Quality of a Medicine as a Legal Category

Student: Shilova Ekaterina

Supervisor:

Educational Programme: Pharmaceutical and Health Care Law (Master)

Year of Graduation: 2024

Drugs play a key role in modern medicine and healthcare. Regulating the quality of medicines is aimed at ensuring their effectiveness and safety. However, the specifics of this regulation are evident in the complexity of assessing the quality of drugs, which must be considered through the lens of quality control and assurance of pharmaceutical quality at all stages of their use. The aim of this work is to examine the legislative regulation of issues related to ensuring the quality of medicines in the Russian Federation and the Eurasian Economic Union, taking into account legislative acts, judicial practice, and international experience.

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