RUSSIAN FEDERATION

FEDERAL LAW

ON CIRCULATION OF MEDICINES

Adopted by the State Duma March 24, 2010

Approved by the Federation Council March 31, 2010

Chapter 1. GENERAL PROVISIONS

Article 1. Subject of Regulation of This Federal Law

1. This Federal Law regulates relations arising in connection with circulation, i.e. development, preclinical testing, clinical trials, expert examination, state registration, standardization and quality control, manufacture, compounding, storage, transportation, import into the Russian Federation, export from the Russian Federation, advertising, dispensation, distribution, transfer, use and destruction of medicines.

(as amended by Federal Law of December 06, 2011, No. 409-FZ)

2. This Federal Law establishes the priority of the state regulation of safety, quality and efficacy of medicines in the process of their circulation.

(as amended by Federal Law of June 25, 2012, No. 93-FZ)

Article 2. Scope of Application of this Federal Law

This Federal Law applies to relations arising in the process of circulation of medicines in the Russian Federation.

Article 3. Legislation on Circulation of Medicines

1. Legislation on circulation of medicines comprises this Federal Law, other federal laws and other regulatory legal acts of the Russian Federation.

1.1. The legislation on circulation of medicines applies to the legal entities and individual entrepreneurs carrying out activity on the territory of the international medical cluster, the legislation applies with account of the specifics set forth by the Federal Law "On the international medical cluster and introduction of amendments to certain legislative acts of the Russian Federation".

(clause 1.1 introduced by Federal Law of June 29, 2015, No. 160-FZ)

2. This Federal Law applies to circulation of narcotic and psychotropic medicines with account of the specifics established by the legislation of the Russian Federation on narcotic drugs, psychotropic substances and precursors thereof.

3. This Federal Law applies to circulation of radiopharmaceutical medicines with account of the specifics established by the legislation of the Russian Federation in the area of radiation safety.

4. If an international treaty of the Russian Federation establishes rules other than those stipulated by this Federal Law, the rules of the international treaty shall apply.

5. In the Russian Federation in accordance with the international treaties of the Russian Federation and (or) based on the principle of reciprocity, results of clinical trials of medicinal products for medical use conducted outside the Russian Federation shall be acknowledged.

Article 4. Basic Terms Used in this Federal Law

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Chapter 2. POWERS OF FEDERAL EXECUTIVE BODIES AND EXECUTIVE BODIES OF CONSTITUENT ENTITIES OF RUSSIAN FEDERATION WITH RESPECT TO CIRCULATION OF MEDICINES

Article 5. Powers of Federal Executive Bodies with Respect to Circulation of Medicines