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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of October 29, 2010 No. 865

About state regulation of the prices of the medicines included in the list of vital and essential drugs

(as amended on 18-11-2020)

According to the Federal Law "About Drug Circulation" Government of the Russian Federation decides:

1. Approve enclosed:

Rules of state registration and marginal re-registration of selling prices of producers on the medicines included in the list of vital and essential drugs;

Rules of obligatory re-registration in 2019 - 2020 of the registered marginal selling prices of producers on the medicines included in the list of vital and essential drugs;

Rules of maintaining the marginal state register of selling prices of producers on the medicines included in the list of vital and essential drugs;

Rules of establishment by executive bodies of subjects of the limiting Russian Federation of the sizes of wholesale allowances and the extreme sizes of retail allowances to the actual selling prices established by producers of medicines on the medicines included in the list of vital and essential drugs;

Rules of forming of selling prices on the medicines included in the list of vital and essential drugs, the organizations of wholesale trade, the pharmaceutical organizations, individual entrepreneurs and the medical organizations;

changes which are made to orders of the Government of the Russian Federation on the questions connected with price regulation on vital and major medicines.

2. Marginal selling prices of producers on the vital and major medicines registered before entry into force of this resolution are subject to inclusion in the marginal state register of selling prices of producers on the medicines included in the list of vital and essential drugs.

3. Registered till October 26, 2010:

marginal selling prices of foreign producers in foreign currency on the medicines included in the list of vital and essential drugs are subject to recalculation till December 1, 2010 in rubles at the Central Bank rate of the Russian Federation for November 1, 2010 (without submission of the statement of producers for price conversion) with entering of corresponding changes into the marginal state register of selling prices of producers on the medicines included in the list of vital and essential drugs;

marginal selling prices of the Russian producers on the medicines included in the list of vital and essential drugs are subject to indexation since November 1, 2010 proceeding from the predicted rate of inflation established for 2011 by the Federal Law "About the Federal Budget for 2010 and for Planning Period of 2011 and 2012" with entering of corresponding changes into the marginal state register of selling prices of producers on the medicines included in the list of vital and essential drugs.

4. At least once a year, no later than October 15 to represent to the Ministry of Health of the Russian Federation in coordination with the Ministry of Industry and Trade of the Russian Federation, the Ministry of Economic Development of the Russian Federation, the Ministry of Labour and Social Protection of the Russian Federation, the Ministry of Regional Development of the Russian Federation, Federal Antimonopoly Service, Federal Service for the Oversight of Consumer Protection and Welfare, the Ministry of science and the higher education of the Russian Federation and the Ministry of Finance of the Russian Federation to the Government of the Russian Federation the draft of the list of vital and essential drugs.

5. To give to the Ministry of Health of the Russian Federation and Federal Antimonopoly Service in need of explanation on application of the rules approved by this resolution.

6. Recognize invalid:

the order of the Government of the Russian Federation of November 9, 2001 N 782 "About state regulation of the prices of medicines" (The Russian Federation Code, 2001, N 47, the Art. 4448);

the order of the Government of the Russian Federation of October 17, 2005 N 619 "About enhancement of state regulation of the prices of medicines" (The Russian Federation Code, 2005, N 43, the Art. 4400);

Item of 3 changes which are made to acts of the Government of the Russian Federation concerning activities of the Ministry of Industry and Trade of the Russian Federation, approved by the order of the Government of the Russian Federation of June 7, 2008 N 441 (The Russian Federation Code, 2008, N 24, the Art. 2869);

Item 1 of the order of the Government of the Russian Federation of December 30, 2009 N 1116 "About modification of some orders of the Government of the Russian Federation on the questions connected with price regulation on vital and major medicines" (The Russian Federation Code, 2010, N 2, the Art. 179).

Russian Prime Minister

V. Putin

Approved by the Order of the Government of the Russian Federation of October 29, 2010 No. 865

Rules of state registration and marginal re-registration of selling prices of producers on the medicines included in the list of vital and essential drugs

1. These rules establish procedure of state registration and marginal re-registration of selling prices of producers on the medicines included in the list of vital and essential drugs approved by the Government of the Russian Federation (further - medicines).

