Updated versions of 4 electronic Application Forms (eAF v. 220.127.116.11) have been published following reported issues. The updated forms and related release notes are now available here.
The User guide to the XML delivery file creation has been updated and is now available here.
The Annex1 - A Guide to the EMA filenaming convention for eSubmission has been updated and is available here.
Essential maintenance to PSUR Repository and eSubmission Gateway this weekend
Due to essential maintenance the PSUR Repository and the eSubmission Gateway are unavailable this weekend from 18:00 UK time on Friday, 14 October until 06:00 AM UK time on Monday 17 October 2016.
EMA IT systems unavailable from 18:00 Friday 28 October to 06:00 Tuesday 1 November
All European Medicines Agency (EMA) IT systems will be temporarily unavailable from 18:00 on Friday 28 October to 6:00 on Tuesday 1 November (UK time), due to an essential exercise to test the Agency’s IT recovery capacity in case of a major event.
During this period, it will not be possible to access the EMA public website, www.ema.europa.eu, or any other EMA-hosted website or online application, including the systems used to send and receive applications for EMA regulatory procedures. MAHs should plan their submissions around the availability of the systems.
Emails sent to EMA email addresses during this period will be queued and delivered to recipients on 1 November.
Normal service will resume on 1 November.
The EMA product emergency hotline and phone number for notifying suspected quality defects or product recalls will operate as usual. While the EMA public website is unavailable, a holding page will be displayed with details of these emergency numbers. We would like to thank you in advance for your patience and cooperation during this essential IT maintenance work.
If you require more information, please contact the IT Service Desk ITServiceDesk
An updated version of the PSUR Repository has been made available on Thursday 6th October 2016. This release improves the product availability for the submission of responses. The updated release notes are available here.
An updated version of the eSubmission Gateway XML delivery file web UI is now available. This version improves the availability of Referral and ASMF procedures as well as fixing known defects. The updated release notes are available here.
Essential maintenance to PSUR Repository on Thursday evening.
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 18:00 and 19:00hrs on Thursday, 6 October 2016. However, Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed.
If you have any questions, please contact the EMA IT Service Desk
Essential maintenance to Gateway - 14-17 October 2016
The European Medicines Agency will be carrying out essential maintenance activities on the Gateway during the period specified below. Users may therefore find the Gateway unavailable during this time.
- Friday, 14th October from 20.00hrs (UK time) to Monday, 17th October, 6.00hrs (UK time)
During this period, it will not be possible to send messages via the Agency’s Gateway. Depending on the routing, either there will be a failure to connect and the message will not reach the Agency, or the message will be queued and delivered once services have been restored. Only in the second case will an MDN be received and the message processed once the service has been restored. Users should therefore plan their submissions around the availability of the systems.
Normal service will resume at 6.00hrs (UK time) on Monday, 17 October 2016.
We would like to thank you in advance for your patience and co-operation during this essential IT maintenance work and we apologise for any inconvenience this may cause. Should you have any questions please contact the EMA IT service desk at https://servicedesk.ema.europa.eu
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The use of the updated EU Module 1 Specification v3.0 and/or v3.0.1 is now mandatory for all eCTD format submissions in the EU. The specification and related documents are available here.
The use of the XML delivery files for submissions via the eSubmission Gateway and the Web Client is now mandatory. The use of XML delivery files has replaced the use of filenaming conventions for majority of human and veterinary submissions to the EMA. More information on the use of the delivery files for submissions via the eSubmission Gateway and the Web Client is available here. The Annexes describing the filenaming conventions have been updated.
Applicants are reminded that the section 2 of the electronic Application Form (eAF) should be filled in. The use of the footnote is only allowed for form and strength information for complex vaccines/combination products. The eAFs and related user guides are available here.
Applicants are reminded that eCTD validation reports must not be provided in the working documents folder in the submissions to EMA. More information on the use of the working documents folder is available in the Harmonised Technical Guidance for eCTD Submissions in the EU document.
A further update to the revised Annex II to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions is available here.
The use of the eAF v1.20 will become mandatory on Monday 19th September 2016. Use of previous versions is accepted only for ongoing applications – the version of the form should not be changed in the middle of the procedure. The latest version of the forms and relevant guidance is available here.
Essential maintenance to PSUR Repository and the eSubmission Gateway on Tuesday evening 20th September 2016
Please note that the PSUR Repository will be unavailable for Member State and industry users between 18.00-19.00hrs UK time on Tuesday, 20th September due to essential maintenance. The EMA eSubmission Gateway/Web Client will not be available during this time.
If you have any questions or issues, please contact the EMA IT Service Desk
Updated versions of 4 electronic Application Forms (eAF v. 18.104.22.168) have been published following reported issues. The updated forms and related release notes are now available here. Version 1.20 of the forms has been available for use since 14th June 2016 and will fully replace version eAF v. 01.19 after an extended transitional period on19 August 2016. Version 1.19 of the forms may be used until 18 September 2016.
Recordings from the webinar training on the use of the updated XML delivery files for submissions via the eSubmission Gateway held on 21st July and the interactive Q&A sessions held on 25 and 26th July are now available here.
The recording of the PSUR Repository v1.07 webinar training held on 25 July and recordings from the webinars on the Mandatory use are now available here.
Previous news is available here