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Matters associated with the state registration of the food supplements are regulated by the Department of Disease Prevention and State Sanitary and Epidemiological Supervision under the Ministry of Health of the Republic of Kyrgyzstan.
Registration procedure
According to the legislation of the Kyrgyz Republic, in order to be freely circulated within the country, food supplements must be registered in the Unified Register of Certificates of State Registration of the Eurasian Economic Union under the legislative acts of the EAEU. Following Decision No. 299 of the Commission of the Customs Union dated May 28, 2010, the state registration of the food supplements is possible only after carrying out complex studies of said product samples in the authorized and accredited research institutions and obtaining an expert conclusion therefrom.
Pay attention
The applicant shall be a legal entity or an individual duly registered in accordance with the legislation of a Member State on its territory as an individual entrepreneur. The applicant may act as the manufacturer, a distributor, or as an authorized representative of a foreign manufacturer under a formal agreement, assuming responsibility for ensuring the conformity of the supplied products with the applicable regulatory requirements. If no such representative is available on your behalf, we will be pleased to provide said service.
Required documents
For carrying out the complex studies and further state registration procedure, the following should be submitted:
1) Application form with the attached documents:
- Legalized Power of Attorney from the applicant to the representative;
- Certified copies of the documents according to which a food supplement is manufactured (standards, technical conditions, regulations, technological instructions, specifications, recipes, certificate of composition);
- Document indicating the genus, species, and strain in Latin, as well as information on the strain’s deposition (such as passport, certificate, etc.) certified by the manufacturer (for food supplements containing living microorganisms);
- 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 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 Kyrgyzstan;
- Certified copy of the trademark certificate (if available);
- Certified copies of the documents about the specific activity of the food supplement (if available);
- Certified copy of the Registration Certificate issued by the competent authority of the applicant’s or manufacturer’s country or justification of its absence;
- Statement from the manufacturer regarding the inclusion or exclusion of GMOs, substances with narcotic or psychoactive properties, nanomaterials, hormones, pesticides, or unidentified impurities in the food supplement.
2) Samples of the food supplement, accompanied by a corresponding Certificate of Analysis, in the amount required for the laboratory studies as requested by the authorized institution, along with a certified copy of the declaration confirming the importation of the samples into the customs territory of Kyrgyzstan.
Timeframe
The complex studies may be conducted in the accredited testing laboratories located in any member state of the Eurasian Economic Union. It takes about 4 months after submission of the product samples and necessary documents. The examination procedure for the documents and further issuance of the Registration Certificate on a food supplement shall not exceed 30 calendar days after conducting the required studies in the authorized institution. However, in practice, due to the high volume of the submitted applications, the Department officially warns about delays in the processing of the submitted dossiers. Therefore, the state registration procedure for a food supplement in Kyrgyzstan may take about 5-7 months, not including the time for the preparation of responses to the requests (if any).
Validity term
The State Registration Certificate on a food supplement in Kyrgyzstan is valid on a permanent basis.
Important
Obtaining registration approval for the food supplement in Kyrgyzstan (or any other EAEU member state) will allow the product to be imported into all five EAEU countries (Kazakhstan, Belarus, Russia, Kyrgyzstan, and Armenia) without the need for separate national registrations.
To provide you with information on the costs related to the registration of food supplements in Kyrgyzstan, along with detailed information, a list of documents required from your side, as well as a sample Power of Attorney for execution, etc. please contact our specialists.
