Overview of changes in the sphere of information security and personal data (hereinafter referred to as the “PD”) that will affect the activities of organizations involved in the wholesale and retail trade of medicinal products. We remind you that starting from September 1, 2025, consents for PD processing must be stand-alone documents, separate from website Privacy Policies

On September 1, 2025, Federal Law No. 150-FZ dated June 7, 2025, 'On Amendments to Certain Legislative Acts of the Russian Federation' (hereinafter referred to as 'Federal Law No. 150'), will come into force, introducing a number of changes affecting the regulation of dietary supplements.

On June 24, 2025, the President of the Russian Federation signed Federal Law No. 178-FZ "On Amendments to Part One and Article 846 of Part Two of the Civil Code of the Russian Federation" ("Law"), which introduces amendments to the Civil Code of the Russian Federation ("Civil Code"), allowing one legal entity to be the sole participant or shareholder of another company, even if both are having the sole person in it.

On 23 July 2025, a part of the Good Clinical Practice Guideline, GCP E6 (R3), promulgated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) comes into force. The development of new technologies, the rapidly evolving clinical trial (CT) ecosystem, and the need to respond quickly to deviations in CT processes have prompted the revision of the current version of GCP ICH E6(R2), which is valid until 22 July 2025.

On 1 April 2025, the President of the Russian Federation signed Federal Law No. 49-FZ dated 01.04.2025 “On Amending the Civil Procedure Code of the Russian Federation” (hereinafter referred to as the “Law”).

The key amendments concern the procedure for reinstating missed procedural deadlines, including those for filing appeals, and the procedure for accepting appeals for consideration.

On May 14, 2025, the Resolution of the Government of the Russian Federation № 608 dated 08.05.2025 (hereinafter - “Resolution”) was published on the Official Portal of Legal Information. It establishes the threshold values of the assets of financial organizations supervised by the Bank of Russia; exceeding these amounts, organizations shall obtain the prior consent of the Federal Antimonopoly Service of Russia (hereinafter - “FAS of Russia”) is required.

On 6 May 2025, the updated version of the Order of the Ministry of Health dated 9 February 2016 No. 80n “On the Approval of the Procedure for Maintaining the State Register of Medicines for Medical Use” (the “Order”) came into force. The amendments were made in accordance with Order of the Russian Ministry of Health dated 17 March 2025 No. 129n, officially published on 25 April 2025.

The Eurasian Economic Union has published on its official legal website the Order No. 34 dated 08.04.2025 approving the draft decision on the extension of temporary measures related to specifics of medicines circulation in connection with special economic measures (“Draft Decision”).

From 01.07.2025 the Federal Law No. 23-FZ dated 28 February 2025 “Concerning Personal Data and Certain Legislative Acts of the Russian Federation" will enter into force, containing a new version of part 5 of Article 18 of Federal Law No. 152-FZ

On 14 February 2025 the Draft Law No. 841857-8 “On Amending Articles 247 and 259.3 of Part One, Articles 689 and 700 of Part Two and Article 1137 of Part Three of the Civil Code of the Russian Federation” (hereinafter – the “Draft Law”), providing for the possibility of registering information on the order of possession and use of real estate in common shared ownership, was submitted to the State Duma.