eSubmission Gateway and eSubmission Web Client
Previous News
22-06-2023
Planned maintenance of the eSubmission systems on 24 June 2023
Due to planned maintenance, the following eSubmission systems will not be available on Saturday 24 June 2023, between 8:00 and 18:00: Common Repository (Interface and API), PSUR Repository, Gateway FileHandler. For any further information, please contact EMA Service Desk.
15-06-2023
Planned maintenance of the eSubmission systems on 17 June 2023
Due to planned maintenance, the eSubmission systems (including eAF and PLM Portal eAF) will not be available on Saturday 17 June 2023, between 8:00 and 16:00. For any further information, please contact Service Desk.
06-06-2023
Planned maintenance of the eSubmission systems on 9 June 2023
Due to planned maintenance of the eSubmission systems on Friday 9 June 2023, between 18:00 and 21:00 no submissions will be processed, therefore avoid sending submissions during this maintenance window. For any further information, please contact Service Desk
01-06-2023
eSubmission Gateway XML delivery file update for obsolete Veterinary submission types
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Veterinary submissions (removal of obsolete submission types: extension, var-type1b, var-type2 and vet-psur).
The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.
30-05-2023
Planned maintenance of the eSubmission systems on 31 May 2023
Due to planned maintenance of the eSubmission systems on Wednesday 31 May 2023, the Delivery File UI and the Gateway FileHandler will be unavailable between 18:00 and 20:00. During this time, submissions uploaded through Syncplicity will not be processed, therefore avoid sending submissions during this maintenance window. For any further information, please contact Service Desk
17-03-2023
Planned maintenance of the eSubmission systems on Saturday 25 March 2023
The eSubmission systems are unavailable for planned maintenance and will be unavailable from Saturday 25th of March 2023 08:00 until 18:00 due to essential maintenance. For any further information, please contact Service Desk
21-02-2023
ePMF
eSubmission in eCTD format is mandatory for all PMF applications including new PMF certification and changes (variations).
Before submission an XML delivery file must be created and included in the submission package. It is important that the guidance is followed step by step. Please access the ePMF page for more details.
26-10-2022
eSubmission Gateway XML delivery file update for Raw Data submissions
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file (addition of new submission type for 'Raw data submission' (human domain only). Further information on the Raw data pilot submissions can be found here. Please note that this new submission type should only be used when it has been previously agreed that the product is taking part in the pilot. The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.
Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.
11-07-2022
eSubmission Gateway Web Client - upgraded Syncplicity portal now in production
The eSubmission Web Client portal has now been upgraded to Axway Syncplicity portal. Please access the new Web Client to send submissions to the EMA here.
All previously registered eSubmission Gateway Web Client users should have now received an email from Axway with a link to reset your password for the production Web Client.
05-07-2022
eSubmission Gateway Web Client upgrade - Syncplicity go-live for production environment on this weekend (8th - 10th July 2022)
As previously published, the EMA is in the process of upgrading our current Axway Gateway solution.
Please note that migration of all users in the Production System will be done this weekend, starting from Friday, 8 July 2022, at 17:00 CEST until Sunday, 10 July 2022, at 18:00 CEST. Should this need to be postponed, an update will be published on this webpage.
Please note that registered production environment users will receive an email from Axway Syncplicity with a link to reset your password for the production environment. Please see the guidance on how to reset your password.
In the view of the update for Gateway to Gateway users only, we have requested you to make the required changes to update your firewall rules in line with the gateway connections document. If you use the Gateway to Gateway connection (not relevant to Web Client users), please implement the required changes by Friday, 8 July 2022, at 17:00 CEST to avoid any business disruption.
15-06-2022
eSubmission Gateway Web Client upgrade - External UAT for all XCOMP users now open
The issues relating to preparations for the external UAT have been solved and all eSubmission Web Client XCOMP users are now invited to start user acceptance testing (XCOMP environment). Please refer to the Guidance on how to submit using Syncplicity Web Client.
There is no need to register for the UAT. Please provide any feedback via the EMA Service Desk as soon as possible, but latest by Wednesday 22nd June 2022.
It is currently anticipated by Axway that the go-live of the new Web Client (Syncplicity) will be in take place in late June 2022. Date is yet to be confirmed. Before the go-live in production, the 'sun Java' which is only available in Internet Explorer is still required.
