formatted Table Template that is currently provided as a part of the submission in cover letter.

We would like to know how existing business processes will be affected when this document is no longer required. The survey can be found here.

 

Previous news is available here

 

EMA
©1995-2018 European Medicines Agency | Disclaimer | For technical support, please visit the EMA Service Desk 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