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Bill On Manufacturing Individual Gene Therapy Pharmaceuticals In Medical Organisations Without State Registration Submitted to The State Duma

28 October 2026

On 16 October 2026, the Russian Government submitted to the State Duma bill No. 12837-9 (Bill) amending Federal Law No. 61-FZ dated 12 April 2010 "On Circulation of Medicines" (Law on Circulation of Medicines).

The Bill introduces a special circulation regime for individual gene therapy pharmaceuticals (IGTPs): a medical organisation will be able to manufacture such a pharmaceutical for a specific patient and use it on its own premises without registration, on the basis of an authorisation issued by the Russian Ministry of Health.


Turkey’s Nuclear Regulatory Agency Has Tightened the Procedures for Modifying Equipment and Operating Procedures at Nuclear Facilities

27 October 2026

On October 2, 2026, the Official Gazette of Turkey (Resmî Gazete) published amendments by the Turkish Nuclear Regulatory Authority (Nükleer Düzenleme Kurumu, “NDK”) to the Regulation on Licensing Activities for Nuclear Facilities (“Licensing Regulation”) and the Regulation on the Management System for Nuclear Facilities, Radiation Facilities, and Radioactive Waste Management Facilities (“Management System Regulation”). Most of the amendments took effect on the date of publication. The new procedure for making changes at nuclear facilities (Article 41 of the Regulations on Licensing Activities) will take effect on January 2, 2027.

The amendments apply to organizations that carry out activities related to nuclear facilities based on NDK licensing documents (approvals, permits, and licenses). With regard to the Akkuyu NPP, the licensee is Akkuyu Nükleer A.Ş. Organizations within the Rosatom State Corporation that participate in the project as designers, equipment manufacturers, contractors, and service providers are indirectly affected by the amendments through the licensee’s processes and the terms of supply contracts.


Critical Infrastructure Facilities Face the Risk of Temporary Administration

26 August 2026

On 24 August 2026, Decree of the President of the Russian Federation No. 604 “On Measures to Ensure the Security of Critical Infrastructure Facilities of the Russian Federation” (the Decree) was published and entered into force. The Decree empowers the Government of the Russian Federation, acting upon an instruction of the President, to introduce temporary administration over business entities connected with critical infrastructure facilities.

Changes To Counter-Sanctions Regulations in July 2026

30 July 2026
On July 10, 2026, the Ministry of Finance of the Russian Federation issued Official Clarification No. 5 ("Clarification No. 5") on the application of Decree of the President of the Russian Federation No. 618 dated September 8, 2022, "On the Special Procedure for Carrying Out (Executing) Certain Types of Transactions (Operations) Between Certain Persons" ("Decree No. 618").

Changes to Counter-Sanctions Regulations (June 2026)

09 June 2026

On June 1, 2026, the decision of the Bank of Russia Working Group dated June 1, 2026  No. PRG-43-11/1199 (hereinafter – “Decision”) and Presidential Decree No. 377 dated June 1, 2026 “On Amending Presidential Decree No. 95 of March 5, 2022 ‘On the Temporary Procedure for Fulfilling Obligations to Certain Foreign Creditors’” (hereinafter – “Decree No. 377”) were published, introducing changes to the current counter-sanctions regulation.

Draft Law on Consolidated Financial Statements: Conditions and Exemptions

04 February 2026

On January 20, the State Duma adopted in the first reading Draft Law No. 1082205-8 ("the Draft Law"), which exempts a number of legal entities from the obligation to submit mandatory consolidated financial statements ("CFS"). The Government of the Russian Federation acted as the subject of the right of legislative initiative.

The Draft Law amends Federal Law No. 208-FZ dated 27 July 2010 "On Consolidated Financial Statements" and Federal Law No. 39-FZ dated 22 April 1996 "On the Securities Market."


Changes to the Procedure for Paying the Actual Value of a Share in an LLC Came into Force

30 December 2025

On 28 December 2025, the President of the Russian Federation has signed Federal Law No. 514-FZ "On Amending the Federal Law 'On Limited Liability Companies' and Certain Legislative Acts of the Russian Federation" (hereinafter, the "Law"), which introduces changes to the procedure for paying the actual value of a share in limited liability companies (hereinafter, the "LLC").

The President of Russia Signed a Decree on Supporting the Resettlement of Key Interest Foreigners for The Russian Federation

30 December 2025

On 2 December 2025, the President of the Russian Federation has signed Decree No. 883 "On Supporting the Resettlement of Foreign Citizens and Stateless Persons, Who Represent Interests for the Russian Federation, and on the Features of Their Legal Status in the Russian Federation" (hereinafter – the "Decree") together with the Regulation "On the Procedure for Recognizing Foreign Citizens and Stateless Persons as Representing Interests for the Russian Federation" (hereinafter – the "Regulation").