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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

(as amended on 31-10-2020)

The government of the Russian Federation decides:

1. Approve enclosed:

changes which are made to the 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" (The Russian Federation Code, 2010, No. 45, Art. 5851; 2011, No. 50, Art. 7390; 2012, No. 37, Art. 5002);

marginal method of calculation of selling prices of producers on the medicines included in the list of vital and essential drugs.

1(1). To give to the Ministry of Health of the Russian Federation and Federal Antimonopoly Service in need of explanation on application of method of calculation of the marginal medicines of selling prices established by producers on the medicines included in the list of vital and essential drugs in case of their state registration and re-registration approved by this resolution.

2. This resolution becomes effective since October 1, 2015.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of September 15, 2015 No. 979

Changes which are made to the Order of the Government of the Russian Federation of October 29, 2010 No. 865

1. To state paragraph two of Item 1 in the following edition:

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

2. Rules of marginal state registration of selling prices of producers on the medicines included in the list of vital and essential drugs, approved by the specified resolution to state in the following edition:

"Are approved by the Order of the Government of the Russian Federation of October 29, 2010 No. 865 (in edition of the Order of the Government of the Russian Federation of September 15, 2015 No. 979)

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

1. These rules establish procedure of state registration and re-registration of the state members of the Eurasian Economic Union established by producers and foreign producers of medicines (further - producers) marginal selling prices on the medicines included in the list of vital and essential drugs which is annually approved by the Government of the Russian Federation (further - medicines).

2. State registration and marginal re-registration of selling prices of producers on medicines is 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. For state registration and marginal re-registration of selling price of the producer on medicine the following documents are submitted to the Ministry of Health of the Russian Federation (on paper in 2 copies and in electronic form):

a) the statement for registration or marginal re-registration of selling price of the producer on medicine in the form approved by the Ministry of Health of the Russian Federation containing the following data:

the name of the holder or owner of the registration certificate of medicine, the e-mail address, the name of the producer, the location of the production sites participating in medicine production process with indication of production process stage;

name of medicine (international unlicensed, either grouping, or chemical and trade names);

number of the registration certificate of medicine;

dosage form with indication of dosage of medicine and its quantity in secondary (consumer) package, and also completeness;

the bar code applied on secondary (consumer) package of medicine;

medicine code on anatomo - the therapeutic and chemical classification recommended by the World Health Organization;

medicine code according to the All-Russian Product Classifier and (or) the single Commodity nomenclature of foreign economic activity of the Eurasian Economic Union;

the marginal selling price of the producer on medicine calculated according to method of calculation of the marginal medicines of selling prices established by producers on the medicines included in the list of vital and essential drugs in case of their state registration and re-registration 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 method of calculation of the marginal medicines of selling prices established by producers on the medicines included in the list of vital and essential drugs in case of their state registration and re-registration" (further - technique);

signature and disaggregation of the authorized signature, position, contact telephone numbers;

b) copy of the license for production of medicines;

c) copy of the registration certificate of medicine;

d) the following documents submitted taking into account requirements of technique:

data on amounts and the prices of leave of the medicines of production of state members of the Eurasian Economic Union which are in circulation in the Russian Federation;

marginal calculation of selling prices on medicines of production of the state members of the Eurasian Economic Union represented on state registration;

marginal calculation of selling prices on medicines of production of the state members of the Eurasian Economic Union represented on the state re-registration;

marginal reasons for selling prices on the medicines included in the list of the vital and essential drugs represented on state registration or re-registration;

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

marginal calculation of the selling prices on medicines of foreign production represented on state registration.

5. The Ministry of Health of the Russian Federation has no right to require from the holder or the owner of the registration certificate of medicine (authorized by it persons) the submission of copies of the documents provided by subitems "b" and "v" of item 4 of these rules. The holder or the owner of the registration certificate of medicine (person authorized by it) has the right to provide copies of the specified documents on own initiative.

6. In case of submission by the holder or owner of the registration certificate of medicine (authorized by it person) of the statement for marginal registration of selling price of the producer for medicine before the expiration of 3 years from the date of decision making about marginal exception of selling price on the declared medicine from the state register accepted based on the statement of this holder or the owner of the registration certificate of the medicine (authorized by it persons), the declared marginal selling price cannot exceed earlier excluded.

7. 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):

a) performs check of completeness of the these rules of documents provided according to item 4 (further - documents) and the data containing in them;

b) if the holder or the owner of the registration certificate of medicine (person authorized by it) did not provide:

the copy of the registration certificate on medicine, - checks data on state registration of medicine based on the medicines this the state register;

the copy of the license for production of medicines, - requests and receives according to the procedure of interdepartmental information exchange from the Ministry of Industry and Trade of the Russian Federation information on availability according to the register of licenses for production of medicines for medical application of the corresponding license at the producer (concerning the Russian producer);

c) performs according to marginal technique of selling price of the producer on medicine for the solution of question of the direction of 1 copy of documents in Federal Antimonopoly Service;

d) makes the decision on refusal in state registration or marginal re-registration of selling price of the producer on medicine in case of absence in the submitted documents of necessary data, detection of the false information or exceeding of the declared marginal selling price containing in them in case of filing of application taking into account requirements of Item 6 of these rules, and also in case of non-presentation of data according to Item 10 of these rules.

8. Federal Antimonopoly Service within 15 working days from the date of receipt of documents carries out according to 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 approval of the specified marginal selling price or on refusal in its approval (with statement of causes of failure).

