State registration of food supplements

in Russia

Select country for information

State registration of food supplements

Service available for:

  • EEU
  • Russia
  • Kazakhstan

Food supplement is a substance that relates to specialized food products

Food supplements contain bioactive substances of natural origin (or identical to natural ones) and are used to enrich human diet, but they are not a medicine. Biosupplements only compensate the lack of useful substances in food and make it more complete and varied, and therefore, they can contribute to improving well being and health in general

In the Russian Federation, food supplements registration is implemented by Rospotrebnadzor
The issues related to state registration of biosupplements in Russia are regulated by the Technical Regulation of the Customs Union (TR CU) 021/2011 “On Food Safety,” as well as Sanitary Regulations and Standarts and other technical regulation


Registration of food supplements in the Russian Federation

Food supplements are bioactive substances of natural origin or identical to thereof, as well as probiotic microorganisms intended for dietary consumption or incorporated into food products
  • Biosupplements should not and cannot include medicinal substances and do not have medicinal properties

What problems may arise if you decide to do the registration yourself?

You will have a lot of work, the nuances of which are unknown to you: 

The procedure may take a long time

You may not know the details of the regulatory environment

You may not know the nuances of communication in regulatory bodies or in the country

The benefits of registration with the MedExpert company:

We will undertake all the routine work.

You save time and therefore money

We have a team of professionals in different areas of regulatory affairs

We select individual solutions for each project

We guarantee confidentiality

We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the registration process

List of services

Consulting

Preparation and collection of the registration dossier

Development and analysis of technical documentation

Collaboration with testing centers

Support for testing

Interaction with registration bodies

Registration stages

According to the current rules of the Russian Federation, food supplements registration includes the following stages:

  1. Preliminary examination:
    checking the completeness of the collected materials and assessing their compliance with established requirements

  2. Examination:
    organization and completion of research and testing, reporting, and protocols

  3. Consideration elimination

  4. Preparation of documentation:
    collection of the required documents and samples and materials for submission to the authorized state bodies

  5. Submission of application

  6. Submission of the dossier:
    final completion and compilation of the dossier and its submission to authorized state bodies (Rospotrebnadzor)

  7. End of the procedure:
    obtaining state registration certificates

State fee

State fee for the registration of food supplements

5,000 rubles

State fee for the introduction of changes into state registration certificate

350 rubles

We will calculate the final cost and terms of registration at your request

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Questions and Answers

2. Interpretation of the concept of Food supplements in the territory of the Customs Union