10/11 April 2024
Due to inquiries concerning the handling of ICRs in EudraVigilance, the European Medicines Agency EMA has published a "Note for clarification".
"With the launch of the new EudraVigilance system on 22 November 2017, the simplified (electronic) reporting of suspected adverse reactions related to medicines in the format of Individual Case Safety Reports (ICSRs) by National Competent Authorities (NCAs) and marketing authorization holders (MAHs) to the EudraVigilance database became mandatory. Based on this simplification, NCAs and MAHs no longer have to report to each other directly, thus reducing duplicative reporting."
The brief document with the title "Recording by marketing authorization holders of information on suspected adverse reactions held in EudraVigilance" describes on three pages (and an additional Annex A on "Pharmacovigilance obligations with focus on the safety monitoring and benefit-risk assessment of medicinal products") the regulatory expectations on the handling of SAR cases (Suspected Adverse Reactions) published in EudraVigilance.
According to the agency, cases which have been submitted by authorities since 22 November 2017 for own products and for such where ownership cannot be excluded should be actively monitored in EudraVigilance and recorded in the MAH database. For entries made by other MAHs, this is not generally mandatory. However, the decision and justification of not recording the data must be documented:
More information can be found on the EMA's website in: EudraVigilance training and support.