Issues associated with the state registration of food supplements are regulated by the Ministry of Health Protection of the Republic of Uzbekistan. In accordance with Decree of the Chief State Sanitary Doctor No. 1 of February 04, 2009 "Procedure of issuing a permit for imported biologically active food supplements in Uzbekistan" food supplements are allowed for use in Uzbekistan after state registration.
What is required for registration
In order to register the food supplement, it is necessary to provide the following to the Main Department of Sanitary and Epidemiological Supervision of the Ministry of Health of the Republic of Uzbekistan (Department):
1) Application form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- legalized extract from the register of legal entities for the applicant;
- legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers (if available);
- legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers (if available);
- legalized copy of registration certificate issued by the competent authority of country of applicant or manufacturer (if available);
- proposed mockups for the market of Uzbekistan;
- certified copy of instruction for use or summary of product characteristics (composition, product form, description, shelf-life, storage conditions, etc.);
- description on types of strain of living organisms in Latin, passport or certificate on strain (for food supplement containing living organisms);
- document confirming prion safety (for food supplement containing products of animal origin);
- document confirming transmissive safety (for food supplement containing blood components);
- botanical name of parts of plants in Latin, pharmacopoeial articles, form and method of preparation (for herbal food supplements);
- scientific data;
- methods of control of food supplement;
- certificate of analysis for food supplement from its manufacturer;
- clinical studies report (if available);
- stability data.
2) Samples of food supplement for conducting the required studies.
Procedure
Upon filing the application for registration of food supplement toxicological studies are conducted simultaneously with examination of the registration materials. Required amount of studies and samples of said product depends on the type of product and is requested after submission of the registration dossier to Department and its preliminary expertise.
In case of absence of own clinical studies, it is necessary to include all well-known public information into the registration dossier. If this information is not enough after submission of the registration dossier the Department will require conducting the additional studies in the territory of Uzbekistan during the registration procedure.
Timeframe
In accordance with the usual practice depending upon the completion of the provided materials and scope of documentation, number of requests of the competent authority and other factors, the procedure of state registration of food supplement in Uzbekistan may constitute about 6-10 months without considering the time for preparation of responses to the remarks.
Validity term and renewal
The Certificate about the state registration of food supplement in Uzbekistan is valid for 5 years and after that it is necessary to renew it each time for the next 5 years.
In order we could provide you with the information on costs associated with registration of food supplements in Uzbekistan together with the detailed information and list of documents required from your side, as well as a sample of the Power of Attorney for execution, etc. please contact our specialists.
