OREANDA-NEWS. October 04, 2011. The Expert Council of the Federal Antimonopoly Service (FAS Russia) on developing competition in the social field and health care held a meeting to discuss the problems of registration of medicines, reported the press-centre of FAS Russia.

The Expert Council was attended by representatives of FAS Russia, the Ministry of Health Care and Social Development, the Federal Service for Supervision of Public Health and Social Development, the Federal Services for Consumer Rights and Human Well-Being, the State Duma of the Russian Federation, associations of international and Russian pharmaceutical companies, etc.

Representatives of pharmaceutical associations in their presentations raised the most pressing issues related to registration of medicines, confirming their registration, introducing changes to registration files, carrying out clinical research, observing norms and procedures of No.61 Federal Law by the Ministry of the Russian Federation for Health Care and Social Development, and issues related to introduction of the State Medicine Register.

Deputy Director of the Department of State Regulation of Medicine Circulation, the Ministry of Health Care and Social Development, Ms. Alphia Gabidova, discussed the measures taken by the Ministry to resolve those issues. For instance, in is planned to change the concept of “civil turnover” in the Law “On Medicine Circulation” to the concept of “circulation”; to introduce amendments to the Decree of the Government of the Russian Federation “On Approving the Lists of the Codes of Medical Goods Liable to 10% Tax on Sales”. It is also proposed to improve keeping the State Medicine Register.

Based on the discussion, the Expert Council made several decisions; in particular, FAS Russia and the Ministry of Health Care and Social Development jointly with pharmaceutical associations will monitor compliance with the law when registering medicines, on the outcome of which will forward their analysis of medicine registration problems and proposals to resolve them to the Ministry of Health Care and Social Development and the Government of the Russian Federation.

“Timely and adequate medicine registration is of key importance for developing competition and reducing prices on the market of medicines because it predetermines the issues related to introduction of competing drugs to the market and establishing their consumer features and qualities”, said the Head of FAS Department for Control over Trade and Social Sphere, Timophei Nizhegorodtsev.

At the forthcoming meetings the Expert Council will discuss “ the work of private clinics in the system of mandatory medical insurance”, “antimonopoly regulation of licensing medical activities”, “the problem of repeated quality control of medicines brought in the Russian Federation”, and “analysis of the results of executing action plans aimed at improving supervisory and licensing functions and optimizing government functions in the field of health care, social development sanitary-epidemiological welfare and consumer market in 2011-2012”.