In accordance with the Law of Belarus No 217-3 "On quality and safety of the food raw material and food products for human life and health" dated June 29, 2003 food supplements that are imported into the territory of Belarus for the first time are subjects to the state registration before their entry into the territory of Belarus.
According to the Decision of the Commission of the Customs Union dated May 28, 2010 No. 299 the state registration of food supplements is possible only after conducting the complex studies of samples of said product in authorized and accredited research institutions and obtaining the expert conclusion from these institutions.
The procedure of the state registration is divided in 2 stages:
- submission of the required documents to the authorized institution for conducting the complex studies to obtain an expert conclusion;
- submission of the application and required documents along with the above-mentioned expert conclusion to the Republican Center for Hygiene, Epidemiology and Public Health of the Republic Belarus to obtain a registration certificate.
What is required for registration
For conducting the complex studies and the further procedure of state registration it is necessary to submit the following documents:
1) Application form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- certified copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers (if available);
- certified copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers (if available);
- certified copies of documents according to which a food supplement is produced (standards, technical conditions, regulations, technological instructions, specifications, recipes, information on the composition);
- declaration of the manufacturer about the presence of GMO, nanomaterials, hormones, pesticides in food supplement;
- certified copy of instruction for use or summary of product characteristics (composition, product form, description, shelf-life, storage conditions, etc.);
- certified copy of Certificate of Analysis or Quality Certificate or Material Safety Data Sheet or Free Sale Certificate;
- certified proposed mockups for the Belarusian market;
- certified copies of documents on the specific activity of a food supplement (for products containing unknown components, unofficial prescriptions);
- certified copy of registration certificate issued by the competent authority of country of applicant or manufacturer;
- protocols of studies.
2) Samples of food supplement for conducting the required studies.
The procedure of obtaining an expert conclusion from the authorized institution may last from about 4 to 10 months after the submission of the product samples and necessary documents.
According to the Belarusian legislation the procedure of state registration of food supplement should be conducted within 30 days. However, in accordance with the usual practice the procedure of state registration may last from 2 to 3 months.
The Certificate about the state registration of food supplement in Belarus is valid on the permanent basis.
In order we could provide you with the information on costs associated with registration of food supplements in Belarus 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.