Pharmacovigilance
The safety of patients is so important for us that we monitor all our medicinal products.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
It is a mandatory activity to be performed and involves patients, prescribers, physicians, healthcare professionals, pharmaceuticals companies, academies.
In Italy, the regulatory agency AIFA receives all the adverse events reports through the RNF, the Italian Pharmacovigilance Network. All these data are re-routing to the European Medicines Agency (EMA), which coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.
HOW TO REPORT ADVERSE EVENTS
Patients and Healthcare Professionals (HCPs) can report adverse events through:
- The reporting form available at
https://www.aifa.gov.it/moduli-segnalazione-reazioni-avverse - The online form at:
https://servizionline.aifa.gov.it/schedasegnalazioni/#/
Otherwise, patients and HCPs can report adverse events directly to Bruno Farmaceutici through the Adverse Event Reporting Form available in this website.