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The Federal Antimonopoly Service of the Russian Federation (FAS) and the Ministry of Health of the Russian Federation (Ministry of Health) Recommend Verifying Exclusive Rights When Calculating the Initial (Maximum) Contract Price

30 July 2025

On July 11, 2025, a joint letter from the FAS and the Ministry of Health № ТН/61566/25, № 25-7/И/2-13136 dated July 2, 2025 (hereinafter referred to as the "Joint Letter") was published, clarifying the procedure for determining the initial (maximum) contract price (IMCP) in the procurement of pharmaceuticals.

Overview Of Changes in Information Security and Personal Data Protection Affecting Wholesale and Retail Trade of Medicinal Products

15 July 2025

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

Guideline For Good Clinical Practice (Ich E6 R (3)): Overview of Key Changes in The New Edition

17 June 2025

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.



Lidings Strengthens Business Ties Between Russia and Iran

10 June 2025
Lidings successfully hosted a two-day visit by an Iranian business delegation on June 5–6, 2025, organized with the support of the Ferdowsi Legal dedicated to the markets of the Middle East countries. The event marked an important step in the development of economic and legal cooperation between Russia and Iran, opening new horizons for joint initiatives.

Amendments to the Procedure for the State Register Medicines Maintaining: What Has Changed?

15 May 2025

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.

Lidings – Strategic Partner of the Conference on Legal Issues in Pharmaceutical Industry

10 April 2025

April 10th, 2025 annual conference Pharmaceuticals – 2025: Legal Issues will take place in Moscow organized by Pravo.ru. Lidings lawyers take an active part in the event’s program.

As a strategic partner of the conference, we aimed to make the program rich and actual. Together with pharmaceutical industry experts and lawyers, we will discuss how the market has changed in 2024 and what awaits us in 2025.