Tag Archives: Head

COVID-19. Are there any effective medicinal products?

Since December 2019, the world has been struggling with a new infectious disease COVID-19 (COrona VIrus Disease 2019). This disease is caused by a virus belonging to the Coronaviridae family. The family includes two subfamilies and five genera which bring together more than 10 species that cause lesions of respiratory organs, gastrointestinal tract, nervous system in humans and animals. On

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Fast track registration for products from special list

Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list of products: medical devices with 1 risk class are included in this list (for example, gloves), “fast track” includes initial submission with very limited amount of documents – with providing main dossier after registration certificate

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Classification of perfumery and cosmetic products

According to the official website of the Federal Accreditation Service (https://pub.fsa.gov.ru/rds/declaration), 1,461 perfumery and cosmetic products (PCP – if shortly) names have been certified in the territory of the Russian Federation and have the status of “Valid”. Which categories do declared products refer to? How are the PСP generally classified? Answers to these questions will be provided in this article.

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World views on dietary supplements

In the section devoted to biological active additives (BAS), several articles were published about the “Russian” view of this category of products. According to Russian legislation, dietary supplements are natural and (or) identical to natural biologically active substances, as well as probiotic microorganisms. which are intended to be consumed at the same time as food or to be introduced into

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Market of registered pharmaceuticals for human use in Russia

When registering medicines in the territory of the Russian Federation, information about them is reflected in the state register of medicines. The GRLS contains basic information about the drug (registration certificate number, date of registration and re-registration, information about the holder of the RC and the form of release, etc.) Interestingly, GRLS can be opened not only online, but also

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CAR-T products as a promising BMCP on the territory of Russia and the EAEU

More than a year has passed since our latest publication dedicated to CAR-T therapy — cell products belonging to the BMCP category. Since then, the Russian Federation has introduced several normative legal acts regulating the process of registration of BMCP, and it would seem that the process of putting into circulation such high-tech products, slowly but surely acquires standardized forms,

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Registration of pharmaceuticals for human use in Ukraine

The procedure for registration of medicines in Ukraine is in the stage of harmonization with the registration in the European Union, which leads to regular updating of the regulatory framework and some changes in the organization of work on registration. However, the new registration of pharmaceuticals for human use now includes three main stages: preparatory step, registration process and fulfillment

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The system of state regulation of registration of medicines in Ukraine

The procedure of registration, re-registration of medicines, as well as amendments to the registration dossier in Ukraine is somewhat different from the Russian procedures. For example, in Ukraine it is mandatory to comply with the IFU for a drug with the instructions of the reference European state (if the drug is registered in the EU), the national expert center of

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Diseases of the population of Russia. Epidemiological review (2018)

Perhaps nothing so objectively reflects the reality as figures. Of course, if the numbers are real. They can scare, please, make you think about the past, present and future, or leave indifferent, if they do not specifically concern us. So, “figures” showing the state of affairs of any economic organization, are unlikely to interest the housewife, and the number of

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