MAHs should not submit ICSRs and SUSARs to IMA during EudraVigilance downtime from 8 to 21 November 2017

12.10.2017

In the EudraVigilance Go-Live Plan, published 3 October 2017, IMA has been classified as belonging to option 2C in table 4 (page 30 and so on in the Go-Live Plan). According to this, MAHs have to report individual cases originating from Iceland using the IMA´s web portal. IMA would like to bring to all MAH´s immediate attention that this is information is not correct and is due to a mistake made by IMA when providing information to EMA earlier this year.

The correct arrangement is that during the aforementioned scheduled downtime of EudraVigilance, from 8 to 21 November 2017, MAHs should not submit ICSRs and SUSARs to the agency. IMA should accordingly have been classified as option 1 in table 3 (page 21 and so on in the Go-Live Plan).

IMA apologises for any resulting inconvenience