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4
August
2014

VEGAS LEX sits on FAS Expert Council for Competition in Social Sphere and Health Care

The meeting focused on draft legislation to amend the Federal Law No. 61-FZ On Circulation of Medicines (draft law No. 555485-6) initiated by the Russian Government and scheduled for first reading at the State Duma hearing in September 2014.

The Council meeting was attended by Timofei Nizhegorodtsev, head of the FAS Department for Control over Commerce and Social Sphere; Yelena Maksimkina, director of the Department for Pharmacological Support and Regulation of the Circulation of Medical Supplies at the Ministry of Healthcare; Yulia Yermakova, deputy head of FAS Department for Control over Social Sphere and Trade; and representatives of public associations, and Russian and foreign pharmaceutical producers.

Maria Borzova, Manager of Life Sciences Projects at VEGAS LEX, spoke at the meeting, discussing various aspects of interpreting draft law No. 555485-6.

The participants discussed the possible influence of the planned amendments on the Russian market for clinical trials, the need to adjust some other provisions of Law No. 61-FZ that were not included in the draft in question (such as the legal status of bioactive food supplements, tighter oversight of the pharmaceutical market and drug quality control), the regulation of the medicines market and availability of vaccines for mass vaccination of children and other issues.

Following the discussion, Timofei Nizhegorodtsev proposed sending the discussed changes to the draft to the FAS and the Healthcare Ministry before September 2014 for further consideration by the Expert Council working group.

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For more information on VEGAS LEX services related to the pharmaceutical industry, please go here.

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