Separate Issues of Naming Biomedical Cell Products: Russian and Foreign Experience
( Pp. 191-194)

This article examines the current practice of naming biomedical cell products in the Russian Federation. In particular, the author notes the lack of legal regulation of this issue. On the other hand, on the territory of the EAEU, high-tech medicines are equated to medicines and the practice of their names is similar to the practice of names of medicines in accordance with the international non-proprietary name. The aim of the research is to consider possible scenarios for regulating the practice of naming biomedical cell products at the legislative level in Russia. Research methodology: analysis of the current legislative framework of the Russian Federation in the field of biomedical cell products and foreign experience in the field of naming such medical products. The novelty of the research lies in the determination of a possible scenario for the regulation at the legislative level in the Russian Federation the issue of the correct compilation of the name of biomedical cell products.

Davidenko A.O., (2022), SEPARATE ISSUES OF NAMING BIOMEDICAL CELL PRODUCTS: RUSSIAN AND FOREIGN EXPERIENCE. Economic Problems and Legal Practice, 2 => 191-194.

Federal Law No. 323-FZ of 08.06.2016 (as amended on 27.12.2019) «On biomedical cell products». -[Electronic resource]. Access mode: http://pravo.gov.ru/proxy/ips/?docbody=&nd=102402596.
Order of the Ministry of Health of the Russian Federation No. 281n dated 31.05.2017 [Electronic resource]. Access mode: https://docs.cntd.ru/document/436743536
Order of the Ministry of Health of the Russian Federation No. 567n dated 28.08.2017. -[Electronic resource]. Access mode: https://cdnimg.rg.ru/pril/145/12/71/48162.pdf
Decision of the Council of the Eurasian Economic Commission No. 78 of 03.11.2006 «On the Rules of registration and examination of medicines for medical use». -[Electronic resource]. Access mode: https://docs.eaeunion.org/docs/ru-ru/01411969/cncd_21112016_78.
The Federal Service for Supervision in the Field of Healthcare has issued GENERIUM JSC the first license in Russia for the production of biomedical cell products. -[Electronic resource]. Access mode: https://vladimir.tpprf.ru/ru/news/358657
SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes. Elektronnyy resurs . Rezhim dostupa: https://www.fda.gov/media/96219/download.
World Health Organization. Discussion on Nomenclature for Cell Therapy Products and Proposal for Biosimilars, 15 October 2012. Elektronnyy resurs . Rezhim dostupa: https://www.who.int/medicines/services/inn/INN cell therapy report 2014.pdf.

biomedical cell product, high-tech drug, name, drug, international non-proprietary name.