News Digest 01.12.2023-04.12.2023
Regulators
Excise tax on the pharmaceutical substance ethanol may be introduced from April 2024
The Ministry of Finance has developed a bill introducing an excise tax on ethyl alcohol, including the pharmaceutical substance ethanol. “FV” has read the document. If adopted, the changes will come into force no earlier than the first day of the next tax period - that is, in April 2024, said Stanislav Naumov, Deputy Chairman of the State Duma Committee on Economic Policy.
What will change in medical device maintenance licensing in 2024
Decree of the Government of the Russian Federation No. 1332 of August 12, 2023, establishing the procedure for licensing activities for the maintenance of medical devices (TOMI), amends the current procedure. The amendments will take effect on September 1, 2024 and will require companies that received a TOMI license before March 1, 2022 to re-issue them before the new regulation comes into force.
Legal entities and individual entrepreneurs operating under a license received before 03/01/2022 on the basis of Decree of the Government of the Russian Federation No. 469 of 06/03/2013 must renew a license for TOMI. As well as organizations, including individual entrepreneurs, planning to engage in maintenance of medical devices (MD). This requirement does not apply to companies and individual entrepreneurs performing work on TOMI to meet their own needs, and those who service medical equipment with a low degree of potential risk of use.
The list of exceptions also includes medical devices that do not correspond to any of the groups of medical devices according to the classes of possible risk of use listed in Appendix No. 1 to the current Decree of the Government of the Russian Federation No. 2129 of November 30, 2021: class 2a - medical devices with an average degree of risk; 2b - with an increased degree of risk, 3 - with a high degree of risk.
Market news
Zaslon intends to occupy at least 15% of the ultrasound market
The St. Petersburg enterprise Zaslon JSC (part of the Leninets defense holding) intends to occupy at least 15% of the domestic ultrasound device market with a line of portable medical ultrasound scanners under the SmartScan brand. The production capacity is estimated at one thousand devices per year. The volume of investments in the project is not disclosed, but the total volume of investments in the production of microcircuits both for anchor projects and for the direction of diagnostic medical equipment in June 2023 was estimated at 2 billion rubles.
Source: https://vademec.ru/news/2023/12/01/zaslon-nameren-zanyat-15-rynka-uzi/
Other
Amazon and Amgen expand collaboration on AI
Amazon and Amgen have announced an expanded collaboration to develop drugs using generative artificial intelligence (AI). This is stated in a press release published on the Amazon website.
As part of the partnership, the pharmaceutical manufacturer will leverage Amazon's infrastructure and advanced services to enhance its digital data and analytics platform, which will be integrated into its enterprise operations. As noted, the company plans to open a new plant next year in Ohio, which will be equipped with the latest digital and robotic technologies, including the Amazon SageMaker service for training machine learning models that analyze daily data from production processes. This will help reduce human intervention, fully automate work, and even predict possible equipment failures.
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