Current issue #35, 2015

FAS is not exactly the right agency for the job

Pilot projects cannot be launched without EEC’s approval

The Eurasian Economic Commission (EEC) developed a draft regulation on making exemptions from applying the principle of exhaustion of the exclusive right to an EEC trademark in respect of specific categories of goods (this draft document is available to PharmVestnik). This draft regulation, in particular, once again confirms the fact that the parallel import implementation timeframe and the lists of goods falling under this principle are completely within the EEC’s competence. Earlier, Federal Antimonopoly Service’s (FAS) head Igor Artemiev stated that by 2020, the EEU member states would approve the lists of goods for parallel import. However, it is known that not all of the member states agree with the list proposed by Russia. Therefore it is likely that the FAS that has previously declared that parallel import might be authorized before 2020 will be able to accelerate the process.

[PharmVestnik # 35, 03/11/2015, p. 1, cont’d p. 5]

Revised and expanded

The 13th revision of the Russian State Pharmacopeia to be published

In the end of October, Russia’s MoH declared that the work on a new edition of the Russian State Pharmacopeia had been completed. According to Russia’s Health Minister Veronica Skvortsova, without this document, it is impossible either to provide for high-quality, efficacious, and safe drugs for the domestic market or export local medicines. While being positive about this event in the pharmaceutical industry’s history, experts reiterate the necessity of developing an EEU’s Pharmacopeia. At the same time, they are waiting for an answer to the question on how the drug circulation is to be regulated in the EEU common market before such pharmacopeia is developed and approved.

[PharmVestnik # 35, 03/11/2015, p. 2]

A step forward and two steps back

Local medical device manufacturers secured significant amendments to the “odd-man-out” regulation

The Ministry of Industry and Trade intends to expand the list of imported medical devices falling under restrictions in the state bidding field. Deputy Minister of Industry and Trade Sergey Tsyb voiced this intent at the conference “State Regulation Regarding Drug and Medical Device Circulation”. A PharmVestnik source of information asserts that a rel...