Current issue #1, 2016

Myth busters

Russian medical device manufacturers actively defend their interests in state biddings

For nearly a year, the Russian medical industry has been living according to the new rules pursuant to the government resolution # 102. However, the time tells that there are many pitfalls on the way to achieving the goal of this document that set a priority of the local companies over foreign players in the state biddings. Seemingly, this regulatory document has clearly defined the rules of game by limiting access of foreign companies to the state bidding procedures in Russia provided that local companies have similar products. Nonetheless in practice, foreign colleagues appear to have a lot of tricks up their sleeves.

[PharmVestnik # 1, 19/01/2016, p. 1, cont’d p. 4]

No fraud

The regulators have corrected a dangerous mishap that slipped in Federal law # 61-FZ after numerous amendments

In 2016, foreign pharmaceutical manufacturers may provide GMP certificates issued abroad to confirm their drug registration in Russia. The regulation amending the Federal law # 61-FZ was signed by the President of Russia in late 2015. In response to charges of lobbying their interests at the legislative level that has resulted in postponing the site inspection starting date, foreign manufacturers remind that the date of January 1, 2017, has been stipulated back in the Federal law # 429-FZ and that by another amendment to 61-FZ the regulators admit that the Russian Inspectorate is not ready to inspect f...