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eSubmission

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Human eSubmission

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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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16-05-2018

Essential maintenance to computer applications

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 18:00-19:00hrs (UK time) on Thursday, 17 May 2018.  Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF)  will be affected during this time. 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.  
The eAF will be impacted for the ATC code field (MAA human and vet and the renewal form) and for the areas where Organizations and Locations are used (however manual input of data is allowed for these areas). There is no impact to the Variation application form. All other dropdown menus for controlled terminology continue working during this maintenance activity

15-05-2018

The updated Annexes to the Roadmap are being published as they become available to reflect further details on the practical implementation steps. Annex 1 to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0 and Annex 2 to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for Human regulatory submissions can be found here.

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The updated DES documents and XSD files are now available for all 4 forms under the Technical Documents section. This is in preparation for the scheduled go live of eAF Version 1.23.

17-04-2018

Essential maintenance to computer applications on Wednesday 18 April 2008

The Gateway File Handler Registration module will be unavailable between 07:00 and 08:00 on Wednesday, 18 April 2018.However, the EMA gateway will remain available for all communities throughout.  If you have any questions, please contact the IT Service Desk.

16-04-2018

The guideline on eSubmissions for Veterinary products – version 2.6, related Validation checklist 2.6 and VNeeS Checker version 2.6 have now been published. They will enter into force on 1 September 2018 - see links under section “Future Guidance” on the vet esubmission webpage.

The update of the guideline is related to alignment with the eSubmission roadmap and forthcoming CESP dataset module, clarification on upper-case file extension, update of CMDv reference guidance, addition of a pass/fail criterion related to hidden files, update of the MRL dossier structure.

13-04-2018

The eAF guidance for how to request new substances and terms has been updated. Please refer to the eAF Term Request Form section here.

12-04-2018

Updated version 2.1 of the eSubmission roadmap published

The updated version 2.1 of the eSubmission roadmap has been endorsed by HMA at their February meeting and has now been published here.

09-04-2018

Stepwise implementation towards mandatory use of the Common Repository for veterinary submissions

The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions will be mandatory from 1st June 2018. Until this time, a transition period is ongoing, whereby the use of the Common Repository is being implemented in a stepwise approach, as indicated in the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (EMA/466102/2007)

15-03-2018

Essential maintenance to EMA computer applications affecting PSUR Repository and eSUB UI on Sunday, 18 March

PSUR Repository and eSUB UI will be affected by essential maintenance to EMA computer applications between 09:00 and 14:00hrs (UK time) on Sunday, 18 March 2018.  During this time, the NCA user interface (PSUR Repository access to documents) and the User Interface (for generation of the XML delivery file) will be unavailable.  The eSubmission Gateway will continue to be available throughout this period so MAHs can send PSUR submissions.

08-03-2018

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce improvements and new fields to the user interface. This change is a further step towards integration of the XML delivery file and the Formatted Table Template; however this release does not affect yet the use of the Formatted Table Template.

Please note that the delivery files created prior to the new release should work following the deployment of the new versions. One of the new features will be introduction of Brexit Related procedure indicator.
Users can indicate if the change is a Brexit related procedure. This is applicable to initial submissions for the following submission types:

  • Variations Type IA (H & V)
  • Variations Type IAIN (H & V)
  • Variations Type IB (H & V)
  • Variations Type II (H & V)
  • Transfer MA (H & V)
  • Notification 61-3 (H only)

brexit related procedure

Common Repository (User Interface and API) is now extended to include the following types of submissions related to procedures for Human Medicinal Products: Signal Detection, PASS 107 NAPs, Work share NAPs and Ancillary products for new submissions from the 8th of March 2018 onwards. This will be followed by a transitional period of 6-9 months, during which all NCAs will have time to adapt their systems and business processes in order to switch to the sole use of the Common Repository. During the transitional period, NCAs can still receive submissions directly from applicants, but they will also have the opportunity to switch to the sole use of the Common Repository during this period as and when they are ready to do so. Following the transitional period, the use of the Common Repository for above submissions will become mandatory for all NCAs. The date for the mandatory use is not yet decided.

07-03-2018

Essential maintenance to computer applications

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 07:00 (UK time) on Saturday, 10 March and 18:00 (UK time) on Sunday, 11 March 2018.  Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF)  will be affected during this time. 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, 9 March, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.

The eAF will be impacted for the ATC code field (MAA human and vet and the renewal form) and for the areas where Organizations and Locations are used (however manual input of data is allowed for these areas). There is no impact to the Variation application form. All other dropdown menus for controlled terminology continue working during this maintenance activity.

06-03-2018

The updated eCTD validation criteria v7.1 is now available here. The updated validation criteria will enter into force on 1st of September 2018.

The NeeS validation criteria v4.3 has been updated in-line with the updated eCTD validation criteria. The updated document is now available here. The updated validation criteria will enter into force on 1st of September 2018.

The EU Harmonised Technical Guidance for ASMF Submissions in eCTD format (version 2.1) has be edited in chapter 4 to clearly address rules on how to submit Letter of Access.

And

Essential maintenance to computer applications on Thursday 8 March 2018

Common Repository, PSUR, Gateway File Handler and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 14:00 and 15:00 hrs (UK time) on Thursday, 8 March 2018.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.  

23-02-2018

A new version of the Common Repository will be available in March 2018 extending the system to other EMA led EU procedures submissions.
Common Repository will extend and/or add new Cabinets to include the following types of submissions related to Human procedures:

    • Signal Detection
    • PASS 107 NAPs
    • Work share NAPs
    • Ancillary Products

19-02-2018

The use of the eSubmission Gateway and/or the Web Client become mandatory for all paediatric applications from 1 January 2018. To allow applicant to adapt to the new submission requirements, the EMA will allow a transition period until 15 March 2018. After this date, the European Medicines Agency (EMA) will no longer accept submissions by Eudralink.

16-02-2018

New versions of the 4 electronic Application Forms (eAF v. 1.22.0.1) and the related release notes are now available. This new version is a hotfix release v1.22.0.1 of the forms and can be used as of today, 16th February 2018. The version of the form should not be changed during an ongoing procedure.

15-02-2018

As of 15 February 2018 version 1.22 of the four electronic Application Forms (eAFs) are mandatory. Older versions of the forms will no longer be supported.

 

Previous news is available here

 

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©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