Государственные гарантии качества лекарственных препаратов

С. 71–88.

Kalmykova A. V.

The publication entitled "Citizens ' right to medication" is a monographic study of

the basic aspects of the legal regulation of medicines for citizens of the Russian

Federation. By emphasizing the social security nature of the set of rights in question, the

authors turn to foreign experience and international law. The aim of this work is to show

the differences in the rights and responsibilities of the main subjects of circulation of

medicines, depending on the stages of the process. The uniqueness of the work lies in

the consideration of these relations as a complex dynamic system, where the rights of a

citizen, patient, buyer, user of drugs. The readers are offered a comprehensive analysis

on the regulation of the most acute problems: orphan diseases, provision of medicines

for socially significant diseases, the state's participation in the system of guarantees of

quality and availability of drugs etc.

The scientific publication is addressed to medical and pharmaceutical specialists,

to persons who receive higher medical or pharmaceutical education, to social protection

professionals, to employees of the State authorities whose activities involve the

treatment of medicines and the provision of social assistance to individual categories of

citizens.

Keywords: государственный надзор, обращение лекарственных средств, лекарственные препараты, гарантии качества, фальсифицированные лекарственные средства, фармаконадзор, гарантии качества лекарственных средств, фармакопейная статья, призвосдство лекарственных средств, надлежащие производственные практики, инспектирование

In book

Право граждан на лекарственное обеспечение

Kalmykova A. V., Путило Н. В., Волкова Н. С., Цомартова Ф. В., Препьялов А. В., Махник Д. И., Баранков В. Л., Еремина О. Ю., Мельник Т. Е., Пуляева Е. В., Шадрин А. Д. М.: Юридическая фирма «КОНТРАКТ», 2017.