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 AN ADVERSE EFFECT?

Any unfavourable or unwanted effect that occurs in a patient who has been given a medicinal product.

HOW TO REPORT ADVERSE EFFECTS

Reporting adverse effects of medicinal products is important because it allows continuous monitoring of their benefit/risk balance. Healthcare personnel are required to report any adverse effects associated with the use of medicinal products to the National Health Authority.

Any adverse effects occurring during the course of or following therapy with a medicinal product should be promptly reported to the family doctor or pharmacist. If you cannot contact them directly and you want to report an adverse effect, you can do so by going to the Italian Medicines Agency website at the following link:

www.aifa.gov.it/content/segnalazioni-reazioni-avverse

The Genetic Pharmacovigilance service can be contacted at:

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Tel : +39 089 890424 (Pharmacovigilance office)

Mob (h24) : +39 346 7007747

Tel: +39 089 8289111 (Genetic S.p.A. laboratory switchboard)

QPPV: Dr Laura De Donato