Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Marketing authorization process and regulation of veterinary medicinal products in the CIS countries ***

Dr. Elza Okon (Abschlußjahr: 2017)

Summary
Language: English
The pharmaceutical industry for humans and animals is one of the most important components of the strategy of national and political security of any state, as well as one of the most profitable and rapidly developing segments.
One of the most dynamically developing regions in the world for pharmaceutical products is the Commonwealth of Independent States (CIS). Eleven CIS countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russian Federation, Tajikistan, Uzbekistan, Turkmenistan and Ukraine) together occupy a territory of approximately 22.25 million square kilometers and have a population of 280 million people, which is the reason why the interest of pharmaceutical companies in expanding their business and product footprint across the CIS region has been constantly growing. To achieve this goal the knowledge of the respective veterinary medicinal product regulations is indispensable.
The CIS countries are not equally successful in implementing market reforms and embracing a global competitive environment. Many of the CIS member states are still in the midst of the transition from being a former member of the Soviet Union to an independent state when it comes to standards, regulations and especially the relation between the written law and its interpretation and implementation.
Every CIS country has its own laws, standards, rules and practices, including the organization of business and product promotion. Despite the differences among the CIS countries in the development of veterinary products and their registration procedures, the requirements concerning the registration dossier, registration tests procedure and labelling are quite similar. This can be explained by their common history as former states in the Soviet Union.
The transparency of the authorization processes itself varies dramatically between the CIS member states. In particular, Moldova, Tajikistan and Turkmenistan are examples of CIS member states with hardly any publicly available information on the registration process. In contrast, Armenia and Ukraine do provide a very clear and easy to access information also in English language (registration process, legislation, normative documentations and others).
Nevertheless, a steady progress can be observed in the CIS countries. There are member states forming additional unions like the EAEU to bring the standardization to the next level. The overall the tendency is clear: the regulation is becoming more transparent and strict leading to the need of a much deeper understanding by international companies intending to place their veterinary medicinal products on the increasingly important CIS markets.
Within this master thesis, a comprehensive overview of the most relevant aspects of the marketing authorization processes for each of the CIS countries is provided. A comparative analysis of the registration system of the EAEU and EU shows essential differences in the submission system, duration of the authorization, registration documents, process of registration, legislation, quality assurance, quality documentation and post-authorization control.
Pages: 66