In accordance with the Federal Law of the Russian Federation No 29-FZ "On quality and safety of the food product" dated January 02, 2000 food supplements that are imported into the territory of the Russian Federation for the first time are subjects to the state registration before their entry into the territory of the Russian Federation.
According to the Decision of the Commission of the Customs Union dated May 28, 2010 No. 299 the state registration of food supplements is possible only after conducting the complex studies of samples of said product in research institutions authorized by the Federal Service for Surveillance on Consumer Right Protection and Human Wellbeing of the Russian Federation and obtaining the expert conclusion from these institutions.
So procedure of the state registration is divided in 2 stages:
- submission of the required documents to the authorized institution for conducting the complex studies to obtain an expert conclusion;
- submission of the application and required documents along with the above-mentioned expert conclusion to the Federal Service for Surveillance on Consumer Right Protection and Human Wellbeing of the Russian Federation to obtain a registration certificate.
For conducting the complex studies and the further procedure of state registration it is necessary to submit the following documents:
1) Application form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- certified copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers (if available);
- certified copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers (if available);
- certified copies of documents in accordance with which a food supplement is produced (standards, technical conditions, regulations, technological instructions, specifications, recipes, information on the composition);
- declaration of the manufacturer about the presence of GMO, nanomaterials, hormones, pesticides in food supplement;
- certified copy of instruction for use or summary of product characteristics (composition, product form, description, shelf-life, storage conditions, etc.);
- certified copy of Certificate of Analysis or Quality Certificate or Material Safety Data Sheet or Free Sale Certificate;
- certified proposed mockups for the Russian market;
- certified copies of documents on the specific activity of a food supplement (for products containing unknown components, unofficial prescriptions);
- certified copy of registration certificate issued by the competent authority of country of applicant or manufacturer;
- protocols of studies.
2) Samples of food supplement for conducting the required studies.
The procedure of obtaining an expert conclusion from the authorized institution may last from about 4 to 10 months after the submission of the product samples and necessary documents.
According to the Russian legislation the procedure of state registration of food supplement should be conducted within 30 days. However, in accordance with the usual practice the procedure of state registration may last from 2 to 3 months.
The Certificate about the state registration of food supplement in the Russian Federation is valid on the permanent basis.
In order we could provide you with the information on costs associated with the registration of food supplements in Russia together with the detailed information and list of documents required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.