The list of the documents for registration of biologically active supplements (BAS)

  1. Power of Attorney issued by the manufacturer confirming that the manufacturer of BAS transfers to legal representative their rights to represent their interests in Russian Federation on registration of their production (in case if the applicant is not the manufacturer of BAS)
  2. Documents of the authorized organs of the manufacturer’s country confirming, that given production is referred to BAS (nutritional products) or is not a drugs;
  3. The document confirming the free circulation of production on the territory of the manufacturer’s country (for example: Free Sale Certificate) or the document about absence of necessity of such document, which was given according with the manufacturer’s country legislation;
  4. Document confirming, that products are produced according with national and/or international requirements for nutritional BAS on issues of production organization. (for example: GMP Certificate)

Documents (1-4) should be in the notary’s copies, certified by consular establishments of the Russian Federation or with assurance the Apostille according to the Hague convention.

  1. Full ingredient composition of BAS. (stamp and sign)
  2. Brief information about the technology of production, standard on production of BAS (stamp and sign).
  3. The copy of Certificate of trade mark, patent, license agreement (in the presence).
  4. Explanatory note containing the scientific substantiation of BAS composition, scientifically reasonable recommendations for application with the instruction of a duration of a reception and accepted amounts of BAS, contra-indications, restriction on application of BAS, if it exist; materials (original and literature for analogs) on a toxicological – hygienic and biological evaluation of BAS and its clinical efficiency, protocols or attested copies of outcomes of clinical tests in a comparison with control group with the indication of institution spending these tests (stamp and sign).
  5. Declarations about absence in composition of BAS of toxic, drastic, psychotropic or narcotic compounds or synthetic pharmaceuticals, also declaration about use or absence in composition of BAS of components obtained from generically of modified sources;
  6. For BAS, containing:

    • The alive microorganisms – It must be indicated in Latin language the kind and species of a microorganism, indication of the strain, information about registration (passport, certificate etc.) (stamp and sign);
    • The parts of plants – It must be indicated the botanical title in Latin language, form and method of preparation (for example: an extract – 1:4, tincture – 1-10 etc.) (stamp and sign)
    • Assigned for the sportsmen, for increase of muscular mass of body, for persons with increased physical activity – the submission from the manufacturer of BAS of the document confirming absence in its composition of substances and components, referred to dope is necessary (stamp and sign).
  7. The original label from the manufacturer’s country.
  8. Information about methods of analysis of general active ingredients. Certificate of analysis (stamp and sign).
  9. Instruction for use (in case, the label don’t have full information) (stamp and sign);
  10. Certificate of sampling of the established form, in which the date, the place of sampling, amount of samples, the legal address of the manufacturer’s enterprise, date of BAS production, surnames, titles and signatures of persons, performing sampling, must be indicated.
  11. Samples of BAS, in an amount necessary for realization of sanitary – epidemiological examination.

    • Samples in an amount of 5 pieces in consumer packing (volume of represented samples should be sufficient for realization of laboratory researches).
    • For preparations of a vegetative origin 1 sample (not less 100 grams for a radiological expertise) in addition is represented.

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