EudraVigilance unavailable from 8 until 21 November 2017
On 22 November 2017, the European Medicines Agency (EMA) will launch an update of EudraVigilance, the European system for sponsors to report Suspected Unexpected Serious Adverse Reactions (SUSARs). Due to the update, it will not be possible to report SUSARs in EudraVigilance from 8 until 21 November 2017.
What does this mean for reporting SUSARs to the MREC and the Competent Authority in the Netherlands during the downtime?
Reporting to MREC: During the downtime you can continue your current reporting procedure. Do you use the possibility to upload your SUSAR report to ToetsingOnline? Then during the downtime you must fill in at question A7 that the SUSAR is already reported in EudraVigilance, and you must attach a pdf file in which the SUSAR is described to the SUSAR form. You must still report the SUSAR to EudraVigilance after the downtime.
Reporting to Competent Authority: During the downtime you can continue your current reporting procedure. Are you authorized to report SUSARs in EudraVigilance? Then you must still report the SUSARs to EudraVigilance after the downtime. It is not required to also report these SUSARs to the Competent Authority.