On July 21, 2011 the new European legislation on pharmacovigilance will come into force. This is the EU Directive 84/2010 and the EU Regulation 1235/2010, amending respectively Directive 83/2001, the Community code relating to medicinal products for human use (implemented in Italy by Legislative Decree 219/06), and Regulation 726/04 providing for Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing an European Medicines Agency (EMA). The purpose of these new provisions, which has been adopted after the Pharma Package(adopted by the European Commission in 2008) and in view of the alarming data collected by the European Union concerning the adverse reactions to drugs (Adverse Drug Reactions,ADRs), is to strengthen the system of pharmacovigilance, in particular allowing a more rapid and efficient information circulation on ADRs and establishing who (among the holders of marketing authorizations-MA, Member States, health workers, etc..) is required to do what. The most significant modifications concern: the inclusion of a requirement for additional monitoring of some drugs indicated in a list of the EMA, the strengthening of the database EudraVigilance, the change in the definition of "adverse reaction", the possibility to impose to marketing authorization holders to conduct additional studies on safety and /or efficacy of the drug, the obligation for each Member State and for each holder of a MA to adopt a precise system of pharmacovigilance and the provision of a committee on risk assessment for pharmacovigilance within the EMA.