2. State registration and marginal re-registration of selling prices of producers of medicines on medicines are performed in rubles.

3. The Ministry of Health of the Russian Federation performs marginal registration of selling price of the producer for medicine, its re-registration, entering of the specified registered (re-registered) marginal selling price into the marginal state register of selling prices of producers for the medicines included in the list of vital and essential drugs (further - the state register), issue to the holder or owner of the registration certificate of medicine (authorized by it to person) of the statement from the order of the Ministry of Health of the Russian Federation on state registration of marginal (re-registration) of selling price of the producer on medicine.

4. Federal Antimonopoly Service performs the marginal economic analysis of selling price of the producer on medicine in case of its state registration (re-registration).

5. For state registration of marginal (re-registration) of selling price of the producer on medicine to the Ministry of Health of the Russian Federation by the holder or the owner of the registration certificate of medicine (authorized by it person) submit the following documents (in 2 copies on paper and in electronic form):

a) the statement for marginal state registration of selling prices of producers on the medicines included in the list of vital and essential drugs in form according to appendix No. 1 (further - the statement for state registration) or the statement for marginal re-registration of selling prices of producers on the medicines included in the list of vital and essential drugs in form according to appendix No. 2 (further - the statement for re-registration);

b) data on the license for production of medicines;

c) data on the registration certificate of medicine;

d) the documents submitted taking into account requirements of the marginal method of calculation of selling prices of producers of the medicines included in the list of vital and essential drugs, approved by the order of the Government of the Russian Federation of September 15, 2015 No. 979 "About modification of the order of the Government of the Russian Federation of October 29, 2010 No. 865 and about approval of marginal method of calculation of selling prices of producers on the medicines included in the list of vital and essential drugs" (further - technique), including:

data on amounts and on the prices of leave of the medicine of the producer of state member of the Eurasian Economic Union and medicine of foreign production which is in circulation in the territory of the Russian Federation which primary and (or) secondary package is performed or planned to be performed in the Russian Federation;

marginal calculation of the selling price of the producer on medicine represented on state registration (re-registration);

data on amounts and the prices of import of medicine of the foreign production which is in circulation in the territory of the Russian Federation;

data on availability of the registered marginal selling prices of the declared medicine;

marginal calculation of the selling price on the reproduced, bioanalog (biosimilar) medicine represented on state registration;

marginal calculation of selling price on medicine of the producer of the state member of the Eurasian Economic Union represented on state registration;

reasons for marginal calculation of selling price on medicine of the producer of the state member of the Eurasian Economic Union represented on re-registration;

reasons for marginal calculation of selling price of medicine of foreign production, including primary and (or) secondary package of which are performed or planned to be performed in the Russian Federation represented on re-registration;

e) the document confirming powers of the authorized person.

6. The data containing in the statement for state registration and the statement for re-registration shall correspond to the data specified in the registration certificate of medicine on the date of submission of such statement.

7. The holder or the owner of the registration certificate of medicine (person authorized by it) has the right to provide the copy of the license for production of medicines and the copy of the registration certificate of medicine, and also the copy of form No. 2-LEK (pry) "Data on production, shipment and the prices of medicines on own initiative.

8. In case of representation by the holder or owner of the registration certificate of medicine (authorized by it person) statements for state registration before the expiration of 3 years from the date of acceptance by the Ministry of Health of the Russian Federation decisions on exception of the marginal state register of selling price on medicine the declared marginal selling price of the producer cannot exceed earlier excluded marginal selling price of the producer (without the production site) proceeding from the cost of one dosage form of the corresponding dosage of medicine.

9. The selling price of the producer declared to marginal state registration on reference medicine cannot exceed the price specified in subitem 5.5.4 of appendix No. 1 to the Rules of forming of lists of medicines for medical application and the minimum range of the medicines necessary for delivery of health care approved by the order of the Government of the Russian Federation of August 28, 2014 No. 871 "About approval of Rules of forming of lists of medicines for medical application and the minimum range of the medicines necessary for delivery of health care".

