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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.

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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