A draft order of the Ministry of Health has been developed “On Amending the List of Diseases and Conditions and Corresponding Medicines Containing Narcotic Drugs or Psychotropic Substances in order to import them into the territory of the Russian Federation for the provision of health care according to the vital indications of a specific patient or group of patients, approved by the order of the Ministry Healthcare of the Russian Federation No. 80n dated February 13, 2020”.

Resolution of the Government of Russia dated April 30, 2021, No. 687 “On state support of organizations to compensate for part of the costs associated with the certification of products, including products of the pharmaceutical and medical industry, in foreign markets” (hereinafter – “Resolution No. 687”) sets goals, conditions and procedure the provision of subsidies from the federal budget to organizations to compensate for part of the costs associated with the certification of products, including products of the pharmaceutical and medical industry, in foreign markets, within the framework of the federal project “Industrial Export” of the national project “International Cooperation and Export”.

Decree of the Government of Russia dated 06.04.2021 No. 545 approved the Procedure for the acquisition of medicinal products, medical devices and technical means of rehabilitation for a specific child with a serious life-threatening and chronic disease, including a rare (orphan) disease, or for groups of such children (hereinafter referred to as the “Procedure”).

The Russian Ministry of Health has developed a draft Rules for the Dispensing of Medicines for Medical Use” (project ID 01/02 / 04-21 / 00114788) (hereinafter referred to as the Rules).

On April 26, 2020, Roman Shabrov, attorney at BRACE, spoke at the PHARMAPAK forum within the section “New rules of the game in the context of rapid development of e-commerce” with a report on the topic: “Current legislative framework for online trade of medicines and dietary supplements. What is allowed and what is not? Initiatives for the near future”.

By the ruling of the Supreme Court of the Russian Federation dated 09.21.2020 No. 310-ES20-13277 in case No. A64-3869 / 2019, it was refused to transfer the case to the Judicial Collegium for Economic Disputes of the Supreme Court. The Supreme Court confirmed the correctness of the conclusions of the Arbitration Court of the Central District, which overturned the judgments of the lower courts, which recognized the decisions of the regional Department of the Federal Antitrust Service on the groundlessness of the rejection of the bid of the procurement participant by the customer.

On October 23, 2020, Roman Shabrov, attorney at BRACE, spoke at a webinar organized by PHARMAPAK, “Practice of reducing costs and risks during transportation and storage of medicinal products” with a report on the topic: “Actual legal risks of pharmaceutical logistics”.

Decree of the Government of Russia dated September 15, 2020 No. 1440 approved the Rules for the destruction of seized falsified medical devices, substandard medical devices and counterfeit medical devices (hereinafter referred to as the Rules for the destruction of seized medical devices, the Rules). The document comes into force on January 1, 2021 and will be valid until January 1, 2027.

In accordance with paragraphs B of clause 2 of the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 “On Approval of the Rules for State Registration of Medical Devices” certificates of registration for medical devices and medical equipment of unlimited validity, issued before the date of entry into force of this Decree, are valid and must be reissued until January 1, 2021 for registration certificates in the form approved by the Federal Service for Surveillance in Healthcare.

The official website of the Federal Service for Surveillance in Healthcare on September 28, 2020 contains information on the launch of the electronic service “Import of unregistered medical devices”.