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:
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 (in electronic or paper form) to be sent to the Responsible of Pharmacovigilance and sending it to the Responsible of Pharmacovigilance of the local structure or to the MA holder of the medicinal product suspected for the adverse reaction. The MA holder shall take care of sending the file to the Responsible of Pharmacovigilance of the local structure.
The files for Healthcare Operators or Citizens are available below:
the “paper file” for reporting a suspected adverse reaction (introduced by the Ministerial Decree 12/12/2003) can be downloaded and printed by clicking on:
the “electronic file” for reporting a suspected adverse reaction can be filled online by clicking on:
• Healthcare Operators:
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 http://www.agenziafarmaco.gov.it/it/responsabili
Such Responsibles of Pharmacovigilance shall insert the reports of suspected adverse reactions into the National Pharmacovigilance Network. This way a constant and continuous monitoring of the adverse reactions and safety of use of the medicinal products shall be performed.
Please refer to.: Agenzia Italiana del Farmaco
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