This paper deals with introduction of serialization of medicinal products on the market of the Republic of Croatia. The objective of this paper is to explain the concept of serialization, the impact of serialization on production and sales of medicinal products, the reasons and preconditions for its implementation as well as activities necesary for successful introduction of serialization. The focus of this paper is to identify potential risks related to process, strategies developed and used for risk managemet in case of serialization of medicinal products. The paper uses theoretial knowledge in the field of analysis and risk management as well as practical experience and cognitions gained participating in local project of implementation of seralization of medicinal products held by pharma company Merck. During the process of implementation of serialization to the market of Republic of Croatia, company has identified risks that could endanger the process: the risk of partial loss of company revenue as a consenquence of the implementation process of serialization, the risk of unforeseen increase of company operating costs, risks associated with changes in external packaging of medicinal products, risks associated with functioning of the ERP system used to authenticate produced drugs and the risk of a fall in business reputation of pharma company associated with serialization process.