OREANDA-NEWS. November 23, 2011. The Federal Antimonopoly Service (FAS Russia) found that Roszdravnadzor the Federal Service for Supervision of Public Health and Social Development) violated Part 1 Article 15 of the Federal Law “On Protection of Competition”, reported the press-centre of FAS Russia.

On 9th March 2005 and 4th February 2010 Roszdravnadzor issued registration certificates to AstraZeneca UK Limited (the UK) for “Meronem”medicine, unreasonably specifying its pharmaceutical form as “lyophilizate”, while similar medicines of eight other producers were registered as “powder”.

In spite of current standard clinical-and-pharmacological Clause obligating to include information regarding possible by-side effects to cardio-vascular system in the directions for use of medicines with “Meropenem” International Non-Patented Name, Roszdravnadzor failed to insert such information in the directions for use of “Meronem”. As a result, directions for use of similar medicines were different, which misled consumers with regard to the qualities of those medicines.

Such actions and omissions by Roszdravnadzor created unequal conditions for producers and suppliers of medicines with “Meropenem” International Non-Patented Name, restricted competition in course of numerous regional auctions for purchasing those medicines and did not help saving budgetary funds.

Reference:

Part 1 Article 15 of the Federal Law “On Protection of Competition” prohibits federal executive bodies, the authorities of the constituent territories of the Russian Federation, local self-government bodies, other bodies and organisations exercising the functions of the above bodies, as well as state extra-budgetary funds, the Central Bank of the Russian Federation to pass acts and (or) exercise actions (omissions) that lead or can lead to preventing, restricting, eliminating competition, except when cases of passing such acts and (or) exercising such actions (omissions) are provided for by the federal laws.