The Italian pharmacovigilance system is based on the National Pharmacovigilance Network (RNF), which guarantees the collection, management and analysis of spontaneous ADR reports and involves not only the Competent Authority (AIFA) but also Regions, autonomous Provinces, local health structures and pharmaceutical companies.
The MAH shall have permanently and continuously at his disposal an appropriately qualified person responsible for PV (the EU QPPV), and AIFA may request the nomination of a contact person for PV issues at national level reporting to the EU QPPV. The contact person for PV at national level, shall register himself/herself into the RNF.
Healthcare professionals and patients should send spontaneous ADR reports to the PV responsible person of the local health unit/hospital to which they belong; if the MAH gains knowledge directly from the healthcare professional/patient of an ADR report that has not been yet entered into the RNF, the report should be sent to the PV responsible person of the local health unit/hospital to which the reporter belongs. Afterwards, the PV responsible person should enter the report into the RNF, after a check of its validity/completeness.
Following the data entry, the report is visible to AIFA, to the concerned MAH of the medicinal product and to the concerned PV Regional center; all the reports entered in the RNF are automatically synchronized with the EudraVigilance database.
Follow-up information requests by the MAH for ADR reports entered in the RNF, should be performed through the RNF.
RPN support the MAHs for the management of Pharmacovigilance activities.