Vigilance

Market vigilance is a set of activities aimed at continuously evaluating all information relating to the safety of Freia products, including suspected accidents and / or adverse reactions to their intake, and to ensure the reduction of the possibility that the same accident and / or adverse reaction may recur at a later time.

Medical devices

The reporting system for medical devices is managed by the Ministry of Health which has the task of evaluating and classifying accidents involving medical devices and, within the Community, guaranteeing a high level of health protection through integrated surveillance systems between Member States and the European Commission.

Further information on Italian MoH

For healthcare professionals

Public or private healthcare professional, when in the exercise of their activity detect an accident involving a medical device, are required to notify the Italian Ministry of Health, with the terms and conditions are established by the legislation.

See the following link (in italian):

Rapporto di incidente da parte di operatori sanitari al Ministero della Salute.

The pdf file so generated must be sent to Office 5 of the Directorate General for Medical Devices and Pharmaceutical Service, at the address
dgfdm@postacert.sanita.it

Nutritional supplements vigilance

The system for reporting adverse reactions due to the intake of food supplement, dietetic product or food for special medical purposes is managed by the Istituto Superiore di Sanità.

See the following link (in italian):

Vigierbe

The pdf file so generated must be sent to dirscientifica.vigilanza@freiafarmaceutici.it

Update: april 2020