Licensed Biomedical Cellular Products Circulation: Enforcement Issues
https://doi.org/10.17803/1994-1471.2020.114.5.160-167
Abstract
The paper is devoted to the consideration of issues related to legal regulation in the field of biological safety. The study highlights the features of the licensed regime for the production and circulation of biomedical cell products both in Russia and abroad. The author conducts a differentiated analysis of the concepts of “legal regime” and “licensed regime” of the turnover of biomedical cell products, studies the organizational and legal features of the general and special licensed regimes circulation of biomedical cell products. The paper identifies priority areas of legislative activity in terms of ensuring the functioning of special licensed treatment regime for biomedical cell products. It is established that in the domestic legislation there is no definition of the licensed regime in general and the licensed regime for the production and circulation of biomedical cell products in particular, the features of the special licensed regime for the circulation of biomedical cell products have not been fixed. The author concludes that the formation of the regulatory framework of the licensed regime for the production and circulation of biomedical cell products is one of the leading directions in ensuring biological safety both in Russia and abroad. The absence of a normatively fixed set of preventive measures aimed at minimizing the risks of the spread of infectious diseases because of the use of biomedical cell products can significantly harm the biological safety of the state.
About the Author
N. S. Posulikhina
Kutafin Moscow State Law University (MSAL)
Russian Federation
Russian Federation
Cand. Sci. (Law), Lecturer of the Department of Medical Law
ul. Sadovaya-Kudrinskaya, d. 9, Moscow, Russia, 125993
References
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Review
For citations:
Posulikhina N.S. Licensed Biomedical Cellular Products Circulation: Enforcement Issues. Actual Problems of Russian Law. 2020;15(5):160-167. (In Russ.) https://doi.org/10.17803/1994-1471.2020.114.5.160-167
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