Biologically active additives  (BAA) to the food — the composition of biologically active substances intended for direct reception with food, or the introduction of the foods.
Turnover of dietary supplements and raw materials for dietary supplements regulated by the Federal Law of the Russian Federation on March 30, 1999 N 52-FZ  «On the sanitary-epidemiological welfare of population»,and the Technical Regulations of the EurAsEC Customs Union TR CU 021/2011  «On food safety», TR CU 022/2011  «Food products in terms of their labeling»according to which BAA are subject to obligatory state registration, raw materials — declaration..

Stages BAА state registration:
— Preliminary assessment of ingredient composition of products for compliance with the existing requirements;
— Preparation of the registration dossier. If necessary — development of normative documentation  (specifications, TI, instructions, labels, declarations);
— The organization and monitoring tests  (microbiological, organoleptic, toxic-hygienic, physical, chemical, radiological, assessment of effectiveness);
Organization and support of the federal center of expertise or the Institute of Nutrition;
— Submission of the registration dossier to the Federal Service; monitoring the passage of registration;
— The certificate of state registration  (PDS).

Documents required for state registration of Biologically Active Additive, raw materials for BAA production


— An apostilled manufacturer’s certificate (i.e. a copy of the registration certificate of the manufacturer as a legal entity issued by a national governmental authority and legalized in accordance with an established procedure);

— An apostilled certificate of product quality and safety issued in the manufacturer’s country (i.e. a copy of the certificate of free sale or safety issued by a national governmental authority and legalized in accordance with an established procedure);

— Information on ingredient composition in a standard document issued and stamped by the manufacturer;

— Directions for use issued and stamped by the manufacturer;

— A draft label or model label issued and stamped by the manufacturer;

— A sampling statement issued and stamped by the manufacturer;

— An apostilled power of attorney for the applicant issued by the manufacturer (this document must be certified by a consular mission or a notary and submitted in the original);

Products that have already been registered may be sold by any country (company) contracted by the manufacturer.

— Documents confirming that the products have been officially imported (documents bearing customs clearance).

Bank details for payment of state fees


Transregional operational FTD (Federal Service for Surveillance in Consumer Rights Protection and Human Welfare, personal account 04951001410)

INN  (Taxpayer identification number) 7707515984 KPP  (Tax registration reason code)770701001 
GAC code: 45382000 
Account: 40101810500000001901 
Beneficiary’s bank: Operations Department of Bank of Russia, Moscow 701
BIC – 044501002
WBS code 141 1 08 07200 01 0038 110 – Budget classification code for the state registration of goods (5000 rubles)
WBS code 141 1 08 07200 01 0039 110 – Budget classification code for the renewal of the certificate of state registration of goods (350 rubles)

Guarantee 100%
Ready to contact us?

Our managers will provide you with exhaustive information and will answer any questions
• We will contact you in some minutes and will provide additional details about the process of obtaining the necessary documents
Thank you! Your request has been sent!
Our specialists will be in contact with you very soon

An error occurred

Your request has not been sent. Sorry, try later.

About a company

Contact us and we will take care of the rest for you


Address: c. Moscow, 2-й Syromyatnicheskiy str., д.1
Phone: +7(495)665-81-35
Address: г. Kazan, Pr. Yamasheva 46/33
Phone: 8 (843) 226-03-63 ,
WhatsApp: +7(495)665-81-35
Skype: ailfarma@mail.ru

AiLFarma - licensing of medicines
Работает на HostCMS