14-06-2022
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available here. The new version provides an update of the framework for the delivery file user interface for both, the eSubmission Gateway delivery file UI and the PSUR Repository UI. The update is mainly technical, providing a slightly different look and feel.
Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added into the Gateway Delivery file UI human domain. No other functional changes have been introduced in the user interface.
10-06-2022
eSubmission Gateway Web Client upgrade
eSubmission Gateway Web Client upgrade - Migration of all (XCOMP) users to Syncplicity ongoing
The issues relating to preparations for the external UAT have been solved and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). Please note that internal testing is still ongoing, and it is recommended that external testers do not start testing yet.
The migration of all existing XCOMP environment users to Syncplicity was done on Wednesday 8th of June 2022 - please note that registered XCOMP users have received an email from Axway Syncplicity with a link to reset your password for the XCOMP (test) environment. Please note that this resetting of the password has no impact in the password in production eSubmission Gateway Web Client. Please see the guidance on how to reset your password.
The details on how to send test submissions will be published as soon as the user guide becomes available once the migration activities have been finalised.
There is no need to register for the UAT, and the link to the system will be provided via this website.
It is currently anticipated by Axway that the go-live of the new Web Client (Syncplicity) will be in take place in late June. Date is yet to be confirmed. Until then, the 'sun Java' is still required (only available in IE).
eSubmission Gateway Delivery file UI - technical update go-live postponed until Tuesday 14th June 2022
The eSubmissions team has been working on an update of the framework for the delivery file user interface.
This updated user interface will be deployed in production on Tuesday 14th of June 2022.
08-06-2022
eSubmission Gateway Web Client upgrade
The EMA is in the process of upgrading our current Axway Gateway solution.
The Gateway tool provider Axway is currently facing some issues with the new tool, however it is expected that the testing by external users can start within next couple of days.
Details and updated user guide will be published to support testing.
eSubmission Gateway Delivery file UI - technical update go-live 10th June 2022
The eSubmissions team has been working on an update of the framework for the delivery file user interface. This is mainly a technical update only providing a slightly different look and feel.
Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added. There are no other functional changes to the MAH user interface.
This updated user interface will be deployed in production on 10th of June 2022.
24-05-2022
eSubmission Gateway Web Client upgrade
Update on the project status
The EMA is in the process of upgrading the current Axway Gateway solution.
The Gateway tool provider Axway is currently facing some issues with the tool and this has caused a delay in the start of the User Acceptance Testing (UAT). Once these Syncplicity issues are resolved, Axway will propose a new timeline for the UAT and a date will be announced for the go-live in production.
Update of IP addresses for Gateway to Gateway connections
As part of an upcoming eSubmission Gateway upgrade which affects the Gateway to Gateway submission, the EMA will be changing the IP addresses of the AS2 Gateway connections. To ensure smooth transition, all current eSubmission Gateway to Gateway users are advised to update firewall rules in line with the gateway connections document. No other configuration changes are required as part of this upgrade.
This IP address range change does not affect the Web Client users.
If you have any questions on the upgrade, contact us using the EMA service desk.
eSubmission Gateway Delivery file UI - technical update
The eSubmissions team has been working on an update of the framework for the delivery file user interface. This is mainly a technical update only providing a slightly different look and feel. Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added. There are no other functional changes to the MAH user interface.
The updated user interface will be deployed in production once the internal user acceptance testing has been finalised (exact date TBC).
An updated user guide and release notes will be published at the time of the go live.
21-04-2022
eSubmission Gateway Web Client upgrade - Migration of all (XCOMP) users to Syncplicity starting now
The preparations for the external UAT are almost finalised and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). The link to the test system and details on how to send test submissions will be published as soon as they become available.
There is no need to register for the UAT, and the link to the system will be provided via this website.
The migration of all existing XCOMP environment users to Syncplicity starting today - please note that you will be receiving an email from Axway Syncplicity with a link to reset your password for the XCOMP (test) environment. This resetting of the password has no impact in the password in production eSubmission Gateway Web Client.
The vgateway (old XCOMP environment) is currently not accessible.
The new Web Client (Axway Syncplicity) will be implemented in production environment in May 2022 following successful user acceptance testing.
