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.
Regulatory Body - Russia
The regulatory body in Russia responsible for the registration of drugs is called Rosminzdrav (Министерство здравоохранения Российской Федерации).
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).
Pharma Prescription Drugs
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 prescription. In general, a pharma/prescription drug registration process in Russia is relatively fast and easy.
Consumer Healthcare Drugs/OTC
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.
Medical Devices
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.
Food Supplements/Nutraceuticals
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.
Cosmetics and Derma
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.
Photo by Michael Parulava on Unsplash
Frequently Asked Questions from clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- 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?
- 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?
- 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?
- 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?
- 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?