Description of the System of State Registration of Medicines in the Republic of Georgia as a Development Potential of Domestic Manufacturers

Abstract

Introduction. One of the main business objectives of Russian pharmaceutical companies is export development. To obtain marketing authorization in countries with a good potential for business it is of greater importance to be competent in drugs registration procedure.Aim. The purpose of this study is to overview general aspects of registration procedure for generic drugs in Georgia for potential launching on pharmaceutical market.Materials and methods. For research purposes we have utilized data obtained from research articles, official websites, regulatory documents for drug registration procedure in both Russian Federation and Republic of Georgia, and documents of registration dossier. Also for this research we have applied benchmarking study, generalized and classified obtained information.Results and discussion. The similarities and differences of drug registration procedure have been determined, e.g. timelines, dossier format, and legal frameworks in both Russian Federation and Republic of Georgia. Also we have emphasized a list of features that could be benefiting for drug registration in Georgia.Conclusion. A review of the state regulation procedure in the field of drug circulation in the Republic of Georgia allows us to conclude that there are favorable conditions for state registration of drugs from a Russian manufacturer.

Keywords

• drug registering
• marketing authorization
• authorization procedure in russian federation and georgia republic
• registration dossier
• drug products export