Russian changes in regulation of pharmaceutical circulation now in place

Changes to the regulation of the Russian pharmaceutical market are coming into effect or have been proposed during 2010 by the Health and Social Development Ministry. The changes come in response to recent increases in the cost of drugs and the H1N1/swine flu epidemic. The Ministry is also concerned about administrative barriers in the registration process for drugs and the fees payable to the network of controlling agencies and expert organizations, wrote Kirill Saturov, senior attorney, and Derek Bloom, a partner, at Capital Legal services in a recent issue of the Moscow Times.

As of April 13, 2010, a new law on the circulation of drugs has been approved by the State Duma and the Federation Council and signed by the president of the Russian Federation. The new law sets out new pricing regulations and restates existing ones. This new law has been the cause of heated debate in the Duma and the entire pharmaceutical community. More than 300 amendments were submitted prior to the second reading of the draft law in the Duma, and only 45 of the proposed amendments were approved. The new law will come into force on Sept. 1, 2010, and will replace the current federal law on drugs.

Approval requirements