The Russian Government adopted Regulation No. 947 “On the use of an invention to produce of a medicine in the Russian Federation for its further export without the patentholder consent” on 25 May 2022. The Regulation establishes the procedure for issuing export licenses, as well as the methodology for calculation of the sum of compensation to patentholders.

The Draft Order of the Russian Ministry of Healthcare on multiagency commission on the detection of medicines shortage or a risk of shortage was published on the official website for draft regulatory acts.

On March 26, 2022, the Federal Law No. 64-FZ “On Amendments to Certain Legislative Acts of the Russian Federation” was adopted (“Law”). It provides for the establishment of certain features of the circulation of medical products (“MP”) and medical devices (“MD”) in Russia in connection with the current economic situation. Such features include the following.

Lidings takes high positions in the new rating of the leading legal advisors in Russia based on the analytical research held annually by the “Kommersant” newspaper.

On 8 March 2022, Federal Law No. 46 “On Amending Certain Legislative Acts of the Russian Federation” entered into full force and effect, suggesting considerable changes in regulations and intellectual property in the pharmaceutical sphere.

On March 04, 2022, the Council of Federation has approved and sent to the President the Federal Law “On Amending Certain Legislative Regulations of the Russian Federation” (the “Law”). This Law provides for a number of changes in the regulation of procurement and circulation of medical products (“MP”) and medical devices (“MD”), corporate and financial relations, and even social matters.

The Russian Government brought a draft law “On amendments to the Part IV o the Russian Civil Code” to the State Duma. 

Review of the most notable advertising disputes in Life Sciences in Russia (in Russian).

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Amendments to the Federal Law “On fundamental healthcare principles in the Russian Federation” will come into force on June 29, 2022, allowing doctors to prescribe off-label drugs to minors, i.e. for indications not specified in their instructions for use.

In December 2021, new amendments to the Law “On Veterinary Medicine” and the Federal Law “On Circulation of Medicines” in terms of the procedure for circulation of medicinal drugs for veterinary use were adopted.