List of documents, required for biologically active food supplements (bioactive food additives, BAD) sanitary & epidemiologic assessment

1. An application affirmed standard form.

2. A power of attorney, or affidavit, confirming that the manufacturer of the biologically active food supplements, confirming that the applicant (a firm, or an individual) can represent the producer in the Russian Federation (if the manufacturer is not the applicant).

3. Documents issued by authorized organizations in the state of origin confirming that production is a bioactive food supplement (food product) and is not a medical cure (treatment), as well as the document confirming that the bioactive food supplement (food product) is permitted to production and sale in the country of origin.

4. A document confirming, that the production of the bioactive food supplement (food product) is carried on according to national, or international requirements to bioactive food supplements concerning the production organization.

5. Complete ingredient list.

6. Brief information on manufacturing technology, manufactory standard.

7. Explanatory note on scientific basis of composition of the bioactive food supplement, scientifically approved recommendations for usage, with indication of durability of usage and doses, contraindications/interactions, limits for usage if there are some; materials (original, or from special literature on analogues) on toxicology, medical (hygiene), and biological assessment of the bioactive food supplement (food product) and its clinical efficacy, trial reports and confirmed copies of clinical trials results compared to results in control group with indication of the organization, that conducted the trials.

8. For bioactive food supplements, that contain

For bioactive food supplements designed for sportsmen for muscle mass building, for persons with high physical activities that is necessary to provide a document issued by the bioactive food supplement manufacturer confirming, that the bioactive food supplement does not contain doping.

9. GMS-declaration on presence or absence of components made of genetically modified food sources in the bioactive food supplement (food product);

10. Label for consumers or its draft in Russian, acknowledged by the manufacturer, as well as the original label sample made in the country of origin.

11. Trial, research records (if there are some).

12. Samples of the bioactive food supplement (food product) in the quantity necessary for sanitary & epidemiologic assessment; if any toxicology testing or clinical trials are required - quantity of the samples is defined additionally.

13. Sampling act of the standard form, in which indicated are the date and place of the sampling, quantity of the samples, name of the product, juridical person address, bioactive food supplement (food product) production date, surnames and signatures of persons, that provided the sampling.

14. Document confirming the right to get sanitary and epidemiologic conclusion (power of attorney, decree, constituent contract, etc.).

15. Certificate of Tax Registration.

All the documents of the state manufacturer are to be provided in original, with translation into Russian with legalization.