Chapter 1 Analysis of Russian health products market

Also known as the Russian Dietary Supplement Registry, the Russian dietary supplement market size has an average annual growth rate of around 10.62% in terms of value between 2019 and 2021. By the end of 2022, the size of the Russian dietary supplement market was $1.026 billion, 19% higher than in 2021, and the market size is expected to reach $1.35 billion in 2024.

Due to market changes, a large number of foreign brands, such as health products brands in Europe, the United States and other countries and regions choose to leave Russia, in this environment, Chinese health products manufacturers also ushered in a wave of new market opportunities, for the export of health products to Russia, has considerable market prospects.

According to the Russian Ministry of Health, in order for any health product to be placed on the market, the owner of the product brand must ensure that the product complies with the requirements for health epidemiological checks, national registration and labelling of health products. For new health products, premarket authorization is based on health and epidemiological tests. In order to successfully introduce a health product to the Russian market, manufacturers need to verify that the product can be registered as a health product in the SGR of the Russian Federation, after which they prepare and submit registration documents, analyze samples, organize the import of the product into Russia, and communicate with Rospotrebnadzor and accredited expert laboratories.

Chapter 2 Regulatory requirements and regulatory bodies for the registration of health products in Russia

The Russian state agency responsible for the registration of health products is the Federal Bureau of Consumer Rights Protection and Human Welfare Supervision (Rospotrebnadzor), and the document after the successful registration of health products is the Russian State Registration Certificate (SGR), and the SGR certificate is valid permanently.

Chapter 3 Precautions for registration of health products in Russia

The Russian State registration of dietary supplements is possible only if the declared product complies with the corresponding requirements and the active substances that make up it are not included in the list of Prohibited Ingredients (TR CU 021/2011, Appendix No. 7).

According to the Customs Union, health products include bioactive ingredients of natural origin, as well as probiotics used with food or present in food ingredients. National registration of health products is therefore possible only in the following cases:

（1）The product description does not indicate that it is used for medicinal purposes;

（2）The products displayed do not possess any medical or medicinal properties;

The advertisement for this dietary supplement (if the product is already sold in other countries) does not contain incorrect information and calls for forgoing a healthy diet. If you find any inconsistencies, we strongly recommend that you correct them before you start registering health products in Russia. In the absence of contradiction, it is important to ensure that the chemical and biological characteristics of manufactured products comply with legal requirements (i.e. TR CU 021/2011, Appendix No. 8).

Chapter 4 WISELINK can provide services

Our experts can assist in the provision of dietary supplement registration, formulation/ingredient evaluation, label and claim review, technical dossier compilation, submission to health authorities (HA), obtaining a food supplement registration certificate (Registration certificate allows placing the product on the market in all countries of the Eurasian Economic Union (EAEU), Including Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan, without any additional payment or review by other EAEU ministries of Health).