Separate Issues of Naming Biomedical Cell Products: Russian and Foreign Experience
- Authors: Davidenko A.O.1
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Affiliations:
- Academy of Labor and Social Relations
- Issue: Vol 18, No 2 (2022)
- Pages: 191-194
- Section: Articles
- URL: https://journals.rcsi.science/2541-8025/article/view/147074
- ID: 147074
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Abstract
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##article.viewOnOriginalSite##About the authors
Anastasia O. Davidenko
Academy of Labor and Social Relations
Email: nastya.anastasya96@yandex.ru
Postgraduate student of the Department of Civil Law and Procedure Moscow, Russian Federation
References
- 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. [Электронный ресурс]. Режим доступа: https://www.fda.gov/media/96219/download.
- World Health Organization. Discussion on Nomenclature for Cell Therapy Products and Proposal for Biosimilars, 15 October 2012. [Электронный ресурс]. Режим доступа: https://www.who.int/medicines/services/inn/INN_cell_therapy_report_2014.pdf.
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