10-03-2022
eSubmission Gateway Web Client upgrade planned for Spring 2022
The EMA eSubmission team is pleased to announce that a project to upgrade the eSubmission Gateway Web Client is ongoing and the updated version of the Web Client (Axway Syncplicity) will be implemented in May 2022 subject to successful user acceptance testing planned to take place in April 2022.
This upgrade will result in need for an update of the user passwords to allow access to the updated system. Further details on the participation in the UAT and on the steps required from existing users will be published in advance of the change.
28-01-2022
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a large number of changes to the delivery files for Veterinary submissions reflecting the requirements/changes from the VMP-Reg (e.g. addition of new submission types, removal of submission types/submission units that are no longer relevant, update of available business units in relation to submission types for which no ‘new applications’ can be made once the new legislation is in force and addition of new values for Submission format dropdown menu).
Users should note that the delivery files created prior to the new release will not work after the go live.
18-01-2022
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file (addition of new submission description 'Raw data pilot submission' for MAA 'additional information' (human domain only). Further information on the Raw data pilot submissions will be published soon and this new submission description should only be used when it has been previously agreed that the product is taking part in the pilot.
Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly .
11-03-2021
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of ‘nitrosamine related’ radio button for initial variation submissions (human domain only) and renaming the ‘Customer Reference’ field to ‘purchase order number’ for all relevant submission types and submission units (H&V).
Users should note that the delivery files created prior to the new release will not work after the go live.
08-03-2021
A new version of the eSubmission Gateway XML delivery file for veterinary changes is now available
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is now available. This update has introduced changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number).
Users should note that the delivery files created prior to the new release will not work after the go live.
19-11-2020
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced multiple changes ranging from new fields to changing previously optional fields to mandatory fields and a major change for Paediatric submissions by completely transforming the delivery files for these types of submissions as we are preparing to extend the Common Repository to contain Paediatric submissions.
Users should note that the delivery files created prior to the new release will not work after the go live.
05-11-2019
A new version of the eSubmission Gateway XML delivery file now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update has introduced an additional submission unit for PAM submissions and a mandatory selection of yes/no to indicate if a change of MAH is included in a response submission for MAA human and vet. Additionally some minor defects have been fixed.
Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release deployed on the evening of 4th of November 2019 should continue to work following the deployment of this new version. It is however, recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.
09-10-2019
Formatted Table Template implementation in the XML delivery files
An updated version of the eSubmission Gateway XML delivery file user interface is now available.
Following this release the use of the Formatted Letter Template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submissions (including PSUSA procedures) and after this it will be optional for applicants to provide the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.
From 1 January 2020, the Formatted Letter Template will no longer be maintained by EMA and the document and references removed from EMA corporate website.
Users are required to fill in all the submissions attributes correctly through eSubmission Web UI by creating an XML delivery file since all attributes in the XML delivery file are used to support important searches in Common Repository. The use of XML delivery files will also support EMA internal processes by significantly reduce the time required for receiving, processing and validating incoming applications and ensures continuous and immediate access to up-to-date dossiers.
Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release will not work following the deployment of the new version. It is always recommended to clear the cookies, and refresh your browser before creating delivery files using the updated user interface, to avoid any issues.
25-09-2019
Formatted Table Template implementation in the XML delivery files
An updated version of the eSubmission Gateway XML delivery file user interface will be made available in early October 2019.
Following this release the use of the Formatted Letter Template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and after this it will be optional for applicants to provide the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.
From 1 January 2020, the Formatted Letter Template will no longer be maintained by EMA and the document and references will be removed from EMA corporate website.
Users are required to fill in all the submissions attributes correctly through eSubmission Web UI by creating an XML delivery file, since all attributes in the XML delivery file are used to support important searches in Common Repository. The use of XML delivery files will also support EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications and it ensures continuous and immediate access to up-to-date dossiers.
Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release may not work following the deployment of the new version. It is always recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues. The updated system release notes detailing the changes will be made available at the time of the release
10-04-2019
The eSubmission Gateway and Web Client online registration guidance has been updated with new contact information.
04-02-2019
Delay in the Formatted Table Template implementation in the XML delivery files – please continue to use the Formatted Table Template until further notice (Human and Veterinary).
