The VNeeS Q&A relating to eSubmission for Veterinary Applications has been updated and can be found here. General FAQ relating to PDF/A has been published on the Veterinary eSubmission page.
The updated version of the eCTD v4.0 EU M1 Implementation Guide was released for public consultation on 20th May 2017. The commenting period has been extended to allow sufficient time for thorough review by pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities. The new date to submit your comments is 20th of October 2017. Please provide your comments using the comment template to eCTD4consultation@ema.europa.eu.
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 2018. All vendors are invited, at their own cost to take part. All participants must register in advance, by 22nd September 2017, via email to eCTD4consultation@ema.europa.eu.
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 here. 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.
Essential maintenance of affecting eSubmissions
The EudraVigilance XCOMP Gateway will be unavailable between 09:00 and 17:00 on Sunday, 13 August due to essential maintenance. As part of the exercise, the EMA Production Gateway will be unavailable for 30 minutes at a point between 09:00 and 13:00. In consequence, no Production inbound messages relating to eSubmissions or EudraVigilance will be processed during those 30 minutes and no outbound MDN or ACK messages will be sent. There may also be a very brief interruption to other services as the EMA Production Gateway is brought back online.
A defect in section 1.4 of the MAA veterinary eAF, affecting the MRL substances has been detected and subsequently fixed. New version v.220.127.116.11 of the MAA veterinary form and the updated release notes are now available.
Defects in section 1 and 3 of the Renewal eAF, affecting the MA Numbers fields and the overages field respectively, have been detected and subsequently fixed. New version v.18.104.22.168 of the Renewal form and the updated release notes are now available.
Please note that the Data Exchange Standard (DES) has not changed in this release – the change in the release number reflects that there is no change in the DES. The new version of the forms should be used as of today. Please note that there is no change to the Variation form – the version number 22.214.171.124 will remain for the Variation form.
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
A defect in section 1.1 of the MAA human eAF, affecting the PRAC rapporteur field (Centralised Procedure applications) has been detected and subsequently fixed. New version v.126.96.36.199 of the MAA human form and the updated release notes are now available here.
Please note that the Data Exchange Standard (DES) has not changed in this release – the change in the release number reflects that there is no change in the DES. The new version of the forms should be used as of today. The issue in version 188.8.131.52 does not affect MRP/DCP/NP applications. Please note that there is no change to Variation, Renewal and MAA vet forms – the version number v.184.108.40.206 will remain for variation, renewal and vet MAA forms.
Updated release notes are now available for eSubmission Gateway XML delivery file user interface. The updated document highlights a known issue with submission description ‘Response to RSI’ when submission units ‘initial, validation-response, additional-info, closing, consolidating and corrigendum’ are selected. This defect does not affect the submissions process and will be fixed in the next release.
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. Release notes detailing the changes are available here.
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.
Essential maintenance to computer applications on Tuesday afternoon
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:00 and 17:00 on Tuesday, 27 June 2017. 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.
A presentation on the outcome of the first ‘proof of concept’ UAT on CESSP is now available here.
Essential maintenance to EMA computer applications affecting PSUR Repository on Saturday, 24 June
PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 19:00 on Saturday, 24 June due to essential maintenance. EMA’s gateway will remain available for all communities throughout and any files submitted during that time will be put in a queue for processing once the deployments have been completed.
If you have any questions, please contact the EMA Service Desk.
New versions of the 4 electronic Application Forms (eAF v. 1.21) and the related release notes are now available here. This version of the forms provides usability improvements and defect fixes and aims to improve the user experience for all users. This new version, 1.21 of the forms can be used as of today (20th June 2017) and will fully replace the version 220.127.116.11 after transitional period, on1 September 2017. Version 18.104.22.168 of the forms will be withdrawn from the eAF website on 20th June 2017 however it may be used until 31st August 2017. The version of the form should not be changed during an ongoing procedure.
Version 1.21 of the eAFs will be available on 20 June 2017. The release v1.21 provides usability improvements and technical defect fixes. Following a successful User Acceptance Testing (UAT) the release schedule has now available to provide more information regarding the mandatory use of version 1.21.
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.
Essential IT maintenance to EudraVigilance applications the Weekend of June 17th 2017
Due to essential maintenance between Friday, 16th June 2017 17:00hrs and Sunday 18th June 2017 23:30hrs (UK time), EudraVigilance Human (for ICSR and Product) and EudraVigilance Veterinary (including EV Web and Gateway) will be unavailable. For any questions, please contact the EMA Service Desk.
An updated version of the eCTD v4.0 EU M1 Implementation Guide is now available for public consultation. The eSubmission Change Management Board invites all pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities to take part in this consultation and provide comments by 30th September 2017. Please provide your comments using the comment template; and any questions regarding further development and clarifications of the released draft documents to: eCTD4consultation@ema.europa.eu. The Implementation Guide and relevant documents can be found here.
The Annex VI of the eSubmission Roadmap on the implementation of mandatory use of VNeeS format for Veterinary regulatory submissions has been updated to reflect the updated eSubmission Roadmap v2.0 and is now available here.
Version 1.21 of the eAFs will become available on 20 June 2017. The release v1.21 will provide usability improvements and technical defect fixes.
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 22/05/17 to Fri 26/05/17
- NCAs*: from Mon 29/05/17 to Fri 02/06/17 (*Based on the eAFs received from Industry)
If you wish to participate, please email eSubprogofficer@ema.europa.eu. A feedback form for consolidated comments will be provided to you following your registration.
Previous news is available here