Ua 
中文 
De 
Fr 
Es 
Pl 
Home
Matters 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 July 7, 2020, food supplements are allowed for use in Kazakhstan after state registration.
Registration procedure
According to Decision No. 299 of the Commission of the Customs Union dated May 28, 2010, the state registration of food supplements is possible only after conducting complex studies of samples of said product in the authorized and accredited research institutions and obtaining the expert conclusion from these institutions.
Pay attention
According to the above-mentioned regulations a legal entity or an individual person should be declared as an applicant and registered in accordance with the legislation of a member-state on its territory as an individual entrepreneur, either being a manufacturer or a distributor, or performing the functions of a foreign manufacturer on the basis of an agreement with him in terms of ensuring the conformity of the supplied products with the established requirements. In case of absence of such a representative from your side, we will be pleased to provide said service.
Required documents
For conducting complex studies and further procedure of state registration it is necessary to submit the following:
1) Application form with the attached documents:
- Legalized Power of Attorney from the applicant to the representative;
- Legalized copies of the Manufacturer’s Authorizations or GMP certificates, or HACCP, or ISO 22000 certificates for all manufacturing sites involved in the manufacturing process issued by the competent authorities of the 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 copies of Certificate of Analysis or Quality Certificate, or Material Safety Data Sheet, or legalized copy of Free Sale Certificate;
- Certified copy of the 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 from the manufacturer about the presence or absence of GMO, substances with narcotic or psychotropic effects, nanomaterials, hormones, pesticides, unknown impurities in the food supplement.
2) Samples of the food supplement with the appropriate Certificate of Analysis in the amount required for the laboratory studies at the request of the authorized institution and the certified copy of the declaration confirming the import of samples into the customs territory of Kazakhstan.
Timeframe
The required studies are usually conducted in the authorized institution within about 4 months after submission of the product samples and necessary documents. According to Kazakh legislation, the procedure of examination of documents and further state registration of a food supplement should be conducted within 15 business days after conducting the required studies in the authorized institution. However, in accordance with usual practice, depending on the completeness of the provided materials and the scope of documentation, the number of requests of the competent authority, and other factors, the procedure of state registration of a food supplement in Kazakhstan may last from 5 to 7 months without considering the time for preparation of responses to the requests (if any).
Validity term
The State Registration Certificate on a food supplement in Kazakhstan is valid on the permanent basis.
Important
Approval of registration of food supplement in Kazakhstan (or another member-state of the EAEU) will give an opportunity to import said product to all 5 EAEU countries (Kazakshtan, Belarus, Russia, Kyrgyzstan and Armenia) without additional separate registration procedures.
In order we could provide you with the information on the costs associated with the registration of food supplements in Kazakhstan, along with the detailed information and a list of documents required from your side, as well as a sample of Power of Attorney for execution, etc. please contact our specialists.
