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The proposed amendments will allow improve the system of state regulation for EDs prices, including via an option to introduce reference pricing systems. In addition, the draft law will separate the procedures for price registration and and re-registration.
In particular, the draft law contains a number of provisions in relation to preferential treatment for domestic producers. Thus it is being proposed that, in order to stimulate the domestic economy, the Russian Government be entitled to impose restrictions on the purchase of imported goods and services.
As a result, the Government will have the right to make decisions to limit foreign producers’ access to certain segments of pharmaceutical market.
The draft law proposes that advertisements for biologically active additives must stipulate that such additives are not medicines and that in the event of any infringements, both advertisers and the distributors of advertisements are to be held liable.
In particular, advertisers and the distributors of advertisements will be subject to increased penalties: the lower penalty bracket will rise from RUB 100 thousand to RUB 200 thousand.
Consequently, should the amendments to the Administrative Code be adopted, the fine for such violations will be in range from RUB 200 thousand to RUB 500 thousand.
The regulations inter alia establish:
The deadline for issuing the permission for importing a specific batch of registered or unregistered pharmaceuticals intended for clinical trials should not exceed five working days after the registration of an application.
In response to numerous requests, Rospotrebnadzor has reported that all food ingredients are permitted for use in biologically active additives production. In addition, it was confirmed that products containing nutrients (e.g. vitamins and minerals) listed in the pharmacopoeia will be permitted for registration.
© 2017 KPMG Audit LLC, the Mongolian member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity.