ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION AND FEDERAL TARIFF SERVICE

of December 14, 2009 No. 983n/447-and

About approval of technique of marginal determination of selling prices of the producer on vital and major medicines

According to Item 2 of the order of the Government of the Russian Federation of August 8, 2009 N 654 "About enhancement of state regulation of the prices of vital and major medicines" (The Russian Federation Code, 2009, N 33, 4086) we order to the Art.:

1. Approve in coordination with the Ministry of Industry and Trade of the Russian Federation and the Ministry of Economic Development of the Russian Federation the enclosed technique of marginal determination of selling prices of the producer on vital and the major medicinal средства*.

2. This order becomes effective since January 1, 2010.

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* It is published on the website of the Ministry of Health and Social Development of the Russian Federation to the address: http://www.minzdravsoc.ru/docs/mzsr/orders/974

Approved by the order of the Ministry of Health and Social Development of the Russian Federation and Federal Tariff Service of December 14, 2009 No. 983n/447-and

Technique of marginal determination of selling prices of producers on vital and major medicines

1. General provisions

1.1. This technique of marginal determination of selling prices of producers (further - the Technique) on vital and major medicines (further - medicines) is developed according to:

The Federal Law of June 22, 1998 N 86-FZ "About medicines" (The Russian Federation Code, 1998, N 26, Art. 3006; 2000, N 2, Art. 126; 2002, N 1, Art. 2; 2003, N 2, Art. 167, N 27, Art. 2700; 2004, N 35, Art. 3607; 2006, N 43, Art. 4412; N 52, of Art. 5497; 2009, N 1, Art. 17);

the order of the Government of the Russian Federation of November 9, 2001 N 782 "About state regulation of the prices of vital and major medicines" (The Russian Federation Code, 2001, N 47, Art. 4448; 2005 N 43, Art. 4400; 2008, N 24, Art. 2869; 2009, N 33, Art. 4086);

the order of the Government of the Russian Federation of August 8, 2009 N 654 "About enhancement of state regulation of the prices of vital and major medicines" (The Russian Federation Code, 2009, N 33, the Art. 4086).

1.2. The technique determines marginal procedure of payments of selling prices of producers on the medicines included in accordance with the established procedure in the List of vital and major medicines.

1.3. The technique is held for use:

- Federal Service on Surveillance in Healthcare and Social Development (further - Roszdravnadzor) in case of marginal registration of selling prices of the domestic and foreign manufacturers declared to state registration;

- Federal Tariff Service (further - Federal Tariff Service) in case of marginal approval of selling prices of the producers declared by domestic and foreign manufacturers of medicines for state registration;

- the Russian and foreign producers of medicines by preparation of documents on reasons for marginal level of selling prices of the producers declared to state registration.

1.4. The terms and determinations used in this Technique correspond accepted in legislative and regulatory legal acts of the Russian Federation.

2. Basic provisions

2.1. Marginal selling prices on the medicines included in the List of vital and major medicines are subject to state registration.

2.2. Marginal state registration of selling prices of producers is performed concerning medicines of both the Russian, and foreign production.

2.3. Marginal state registration of selling prices of producers is carried out in case of state registration of medicines, and also in case of change of packaging of already registered medicines.

Marginal state registration of selling prices of producers is performed free of charge.

2.4. Review marginal (re-registration) of selling price of producers is performed not more often than 1 time a year till December 1 of the year preceding new financial year.

Till September 1 of the year preceding new financial year, Roszdravnadzor publishes on the Website www.rznd.ru inflation coefficient (expectational inflation level) in the year preceding new financial year which can be considered in case of marginal re-registration of selling price of the producer.

Source of receipt of information on the expectational inflation level is the Forecast of social and economic development of the Russian Federation approved by the Government of the Russian Federation as a part of materials to the federal law draft about the Federal budget for the corresponding financial year.

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