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eSubmission

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Human eSubmission

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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

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What's New in eSubmission Today?

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22-11-2017

Common Repository, PSUR Repository, Gateway File Handler and the eSubmissions Web User Interface (to create XML delivery files) will be unavailable between 07:00 and 09:00 on Thursday, 23 November 2017.The EMA eSubmission Gateway and Gateway Web Client will remain available and any files submitted during that time will be queued for processing when the work is complete. If you have any questions, please contact the EMA IT service desk A new version of the Common Repository, extending the system to all EMA coordinated veterinary submissions is available from Thursday 23rd of November 2017. The new system can be accessed by all National Competent Authorities (NCAs) and committee members to search, view and download veterinary submissions.

The dossier requirements for veterinary submissions remain in place until the use of the system becomes mandatory in Q2 2018. Applicants should continue sending applications to EMA via the eSubmission Gateway and to the NCAs via CESP or CD/DVD as listed the dossier requirements document until it is announced by the EMA that the NCA is using the system exclusively.

The eSubmission Web User Interface for creation of the XML delivery files has been updated to include submission description (submission description – Responses to RSI) and updated values in submission format for veterinary PSUR submissions. A procedural change is also being introduced to the submission process for Worksharing (WS) and Internal Grouping (IG) procedures. An updated User Guide to XML delivery files will be made available here.

A webinar on the use of OMS and RMS data in eAF will be held on 28 November 2017 at 14:00-16:00 UK time. If you would like to participate in this webinar, please register by email to SPOR-Change-Liaisons@ema.europa.eu. Please note that participation in this webinar is on first come first serve basis as the maximum capacity of the virtual room is 200 participants. The webinar will be recorded and published on the eAF website.

And

eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.3 and the related release notes are available here. There are no changes to the DTD and hence this version enters into force as of today and can be used immediately. The users are recommended to use the new version as soon as possible.

The updated eCTD validation criteria v7.0 and related release notes are now available here. The updated validation criteria will enter into force on 1st of September 2018.

The NeeS validation criteria v4.2 have been updated in-line with the updated eCTD validation criteria. The updated document and the related release notes are now available here. The updated validation criteria will enter into force on 1st of September 2018.
A draft release schedule for 2018 the electronic Application Form is now available here.

User Acceptance Testing (UAT) started for the eAF v1.22 on Monday 13th November and will run until Friday 24th November 2017. The version 1.22 will integrate use of OMS (organisational data from SPOR programme) into all 4 forms as well as number of other user improvements. If you wish to take part in the testing, please register by email with eSubprogofficer@ema.europa.eu.

14-11-2017

Essential maintenance to computer applications on Wednesday

PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 17:00-18:00 on Wednesday, 15 November 2017.However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.  

31-10-2017

An updated version of the Harmonised Technical Guidance for ASMF Submissions in eCTD format and the related Release notes are now available here. This version comes into force immediately.

Please note, that the EU eSubmission Roadmap and related Annex II include details on mandatory use of eCTD format for all submissions within EU procedures from January 2018. This is also applicable to ASMFs used for Marketing Authorisation Applications in all EU procedures.

25-10-2015

Updated versions of the Data Exchange Standard (DES) and XSD are now available on the eAF webpage for the next version of the electronic Application Forms (eAF).

The version 1.22.0.0 is planned to go live on 15th December 2017 following User Acceptance Testing (UAT) taking place in November 2017. If you wish to take part in the UAT, please register via email eSubProgOfficer@ema.europa.eu

The updated ‘CESSP Essentials’ presentation and a new CESSP Q&A document are now available on the CESSP webpage.

19-10-2017

Version 1.22 of the electronic Application Forms (eAFs) will become available on 15 December 2017. The release v1.22 will provide integration with OMS from SPOR (Organisational/address data), usability improvements and technical defect fixes. User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:

  • The testing by Industry and NCAs will take place
    • Industry: from Mon 13/11/17 to Fri 17/11/17
    • NCAs*: from Mon 20/11/17 to Fri 24/11/17   (*Based on the eAFs received from Industry)

If you wish to participate, please register by email with eSubprogofficer@ema.europa.eu.  A feedback form for consolidated comments will be provided to you following your registration. A kick-off meeting is planned to take place on 13th November 2017 to explain the new features.

09-10-2017

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 18:00 (UK time) on Thursday 12 October and 24:00 (UK time) on Monday, 16 October 2017.  Applications consuming real-time RMS data (PSUR Repository, ECD Self registration, MMS-e, EudraGMDP, EudraCT, EU PASS (ENCepp), and eAF)  will be affected during Thursday evening and Friday.  

Should you have any questions please contact the EMA IT Service Desk.

The PSUR Repository will be impacted for industry users sending non-EU single assessment PSURs only and the NCA users using performing searches in the non-EU single assessment area of the PSUR Repository. Search attribute MA authorisation type is also unavailable during this period. Please note that if you have submission deadline for non-EU single assessment PSUR on Friday 13th October, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
The eAF will be impacted only for the ATC code field (MAA human and vet and the renewal form). There is no impact to the Variation application form. All other dropdown menus for controlled terminology continue working during this maintenance activity.

