Pharmacovigilance

The Icelandic Medicines Agency wishes to receive reports of cases occurring in Iceland according to the following:

• All serious reports
• All unexpected reports, both serious and non-serious
• All reports of drugs registered within the past 5 years, druglist, if the ADR is not listed as common in the SPC.
• All reports of ADRs that are not listed as common in the SPC and seem to be more frequent or serious.

IMCA has posted a letter on the EudraVigilance website stating the Icelandic requirements for electronic reporting.

Send all serious ICSRs of cases occurring in Iceland electronically to both EudraVigilance with the message receiver identifier EVHUMAN and to the IMA with the message receiver identifier ADALIMCA01.

When a local representative of a MAH in Iceland receives a report directly from a healthcare professional, the report should be submitted to IMA as well as  to the MAH,.

Third country (non-EEA) suspected unexpected serious adverse reactions should be sent to EudraVigilance only, with the message receiver identifier EVHUMAN.

Please also note that MAHs, which are not yet able to report electronically, must perform paper-based reporting to  IMA until they have successfully implemented electronic reporting to EudraVigilance.

Further informations regarding Pharmacovigilance

Further informations regarding EudraVigilance