Kolyada V. Improvement of organizational and legal system to regulare circulation of OTC and POM drugs

The thesis is devoted to the improvement of organizational and legal system regulating circulation of prescription-only medicines (POM) and over-the-counter (OTC) medicinal products by determining the objective criteria of referring the finished medicinal product to one of these categories during the Procedure for State Registration. Based on the thorough analysis of the legislation of Ukraine regulating circulation of medicinal products of different classes and groups and the Database of Registered Medicinal Products (as of 01.01.2006) the algorithm of referring medicinal product to one of the categories (POM or OTC) at the stage of state registration has been developed. There were first established the objective (quantitative) criteria of referring a medicinal product to the appropriate dispensing category. Provision of regions of Ukraine with narcotic medicinal products and psychotropic substances has been analyzed. Formula for calculating the total amount of these products being stored at the territory of Ukraine has been proposed as well as the mechanism of forming so-called 'quota' (at the different stages of circulation) has been identified. Draft Order the Ukrainian Ministry of Health Ukraine "On Procedure of Importing Unregistered Medicinal Products on the Territory of Ukraine for Conducting Pre-clinical Studies, Clinical Trials and State Registration" has been presented in order to settle one of the issues related to the state registration of medicinal products