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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.



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.

New Procedures for Conducting Clinical Trials Have Taken Effect

17 February 2025

On 4 February 2025, the official portal of legal information were posted:

  1. Order of the Ministry of Health No. 708n of 23 December 2024 “On Approval of the Procedure for Maintaining the Register of Issued Permits to Conduct Clinical Trials of Pharmaceuticals” (“Order No. 708n”) - the document replaces Order of the Ministry of Health No. 754n dated 26 August 2010;
  2. Order of the Ministry of Health No. 706n dated 20 December 2024 establishing the procedure for the Ministry of Health to publish on its website a list of medical organisations conducting clinical trials (“Order No. 706n”) - the document replaces Order of the Ministry of Health No. 752n dated 26 August 2010.

Both documents entered into force on 15 February 2025 and aim to harmonise with the provisions of the EAEU regulations, as well as to simplify the system of information resources maintenance by the Ministry of Health by abolishing the “paper” document flow.

Start Of the Experiment on Monitoring of Manufacturers of Dietary Supplements, Clothing and Footwear

29 November 2024

On November 22, 2024, the Government of the Russian Federation (the “Government”) approved Resolution No. 1607 dated November 22, 2024 (the “Resolution”) on the experiment in the territory of the Russian Federation to conduct monitoring of Russian manufacturers of goods which are subject to mandatory marking with means of identification using the state information monitoring system for the circulation of goods subject to mandatory marking with means of identification (the “Experiment”).

More in our update.