First of all it is necessary to designate a permanent Pharmacovigilance Manager, who must be different from the Scientific Manager.

The Pharmacovigilance Service must manage, in Italy or in other countries, the suspected ADR communicated to the company personnel and representatives.

The Pharmacovigilance Service must report Serious Adverse Drug Reactions (SADR) occurring in Italy and in other countries within 15 days. From 20 November, the SADR warnings must be sent electronically to the European Pharmacovigilance system “EudraVigilance”.

For each single product, the Marketing Authorization Holder must regularly update safety information (Periodic Safety Update Report - PSUR). The frequency depends on the date of release of Marketing Authorization and may vary from 6 months to 5 years.

The Marketing Authorization Holder, through the Pharmacovigilance Service, must inform the Ministry of Health as regards any safety provisions adopted for his products by other competent authotrities, such as foreign ministries, ethics committees etc...
The Marketing Authorization Holder must ensure that Physicians are informed of the PSUR of every single product, guaranteeing that all the information will be rapidly promptly communicated to health personnel, also by means of their own network of pharmaceutical representatives.

Every three months, the Marketing Authorization Holder must send, by computer, the sales data for every product..

As regards Clinical Trials, Pharmacovigilance follows “ad hoc” rules. However, channels and criteria of notification are similar to those established for marketed products.