2. MATCH UP: FUNCTIONAL AREA of PRICING REGULATION: REGULATORY AGENCIES: a) Approval of the list of vital and essential medicinal products; b) economic analysis of the manufacturers' maximum ex-works prices 1) Ministry of Health of the for the medicinal products included in the list of vital and the essential medicinal products; Russian Federation 2) Federal Antimonopoly Service (FAS of Russia) 3) Federal Service for Surveillance in Healthcare (Roszdravnadzor) c) registration and re-registration of the manufacturers' maximum ex- works prices for the medicinal products included in the list of vital and the essential medicinal products (taking into account the FAS decision); d) making a decision on coordination of the maximum ex-works prices (or on refusal in its coordination), sending it to the Ministry of Health of Russia; e) maintenance of the state register of the manufacturers' maximum ex- works prices for the medicinal products included in the list of vital and the essential medicinal products; f) Issuance to the holder or owner of the registration certificate of the medicines (to the person authorized by him) of an extract from the order of the Ministry of Health of the Russian Federation about the state registration (re-registration) of the manufacturers' maximum ex-works prices for the medicinal products included in the list of vital and the essential medicinal products; g) approval of the methodology for calculating the maximum wholesale and maximum retail mark-ups to the actual ex-works prices of manufacturers of medicinal products for the medicinal products included

ENGR.ECONOMIC ANALYSIS
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Chapter1: Making Economics Decisions
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2.
MATCH UP:
REGULATORY AGENCIES:
1) Ministry of Health of the
Russian Federation
2) Federal Antimonopoly
Service (FAS of Russia)
3) Federal Service for
Surveillance in Healthcare
(Roszdravnadzor)
FUNCTIONAL AREA of PRICING REGULATION:
a) Approval of the list of vital and essential medicinal products;
b) economic analysis of the manufacturers' maximum ex-works prices
for the medicinal products included in the list of vital and the essential
medicinal products;
c) registration and re-registration of the manufacturers' maximum ex-
works prices for the medicinal products included in the list of vital and
the essential medicinal products (taking into account the FAS decision);
d) making a decision on coordination of the maximum ex-works prices
(or on refusal in its coordination), sending it to the Ministry of Health of
Russia;
e) maintenance of the state register of the manufacturers' maximum ex-
works prices for the medicinal products included in the list of vital and
the essential medicinal products;
f) Issuance to the holder or owner of the registration certificate of the
medicines (to the person authorized by him) of an extract from the order
of the Ministry of Health of the Russian Federation about the state
registration (re-registration) of the manufacturers' maximum ex-works
prices for the medicinal products included in the list of vital and the
essential medicinal products;
g) approval of the methodology for calculating the maximum wholesale
and maximum retail mark-ups to the actual ex-works prices of
manufacturers of medicinal products for the medicinal products included
into the list of vital and essential medicinal products, monitoring its
compliance;
h) monitoring the assortment and prices of the list of vital and essential
medicinal products, maintaining an electronic database of the assortment
and prices of the list of vital and essential medicinal products.
Transcribed Image Text:2. MATCH UP: REGULATORY AGENCIES: 1) Ministry of Health of the Russian Federation 2) Federal Antimonopoly Service (FAS of Russia) 3) Federal Service for Surveillance in Healthcare (Roszdravnadzor) FUNCTIONAL AREA of PRICING REGULATION: a) Approval of the list of vital and essential medicinal products; b) economic analysis of the manufacturers' maximum ex-works prices for the medicinal products included in the list of vital and the essential medicinal products; c) registration and re-registration of the manufacturers' maximum ex- works prices for the medicinal products included in the list of vital and the essential medicinal products (taking into account the FAS decision); d) making a decision on coordination of the maximum ex-works prices (or on refusal in its coordination), sending it to the Ministry of Health of Russia; e) maintenance of the state register of the manufacturers' maximum ex- works prices for the medicinal products included in the list of vital and the essential medicinal products; f) Issuance to the holder or owner of the registration certificate of the medicines (to the person authorized by him) of an extract from the order of the Ministry of Health of the Russian Federation about the state registration (re-registration) of the manufacturers' maximum ex-works prices for the medicinal products included in the list of vital and the essential medicinal products; g) approval of the methodology for calculating the maximum wholesale and maximum retail mark-ups to the actual ex-works prices of manufacturers of medicinal products for the medicinal products included into the list of vital and essential medicinal products, monitoring its compliance; h) monitoring the assortment and prices of the list of vital and essential medicinal products, maintaining an electronic database of the assortment and prices of the list of vital and essential medicinal products.
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