Marketing authorization of dietary supplements in Russia

Dietary supplements — biologically active food supplements. They are kind of food products that qualify as “natural” biologically active substances intended to be consumed simultaneously with food. Dietary supplements are obtained from plant, animal or mineral raw materials by chemical or biotechnological methods. Dietary supplements are used as an additional source of biologically active substances to improve the condition of human organs and systems, normalize metabolism and the gastrointestinal tract. Supplements are produced in ready-to-take dosage form: tablets, capsules, suspensions, jellies, syrups, etc.

For the implementation of dietary supplements, both domestic and imported, you must pass the state registration of dietary supplements. An authorized dietary supplement is put into the Registry of products that have passed the state registration, and is issued with a Certificate of a Product State Registration. The recipient of the Certificate acquires the right to sell the registered product on the territory of the Russian Federation and in the countries of the Customs Union (Russia, Belarus and Kazakhstan).

The regulatory framework for the marketing authorization of dietary supplements in Russia is governed by the following documents:

  • Government Decree no.982 of 01.12.2009 “On approval of a single list of products for mandatory certification, and a single list of products, the confirmation of conformity of which is carried out in the form of adoption of conformity declaration” (with amendments and additions until February 21, 2018);
  • Decision of the Commission of the Customs Union No. 229 of May 24, 2010 “On the Application of Sanitary Measures in the Eurasian Economic Union” (amended before June 14, 2018), which deals with the mandatory receipt of dietary supplements by the State Registration Certificate.
  • Technical Regulations of the Customs Union TR TS 021/2011 «On food safety».

State registration in the Russian Federation has several stages:

  1. Preliminary stage (verification of the composition of dietary supplements and documents provided dossier). Receiving product samples from the manufacturer.
  2. Preparation and submission of documents and samples to the test center.
  3. Conducting laboratory studies on the authenticity and safety of the samples obtained in an accredited testing center. If the product meets all requirements, an expert opinion is issued with the results of research.
  4. Payment of state duty and submission of product dossier, including the Expert opinion of the testing center at the Federal Service for Supervision of Consumer Rights Protection and Human Welfare.
  5.  Obtaining a Certificate of State registration of products.

The most time-consuming process is the preparation and collection of documentation package for applying for registration. The lists of documents for dietary supplements imported and domestic production are different. The customer is to provide a package of documents, usually we request only the main ones from the manufacturer, everything else is prepared by our experts.

We will also save you from translation and technical processing of documents, if they are made in foreign languages. Copying, notarization — we will undertake all these routine procedures.

For registration of dietary supplements you will also need to provide samples for testing (officially cleared) — 6-8 pcs. (depending on the standard packaging).

Special attention should be paid to the preliminary examination of the composition of dietary supplements. An important issue is the study and verification of the component composition of dietary supplements for compliance with the requirements of regulatory documentation. The qualitative and quantitative composition of the claimed product is checked. It also checks the presence of prohibited plants, objects of animal origin, microorganisms and other ingredients that are prohibited for use in the composition of biologically active food additives. After the composition checking, our experts make recommendations on the adjustment of the composition, if necessary.

In general, the procedure of marketing authorization of dietary supplements is not complicated and is not in tact.