Changes to the National Network of Pharmacovigilance

The Italian Medicine Agency informed all concerned parties that some changes have been introduced to the National Network of Pharmacovigilance (RFN) allowing the registration of reports of suspected adverse reactions occurred on the national territory by MAHs in specific situations. In particular, for the MAHs it is still mandatory to transmit all reports of serious and non serious suspected adverse reactions occurred in Italy, received directly by the reporter or coming from internet or digital media screening, market surveys, or telephone calls, or other.  In case it is not possible to track back the local Health unit of the reporter, these reports shall be uploaded in the RNF directly by the MAHs, after checking that they have not been uploaded already. The procedure will concern the reports of serious and non serious adverse reactions which are associated with at least one of the medicinal products held by the company. The communication also includes a technical document showing the changes in details. The new provision will be applied starting from April 1st 2015.