SERIALIZATION – LEGAL AND INFORMATION TECHNOLOGY FRAMEWORK TO TRACK PRODUCT FROM PRODUCER TO CUSTOMER

Abstract

Quality of product and safety of product usage is of key importance in different industries specifi cally in health and pharmaceutical industry. Internet becomes a framework for new e-economy development ringing new and inventive opportunities for business development. But in the same time Internet becomes largest channel for selling fake, counterfeit and misbranded products and pharmaceutical products specially, threating people’s life and public health. To solve this problem number of countries in the world started implementation of track and trace systems that will enable customer and authorities to track production and logistic chain for specific product from the trader, to the producer and even to the row material producer of product. This is not a simple task, since it requires adequate legal framework and information technology system development. The purpose of this paper is to explain legal framework and information technology terms and procedures related with serialization. A brief overview of serialization implementation in different countries and EU is given. Legal and IT framework is presented for EU. Product counterfeiting is a general problem which importance grows in e-commerce environment. Thus serialization in pharmaceutical industries is just beginning; it will be base for future development and spreading this solution in other industries as well