There is a delay in the launch of the Formatted Table Template fields in the eSubmission Gateway Delivery file User Interface (UI) due to interdependencies with other systems, extended testing and resource issues due to the move of the agency. We were therefore unable to discontinue the use of the Formatted Table Template as of 1st of February 2019 as previously announced.
The release of the updated eSubmission Delivery file UI for the eSubmission Gateway has been further postponed until a future date. We will provide an update once the timeline for the delivery can be confirmed.
Please continue to provide the Formatted Table Template for Human and Veterinary submissions as a part of the Cover Letter in Module 1 of eCTD submission sequences or Part 1 of VNeeS dossiers.
As usual, users are required to fill in all the submission attributes correctly through the Delivery file UI. The attributes in the XML delivery files are used to support important searches in the Common Repository and they support EMA internal processes. Please note that incorrect submissions may lead to procedural delays of incoming applications.
18-12-2018
Due to a subtle delay in updates to the eSubmission Web User Interface (XML delivery file), the use of the Formatted Letter Template will become obsolete 1st February 2019. This concerns all EMA Human and Veterinary submissions (including PSUSA procedures) and companies should then no longer use the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.
From 1 February 2019, the Formatted Letter Template will not be maintained by EMA and the document and references will be removed from EMA corporate website.
Users are required to fill in all the submissions attributes correctly through theSubmission Web User Interface by creating an XML delivery file as all attributes in the XML delivery file are used to support important searches in the Common Repository. The use of the XMLl will also support EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications. This will ensure continuous and immediate access to up-to-date dossiers.
Please note that incorrect submissions may lead to procedural delays of incoming applications.
05-11-2018
The use of the Formatted Letter Template will become obsolete as of 1st January 2019. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and companies should no longer use the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.
From 1 January 2019, the Formatted Letter Template will not be maintained by EMA and the document and references will be removed from EMA corporate website.
Users are required to fill in all the submissions attributes correctly through the eSubmission Web UI by creating a .XMLdelivery file, as all attributes in the .XML delivery file are used to support important searches in the Common Repository.
Use of the .XML will also support EMA internal processes by significantly reducing the time required for receiving, processing, and validating incoming applications, and ensures continuous and immediate access to up-to-date dossiers.
Please note that incorrect submissions may lead to procedural delays of incoming applications.
09-07-2018
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce an additional business rule to help users correctly select PASS 107 procedures types. Also, a Purchase Order number attribute for PASS 107 procedure was introduced.
This release of the eSubmission Gateway delivery file UI also fixes the known issue related to Veterinary submissions, users can now select from a predefined list of procedure numbers to reference their ASMF submissions. This is aligning with how Human procedure numbers can be linked to ASMF submission.
Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 6st of July 2018 should work following the deployment of the new version. It is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.
19-12-2018
The Q&A on mandatory eCTD in National Procedures (NP) has been published and can be found here.
18-12-2018
Reminder of mandatory use of VNeeS for all submissions in National Procedures by 01 January 2019.
According to the Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions, the use of VNeeS only for all submissions in National Procedures will be mandatory from Q1 2019.
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Formatted Letter Template becoming obsolete from 1st February 2019 (Human and Veterinary)
Due to a subtle delay in updates to the eSubmission Web User Interface (XML delivery file), the use of the Formatted Letter Template will become obsolete 1st February 2019. This concerns all EMA Human and Veterinary submissions (including PSUSA procedures) and companies should then no longer use the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.
From 1 February 2019, the Formatted Letter Template will not be maintained by EMA and the document and references will be removed from EMA corporate website.
Users are required to fill in all the submissions attributes correctly through theSubmission Web User Interface by creating an XML delivery file as all attributes in the XML delivery file are used to support important searches in the Common Repository. The use of the XMLl will also support EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications. This will ensure continuous and immediate access to up-to-date dossiers.
Please note that incorrect submissions may lead to procedural delays of incoming applications.
12-12-2018
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 08:00 (UK time) on Saturday, 15 December and 18:00 (UK time) on Sunday, 16 December 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, 14 December, 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.
03-12-2018
The final version of the implementation package containing the updated eCTD v4.0 EU M1 Implementation Guide is now released for implementation purpose.
Further details can be found here.
