Pharmacovigilance - Reporting requirements of non-serious ICSRs, applicable to marketing authorisation holders

Marketing authorisation holders are no longer required to submit non-serious individual case safety reports.

4.12.2012

As of 4 December The Icelandic Medicines Agency no longer requires Marketing Authorisation Holders (MAHs) to submit non-serious individual case safety reports (ICSRs) for cases occurring in Iceland.

MAHs should continue to submit ICSRs for serious cases directly to EudraVigilance (EVHUMAN).