Current issue #42, 2015

FAS to consider submission on 36.6 & A5 deal

In mid-December, the Russian Federal Antimonopoly Service (FAS) approved a submission by Concern Rossium Ltd, parent company of CJSC Moscow Credit Bank. The FAS website does not specify the assets the concern is planning to acquire, but reportedly it goes about an acquisition of legal entities that are part of A5 Group. According to market experts, A.v.e Group is to manage Rossium’s new asset. Stockholders of 36.6 and A5 pharmacy chains keep sticking to “no comment” policy. If the deal is closed, A.v.e Group will lead a pharmacy giant able to dictate terms both to distributors and manufacturers. No wonder that 36.6 has already declared about cancellation of a contract with CV Protek distributor, allegedly due to an increase of the manufacturers direct supply share. Protek itself called the cancellation of contractual obligations with the pharmacy chain a formality. The distributor stated that shipments for 36.6 had been basically nil because of increased nonpayment risks.

[PharmVestnik # 42, 22/12/2015, p. 1, cont'd p. 3]

Everybody to be inspected

In early December, the Cabinet of Ministers approved the Regulations for the organization and execution of drug manufacturer inspection for GMP compliance as well as the rules of issuing the appropriate expert findings. Experts differ substantially in their attitude to this document. Some are quite loyal and are willing to become familiar with the law enforcement practice, while others make statements on the necessity to reconceptualize the GMP inspection philosophy. The inspection regulations will become effective on January 1, 2016; however, reportedly, the State Duma considers a possibility for foreign manufacturers to be submitting certificates issued by a non-Russian inspectorate for a year following the drug registration in Russia.

[PharmVestnik # 42, 22/12/2015, p. 2]

Russian breakthrough

Local pharmaceutical manufacturers to introduce a breakthrough drug concept

The Russian public associations are willing to upgrade the national legislation governing drug circulation and purchases. The Russian Union of Industrialists and Entrepreneurs and All-Russia Business Association "Delovaya Rossiya" (Business Russia) prepared a package of amendments to the respective laws. One of the amendments concerns innovative drugs being developed in Russia.

[PharmVestnik # 42, 22/12/2015, p. 4]

It is not necessarily the case that counterfeits may be overcome

The Russian economy is d...