OFFICIAL LIST OF DOCUMENTS REQUIRED FOR THE REGISTRATION OF IMPORTED NUTRACEUTICALS IN RUSSIA

  1. Order for services related to product evaluation and testing
  2. Detailed Application to the Russian Health Ministry for State Registration of the product
  3. Copies of licenses and certificates issued by domestic authorities to attest that the product is a nutritional supplement and not a medicine, and that it is safe for human consumption. These documents must be legalized by apostil;
  4. Full ingredients list. For ingredients of herbal origin, their botanic name in Latin should be included.
  5. Technical documents (standards, specifications, formulas) by which the product is manufactured;
  6. Label or its draft in Russian, as well the original label in English;
  7. User instructions, directions, manual etc. (if not fully included in the label);
  8. Scientific Report explaining the composition of the nutraceutical; directions for the dosage and duration of usage; counter indications; limitations of usage;
  9. Documents and publications giving toxicological, hygienic and biological evaluation of the nutraceutical and its effects; reports or statements of clinical tests in comparison the control group;
  10. Documents and publication pertaining to the research of the key ingredient of the product;
  11. Document (passport, report) in Latin describing the strain, if the product contains live microorganisms;
  12. Statement on whether the product contains or contains not components obtained from genetically modified organisms;
  13. Statement confirming that the product does not contain ingredients or substances of narcotic or psychotropic nature, or other substances with strong effect;
  14. Test reports of authorized laboratories of organizations (if available);
  15. Random Sampling Protocols;
  16. Copies of patents or brand registration (if available);
  17. Power of attorney by which the manufacturer authorizes the agent to represent him in Russia as regards the State registration of the product ( if there is an agent). This document must be legalized;
  18. Power of attorney authorizing the agent to receive the Certificate of State Registration.

All documents must be submitted in two identical authentic copies. All documents must be translated into Russian and properly notarized by a Russian notary public.

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