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Russia – Regulatory Affairs

The pharmaceutical industry of Russia is considered to be one of the most positively growing sectors of Russian industry and one of the fastest-growing in the world. Apart from having the world’s largest population, Russia is a part of EAEU which makes it’s market even more attractive and the number of potential patients higher.


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Pharma/Prescription Drugs

Consumer Healthcare Drugs/OTC Drugs

Medical Devices

Food Supplements/Nutraceuticals

Cosmetics & Derma


Our Services & experience

We have more than 20 years of experience in Russia & CIS region, we would gladly guide you through the maze of the regulatory affairs with our local network. We will also make sure that the whole registration process of your product in Russia is very clear to you.

We do not have a standard approach to regulatory affairs, but rather tailor our services to the expectations and needs of our clients.

Some examples: 
1. A very detailed yet easy to understand flow chart with the pharma/prescription drug registration process in Russia
2. A full overview of Medical Devices registration timeline and costs in Russia

1. Russia Registration Process – Tips & Tricks
2. Russia Registration Process – Fast Track Time & Cost

Regulatory Authorities in Russia

The regulatory body in Russia responsible for the registration of drugs is called Rosminzdrav (Министерство здравоохранения Российской Федерации). Click here to go to the official website of Rosminzdrav.

The regulatory body in Russia responsible for the registration of Food Supplements/Nutraceuticals, Cosmetics & Derma products is called Rospotrebnadzor (Федеральная служба по надзору в сфере защиты прав потребителей и благополучия человека). Click here to go to the official website of Rospotrebnadzor.

Contact us to get answers to all your individual product and situation questions!


Pharma/Prescription Drugs

Overview

An official definition of Pharma/Prescription Drug in Russia:  are chemicals of natural or synthetic origin or combinations of substances used to treat, prevent, or diagnose human diseases and require a prescribtion. In general, a pharma/prescription drug registration process in Russia is relatively fast and easy.

Below we have listed the questions that our clients usually have with regards to Pharma drug registrations in Russia:

  • Will my existing BE studies be accepted in Russia?
  • What are the important things to understand with regards to
    trademarks by the regulatory authority in Russia?
  • Can my home company act as a MAH in Russia?
  • What is the difference in a climate zone for stability studies in Russia vs. Europe and Asia?
  • Is the fast track registration process possible for my products in Russia and what to be aware of?
  • What are the pharma/prescription drug registration costs and time in Russia? 

Contact us about your questions on your Pharma and medicine registration in Russia!


Consumer Healthcare Drugs/OTC

Overview

An official definition of Consumer Healthcare Drugs/OTC in Russia:  are chemicals of natural or synthetic origin or combinations of substances used to treat, prevent, or diagnose human diseases. In general, a Consumer Healthcare Drugs/OTC registration process in Russia is relatively fast and easy.

The questions that our clients usually have and we gladly answer are the following:

  • How many trademarks should be suggested to the regulatory authority and why?
  • Should I consider registering my OTC drug as a Herbal Remedy or Medical Devices?
  • How can my own company be MAH in Russia for my products?
  • What are the Consumer Healthcare Drugs/OTC registration costs and time in Russia? 
  • How to register Herbal and Phyto OTC drugs in Russia via a fast track process and why to prepare the market entry strategy before?
  • What do I need to know about climate zone for stability studies in Russia
  • Is a fast track registration process available in Russia and what to make sure of?

Contact us to learn more about Consumer Healthcare Drug/OTC registration in Russia!


Medical Devices

Overview

An official definition of Medical Devices in Russia“all devices, instruments, materials, equipment or other items of a nature that are or are intended to be used for medical purposes.” In general, a Medical Devices registration process in Russia is relatively fast and easy.

The questions that our clients usually ask about Medical Device Registration in Russia:

  • What is the difference between Medical Device Registration and definition in Russia vs. Europe, US, Asia, and Latin America?
  • Is my product a Medical Device by the laws of regulatory authority in Russia?
  • What are the important differences in trademark registration in Russia with regards to the regulatory authority for Medical Devices
  • Are local clinical trials necessary in Russia?
  • Can my company act as a MAH in Russia?
  • Climate zone for stability studies in Russia
  • Is a fast track registration process available in Russia and what to be aware of?
  • How difficult is the registration of Medical Devices in Russia?
  • What are the Medical Devices registration costs and time in Russia? 
  • To which class of Medical Devices does my product belong?

Contact us to learn more about Medical Devices registration in Russia!


Food Supplements/Nutraceuticals

Overview

An official definition of Food Supplements/Nutraceuticals in Russia“a set of biologically active substances used as a food supplement or introduced into its composition. Food Supplements/Nutraceuticals is not a drug in the traditional sense, but it provides the human body with the necessary substances, thereby normalizing and improving the condition of certain internal organs, as well as reducing the risk of occurrence and development of a wide range of diseases.” In general, a Food Supplements/Nutraceuticals registration process in Russia is relatively fast and easy.

The questions that our clients usually ask about the Food Supplement registration in Russia:

  • How to register claims on the pack for Food Supplement in Russia with regulatory authority
  • Why trademark registration in Russia can be a very difficult task with regulatory authority
  • Can my company act as a MAH in Russia for Food Supplement?
  • What Climate zone for stability studies do I need for Food Supplement in Russia
  • How difficult is the registration of Food Supplements/Nutraceuticals in Russia?
  • What are the Food Supplements/Nutraceuticals registration costs and time in Russia?

Contact us to learn more about Food Supplements/Nutraceuticals registration in Russia!


Cosmetics & Derma

Overview

An official definition of Cosmetics in Russia:  if a product belongs to at least 1 of 13 categories defined by Rospotrebnadzor, it must undergo state registration. In general, a pharma/prescription drug registration process in Russia is relatively fast and easy.

It might be beneficial to consider registering derma drug products via a cosmetic registration in Russia. In general, Cosmetic product registration in Russia is relatively fast and easy.

The questions that our clients usually ask us about cosmetic and derma registrations in Russia are the following:

  • How to register claims in Russia for Cosmetics with regulatory authority
  • Why is the trademark registration for Cosmetics and derma product a big topic in Russia
  • Can my company act as a MAH in Russia or do I need a local partner for registration?
  • What are the important topics about climate zone for stability studies in Russia?
  • Is a fast track registration process available in Russia and what to be aware of?
  • How difficult is the registration of Cosmetics in Russia?
  • What are the Cosmetics registration costs and time in Russia? 

Contact us to learn more about Cosmetics registration in Russia!