9. 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 approval of selling price of the producer on medicine or on refusal in its approval makes the decision on state registration or marginal re-registration of selling price of the producer on medicine or on refusal in state registration of the specified price taking into account the decision made by Federal Antimonopoly Service.

10. In case of need amendments of the data containing in the submitted documents of receipt of additional necessary information the holder or the owner of the registration certificate of medicine (person authorized by it) represents the relevant documentary drawn up information at the request of the Ministry of Health of the Russian Federation. At the same time the term of consideration of documents, stipulated in Item 7 these rules, increases no more than for 10 working days.

In case of need amendments of the data containing in the submitted documents of receipt of additional necessary information 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. At the same time the term of consideration of documents, stipulated in Item 8 these rules, increases no more than for 10 working days.

In case of not receipt from the holder or the owner of the registration certificate of the medicine (authorized by it persons) within fixed term of the requested documentary drawn up information Federal Antimonopoly Service within 5 working days from the date of the expiration of its representation makes the decision on refusal in marginal approval 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.

11. In case of decision making about state registration or marginal re-registration of selling price of the producer on medicine the Ministry of Health of the Russian Federation enters the relevant data in the state register, issues to the holder or the owner of the registration certificate of medicine (authorized by it to person) the statement from the order on state registration or marginal re-registration of selling price of the producer on medicine and posts the relevant information on the official site on the Internet.

12. In case of decision making about refusal in state registration or marginal re-registration of selling price of the producer on medicine the Ministry of Health of the Russian Federation notifies the holder or the owner of the registration certificate of medicine (person authorized by it) in writing on the made decision (with statement of causes of failure).

13. The basis for refusal in approval by Federal Antimonopoly Service of state registration or marginal re-registration of selling price of the producer on medicine, refusal in state registration or re-registration by the Ministry of Health of the marginal Russian Federation of selling price of the producer on medicine taking into account the decision made by Federal Antimonopoly Service is:

a) submission of false information;

b) submission of documents in incomplete amount and (or) incompleteness of the data containing in them;

c) exceeding of the selling price of the producer provided for the state registration or marginal re-registration on medicine over the price calculated according to technique.

14. The decision on refusal in state registration or marginal re-registration of selling price of the producer on medicine can be appealed judicially.

15. For marginal state registration of selling prices of producers on the medicines which were not arriving in the address in the territory of the Russian Federation except documents, are represented:

a) producers of state members of the Eurasian Economic Union:

calculation of the expenses connected with development, production and realization of medicine, with submission of necessary documents;

the companies this about accounting policy regarding method of accounting and distribution of general production and general running costs to cost of medicines;

the data documenting the amount of general production and general running costs;

information on method of reference of general production and general running costs on cost of specific medicine;

data on medicine release amounts, its specific weight in total amount of the made medicines;

documentary confirmation and disaggregation of the costs occupying the greatest specific weight in cost of medicines;

disaggregation of expenses on production of medicine under the articles "Raw Materials" and "Materials", and also documentary confirmation of expenses under the specified Articles;

b) the producers of state members of the Eurasian Economic Union which are going to perform primary and (or) secondary package of medicine in the Russian Federation, the holder or the owner of the registration certificate of medicine (authorized by it person) in case of lack of the registered marginal selling price of the foreign producer on this medicine - the extent of the minimum selling price of the producer (without the name of the production sites participating in production process) on medicine in the countries specified in appendix No. 4 to technique taking into account the expenses connected with customs clearance (the customs duties and charges on customs clearance) and also the data (at the choice of the holder or the owner of the registration certificate of the medicine (authorized by it persons), confirming the provided minimum selling price of the producer on medicine (on paper with the translation into Russian certified in accordance with the established procedure);

c) foreign producers - the extent of the minimum selling price of the foreign producer (without the name of the production sites participating in production process) on medicine in the countries specified in appendix No. 4 to technique taking into account the expenses connected with customs clearance (the customs duties and charges on customs clearance) and also the data (at the choice of the holder or the owner of the registration certificate of the medicine (authorized by it persons) confirming the provided minimum selling price of the foreign producer on medicine (on paper with the translation into Russian certified in accordance with the established procedure).

16. The holder or the owner of the registration certificate (person authorized by it) of the reproduced medicine of foreign production or the reproduced medicine of production of state members of the Eurasian Economic Union which is not in circulation in the Russian Federation represents for marginal state registration the selling price of the producer on medicine which is not exceeding 80 percent of the average registered marginal selling price of the producer on reference medicine calculated for the period 3 years before representation by the holder or owner of the registration certificate (authorized by it person) of the specified reproduced marginal medicine of the selling price calculated proceeding from the cost of one dosage form, and in case of its absence - marginal selling price, not exceeding 80 percent of the maximum registered marginal selling price of the producer on similar medicine (according to the international non-proprietary name or in case of its absence - to the chemical or grouping name, the dosage form and dosage (to concentration, activity in terms of action) calculated proceeding from the maximum cost of one dosage form. If from the moment of state registration of the price of reference medicine there passed less than 3 years, calculation is made proceeding from the actual period of state registration of the price of reference medicine.

The holder or the owner of the registration certificate (person authorized by it) of the second and the subsequent reproduced medicines of foreign production which are not in circulation in the Russian Federation represents for marginal state registration selling price of the producer for 5 percent of the one medicine lower final registered marginal selling price of the producer on the similar reproduced medicine (according to the international non-proprietary name or in case of its absence - to the chemical or grouping name, the dosage form, dosage (to concentration, activity in terms of action) calculated proceeding from the maximum cost of one dosage form.

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