A defect in section 2 of variation eAF causing fields to overlap and an issue affecting the co-rapporteur field in the human MAA form have been detected and subsequently fixed. New version v.188.8.131.52 of the variation and MAA human forms 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 versions of the forms can be used as of today and the version 184.108.40.206 will fully replace previous versions on1 March 2017. Please note that there is no change to Renewal and MAA vet forms – the version number 220.127.116.11 will remain for renewal and vet MAA forms.
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. The User guide to the XML delivery file creation and the Release notes have been updated and are now available here.
An updated version of the PSUR Repository is now available. This release provides new functionality, changes to the PSUR Repository notifications and defect fixes. The updated NCA User Guide and updated MAH User Guide as well as the updated release notes are available here.
Essential maintenance to PSUR Repository
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07.00 and 09.00hrs on Monday, 20 February 2017. However, the 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.
Updated versions of 4 electronic Application Forms (eAF v. 18.104.22.168 – initially called v1.21) are now available. This new release provides usability improvements and defect fixes with an aim to further improve user experience. 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 updated forms and the related release notes are now available here. The new versions of the form can be used as of today and the version 22.214.171.124 will fully replace version eAF v.126.96.36.199 after a transitional period on1 March 2017. The version of the forms should not be changed during an ongoing procedure.
Version 1.21 of the eAFs will become available on 7 February 2017. The release v1.21 will provide mainly technical defect fixes and usability improvements.
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 16/01/17 to Thu 19/01/17
- NCAs*: from Tue 23/01/17 to Fri 27/01/17 (*Based on the eAFs received from Industry)
If you wish to participate, please email Beatriz.Calvo@ema.europa.eu. A feedback form for consolidated comments will be provided to you following your registration.
Please use the Service Desk portal https://servicedesk.ema.europa.eu to raise any queries related to the eAFs. Procedural queries related to MRP, DCP and National procedures should be directed to the relevant National Competent Authority.
Previous news is available here