Press centre News Коммерческая практика

18
January
2016

No power

In 2016, during confirmation of pharmaceutical drug (LP) registration in Russia, foreign manufacturers may provide GMP certificates of conformity that were issued abroad. The act, which made the appropriate changes in Law 61-FZ, was signed by the Russian President at the end of 2015. The response to allegations made by lobbyists at the legislative level, was reflected in the postponement of inspections, recall foreign manufacturers: 01 January 2017 was set as the date of entry into force of Federal Law No. 429-FZ, the latest amendments to Law 61-FZ – recognizing the fact that Russian regulators were not ready to carry out inspections of foreign sites in 2016.

Pharmaceutical Bulletin
13
November
2015

Medications will become interchangeable

The Russian government approved the procedure for determining the interchangeability of drugs for medical use. The corresponding decree was signed by Prime Minister Dmitry Medvedev. Some industry representatives did not see in this document anything that the market had been expecting – a decision on interchangeability, and consider it just the next in a series of “guidelines”. However, the FAS has firmly stated that no other regulations on interchangeability are foreseen for the future.

Pharmaceutical Bulletin
17
November
2015

Without discrimination

FAS explained the procedure for the formation of selling prices for Vital and Essential Drugs (VED), depending on the applicable taxation system.

Pharmaceutical Bulletin
22
September
2015

Unlawful relations

The court has invalidated the latest edition of the company charter of Torgoviy Port LLC, the company through which an “affiliate” of the large Turkish manufacturer of cement Nukh Chimento conducted joint business activities with Rostov entrepreneurs. Experts rejected the minutes of the meeting of the shareholders, which had approved the charter. The controversial charter, according to the Turkish side, allowed their former partners to withdraw from the company a land lot and three ship berths.

Gorod N
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