Legal & Regulatory > Russia

Key legal info on biosimilars & biologics in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar drugs are not the same as generic drugs in Russia. A biosimilar drug cannot be a copy of the original biological drug, as in respect of a biosimilar drug…

Want to know more about localization in Russia? Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? The Strategy of the pharmaceutical industry development until 2020 (“Pharma-2020”) defined localization as one of the main tendencies of…

An intro to the legal situation for orphan drugs and rare diseases in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What is the definition of Rare Diseases in your country? The definition of rare diseases is stipulated by Art. 44 of the Federal law dd 21.11.2011 No. 323-FZ “On fundamental healthcare principles in the Russian Federation” (the…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are regarded as narcotic drugs of ‘List I’ which circulation within the Russian Federation is prohibited. Cannabinoid Drugs might be imported for scientific and expertise purposes only.…

Upcoming reforms in Russia’s pharma environment. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are there proposals for reform or significant change to the healthcare system? Functioning of the EAEU common market for drugs and the EAEU common market for medical devices. The authorization of distance selling of OTC drugs subject to the following requirements: The following types of drugs…

All about patents and trademarks in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What are the basic requirements to obtain patent and trademark protection? PATENTS The Russian law provides protection for registered inventions, utility models and industrial designs. Pharmaceutical substance is generally protected as an invention. An invention is a technical solution in any field related to a…

The lowdown on the situation regarding the product liability in Russian Pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What types of liability are recognized in your jurisdiction? There are several types of liability recognized by the Russian Federation, namely: disciplinary liability (for disciplinary offenses); civil liability (for civil offenses); administrative liability (for administrative offenses); criminal liability (for…

A brief overview of the situation regarding traditional medicines and OTC products in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are treated as nutrition products (dietary products or health supplements, as the case may be) under Russian law. Thus, the basic…

Learn more about marketing, manufacturing, packaging & labeling, and advertising in Russian pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications has been already covered by…

All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Under the EAEU regulations, clinical trials are to be conducted in the EAEU in compliance with the Good Clinical Practice of the EAEU (approved by the…

An intro to the legal situation for regulatory, pricing and reimbursement in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authorities responsible for applying and enforcing the regulatory framework shall be: concerning drugs and biologicals – the Ministry of Healthcare…

The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations in Russia, was rich with expectations, events and legislative proposals aiming to reform the Russian pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory framework of the Eurasian Economic Union, etc. This trend is likely to continue in 2020 as well.   Some of the major developments that are yet to be shaped into…

Nadezhda Fedotova and Andrey Zelenin of Lidings law firm gives an update on recent amendments to the labeling legislation for medicines in Russia, their potential impact on the Russian pharmaceutical industry, and the numerous uncertainties still remaining.   Despite the time moving up to January 1, 2020, it seems impossible to say whether the drugs labeling system will or will not be launched in time completely Under the Decree of the Government of the Russian Federation No. 1556 dated December…