FAS: Quality Control of Medicines Brought in Russia Is Unlawful
OREANDA-NEWS. November 24, 2011. The Commission of the Federal Antimonopoly Service (FAS Russia) found that the Ministry of Health of the Republic of Bashkortostan and the Office of Roszdravnadzor (the Federal Service for Supervision of Public Health and Social Development) in the Republic of Bashkortostan violated the antimonopoly law, reported the press-centre of FAS Russia.
The Ministry of Health of the Republic of Bashkortostan passed Orders that forced wholesale suppliers of medicines to provide samples of medicines brought in the Republic of Bashkortostan to the “Republican Centre for Quality Control and Certification of Medicines” State Medical Institution to carry out quality control that was not required by the law. As a result of such “control”, medicines were assigned certain “quality numbers” that constituted the grounds for selling the goods in the Republic.
In January 2009 – June 2011, as a result of such “entry control”, direct losses of the six largest Russian companies involved in wholesale sales of medicines (SIA INTERNATIONAL, APTEKA-HOLDING, ROSTA, Katren, PROTAK and Biotek) reached 12.3 million Rubles, including losses from providing medicines for such quality control.
The Office of Roszdravnadzor in the Republic of Bashkortostan violated the antimonopoly law by approving the Regulations on the Centre for Monitoring Medicines Safety in the Republic of Bashkortostan, which breached the law on medicines circulation and the law on protection of competition because it assigned the functions and the rights of controlling and supervisory bodies to a particular economic entity.
The FAS Commission issued a decision and a determination to abolish the unlawful procedure of quality control of the medicines brought in the Republic of Bashkortostan.
Reference:
During the period from 21st September to 18th November 2011, it was the third time for FAS to make a decision that repeated quality control of medicines brought in constituent territories of the Russian Federation was unlawful. Previously FAS found that the Ministry of Health of the Sverdlovsk Region and the Ministry of Health and Social Development of the Samara Region violated the antimonopoly law.
Currently FAS is gathering evidence to initiate cases on entry control of medicines in the Republic of Buryatia, the Republic of Mordovia, the Chelyabinsk, Kemerovo, Kirov, Nizhny Novgorod, Orenburg, Perm, Pskov and Smolensk regions.
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