22-11-2018
EMA IT systems unavailable from 30 November to 3 December 2018
All EMA online applications will be temporarily unavailable
All European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable from 18:00 on Friday 30 November to 06:00 on Monday 3 December 2018 (UK time), due to essential maintenance. The EMA public website will remain available during this period, however it will not be possible to access any other EMA-hosted website or online application. Normal service will resume on 3 December.The EMA product emergency hotline and phone number for notifying EMA of suspected quality defects or product recalls will operate as usual during this period.
05-11-2018
The use of the Formatted Letter Template will become obsolete as of 1st January 2019. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and companies should no longer use the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.
From 1 January 2019, the Formatted Letter Template will not be maintained by EMA and the document and references will be removed from EMA corporate website.
Users are required to fill in all the submissions attributes correctly through the eSubmission Web UI by creating a .XMLdelivery file, as all attributes in the .XML delivery file are used to support important searches in the Common Repository.
Use of the .XML will also support EMA internal processes by significantly reducing the time required for receiving, processing, and validating incoming applications, and ensures continuous and immediate access to up-to-date dossiers.
Please note that incorrect submissions may lead to procedural delays of incoming applications.
03-10-2018
The eAF User Guidance Human & Vet Q&A has been updated and can also be found under the section “Guidance documents / Q&A" here.
02-10-2018
New versions of the 4 electronic Application Forms (eAF v. 1.23.1.0) and the related release notes are now available. This new version is a hotfix release of the forms and can be used as of 28th September 2018.
The current versions (v1.23.1.0) of the forms can be used and will fully replace the version 1.22.0.1 after a transitional period, on 15 October 2018 as detailed in the eAF Release Milestone plan. The version of the form should not be changed during an ongoing procedure.
13-09-2018
Gateway submission of veterinary applications in VNeeS version 2.6.
Please note that the EMAeSubmission Gateway web UI is being updated to reflect in the field “Submission
format” the VNeeS version 2.6 for Pharmaceutical and Immunological products.
For the time being, therefore, please submit your applications in VNeeS version2.6 using the submission format 2.5.
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Essential maintenance to computer applications on Friday, 14 September
PSUR and eSubmission Web User Interface (to create the delivery file) will be unavailable between 17:30-19:30hrs (UK time) on Friday, 14 September 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.
05-09-2018
Essential maintenance to computer applications on Thursday, 6 September
PSUR and eSubmission Web User Interface (to create the delivery file) will be unavailable between 17:30-19:30hrs (UK time) on Thursday, 6 September 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.
03-09-2018
Guideline on eSubmissions for Veterinary products – version 2.6 now in force.
Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council came into force on 27 January 2017.
With VNeeS version 2.6 now in force, the structure of the electronic dossier has been brought in line with structure described in the Commission Implementing Regulation.
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)
22-11-2017
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. The User Guide to XML delivery files will be updated shortly.
29-09-2017
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.
01-09-2017
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce an additional attribute ‘PAM code’ in to the XML delivery file. More information on the use of the PAM submission form can be found from the Post-Authorisation Guidance on PAMs; Question: How should I structure my PAM submission dossier?
Please note: the PAM submission form should be provided within the eCTD submission package in the same folder as the cover letter (EU M1 section 1.0).
This release of the eSubmission Gateway delivery file UI also fixes the known issue related to submission description ‘Responses to RSI’.
15-08-2017
The eSubmission Gateway Web Client has been updated in the XCOMP environment. This update introduces updated user interface and improved functionality – users no longer need to manually select the large file applet when sending test submissions using the vgateway in XCOMP environment. Please see the mini user guide for the updated test system. This new update will be made available in the production environment on 23rd of September 2017 if no issues are detected in testing. The user credentials remain the same in the updated system. 04-07-2017
PAM Submission Form is now available. The new form aims to provide a better ‘end to end process’ for PAMs by improving the submission and start phase with greater automation, and by increasing transparency for the Applicant with regards to EMA resources allocated to the procedure, evaluation timetables, and scientific committee assigned.
The full functionality of the PAM Submission Form will be achieved when changes to the eSubmission Gateway are implemented on the 1st of September. From this moment on the new form will be mandatory for all PAM submissions
Further information will be provided via the post-authorisation procedural Q&A, the eSubmissions webpage and a dedicated regulatory news item closer to the go-live date.
