>It is the same pharmaceutical product already sold on the Italian market, but from other member countries of the European Union, introduced through the channels of traditional distribution.
Yes, the parallel importation is legal and is based on Articles 28 and 30 of the EC Treaty under which it is legal to the free movement of goods between member countries of Europe. In addition, it is planned and regulated by the Ministerial Decree of 29 August 1997 on parallel imports of medicinal products for which marketing authorization has already been granted.
Certainly, companies 'import' medicines from other EU countries need is an authorization to distribute that of a manufacturing authorization to carry out the secondary repackaging the product and adapt to foreign language and assembly of the destination country. The manufacturing authorization requires distributors parallel the same stringent standards and inspections of any other pharmaceutical manufacturer.
No, it is a generic. It 'a brand name drug with the same content quality and quantity of the active ingredient with the same therapeutic indication and the same dose, and therefore identical to the product already present in the Italian market.
In Italy, the import market is very limited (less than 1% in volume) compared to other European countries where parallel imports are actually established for decades (20-30% of the domestic market).
This difference compared to other countries, is mainly due to state laws that promotes this practice and the presence of many products reimbursed by national health services that represent the majority of the market.
In Italy a few years ago there were the first authorizations of drugs in group A (reimbursed by the NHS)
The prices of imported drugs are always less than the price of the reference brand. For products of class C, can be found depending on the product savings ranging from 5% to 20% compared to the retail price of the reference medicinal product.