The Italian Medicines Agency informs health professionals and citizens that the page of the portal that describes how to report suspected adverse reactions to medicines with the link to report directly online on the site www.vigifarmaco.it.
AIFA recalls that the European legislation on pharmacovigilance requires all healthcare professionals and citizens to report any suspects adverse reaction (serious and not serious, known and not 
Note).
The Decree of the Ministry of Health of 30 April 2015 reaffirmed the obligation to promptly report suspected adverse reactions from drugs and vaccines and defined time limits within which healthcare professionals are required to report to the National Network of Pharmacovigilance (RNF) of AIFA.
Suspected adverse drug reactions should be reported within 2 days of when your doctor or healthcare professional becomes aware of them. The reporting obligation drops to 36 hours in the case of ADRs from medicinal products of biological origin (including vaccines).
It is possible to make a spontaneous report of suspicion adverse reaction in one of the following ways:
- directly online on the site www.vigifarmaco.it following the wizard;
- by filling in the form (electronic or paper) to be sent to the Head of pharmacovigilance of your facility or to the Marketing Authorization Holder (AIC) of the medicine that is suspected to have caused the adverse reaction. It will be the responsibility of the latter to forward it to the Manager of pharmacovigilance of the structure to which the reporter belongs.
For further information go to the page on AIFA portal
Watch the European awareness campaign video on reporting suspected adverse reactions
Related news: AIFA. Signal list
Ed: Please note that the art. 130 of Legislative Decree 219/06 establishes that the marketing authorization holder for medicinal products must have, on a stable and continuous basis, a person in charge of the pharmacovigilance service.
The person in charge of the pharmacovigilance service must be a different person from the person in charge of the scientific service envisaged by article 111 of this decree, and must be able to use all the data of this service. The responsibility of the person in charge extends to all medicines whose marketing authorization is held by the company he employs, even if marketed by other companies.
The marketing authorization holder is obliged to disseminate the information notes and updates on the safety of medicinal products to the prescribers, according to the indications, times and methods established by AIFA, whenever new information emerges relating to the tolerability profile of the medicinal product.
The head of the pharmacovigilance service ensures that all information relating to the safety of medicinal products, subsequent to the act of authorization, is quickly brought to the attention of healthcare personnel also through the contacts of the scientific information service of your company.
The scientific informants they must report to the scientific service referred to in article 126, on which they depend, and to the head of the pharmacovigilance service referred to in paragraph 4 of article 130, all the information on the undesirable effects of medicines, attaching, where possible, a copy of the reporting forms used by the doctor in accordance with Title IX.
