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. 220.127.116.11) 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