Dear EudraVigilance User,

The European Medicines Agency is carrying out essential maintenance activities to release the new EudraVigilance Human system following the announcement in May 2017 by the EMA Management Board.

The EudraVigilance (Human and Veterinary) production environment is partially available from 8 November 2017 (00:00 AM UK time) until 22 November 2017 (09:00 AM UK time).

EudraVigilance Human users:

During the maintenance period, the following modules of the EudraVigilance Human system are NOT available:

The EudraVigilance Gateway remains available for exchange of safety information between MAHs and NCAs but no xml validation will be performed.

Please note that you must not send any ICSRs, SUSARs and XEVMPRM messages to EudraVigilance from 8 November (00:00 AM UK time) to 22 November (9:00 AM UK time). Any messages sent during this period will be deleted.

From 8 - 23 November the daily MLM spreadsheets will be published on the MLM Webpage.

Please note that during this period the sum_ICSR spreadsheet will be that of the 7th November 2017, since no ICSRs will be transmitted to EV during the downtime. The sum_screen spreadsheet will be updated each business day at 9:00 AM UK time.

For details please consult the EudraVigilance go-live plan, in particular for the alternative arrangements that need to be adhered to by stakeholders during the downtime and the mechanisms in place to notify any emerging safety issues by MAHs or sponsors of clinical trials to Member States and the EMA.

 

EVDAS users:

During the maintenance period, EVDAS is affected partially:

 

EudraVigilance Veterinary users:

During the maintenance period, the following modules of the EudraVigilance Veterinary system are NOT available:

The EudraVigilance Gateway remains available for exchange of safety information, for reports having occurred in Germany, Spain or the UK, between MAHs and NCAs but no xml validation will be performed.

Please note that you must not send any ADRs messages to EudraVigilance Veterinary from 8 November (00:00 AM UK time) to 22 November (9:00 AM UK time). Any messages sent during this period will be deleted.

For the backlog reports that have accumulated over the downtime period, these shall be submitted between 22 November (9:00 AM UK time) and 29 November (12:00 PM UK time). For backlog submission the reports having originated within the EEA should be prioritized.

Please refer to the published News item on EMA website and the EudraVigilance Veterinary Website for further information.

 

EVVET DWH users:

During the maintenance period EVVET DHW is partially affected:

 

We apologise for any inconvenience caused.

Should you require any additional information or support during this period, please contact the EMA Service desk (https://servicedesk.ema.europa.eu/).

The EudraVigilance Team