Following the publication by the European Medicines Agency (EMA) of the ‘Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)’, effective from 1 February 2025, the Italian Medicines Agency (AIFA) would like to provide clarification on the nature and management of the Specific AR FUQs.

In particular, how these questionnaires should be managed by the Local Responsible for Pharmacovigilance (RLFV) within the National Pharmacovigilance Network (RNF), in order to collect the information required by the MAH, which will be available to them through the Eudravigilance database.