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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.
The reason for the appeal of the state customer to the court of first instance was the recognition by the regional Department of the Federal Antitrust Service of a substantiated complaint of the procurement participant against the decision of the auction commission to refuse admission to participate in the auction for the supply of the medicinal product Bromhexin + Guaifenesin + Salbutamol as not complying with the requirements of the auction documentation.
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”.
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.
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.
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”.
- The Arbitration Court of the Moscow District rejected the state customer's claim to provide a registration certificate of a combined medical device for the delivered car and mammography device
- FAS Russia has clarified the issue of procurement of medical devices made of PVC plastic for failed tenders
- New Rules for the destruction of seized falsified, substandard and counterfeit medicinal products approved
- The government has set the rules for the circulation of generic drugs and biosimilars before establishing their interchangeability
Earlier articles
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The courts have determined the interchangeability of the drug “Kashnol” on the basis of data from the State Register of Medicines
05-11-2020
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...
Webinar on the topic: “The practice of reducing costs and risks during transportation and storage of medicinal products”
23-10-2020
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”.
The rules for the destruction of seized falsified, substandard and counterfeit medical devices have been approved
21-10-2020
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...
Certificates of registration of unlimited validity for medical devices and equipment are subject to reissuing by January 1, 2021
21-10-2020
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...
Launch of the electronic service “Import of unregistered medical devices”
21-10-2020
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”.
The Arbitration Court of the Moscow District rejected the state customer's claim to provide a registration certificate of a combined medical device for the delivered car and mammography device
21-10-2020
The Arbitration Court of the Moscow District, in its Award No. F05-15092/2020 of 06.10.2020 No. F05-15092/2020 rejected the state customer's claim to provide a registration certificate of a medical device for the delivered car and mammography device.
