La farmacovigilanza: la normativa vigente

DI VALERIA CICONTE

ABSTRACT – The Italian pharmacovigilance system only received a real discipline with Legislative Decree no. 219 of 24 April 2006 (the so-called Drug Code) adopted in implementation of Directive 2001/83/EC; subsequently amended by the Decree of the Ministry of Health of 30 April 2015, which states that the Italian pharmacovigilance system is «a control and reporting system used by the Marketing Authorisation Holder and Member States to carry out the functions and responsibilities identified in the legislation, aimed at monitoring the safety of authorised medicines and detecting any changes in their risk/benefit ratio». It is therefore an activity of public interest, aimed at the continuous monitoring of the so-called adverse reaction which today must be understood as «a noxious and unintended reaction resulting not only from the authorized use of a medicinal product under normal conditions of use but also from therapeutic errors and uses not in accordance with the indications contained in the marketing authorisation, including misuse and abuse of the medicinal product».

KEYWORDS – Pharmacovigilance, Drug code, EMA, AIFA, Decree of the Minister of Health of 30 April 2015, Adverse drug reactions.

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