Essential maintenance to EMA computer applications affecting PSUR Repository and eSUB UI on Sunday, 18 March
PSUR Repository and eSUB UI will be affected by essential maintenance to EMA computer applications between 09:00 and 14:00hrs (UK time) on Sunday, 18 March 2018. During this time, the NCA user interface (PSUR Repository access to documents) and the User Interface (for generation of the XML delivery file) will be unavailable. The eSubmission Gateway will continue to be available throughout this period so MAHs can send PSUR submissions.
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)
Common Repository (User Interface and API) is now extended to include the following types of submissions related to procedures for Human Medicinal Products: Signal Detection, PASS 107 NAPs, Work share NAPs and Ancillary products for new submissions from the 8th of March 2018 onwards. This will be followed by a transitional period of 6-9 months, during which all NCAs will have time to adapt their systems and business processes in order to switch to the sole use of the Common Repository. During the transitional period, NCAs can still receive submissions directly from applicants, but they will also have the opportunity to switch to the sole use of the Common Repository during this period as and when they are ready to do so. Following the transitional period, the use of the Common Repository for above submissions will become mandatory for all NCAs. The date for the mandatory use is not yet decided.
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 07:00 (UK time) on Saturday, 10 March and 18:00 (UK time) on Sunday, 11 March 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, 9 March, 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.
The updated eCTD validation criteria v7.1 is now available here. The updated validation criteria will enter into force on 1st of September 2018.
The NeeS validation criteria v4.3 has been updated in-line with the updated eCTD validation criteria. The updated document is now available here. The updated validation criteria will enter into force on 1st of September 2018.
The EU Harmonised Technical Guidance for ASMF Submissions in eCTD format (version 2.1) has be edited in chapter 4 to clearly address rules on how to submit Letter of Access.
Essential maintenance to computer applications on Thursday 8 March 2018
Common Repository, PSUR, Gateway File Handler and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 14:00 and 15:00 hrs (UK time) on Thursday, 8 March 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.
A new version of the Common Repository will be available in March 2018 extending the system to other EMA led EU procedures submissions.
Common Repository will extend and/or add new Cabinets to include the following types of submissions related to Human procedures:
- Signal Detection
- PASS 107 NAPs
- Work share NAPs
- Ancillary Products
The use of the eSubmission Gateway and/or the Web Client become mandatory for all paediatric applications from 1 January 2018. To allow applicant to adapt to the new submission requirements, the EMA will allow a transition period until 15 March 2018. After this date, the European Medicines Agency (EMA) will no longer accept submissions by Eudralink.
New versions of the 4 electronic Application Forms (eAF v. 220.127.116.11) and the related release notes are now available. This new version is a hotfix release v18.104.22.168 of the forms and can be used as of today, 16th February 2018. The version of the form should not be changed during an ongoing procedure.
As of 15 February 2018 version 1.22 of the four electronic Application Forms (eAFs) are mandatory. Older versions of the forms will no longer be supported.
Previous news is available here