05-10-2017

The EMA is launching an updated version of the EudraVigilance on 22 November 2017. In preparation for this update, there will be a downtime period for the Article 57 database (EXVDMP). During the scheduled downtime from 8th-21st of November 2017 it will not be possible to amend or add product/substance data in Article 57. This will impact the PSUR Repository as the product selection for the PSUR submissions is linked to Art. 57. It will not be possible to update/amend product data for the creation of the XML delivery files during this downtime period.

The EMA strongly recommends that MAHs, with a PSUR submission date falling during the scheduled downtime (8 to 21 November 2017), carefully review the list of products available through the PSUR Repository xml delivery file user interface to ensure availability of the products included in the relevant procedures and make plans to create the xml delivery file and submit their PSUR prior to the 8 November. Alternatively, if an earlier submission cannot be accommodated MAHs are encouraged to review the availability of products and correctness of the entries in the XML delivery file user interface. The MAHs should contact the EMA service desk to request a late submission ID in order to submit initial PSUSAs after the due date. There is no need to request late submission ID for subsequent submissions, such as responses.  

This will also impact eAF use as the substance selection for the Initial MAA is linked to EXVDMP. It will not be possible to update substance data for the creation of eAF dataset during this downtime period. The EMA strongly recommends that MAHs, with a MAA date falling during the scheduled downtime (8 to 21 November 2017), carefully review relevant data and ensure that the required substances are available via the eAFs. More information is available from the EudraVigilance system downtime document.

28-09-2017

An updated version of the eSubmission Gateway XML delivery file user interface is now available and effective 29 September. This update introduces additional attributes to the veterinary domain in preparation for the extension of the Common Repository for Veterinary submissions. This release contains number of changes for veterinary users only, such as use of the ‘Submission description’ and selection of ‘procedure numbers’ for post-authorisation procedures where applicable. The updated User Guide, a short presentation with specific details on the changes and the updated release notes detailing the changes are available here.

26-09-2017

Essential maintenance to computer applications on Friday

eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00 and 09:00 on Friday, 29 September 2017 However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.

 The Common Repository will also be unavailable between 07:00 and 09:00 on Friday, 29 September 2017 due to essential maintenance.

22-09-2017

An updated version of the eSubmission Gateway Web Client will become available on Saturday 23rd of September 2017. The eSubmission Gateway Web Client update will introduce an updated user interface with some updated functionality. The user guide How to send submissions via the Web Client  has been updated and is available here.

Romania is now using the Common Repository to receive Referral submissions. Please do not send any Referral submissions (including CAPs and NAPs) to Croatia, Estonia, Finland, Norway, Latvia and Romania, as these types of submissions are now retrieved via the Common Repository. Please see details on the Common Repository page.

The eCTD v4.0 working group would like to offer an opportunity for all eCTD tool vendors to discuss open points and ask questions on eCTD v4.0 EU Module 1 Implementation Guide. A face-to-face vendor meeting is planned to take place at BfArM in Bonn, Germany on 6th of October 2017. All vendors are invited, at their own expense to take part. All participants must register in advance, by 22nd September 2017 to eCTD4consultation@ema.europa.eu.

18-09-2017

Essential maintenance to EMA computer applications affecting PSUR Repository/eSUB UI/eSubmission Gateway on Saturday, 23 September

PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 14:30 on Saturday, 23 September due to essential maintenance. The eSubmission Gateway will be also unavailable between 09:00 and 17:00 (UK time) due to essential maintenance.

15-09-2017

Croatia and Finland are also now using the Common Repository to receive Referral submissions. Please do not send any Referral submissions (including CAPs and NAPs) to Croatia, Estonia, Finland, Norway and Latvia, as these types of submissions are now retrieved via the Common Repository. More details on the Common Repository can be found on the Common Repository website.

13-09-2017

The Common Repository has been extended to include all human Referral submissions from 1st September 2017. The use of the Common Repository for human Referral submissions will become mandatory for all NCAs on 1st of December 2017. There should be no referral submissions directly to any NCAs from 1st of December 2017 as these will be considered to have been delivered to the NCAs. Please see the Statement of Intent on the mandatory use of Common Repository for human Referral submissions.

Estonia, Norway and Latvia are now using the Common Repository to receive Referral submissions. Please do not send any Referral submissions (including CAPs and NAPs) to Estonia, Norway or Latvia, as these types of submissions are now retrieved via the Common Repository. Please see details on the Common Repository page.

Applicants and MAHs are reminded that eCTD technical validation reports should not be included within the working documents folder when sending submissions to the EMA via eSubmission Gateway. The EMA does not require any eCTD validation reports as a part of a submission.

The use of the eAF versions 1.21.0.0 for variations and v1.21.0.1 for MAA human and vet and renewals is now mandatory since 1st of September 2017.

Please note that the all support calls relating to eSubmissions systems, such as eAF, must be sent via the EMA service portal. The email addresses ‘eAF@ema’ and ‘eCTD@ema’ are no longer in use and queries sent to these email addresses will not be processed.

Previous news is available here

 

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©1995-2017 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