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The Drug Act as of 1 September 2010, Russian Federation

September 10th 2010

The Federal Act "On Drug Circulation" introducing the state regulation of the VED price has been in operation for a year. According to this act, Russian enterprises shall turn to international GMP-standards, and the countrymen shall be fully supplied with pharmaceuticals.

The developed drug registration procedure was implemented.

Previously, the Federal Service for Supervision in Healthcare was entitled to register drugs, but now this issue is controlled by the Ministry of Healthcare, where the Department of Federal Drug Control has been formed. Marat Sakayev, the Head of this Department, was previously the Deputy Director of the department for development of the pharmaceutical and medical equipment markets.

Drug registration periods in Russia

  1. Generic drugs: the drug registration period is up to 60 days.
  2. New pharmaceuticals: the drug registration period is 210 days.

VED price regulation

Manufacturers previously registered prices for vital and most essential drugs (hereinafter– VED) on a voluntary basis. Hence, the local authorities of different regions could use the situation to markup the selling price.

Now, the manufacturers must register the maximum drug selling price every year on the 1st of December.

We should note that this regulation allows the local authorities to increase the price within the limits of the state methods defined by the Ministry of Healthcare of the Russian Federation for this purpose.

Pharmacies and drug manufacturers expect that such actions will help reduce drug prices.

Russian pharmaceutical enterprises shall transition to GMP-standards (which means Good Manufacturing Practice).

GMP standards are a set of rules governing the manufacture of certain drugs. The manufacturer shall strictly follow these unified rules to prevent the production of poor quality goods.

There are 400 local drug manufacturing enterprises in the Russian Federation, of which only 30 of them follow the GMP standards.

According to the plan, all Russian production enterprises shall start working in compliance with the GMP standards by 2014.

According to experts, at least 120 of the 400 registered local enterprises are at risk of collapse. This equates to at least 30% of the total number of enterprises.

The Federal Service for Supervision of Healthcare is responsible for supplying drugs to residents of rural areas. In cases where settlements lack a pharmacy, drugs can be provided in outpatient clinics, rural health posts, and by general practice specialists
Experts are sure that the market for pharmaceutical services with such innovations shall comply with the requirements and expectations of the surrounding people.

There is also another opinion: Analysts and market participants are afraid that the law can have some technical drawbacks. There are still many uncertainties, for example, an unclear system of transition from licensing to declaration from pharmacy chains, the full contents of the VED drug list, etc.

The law should include groups of drugs developed for the treatment of rare diseases (orphan drugs), as well as change the drug price registration system at the bylaw level.

 

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