• On 20 June 2022, the new National Pharmacovigilance Network (RNF) and a new international standard format for collecting data on adverse reactions will go live
• From 20 June 2022, the new online reporting method will also be operational, directly through the AIFA portal, which will replace the current 'Vigifarmaco' website
• There will therefore be a transitional phase, from 9 to 20 June 2022, in which suspected adverse reactions can be submitted by email via the reporting forms

On 20 June 2022, the new National Pharmacovigilance Network (RNF), which is the system by which reports of suspected adverse drug reactions (ADRs) are collected, managed and analysed in Italy, will go live. The new RNF will feature advanced functions for the management and analysis of reports of suspected adverse reactions in order to ensure an increasingly accurate assessment of the safety profile of medicines.

Also new is a new international standardised format for reporting suspected adverse drug reactions, which, as of 30 June 2022, will have to be used in all EU countries to send and receive reports of suspected adverse reactions to and from the EudraVigilance System, the European database of suspected adverse drug reactions, with which the RNF is closely linked.

The transition to the new RNF will involve the replacement of some applications currently in use with specific features developed within the new platform. Among these, the new online reporting method, operational from 20 June 2022, which will comply with the new international standard format and will replace the current "Vigifarmaco" portal (www.vigifarmaco.it).

In order to allow the correct and complete migration of data from the current system to the new RNF, a transitional phase is planned during which some applications will be temporarily suspended.
In particular, the 'Vigifarmaco' site will be permanently deactivated at 6 p.m. on 8 June 2022.

From 9 to 20 June 2022, date of activation of the new web modality for online reporting, healthcare professionals and patients/citizens will be able to submit reports of suspected adverse reactions through the other procedures already known:

• filling in the suspected adverse reaction report form and sending it by e-mail to the Pharmacovigilance Officer of their facility;
• completing the Suspected Adverse Reaction Report Form and sending it by e-mail to the Marketing Authorisation Holder (MAH) of the medicinal product suspected of causing the adverse reaction.

From 20 June 2022, online reporting will be possible by accessing the AIFA portal directly.

Published on: 07 June 2022