The Romanian and European regulatory framework for defining and combating medicines counterfeiting is part of the international context and a long history of legislative measures. The Permanent International Forum against Pharmaceutical Crimes was set up, as a network of law enforcement agencies in 15 countries, to disseminate information and promote cooperation in combating pharmaceutical crime. It published a “Guide to Investigating Counterfeit Medical and Other Pharmaceutical Products”, also used by the Interpol. The Directive also introduced, for the first time, references to sanctions.