The Italian Medicines Agency (AIFA) is making available a notice reminding marketing authorisation holders of the importance of correctly and consistently completing the medicinal product name and active substance fields in ICSRs in accordance with the ICH E2B(R3) standard.

The notice follows issues identified in the automatic mapping of ICSRs transmitted from EudraVigilance to the Italian National Pharmacovigilance Network (RNF).

The aim is to facilitate the correct identification of medicinal products and active substances and the automated receipt of ICSRs through re-routing, thereby reducing the need for manual mapping while ensuring that the information provided by the primary source is preserved and that the requirements set out in the ICH E2B(R3) standard and GVP Module VI are met.

Further information is available in the related document.