Legal Analysis of Medicines Serialization

Student: Kulikov Aleksey

Educational Programme: Pharmaceutical and Biotechnology Law (Master)

Year of Graduation: 2021

The thesis examines the institution of compulsory serialization (compulsory labeling) of medicinal products -track & trace in Russia, the so-called Drug Labeling System (SMDLP) from the legal point of view. The approaches of the concept of "regulatory rights" are applied to this institution. The thesis examines the experience of using similar systems in the leading pharmaceutical markets: in China, the USA, the EU, and analyzes the possibility of using and developing the system within the EAEU. Also, based on existing practices and trends, the author predicts the development of this information system.

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