10. The Ministry of Health of the Russian Federation within 15 working days from the date of the address of the holder or the owner of the registration certificate of the medicine (authorized by it persons) performs check of completeness of the these rules of documents provided according to Item 5 and sends one copy of documents to Federal Antimonopoly Service or makes the decision on refusal in state registration of marginal (re-registration) of selling price of the producer on medicine.

11. The bases for refusal in state registration (re-registration) by the Ministry of Health of the marginal Russian Federation of selling price of the producer on medicine are:

a) absence in the documents specified in Item 5 of these rules, the data provided by these rules and technique;

b) excess of the selling price of the producer declared for marginal state registration on medicine over the selling price determined taking into account requirements of Items 8 and 9 of these rules;

c) non-presentation of data, stipulated in Item 12 these rules.

12. In case of need amendments and (or) amendments of the data containing in the documents specified in Item 5 of these rules the holder or the owner of the registration certificate of medicine (person authorized by it) represent the relevant documentary drawn up information at the request of the Ministry of Health of the Russian Federation.

The term of representation of reply to the request by the holder or owner of the registration certificate of medicine (authorized by it person) cannot exceed 10 working days from the date of receipt of request of the Ministry of Health of the Russian Federation.

At the same time aggregate term of consideration of the documents specified in Item 5 of these rules the Ministry of Health of the Russian Federation cannot exceed terms, stipulated in Item 10 and the paragraph the second this Item.

In case of not receipt from the holder or the owner of the registration certificate of the medicine (authorized by it persons) at the scheduled time of the requested documentary drawn up information the Ministry of Health of the Russian Federation within 5 working days from the date of the expiration of aggregate term makes the decision on refusal in state registration of marginal (re-registration) of selling price of the producer on medicine what in writing notifies the holder or the owner of the registration certificate of medicine (person authorized by it) on.

13. Federal Antimonopoly Service within 15 working days from the date of receipt of the documents specified in Item 5 of these rules carries out according to these rules and technique the marginal economic analysis of selling price of the producer on medicine, and also accepts and sends to the Ministry of Health of the Russian Federation the decision on coordination of the specified marginal selling price or on refusal in its coordination (with statement of causes of failure).

14. In case of need amendments and (or) amendments of the data containing in the documents specified in Item 5 of these rules the holder or the owner of the registration certificate of medicine (person authorized by it), the legal entities performing activities in case of drug circulation executive bodies within their competence represent the relevant documentary drawn up information at the request of Federal Antimonopoly Service.

The term of representation by the holder or owner of the registration certificate of medicine (authorized by it person), the legal entities performing activities in case of drug circulation, executive bodies within their competence) cannot exceed 25 working days from the date of receipt of request of Federal Antimonopoly Service.

At the same time aggregate term of consideration of documents by Federal Antimonopoly Service cannot exceed term, stipulated in Item 13 and the paragraph the second this Item.

In case of not receipt from the holder or the owner of the registration certificate of the medicine (authorized by it persons) at the scheduled time of the requested documentary drawn up information Federal Antimonopoly Service within 5 working days from the date of the expiration of aggregate term makes the decision on refusal in marginal coordination of selling price of the producer on medicine and sends it to the Ministry of Health of the Russian Federation which within 5 working days from the date of receipt of this decision makes the decision on refusal in state registration or re-registration of the specified price what in writing notifies the holder or the owner of the registration certificate of medicine (person authorized by it) on.

The holder or the owner of the registration certificate of medicine (person authorized by it) by consideration of request of Federal Antimonopoly Service can send to the Ministry of Health of the Russian Federation the relevant specifying documents (in 2 copies) within 10 working days from the date of receipt of request of Federal Antimonopoly Service.

The Ministry of Health of the Russian Federation within 5 working days from the date of receipt of the relevant specifying documents from the holder or the owner of the registration certificate of the medicine (authorized by it persons) sends one copy of such documents to Federal Antimonopoly Service.

15. The Ministry of Health of the Russian Federation within 5 working days from the date of receipt of the decision of Federal Antimonopoly Service on marginal coordination of selling price of the producer on medicine or on refusal in its coordination makes the decision on state registration of marginal (re-registration) of selling price of the producer on medicine or on refusal in state registration (re-registration) of the specified selling price depending on the decision made by Federal Antimonopoly Service.

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