Biological responses to exposure to a medicine vary from person to person. That’s why not all side effects (also known as adverse events) associated with the use of medicines can be identified during the clinical development of the drug, before it becomes available on the market.
Reports of adverse events by health professionals and patients are an important tool used to monitor the safety of commercially available medicines and to improve knowledge of the risk-benefit ratio of treatments.
Neopharmed Gentili collects and assesses these reports in order to keep the information on the safety of the Group’s medicines up to date, thereby fulfilling a specific legal obligation and contributing to the protection of public health.
According to the Italian legislation, adverse events can be reported in several ways:
- by filling out the report form of suspected adverse reaction and sending it via e-mail or fax to the responsible person for Pharmacovigilance of their own Local Health District (ASL), whose e-mail can be found at this link https://www.aifa.gov.it/responsabili-farmacovigilanza,
- by specific website Vigifarmaco https://www.vigifarmaco.it/ following the guided procedure.
Reporting forms for healthcare professional and patient are available in the section “Modulistica” of Italian Medicines Agency’s (AIFA) website
Reporting forms templates for Healthcare Professionals regarding incidents and any issue related to the safety of medical devices are available in the section “Sistema di segnalazione per i dispositivi medici” of the Italian Ministry of Health (Ministero della Salute) website
You can contact the Neopharmed Gentili Group’s Pharmacovigilance Service by filling out the following form.