Italy

The European pharmacovigilance requirements have been implemented in Italy by Legislative Decree no. 178 of 29 May 1991 and Legislative Decree no. 44 of 18 February 1997.

The Italian authority responsible for pharma-covigilance is the Department for the Evaluation of Medicinal Products and Pharmacovigilance of the Ministry of Health (the Department of Pharmacovigilance). The Department of Pharmacovigilance liaises with regional health authorities, with the national pharmacovigilance authorities of other Member States, with the Agency and with international institutions, such as the WHO.

In accordance with European requirements, all pharmaceutical companies must appoint, a "qualified person'' responsible for pharmaco-vigilance, on a continuous and permanent basis. Pharmaceutical companies must notify local health authorities of any serious adverse reaction relating to their products of which they have been informed within three to six days (depending on the seriousness of the reaction). Local health authorities must pass this information to the Department of Pharmacovigilance.

Medical doctors and pharmacists are required to provide the same notification, within the same deadline, whether or not they have prescribed or dispensed the product, and even for products which are undergoing clinical trials. Local private or public authorities must inform the Department of Pharmacovigilance within three to five days and give notice to the product's marketing authorisation holder and to the regional authorities. As from 30 April 2002, adverse event reports may be submitted online. A copy of the reporting form is included at Appendix 10.

Non-compliance with the regulatory requirements constitutes a criminal offence. Marketing authorisation holders and "qualified persons'' breaching the regulatory requirements are liable on conviction to a fine between 15 494 and 92 962 Euros. Medical doctors and pharmacists are liable on conviction to a fine between 516 and 5165 Euros.

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