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National Pharmacovigilance Network, everything changes as 20 June

Rete nazionale di Farmacovigilanza

As of 9 June, we are in full transition phase while waiting for the total effectiveness of the new National Pharmacovigilance Network.

The National Pharmacovigilance Network (RNF) is the system where, in Italy, reports of suspected adverse reactions (AdR) to drugs are collected, managed and analysed.

The new version of the RNF will keep its function but will be characterised by advanced functions for the management and analysis of the reports of suspected adverse reactions in order to ensure a more and more accurate evaluation of the safety profile of medicinal products.

The shift to the new RNF will imply the replacement of some applications currently in use with specific functions developed in the new platform.

As of 8 June, the portal “Vigifarmaco (an application of the Italian Medicine Agency for the online transmission of adverse reaction reports for drugs and vaccines, developed by the Regional Pharmacovigilance Center (CRFV) of the region Veneto and extended nationally as of February 2017) will be replaced by a method of online reporting directly in the new portal, to be activated on 20 June.

During this transition phase, and until 20 June, health professionals and patients/citizens can send suspected adverse reactions via email in dedicated reported sheets:

  • to the Pharmacovigilance responsible person of their facility;
  • to the Marketing Authorisation (MA) Holder of the product suspected to be the cause of the adverse reaction.

European Standard for adverse reaction reports

The future online reporting method will comply with the new international standard format.

This standard shall be used within 30 June by all countries of the European Union to send and receive adverse reaction reports to and from the EudraVigilance System (the European Medicine Agency database, operational as of December 2001, collecting adverse reactions reports on medicinal products under development and/or post-marketing), with which the RNF is strictly connected.

Moreover, as of 9 June, the registration and authorisation of new users was suspended in the RNF.

Any request of new registration received after this date were rejected; interested users shall register into the RNF on a second stage according to the new methods becoming effective as of 20 June 2022, concomitantly with the activation of the new RNF.

The registration procedures that had not been completed on 9 June 2022, because of incomplete documentation, were also deleted and users shall register again as of 20 June 2022 according to the new methods provided for by the new RNF. 

Scritto da: Michela Tonci

Foto di StartupStockPhotos da Pixabay