Update on electronic reporting of adverse reactions occurring outside the European Economic Area

05 February 2008

The IMB would like to take this opportunity to highlight an update in the accepted mechanism for reporting of adverse reactions occurring outside the European Economic area (EEA).

Companies and sponsors are advised that with immediate effect there will no longer be a requirement to submit adverse reaction case reports occurring outside the EEA directly to the Irish Medicines Board (IMB) provided those companies/sponsors are meeting their legal obligations for adverse reaction reporting of non-EEA cases through submission of such cases directly to EudraVigilance. However, where required, companies/sponsors must continue to be in a position to provide these data immediately on request to the IMB.

For detailed information and guidance please see the updated IMB ‘Guide to Electronic Submission of ICSRs and SUSARs Associated with Use of Human Medicines’ which can be found in the Pharmacovigilance section of the IMB website at www.imb.ie, under ‘Electronic Reporting’.