The Pharmacovigilance has been defined by the World Health Organisation as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”.
What is meant by adverse reaction?
An adverse reaction is a noxious and unintended response to a drug product:
• used according to the directions contained in the marketing authorisation, or
• not used according to the directions contained in the marketing authorisation (including overdosage, misuse, abuse, therapeutical mistakes), or
• associated to the exposition due to professional reasons.
Please find below the way reporting of suspected adverse reactions can be made:
As per Ministry of Health Decree dated May 31st 2019, the reporting forms for suspected adverse reactions to medicinal products or vaccines are published on the institutional website of the relevant national Authority (Agenzia Italiana del Farmaco – AIFA), at the address:
Healthcare operators and/or citizens can notify suspected adverse reactions to the competent Authority (Agenzia Italiana del Farmaco- AIFA):
- directly online on the website www.vigifarmaco.it following the guided procedure
- by filling the file to be sent to the Responsible of Pharmacovigilance of the local structure or to the MA holder of the medicinal product suspected for the adverse reaction.The file can be downloaded by clicking on:
The references and e-mail contacts of all the Responsible of Pharmacovigilance of the local structures all over the national territory are available by clicking on:
The spontaneous reporting made by physicians, pharmacists, other healthcare operators and patients themselves is essential to allow the Health Authorities operating on Pharmacovigilance and the pharmaceutical companies as well to define the tolerability and safety profile of medicinal product (benefit/risk ratio) and keep it updated.
To contact the Pharmacovigilance Office of SAVIO Pharma Italia S.r.l.:
Tel: +39 3898536958