Price regulation changes for vital and essential pharmaceuticals

This flash report deals with Russian Government Regulation No.654 of 8 August 2009 “On Improving the State Regulation of Prices for Vital and Essential Pharmaceuticals” (hereinafter, the “Regulation”).

The Regulation introduces amendments to existing price regulation acts related to vital and essential pharmaceuticals (hereinafter, the “Essential Pharmaceuticals”). The Regulation introduces the form of the protocol for approving prices for the Essential Pharmaceuticals (hereinafter, the “Price Approval Protocol”).

The Regulation also defines organisational steps to be taken by federal executive bodies and executive bodies of Russian constituent regions for applying the amended rules. The Regulation takes effect from 14 August 2009. The amended rules for regulating Essential Pharmaceuticals’ prices will take effect from 1 January 2010.

The most important changes introduced by the Regulation refer to:
  • The system of state executive bodies in regulating prices for Essential Pharmaceuticals
  • Mandatory state registration of maximum selling Prices
  • Definition and registration of maximum selling prices
  • Maximum wholesale and retail mark-ups
  • Change of license requirements
  • Changes in rules of importation and exportation of Essential Pharmaceuticals