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AIFA publishes new Pharmacovigilance FAQs

The Italian Medicine Agency has published a new FAQ document on the management of reports in the National Pharmacovigilance Network (RNF) to provide practical indications to pharmacovigilance responsible persons and facilitate the inclusion of the information reported in the ADR sheet and the performance of pharmacovigilance activities in the light of the changes following the provisions on the simplified electronic reporting of suspected adverse reactions.

In particular, the MAs are no more bound to ADRs reporting to local Pharmacovigilance responsible persons of the reporters’ health facilities or directly to the RNF, but they have to transmit them directly to the EudraVigilance, that will forward them to the RNF via “re-routing”.

The reporting of suspected ADRs by patients and/or health operators remain unvaried.