In brief
On 20 June 2022, the new national pharmacovigilance network (RNF), which ensures the collection, management and analysis of suspected adverse reaction reports of medicines in Italy, became operative.
- The new RNF is characterized by advanced features for the management and analysis of suspected adverse reaction reports to ensure an increasingly accurate assessment of the safety of medicines. The transition to the new RNF involves the replacement of some applications with specific features developed within the new platform, including the new online reporting method, which is in line with the new international standard format and replaces the “Vigifarmaco” portal.
- In addition, there is also a new international standard format for reporting suspected adverse reactions, to be used in all EU member states from 30 June 2022 to send and receive suspected adverse reaction reports to and from the “EudraVigilance” system, the European database of suspected adverse reactions with which the RNF is closely linked.
