1. INTRODUCTION AND OBJECTIVES LEGAL ASPECTS AND SOCIO-ECONOMIC IMPLICATIONS REGARDING DRUG COUNTERFEITING CIOBANU CONSTANTIN, CORCIOVĂ ANDREIA Faculty of Pharmacy, Drug Analysis, Pharmaceutical Legislation and Deontology Department, Iași, România MATERIAL AND METHODS RESULTS CONCLUSIONS REFERENCES Medicine counterfeiting has become a worldwide problem affecting both the developing and developed countries and has grown into a real menace to the health system, pharmaceutical industry and of course to the patient safety(1). In 1992, the World Health Organization has developed a definition according to which “a counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.” (2). The European law was compared with the Romanian legal provisions. The presented data analysis is related to: the number of counterfeit medicines the origin countries of the counterfeit medicines the therapeutic categories which are most frequently falsified and their estimated value. Falsified medicines pose a major threat to human health, therefore, a better involvement of the authorities and a better public cooperation in combating this phenomenon is necessary. The purpose of this paper was to present the legislative aspects relating to counterfeiting of medicines and the impact that this illegal activity has on the social and economic level. The paper also exposes some statistics provided by the World Health Organization and other international organisms involved in regulating the provisions of medicine’s domain. In Romania, the authorities are closely monitoring the issue of counterfeit medicines. In accordance with Directive 2011/62/EU all necessary measures were taken in order to prevent the falsified medicines from entering the legal supply circuit. According to article no. 834 of Law no. 95/2006 regarding the healthcare reform, any activity related to drug counterfeiting or the placing on the market of a falsified drug is a crime punishable by law. Specialized websites were also created (www.crimemedicine.ro) where any cases of counterfeit drugs may be reported by the specialists in the pharmaceutical field and also by the population (3). In some developing countries, the most used categories of medicines are probably the antibiotics and antimalarics, so the counterfeiters focus on their "production". In many developed countries of the European Union, the most falsified medicines are those so-called “lifestyle medicines” such as those used in the weight loss and erectile dysfunction treatments (1). 1.World Health Organization, 2003. Substandard and Counterfeit Medicines. Fact Sheet No. 275, November. 2.World Health Organization 2010. Counterfeit medical products: Report by the secretariat. 3.Official Journal of the European Communities 2011. Directive 2011/62/EU of the European Parliament and Council. L 174. India China Egypt UAE Switzer Hong -land Kong