The Italian medicines agency has announced that the new Italian National Pharmacovigilance Network adapted to European standards is available. Here are the news.
New Italian National Pharmacovigilance Network
It is available from 20 June 2022, the new National Pharmacovigilance Network, the is the system by which reports of adverse reactions from the use of drugs are collected, processed and analyzed. The new National Pharmacovigilance Network will be characterized by the use of the standard ISO (ICSR) ICH E2B (R3) format. This is essential for the exchange of reports with Eudravigilance, the European database.
We remind you that this format entered into force in 2017, when the transition period began, and that it will have full applicability from 30 June 2022.
New Italian National Pharmacovigilance Network, new reporting method
At the same time, so from 20 June 2022, a new online reporting method is also made available through the AIFA portal. This is compliant with the international standard. “Vigifarmaco” the Italian database, was discharged from 6 pm on June 8, 2022.
Transitional phase of reporting to AIFA
To overcome the time gap between the discharge of Vigifarmaco and the activation of the new platform, from 9 to 20 June, healthcare professionals and patients will be able to report suspected adverse reactions by filling in the appropriate form. They can sending it by e-mail to the company pharmacovigilance responsible or to the MAH of the drug suspected to have caused the adverse reaction.
New AIFA reporting forms
In addition to the new platform, the possibility of reporting by filling in and sending the forms to the pharmacovigilance manager or to the MAH will remain active. AIFA has made available, in place of the existing ones, reporting forms updated to the ISO standard (ICSR ) ICH E2B (R3). Therefore they include the additional fields provided for by the new format, and are graphically updated for better usability.
Here are the links to download them