Author Archives: beawire

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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Renewal of the drug registration within the framework of national regulation

According to the Federal Law No. 61 “On Circulation of Medicines”, a drug, first entered the Russian market, receives a registration certificate for 5 years. During this period, its effectiveness and safety shall be monitored. Further registration must be confirmed. To do this, it is necessary to collect a certain package of documents and send the dossier for expertise. In

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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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THE IMPACT OF POTENTIALLY INTERFERING SUBSTANCES ON THE RESULTS OF CLINICAL LABORATORY TESTS

The reliability and accuracy of the sample results in clinical laboratory tests are influenced by many factors, such as the preanalytical factor, sampling, transportation, storage of samples, as well as the presence of interfering substances in the biomaterial samples. Interfering substances are one of the most common errors in clinical laboratory measurements. The presence of these substances in the samples

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About trials on the spot

Note: This article does not apply to in vitro testing of medical devices for diagnostics, as in this case field trials (trials on the spot or so called factory audit for testing) are not applicable. Introduction Tests conducted for the purposes of the state registration of medical devices are regulated by Order No. 2n dated 09 January 2014 “On Approval

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Lasers used in cosmetology

The invention of the laser became one of the most important and significant achievements of the twentieth century. Currently laser technologies are used in almost all spheres of life: science, armaments, industry, etc. Lasers are also widely used in medicine, one of the areas of which is cosmetology. A laser is a device that converts pumping energy (light, electrical, thermal,

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