New Rules in Pharmaceutical Industry


Since 01.09.2009 Russia introduced new rules which will affect almost all companies operating in the national pharmaceutical market, such as:

- domestic producers of medicines,

- foreign producers importing medicines into Russia,

- drugstores,

- clinical trial centers,

- state authorities supervising pharmaceutical industry and some others.

Implementation of new rules will be connected with the Federal Law dated 12.04.2010 "On circulation of medicines" (New Law) coming into force. This Law replaces the Federal Law dated 22.06.1998 "On medicines" (Law No. 86) and aims to bring into order all regulations related to medicines and adapt them to present conditions in pharmaceutical industry. As a consequence, New Law stipulates powers of the respective state bodies, regulates in detail proceedings previously familiar to participants of the pharmaceutical market and implements certain new proceedings. Within the scope of this overview we have concentrated on new regulations applicable to the state registration of medicines and powers of the state bodies involved in this procedure.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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