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April 12, 2010 N 61-FZ RUSSIAN FEDERATION FEDERAL LAW ON DRUG CIRCULATION Adopted by the State Duma on March 24, 2010 Approved by the Council of Federation on March 31, 2010 (as amended by Federal Laws dated N 192-FZ, dated N 271-FZ, dated N 313-FZ, dated N 409-FZ, dated N 93-FZ) Chapter 1. (as amended by the Federal Law dated N 93-FZ) Article 2. Laws of the Russian Federation pertaining to drug circulation include this Federal Law, other federal laws and other regulations of the Russian Federation. This Federal Law governs circulation of narcotic drugs and psychotropic drugs subject to peculiarities established by laws of the Russian Federation about narcotic drugs, psychotropic substances and precursors thereof. This Federal Law governs circulation of radiopharmaceutical drugs subject to peculiarities established by laws of the Russian Federation in radiation safety. In case any international treaty of the Russian Federation sets rules different from those stipulated by this Federal Law, the provisions of international treaty shall apply. Results of clinical trials of drug products for human use conducted outside the Russian Federation shall be recognized in the Russian Federation according to international treaties of the Russian Federation and/or based on the mutual recognition procedure. Basic terms and definitions used in this Federal Law For the purposes of this Federal Law the following basic terms shall be used: 1) drugs – substances or combinations thereof directly contacting with human or animal organism and penetrating into organs and tissues of the human or animal body, used to prevent, diagnose (except those not contacting with human or animal body) or treat diseases, rehabilitation, maintain, prevent or interrupt pregnancy, being extracted from blood, plasma, as well as from human or animal organs, tissues, plants, minerals, by synthesis or biotechnologies.

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