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Significant Turnaround in Russian Antitrust Practice of Protecting the Exclusivity of Drugs

29 October 2024

Despite the fact that the issue of intellectual property rights turnover is included in the perimeter of antimonopoly regulation, until recently the Russian Antitrust Agency took rather an observant position.

The regulator's position was that the issue of patent infringement is a private legal dispute between original and generic manufacturers, which should not affect the turnover of drugs, particularly the execution of contracts based on the results of public procurement. Only in isolated cases the Russian Antitrust Agency has established the fact of patent infringement and issued a corresponding order on the inadmissibility of anti-competitive practices.

Now the reverse trend has clearly emerged.

More in our update.


The Procedure for Obtaining by Ministry of Industry and Trade Information Constituting a Trade Secret of Pharmaceutical Manufacturers Has Been Changed

30 September 2024

On 1 September 2024, a joint order of the Ministry of Industry and Trade No. 3554 and the Ministry of Health No. 406n dated 7 August 2024 (hereinafter referred to as the “Order”) entered into force, approving a new procedure for providing the Ministry of Industry and Trade with information on medicines necessary for the purposes of licensing their production and inspecting the subjects of their circulation for compliance the requirements of good manufacturing practice. The Order replaced the previously existing procedure for interdepartmental interaction between the Ministry of Health and the Ministry of Industry and Trade.

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.

Natalya Thotahewage, Counsel in Lidings Life Sciences Industry Practice, Spoke at Largest Ophthalmology Conference

22 April 2024

On April 19, Moscow hosted the largest conference in the field of ophthalmology “Ophthalmology 360°. Health care, marketing, digitalization, law", which brought together leading industry experts: practicing ophthalmologists, representatives of regulatory bodies in the field of health care, specialists in the field of medical law and marketing.

The Pharma Legal Handbook: Russia 

13 April 2024

Lidings experts have authored the The Pharma Legal Handbook — practical directory focused on the key aspects of legislative regulation of pharmaceutical industry in Russia. The Handbook covers major issues linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents in Russia and is a must-have for any company operating in the country or looking to enter the market.