News Digest 27.12.2023 — 29.12.2023
Regulators
Additional requirements will be established for the wholesale sale of ethanol
The Ministry of Health of the Russian Federation has developed a draft amendment to the Regulations on licensing of pharmaceutical activities. It is planned that a number of additional requirements will be established for distributors of medical alcohol - for example, companies must have been operating for at least five years before applying for a license to sell ethanol. The draft government resolution was posted for public comment on December 26. The explanatory note states that the document was developed “in order to suppress cases of sales of medicines with the international non-proprietary name “ethanol”.
Among the new licensing requirements for distributors, the draft outlines the introduction of an obligation to obtain a license to carry out pharmaceutical activities, indicating the type of work, services “Wholesale trade of a medicinal product for medical use with the international nonproprietary name “ethanol”, as well as “Transportation of a medicinal product for medical use with the international nonproprietary name.” called "ethanol". In addition, the company is expected to have separate premises for storing medical alcohol. If the resolution is adopted, the new licensing rules will come into force on September 1, 2024 and will be valid until September 1, 2028.
Restrictions on the export of medical devices extended until the end of 2025
The Russian government has extended the framework ban on the export of medical devices from the country until December 31, 2025. At the same time, an exception is provided for samples of medical devices previously imported into Russia for the state registration procedure. They can be exported subject to the provision of documents verified by Roszdravnadzor and confirming the results of tests or studies of medical devices during the registration procedure.
Source: https://vademec.ru/news/2023/12/29/ogranicheniya-na-vyvoz-medizdeliy-prodleny-do-kontsa-2025-goda/
Vendors were exempted from part of the licensing requirements when servicing their medical devices
The Russian government has exempted manufacturers or authorized persons of foreign manufacturers engaged in servicing equipment only of their own brand from some of the licensing requirements, including the presence of a quality management system. The changes were made by Resolution No. 2288 of December 25, 2023, they came into force from the date of publication.
Market news
Interregional offset for the production of medical gloves was announced in Samara
Samarapharmacia announced an offset contract for the creation of a production of nitrile gloves in the region in exchange for the supply of medical products for ten years to two addresses - for the needs of Samarapharmacia itself and the Moscow City Clinical Hospital No. 15 named after. O.M. Filatova. The initial maximum contract is 75.2 million rubles. This is the first interregional offset contract for medical devices, where the supply and production territories are located in different regions.
The application for early diagnosis of skin cancer “About moles” received a regulatory certificate
The mobile application “About Moles”, developed by the team of the Volga Research Medical University, is registered as a medical product. University rector Nikolai Karyakin called this “one of the most long-awaited events of this year” and specially thanked Elena Malysheva for popularizing the application. Using a neural network, the application analyzes photographs of skin tumors and, if suspicious signs are detected, makes a recommendation to consult a doctor. PIMU rector Nikolai Karyakin wrote about this yesterday on his VK page.
Other
National Medical Research Center Blokhin will receive up to 632 million rubles for the development of the industry AI center
Deputy Prime Minister of the Russian Federation Dmitry Chernyshenko spoke about the second wave of selection of research centers in the field of artificial intelligence (AI) in the highest priority sectors of the economy, including healthcare. The list includes six scientific and educational organizations that will receive state support in the amount of up to 632 million rubles. Among them is the National Medical Research Center of Oncology named after. N.N. Blokhin, who intends to develop software for early cancer detection.
New registered medical devices
We publish a list of new medical devices registered from 12.22.2023 to 12.29.2023
Link to the list: [see the table in the attachment]
News
