This report deals with Russian Federal Law of 12 April 2010 No. 61-FZ “On the Circulation of Pharmaceuticals” (hereinafter, the “Law”).
The Law is aimed at improving legislation regulating the circulation of pharmaceuticals, taking into account the development priorities for the pharmaceutical industry in Russia. The new Law is structured around the successive stages of the circulation of pharmaceuticals in Russia.
Gaps in current regulations and the declarative nature of certain provisions of Federal Law of 22 June 1998 No. 86-FZ “On Pharmaceuticals”, as well as some other deficiencies revealed during its application in practice, were the major factors for adopting the Law. In addition, Russian legal regulations in other related areas have changed considerably – including in relation to pricing and technical regulations – and the Law’s adoption is intended to bring the key law of the pharmaceutical legislation into line with such changes.