Issues associated with the state registration of food supplements are regulated by the Ministry of Health Protection of the Republic of Kazakhstan. In accordance with the Code of the Republic of Kazakhstan "On the health of the people and the health care system" dated September 18, 2009 food supplements are allowed for use in Kazakhstan after state registration.
According to the Decision of the Commission of the Customs Union dated May 28, 2010 No. 299 state registration of food supplements is possible only with conducting the complex studies of samples of said product in authorized and accredited research institutions and obtaining the expert conclusion from these institutions.
What is required for registration
In order to register the food supplement, it is necessary to provide the following to the Committee for Public Health Protection of the Ministry of Health of the Republic of Kazakhstan:
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);
- certified copy of Certificate of Analysis or Quality Certificate or Material Safety Data Sheet or Free Sale Certificate;
- certified copy of instruction for use or summary of product characteristics (composition, product form, description, shelf-life, storage conditions, etc.);
- certified proposed mockups for the market of Kazakhstan;
- certified copies of the documents about the specific activity of food supplement (if available);
- certified copy of registration certificate issued by the competent authority of country of applicant or manufacturer or justification of its absence;
- declaration of the manufacturer about the presence of GMO, nanomaterials, hormones, pesticides in food supplement.
2) 2 samples of food supplement with appropriate certificate of analysis in an amount of not less than 150 g in each.
The required studies usually are conducted in the authorized institution within about 4 months after the submission of the product samples and necessary documents. According to the Kazakh legislation the procedure of examination of documents and further state registration of food supplement should be conducted within 30 days after conducting the required studies in the authorized institution. However, 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 Kazakhstan may last from 5 to 7 months without considering the time for preparation of responses to the remarks.
The Certificate about the state registration of food supplement in Kazakhstan is valid on the permanent basis.
In order we could provide you with the information on costs associated with registration of food supplements in Kazakhstan 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.