Tag Archives: News

When drug is not actually a drug on the marketplace.

The PharmComm company, the owner of the exclusive rights to the Bezornil® trademark, found pages of sellers on marketplaces that were not related to this product in any way. The cards of some products also featured the wording “better than bezornil”. After unsuccessful attempts to contact the management of the Wildberries marketplace, the company turned to the Moscow Office of

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4-aminophenol in drugs and not only: in what way it is dangerous?

According to the register of medicines in the Russian Federation, there are 218 drugs containing paracetamol as an active pharmaceutical ingredient. Paracetamol is widely used as an antipyretic and pain reliever among adults and children. The chemical-pharmaceutical synthesis of paracetamol is carried out from 4-aminophenol, the content of which is normalized in all drugs based on paracetamol. What for? 4-aminophenol

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New HIV drug approved in Europe.

On June 23, 2022, an innovative HIV drug called Sunlenca (lenacapavir) manufactured by the American company Gilead was approved in Europe. The drug has been approved under a centralized procedure in all 27 EU member states, including Norway, Iceland and Liechtenstein. The regulators made their decision based on a phase II/III study called CAPELLA. In the trial, 83 % of

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The Federal Service for Surveillance in Healthcare stopped the implementation of unregistered medical devices, as well as the carrying out of illegal plastic surgeries, at the specialized exhibition of the beauty industry “INTERCHARM Professional” in Moscow

On 19 April 2019 the territorial body of the Federal Service for Supervision in Healthcare in Moscow and the Moscow region, together with law enforcement agencies, conducted control and supervisory measures at a specialized exhibition for professionals of the beauty industry and salon business “INTERCHARM Professional”, which was held on the territory of the Crocus Expo exhibition complex in Moscow.

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As a result of joint actions by the Federal Service for Supervision in Healthcare and law enforcement agencies in the Orenburg region, illegal activities to manufacture and market an unregistered medical device were stopped.

As a result of control and supervisory measures the territorial body of the Federal Service for Supervision in Healthcare in the Orenburg region exposed the production of an unregistered medical device Emplastrum “Silver Bridges” in the city of Gai. Information on the illegal production was sent to the Ministry of Internal Affairs of Russia in the Orenburg region to make a

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Профессиональная программа повышения квалификации на тему «Клинические испытания (исследования) медицинских изделий»

ФГБУ «ЦМИКЭЭ» Росздравнадзора проведет профессиональную программу повышения квалификации на тему «Клинические испытания (исследования) медицинских изделий». Федеральная служба по надзору в сфере здравоохранения информирует о проведении Федеральным государственным бюджетным учреждением «Центр мониторинга и клинико-экономической экспертизы» Росздравнадзора дополнительной профессиональной программы повышения квалификации на тему «Клинические испытания (исследования) медицинских изделий» с последующей выдачей документа о повышении квалификации государственного образца (Удостоверения о краткосрочном повышении

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The Federal Service for Surveillance in HealthCare ceases cooperation with MFC

Legal entities and/or private entrepreneurs intending to perform work (services) in the field of medical device circulation shall notify the Federal Service for Surveillance in HealthCare about the initiation of their operations. On 26 May, 2018, an Order of the Government of the Russian Federation was issued (No. 603), amending the list of public services which may be provided by

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Roszdravnadzor: Amendments to the Federal Law on the Circulation of Medicinal Products

  Federal Law No. 140-FZ dated June 04, 2018 On Amendments to the Federal Law On the Circulation of Medicinal Products entering into force on June 15, 2018 has been designed to amend the procedure for the submission of documents for the purpose of the state registration of medicinal products, confirmation of the state registration, and introduction of amendments into

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Roszdravnadzor revealed gross violation of legislation in the clinic where a young woman died during plastic breast surgery. The medical facility in question is closed down

After receiving information about the death of the woman after planned plastic breast surgery in the OOO Elit Clinic company facility, the local office of Roszdravnadzor in Moscow and Moscow Oblast conducted an unscheduled audit of the aforesaid medical facility. During the audit visit, multiple gross violations of the applicable legislation were discovered. In particular, two plastic surgeons (one of

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