dietary supplements regulation

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Registration of Food Supplements in Russia and the EAEU

CRO in Russia - Clinical Excellence Group (CEG)

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Registration of
Food / Dietary Supplements
in Russia, Belarus and Kazakhstan

Your company will launch a new dietary supplement to the united market of Russia, Belarus and Kazakhstan within 3-5 months. All stages are in time.
You will enjoy the quality and reliability of our services and our commitment to result.

Russian Market
Russian food supplements market is #3 in Europe after Italy and Germany, and by forecasts will become #2 in 2020.
In 2017 the size of the Russian market amounted to 51.2 bln. Rub. (about $800 mln.) / 341 mln. packages.
By October 2018, 2 142 trade names of dietary supplements produced by 793 companies were on sale in Russian pharmacies.
Since 2014, annual average growth rate of the market in rubles is about 6%.
The impressive market size is determined by numerous factors, with the primary one being the total population - 143.5 million people (according to the Federal State Statistics Service as of August 1, 2013).
Dietary supplements in monetary terms: foreign – 45%, national –55%.
Scope of price segment "500+ rub. ($8+)" is 36%.

Read more on the following web resources:
National Products Insider,
DMS Group - Annual Report [in Rus],
DMS Group - Report by October 2018 [in Rus],
Deloitte [in Rus],
AlphaRM,
Statista.

Consumption of food supplements worldwide is growing at 3-4% per year. In the Eurasian Economic Union countries this measure is 5-6%.
The population of EAEU is 185+ mln. people.
Russia is a largest country of the Union.
Since July 1, 2013, regulations on registration and circulation of dietary supplements have been changed considerably by the Technical Regulation of the Customs Union TR TS 021/2011 "On safety of food products".
It means that if your company registers a dietary supplement in Russia, it can also sell this product in Belarus (about 9.5 million people) and Kazakhstan (about 17.2 million people), i.e., on the market of more than 180 million people! In the coming years, the list of the Customs Union members is expected to be extended by candidate countries.

Visit the Information Portal of the Union.

Key Stages of the State Registration

1
Preliminary examination +
Preparation of the registration dossier
1.5 months
2
Import of samples (if manufactured outside Russia) +
Quality and safety examinations in accredited laboratories
2-3 months
3
State registration of food supplements by Rospotrebnadzor
1-1.5 months
Registration Procedure
Registration of a dietary supplement is a multi-stage process that results in receipt of a Marketing Authorization from the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor) and including the product into the Unified Register of Specialized Food Products.
In order to successfully launch a dietary supplement to the Customs Union market, one needs to verify, whether the product can be registered as a dietary supplement, to prepare and submit a registration dossier, to conduct sample testing (in the scope determined by product ingredients, product safety and quality), to organize the import of a product to Russia (if needed) and to communicate with Rospotrebnadzor and accredited expert laboratories.

See what we can offer.

We guarantee: within 3-5 months, your company will launch a new food supplement to the united market of Russia, Belarus and Kazakhstan.
All work stages from the idea to receipt of a Marketing Authorization will be completed as scheduled.
You will enjoy the quality and reliability of our services and our commitment to result.

How can we help your company?

We make a preliminary examination of the food supplements' composition and quality (to determine the possibility of launching them as food supplements).
If needed: we make marketing study for your company's products and determine competitors and their sales.
If needed: we develop sales and financing plan, estimate financial indicators, taking into account product strategy and expenses after product launch.
We develop a project plan for the state registration of the products.
We organize the translation of all source documents into Russian.
We make sample testing in accredited expert laboratories.
We provide consultation on national regulations to manufacturing and quality of food supplements.
We submit the dossier and represent your company during review (examination) by Rospotrebnadzor.
We develop documents of the registration dossier(s).
We obtain the Marketing Authorizations (the State Registration Certificates) valid in Russia, Belarus and Kazakhstan.

What you get when you work with us?

You use our expertise when it comes to blind spots.
We will work together to define your goals and will develop an optimal plan for registration of your product and the scope of necessary product sample testing.
Executive staff and key specialists of the CEG company have profound knowledge and vast experience in registration of food supplements. You can see for yourselves when you receive answers to your questions or, for a start, take a look here.
The state registration is completed within 3-5 months and your company can start selling.
It will take 3 months to obtain a Marketing Authorization (State Registration Certificate) if minimal testing is required and a good source documents are available. In more complicated cases, it may take 2 months more to complete the project.
You will know all details of your project before its start and before we sign a contract. More predictability - less problems!
In only 5 days after contacting us and discussing the details you will receive the budget and plan of your project (even if it involves registration of multiple dietary supplements).
We know that it is crucial to understand what investments are needed and at what stages and how long the whole registration process will take.
And yes, it is free of charge.
We have 46 registered dietary supplements in our portfolio.
Additionally, our specialists on registration and regulatory affairs have organized the registration of dozens of dietary supplements in Russia, Ukraine, Belarus and Kazakhstan.
Right proportion of price and quality.
The cost of "turnkey" projects on registration of food supplements depends on the extent of product sample testing and the completeness of a dossier draft.
We will only need 3-5 days to communicate you the precise cost for registration of your products.
Mid-market prices of our services combined with their high quality are a strong argument to work with us.
We carefully listen to our clients and usually respond to the query in 24 hours
So you can always be sure that the solution of current issues is not being delayed.
CEG has standardized business processes, so that you can be confident in quality and timeliness of accomplishing your goals.
Our work is guided by standards established at the market of drug registration and studies.
This goes for development and implementation of Standard Operating Procedures (SOPs), organization of staff training, logistics.
This is an additional guarantee of your project's success.
Our team is constantly improving. And we really mean it.
Sex of our specialists have more than 7 years of work experience in pharmaceutical companies and international contract research organizations, four specialists have more than 12 years of experience.
Our managers on registration and regulatory affairs attend workshops and conferences.
Every year our company's staff takes an assessment test of knowledge of Standard Operating Procedures and the legislation of Russia and the Customs Union.

Contact Us

It is easy, convenient and only takes a few minutes.
Please send us your comments, questions, suggestions, information about you company and products for the state registration through this form. Leave your contact information and we will respond within 24 hours.
Pass the quiz and find out the best option for the health products registration / launch
Fill out the form and we will contact you soon!
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