On 30 April 2015, the Ministry of Health approved a new Decree concerning operating procedures and technical solutions for the effective performance of pharmacovigilance.

The Decree, as well as extending the definition of “adverse reaction” so as to include cases deriving from therapeutic errors and uses not conforming to the indications contained in the marketing authorization (autorizzazione all’immissione in commercio – “AIC”), introduces new and further obligations related to pharmacovigilance in the procedures both for the issuance of new AICs and for their renewal. With regard to the first aspect, the list of information and documents related to pharmacovigilance to be attached to the applications for AICs has been increased. For renewal purposes, an update to the dossier for the medicine is required, which should address all aspects related to the quality, safety and efficacy of the pharmaceutical, including an evaluation of the data contained in the reports on suspected adverse reactions.

Furthermore, the Decree governs studies on the safety and quality of pharmaceuticals after their entry into the market, site inspections at places of manufacture, importation, control and storage of medicines, and also dictates specific rules on the registration and reporting of suspected adverse reactions.

The Decree will enter into force following its publication in the Official Gazette of the Italian Republic.