Tag Archives: Regulation

Secondary packaging has become mandatory for medicinal products.

At the end of May 2023, a letter from the Ministry of Health and the expert center of the Federal State Budgetary Institution ‘SCEEMP’ was published on the State Register of Medicines (GRLS) with clarifications for applicants on the availability of medicines sold without secondary packaging in circulation. What is secondary packaging? According to the information from the general pharmacopoeial

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The procedure for the import of medical devices for the purposes of registration in 2023.

On May 2, 2023, the Ministry of Health of the Russian Federation approved the procedure for importing medical devices for the purposes of state registration. According to Order No. 201n, the applicant must notify Roszdravnadzor of the intention to import medical devices in the electronic form for the purposes of state registration. The notification procedure for the import of unregistered

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Documents confirming the registration of a medical device in the country of origin are not required for registration of a medical device in Russia.

Regarding the national registration of medical devices in the Russian Federation, it is often clarified – is registration required in the country of origin or is a CE certificate, declaration, Free Sale certificate, export certificate and other such documents required? According to the current position of the Federal Service of Roszdravnadzor (the relevant reply to our request was received in

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Which variations to the registration dossier for drugs do not require expertise in 2023?

In April 2023, the Ministry of Health of the Russian Federation issued Order No. 95n, which simplifies the procedure for making some changes to the registration dossier for a medicinal product (MP). Thus, the changes have impact on grounds for making changes to the registration dossiers that do not require an examination of quality, efficacy and safety. Now examination of

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Roszdravnadzor issued the first permission to use an unregistered medical device for in vitro diagnostics.

As part of the implementation of Decree of the Government of the Russian Federation No. 2026 dated November 24, 2021 “On unregistered medical devices for in vitro diagnostics”, Roszdravnadzor for the first time issued permission for the use of an unregistered medical device for in vitro diagnostics “A kit of reagents for high-throughput sequencing of human biological material in order

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Rules for the production and labeling of dietary supplements – 2023.

Rospotrebnadzor plans to amend the technical regulations of the Customs Union “On food safety” (TR CU 021/2011) and “On the safety of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition” (TR CU 027/2012). The changes will concern the production, sale and labeling of dietary supplements. Thus, with the help of amendments to the regulation TR

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Termination of supplies of the drug “Ozempic” in the Russian Federation.

In November 2022, Roszdravnadzor received a notification from the Novo Nordisk manufacturing company about the planned termination of supplies of the Ozempic drug to the Russian Federation. It should be noted that according to the current legislation of the Russian Federation, the holder of the registration certificate must notify Roszdravnadzor in advance (1 year in advance) of the termination of

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