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New Procedures for Conducting Clinical Trials Have Taken Effect

17 February 2025

On 4 February 2025, the official portal of legal information were posted:

  1. Order of the Ministry of Health No. 708n of 23 December 2024 “On Approval of the Procedure for Maintaining the Register of Issued Permits to Conduct Clinical Trials of Pharmaceuticals” (“Order No. 708n”) - the document replaces Order of the Ministry of Health No. 754n dated 26 August 2010;
  2. Order of the Ministry of Health No. 706n dated 20 December 2024 establishing the procedure for the Ministry of Health to publish on its website a list of medical organisations conducting clinical trials (“Order No. 706n”) - the document replaces Order of the Ministry of Health No. 752n dated 26 August 2010.

Both documents entered into force on 15 February 2025 and aim to harmonise with the provisions of the EAEU regulations, as well as to simplify the system of information resources maintenance by the Ministry of Health by abolishing the “paper” document flow.

Overview of the Basic Principles of Fair Advertising Practices

23 December 2024

At the 26th session of the Advertising Coordinating Council under the ICAP the Basic Principles of Fair Practices for Bloggers in Advertising in the CIS countries (hereinafter referred to as the “Basic Principles”) were introduced. Basic Principles is an act for self-regulation. The main purpose of Basic Principles is to assist bloggers from CIS countries in complying with advertising legislation.

Should There Be Dividend Payouts? Amendments To the Rules for The Issuance of The Government Commission Permits Under “Countersanctions” Decrees Are Published

23 December 2024

On 16 December 2024, the Resolution of the Russian Government No. 1772 of 13.12.2024 (“Resolution No. 1772”) was officially published, containing amendments to the Rules for the Issuance of permits by the Government Commission for Control over Foreign Investments in the Russian Federation under “countersanctions” Presidential Decrees established by the Resolution of the Russian Government No. 295 of 06.03.2022 (“Rules”).

Start Of the Experiment on Monitoring of Manufacturers of Dietary Supplements, Clothing and Footwear

29 November 2024

On November 22, 2024, the Government of the Russian Federation (the “Government”) approved Resolution No. 1607 dated November 22, 2024 (the “Resolution”) on the experiment in the territory of the Russian Federation to conduct monitoring of Russian manufacturers of goods which are subject to mandatory marking with means of identification using the state information monitoring system for the circulation of goods subject to mandatory marking with means of identification (the “Experiment”).

More in our update.


Overview of FAS Recommendations on Preventing Greenwashing

28 October 2024

On October 23, the Federal Antimonopoly Service of the Russian Federation (the “FAS”) has published recommendations for preventing greenwashing in marketing communications (the “Recommendations”).

Greenwashing is described as actions involving the distribution of false or incorrect environmental statements that mislead consumers regarding the environmental characteristics of goods in order to obtain unjustified advantages.

The Recommendations provide for the concept of environmental statements, their types and requirements for them, as well as the consequences of non-compliance with the requirements for such statements.

Changes in the Terms for Obtaining the Permission of the Government Commission for Share Deals

16 October 2024

It has been reported in public sources that the Sub-Commission of the Government Commission for Control of Foreign Investments in the Russian Federation (the “Sub-Commission”), which issues permits for the sale of Russian assets by companies from ‘unfriendly’ countries, has decided to tighten the conditions for the exit of foreign companies from the Russian market.

Changes In Regulatory Framework for Dietary Supplements in Russia: What Is to Be Expected?

24 July 2024

On 9 July 2024, the State Duma passed Bill No. 638771-8 “On Introduction of the Draft Federal Law ’On Amendments to Certain Legislative Acts of the Russian Federation’” (the “Bill”) in first reading, which focuses on changes in the regulatory regime for the circulation of dietary supplements in Russia.

The proposed amendments would introduce significant changes affecting the circulation of dietary supplements and, to a certain extent, bringing it closer to the regime established for pharmaceuticals and medical devices.

Key Changes to the Law on Circulation of Medicines

14 March 2024
On January 30, 2024, the President of Russia signed Federal Law No. 1-FZ, which introduced substantial amendments to Federal Law No. 61-FZ dated April 12, 2010 ("Law on Circulation of Medicines").

The legislative novelties are primarily aimed at harmonizing national regulation and rules established in the EAEU unified market.

Personal Data Leak – A Problem To Be Solved

15 December 2023

According to the Group-IB research, last year the amount of publicly released databases of Russian companies six times outnumbered those unlawfully made public in 2021. At the same time, special provisions, regulating liability for personal data leaks, are not foreseen neither in the Code of Administrative Offenses of Russia nor in the Criminal Code.

Therefore, on 4 December 2023, the draft laws No. 502104-8 “On Amendments to the Code of Administrative Offences of the Russian Federation” (“draft law No. 502104-8") and No. 502113-8 “On Amendments to the Criminal Code of the Russian Federation” (“draft law No. 502113-8”), providing toughening liability for personal data leakage, were submitted to the State Duma.

According to the explanatory notes to these draft laws, currently existing liability is disproportional and incomparable to the potential social harm which can personal data leakage result in.