The bill “On amendments to the Federal Law “On circulation of drugs” and to the article 333.32.1. of the second part of the Tax Code of the Russian Federation” (hereinafter referred to as the “Bill”) has been published on the web-site of the Ministry of Healthcare of the Russian Federation.
The Bill offers a number of major changes to the Federal Law # 61- FZ “On circulation of drugs” dated 12th of April 2010 (hereinafter referred to as the “Law- # 61-FZ”) primarily concerning the registration of new drug products. Thus, the Bill amends inter alia the article 4 of the Law- # 61-FZ by clarifying certain existing definitions (for instance, “generic drug”) as well as introducing the new ones: “comparison drug”, “biosimilar product”, “substitutable drug”. More…