Recent Amendments in the Pharmaceutical Industry in Russia September 2010.

Amendments to the Powers of State Authorities in the Sphere of Pharmaceuticals Circulation

On 20 August 2010 the Government adopted Resolution No. 650 (effective as of 7 September 2010) amending certain legislative acts in connection with adoption of the Law on Circulation of Medicines. In particular, it amends Regulations on the Ministry of Healthcare and Social Development, the Federal Service for Supervision in the Sphere of Healthcare and Social Development, and the Ministry of Industry and Trade in relation to their powers in the sphere of medicines' circulation.

The Resolution extends jurisdiction of the Ministry of Healthcare and Social Development to include the powers previously exercised by the Federal Service for Supervision in the Sphere of Healthcare and Social Development. The new powers include: (i) issuing permits for carrying out the expert review of medicines for medical use and permits for the import of medicines; (ii) performing state registration and maintaining the registers of medicines for medical use and manufacturers’ maximum sale prices for essential and necessary medicines; and (iii) certifying specialists involved in medicines circulation and performing accreditation of medical organizations to carry out clinical trials.

The Ministry of Industry and Trade is now authorized to license the manufacture of medicines for medical use and maintain the register of such licenses (prior to the amendments the Federal Service for Supervision in the Sphere of Healthcare and Social Development was entitled to license the manufacture of medicines).

The Federal Service for Supervision in the Sphere of Healthcare and Social Development is now also entitled to place on its website the information regarding decisions on amending instructions on the use of medicines, the suspension or renewal of the use of medicines, and their withdrawal from circulation.

State Registers in the Pharmaceutical Industry

The Ministry of Health Care and Social Development has created a state portal that provides access to the state register of medicines and the state register of manufacturers’ maximum sale prices of essential and necessary medicines. The register of medicines contains information on registered medicines, including their brand and international unpatented names, storage conditions and shelf life, recommended applications and contraindications, side effects, application technique, the manufacturers’ names and addresses. The register of manufacturers’ maximum sale prices, among other things, contains data on medicines’ maximum sale prices and dates of their state registration, numbers of medicines’ registration certificates and their validity period.

The portal also allows medicines’ manufacturers that applied for the state registration of a medicine to monitor on-line the process of such registration.