Related information: Post-authorisation measures: questions and answers
28-06-2017
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce improvements, new business rules 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 the use of the Formatted Table Template.
Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 27th June 2017 will not work following the deployment of the new version. It is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.
15-06-2017
An updated version of the eSubmission Gateway XML delivery file user interface and the PSUR Repository is planned for Tuesday 27th June 2017. The eSubmission Gateway UI update will introduce improvements to the user interface and new fields. This change is a further step towards integration of the XML delivery file and the Formatted Table Template; however this release does not affect the use of the Formatted Table Template.
Users should note that in some cases delivery files created prior to the new release on 27th June 2017 may not work following the deployment of the new versions. It is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.
An interactive training session introducing the changes on the eSubmission Gateway delivery file will be held on Monday 26th June at 11am UK time. Attendance is on first come first serve basis. To register to join the training please contact: eSubProgOfficer@ema.europa.eu by Friday 23rd June 2017.
05-05-2017
An updated version of the eSubmission Gateway Web UI will be made available today at 4pm Friday 5th of May. This version delivers defect fixes and addresses a data protection concern as the application contact person name and contact person contact details are no longer visible in the user interface and the XML delivery file. Please note that the delivery files created prior to the new release for referral and CAP submissions should work following the deployment of the new versions.
31-03-2017
Updated version of the eSubmission Gateway Web UI is now available. This version delivers new functionality to provide information currently provided in the Formatted Table Template. The aim of this phased implementation is to stop using the template once all relevant fields are available in the XML delivery file. This particular release does not affect the use of the Formatted Table Template. Details on the new fields are described in the updated release notes and the updated User Guide. The users should note that in some cases delivery files created prior to the new release for referral and CAP submissions may not work following the deployment of the new versions.
20-02-2017
An updated version of the eSubmission Gateway XML delivery file web UI is now available. This version delivers a change to the Referral submissions by including information from the Referral cover letter in to the XML delivery file and hence simplifying the submission process and allowing further automation. Defect fixes have also been implemented. Details are available in the updated Release Notes.
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.
In anticipation of the mandatory use of eSubmission Gateway / Web Client for veterinary submissions to EMA on 1 January 2017, a follow-up Q&A Session for Industry – Mandatory Use of eSub Gateway will be held on 12 January 2017, from 13:00 to 15:00 UK time. For details see the Veterinary esubmission website.
The use of XML delivery files for all Veterinary submissions will become mandatory on 1 April 2017.
01-10-2016
Use of the XML delivery files for submissions via the eSubmission Gateway and the Web Client is now mandatory. Use of filenaming conventions is only allowed for those submission types where use of delivery files is currently not possible (Ancillary medicinal substances in medical device, PASS 107o, veterinary PSURs and MRLs and number of human and veterinary ASMF submissions). Updated Annex 1 and Annex 2 can be found here.
25-07-2016
An updated version of the eSubmission Gateway user interface to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. This new version will introduce changes in line with the updated EU Module 1 Specification v3.0 and v3.0.1. The introduction of this new version marks the end of the successful pilot phase and introduces transitional period to mandatory use of xml delivery files for eCTD submissions from 1 October 2016. The updated delivery files should also be used for eCTD submissions created using eCTD specification version 2.0.
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. Mandatory use of eSubmission Gateway / Web Client for all eCTD submissions through the centralised Procedure from 1st of March 2014
From 1 March 2014, the use of the eSubmission Gateway and/or the Web Client will become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralised procedure. After this date, the European Medicines Agency (EMA) will no longer accept submissions on CD or DVD. This will apply to all types of procedures, including ASMF submissions. The EMA's strategy for the electronic submission of applications aims to improve efficiency and decrease costs for applicants. The electronic submission channels offer the following benefits:
easier and quicker way to send electronic submissions securely over the internet with possibility for sponsors to send updates within very short deadlines; feedback to the applicant on the reception of the application and in case of Centralised Procedure eCTD submissions confirmation of the outcome of the eCTD technical validation and the upload to the EMA’s eCTD review system; and no need to submit physical copy of dossier or hard copy cover letter to the EMA. Applicants who have not yet registered are invited to register to use the eSubmission Gateway or the free web-based Web Client solution as soon as possible.
Historical documents/Guidance
Multimedia Tutorials
Statements of Intent and announcements
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
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