ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of October 8, 2018 No. 1207

About modification of Orders of the Government of the Russian Federation of October 29, 2010 No. 865 and of September 15, 2015 No. 979

The government of the Russian Federation decides:

1. Approve the 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; 2015, No. 37, Art. 5153; No. 38, the Art. 5302) and 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" (The Russian Federation Code, 2015, No. 38, the Art. 5302).

2. This resolution becomes effective from the date of its official publication.

Approved by the Order of the Government of the Russian Federation of October 8, 2018 No. 1207

Changes which are made to Orders of the Government of the Russian Federation of October 29, 2010 No. 865 and of September 15, 2015 No. 979

1. In 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":

a) state Item 5 in the following edition:

"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.";

b) 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, 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 October 8, 2018 No. 1207)

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 marginal medicines of selling prices established by producers 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 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 state registration of the marginal medicines of selling prices established by 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 re-registration of the marginal medicines of selling prices established by 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 method of calculation of the marginal medicines of selling prices established by producers of 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), including:

data on amounts and the prices of leave of the medicine of producers of state members of the Eurasian Economic Union which is in circulation in the territory of the Russian Federation and the foreign producers performing including primary and (or) secondary package of medicine 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 the selling price on medicine of producers of state members of the Eurasian Economic Union represented on state registration;

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

reasons for marginal calculation of selling price on medicine of the foreign producers performing including primary and (or) secondary package of medicine 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 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) exceeding 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 approval of the specified marginal selling price or on refusal in its approval (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 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.

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 approval of selling price of the producer on medicine or on refusal in its approval 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.

16. In case of decision making about state registration of 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 in time, stipulated in Item 6 Rules of maintaining the state register of the registered marginal selling prices of producers on the medicines included in the list of the vital and essential drugs approved by 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" 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 of marginal (re-registration) of selling price of the producer on medicine and posts the relevant information on the official site on the Internet.

17. Federal Antimonopoly Service in case of verification of documents uses information sources containing the prices of the medicines in the foreign states specified in appendix No. 2 to technique and conforming to the following requirements:

a) the placed information shall be public;

b) information source (the website) shall contain information on the organization responsible for placement of data on the prices of medicines in the Internet;

c) the placed information shall allow to identify necessary characteristics of medicines for the purpose of comparison of data on the declared medicine and medicine, the price for which contains in the found information source;

d) the placed information shall contain data on the price of medicine and currency in which it is provided;

e) information containing the prices of the medicines delivered at the expense of international financial institutions (funds) for the decision of the World Health Organization within the humanitarian assistance or charity cannot be source.

18. In case of decision making about refusal in state registration or marginal re-registration of selling price of the producer on the medicine the Ministry of Health of the Russian Federation in time which is not exceeding 5 working days 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).

19. The bases for refusal in approval of state registration of marginal (re-registration) of selling price of the producer by Federal Antimonopoly Service on medicine, refusal in state registration (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 are:

a) submission of false information;

b) submission of documents not in full and (or) incompleteness of the data containing in them;

c) non-presentation of data, stipulated in Item 14 these rules;

d) 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 these rules and technique.

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

21. For marginal state registration of selling price of the producer on medicine, except the documents specified in Item 5 of these rules data on paper with transfer into Russian (in 2 copies), confirmatory selling prices of the producer on medicine in the foreign states specified in appendix No. 2 to technique are represented for carrying out the economic analysis (at the choice of the holder or the owner of the registration certificate of the medicine authorized by it persons).

22. For marginal state registration of selling price of the producer on the medicine which is in circulation in the territory of the Russian Federation except the documents specified in Items 5 and 21 of these rules for carrying out the economic analysis the following paper documents in one copy are submitted:

a) producers of state members of the Eurasian Economic Union, and also the foreign producers performing primary and (or) secondary package of medicine in the Russian Federation:

the copy of form No. 2-LEK (pry) "Data on production, shipment and the prices of medicines" for the accounting period determined according to Item 23 of these rules;

copies of consignment notes on the specific medicine shipped for the accounting period determined according to Item 23 of these rules (submission of all consignment notes is necessary if the number of shipments on medicine does not exceed 25 pieces, and on medicines on which the number of shipments exceeds 25 pieces, copies of consignment notes with the greatest specific are represented it is powerful in sales amount of specific medicine, but at least 25 pieces);

b) foreign producers - copies of customs declarations on supply of specific medicine for the accounting period determined according to Item 23 of these rules (submission of all customs declarations is necessary if the number of customs declarations on medicine does not exceed 25 pieces, and on medicines on which the number of customs declarations exceeds 25 pieces, copies of customs declarations with the greatest specific are represented it is powerful in sales amount of specific medicine, but at least 25 pieces).

23. In case of marginal state registration of selling price of the producer on medicine the calendar year preceding day of giving in the Ministry of Health of the Russian Federation statements for state registration, and in case of representation on marginal state registration of selling price on medicine in year of the publication of the act of the Government of the Russian Federation of approval of the list of vital and essential drugs the next calendar year - for the current calendar year is accepted to the accounting period.

24. In case of state registration of marginal (re-registration) of selling price on reference medicine for all producers (the production sites of the producer participating in production process) specified in the registration certificate of medicine uniform marginal selling price on medicine for each dosage form, dosage (concentration, activity in terms of action) and total quantity in secondary (consumer) package without release form, except as specified, of stipulated in Item 25 these rules is established.

In case of state registration of marginal (re-registration) of selling price on the reproduced, bioanalog (biosimilar) medicine of producers of state member of the Eurasian Economic Union for all producers (the production sites of the producer participating in production process in the territory of state members of the Eurasian Economic Union) specified in the registration certificate of medicine uniform marginal selling price on medicine for each dosage form, dosage (amount, weight, quantity of doses in primary package) and total quantity in secondary (consumer) package without release form, except as specified, of stipulated in Item 25 these rules is established.

In case of state registration of marginal (re-registration) of selling price on the reproduced, bioanalog (biosimilar) medicine of the foreign producer for all producers (the production sites of the producer participating in production process outside state members of the Eurasian Economic Union and performing or planning to perform primary and (or) secondary package of medicine in the Russian Federation) specified in the registration certificate of medicine uniform marginal selling price on medicine for each dosage form, dosage (amount, weight, quantity of doses in primary package) and total quantity in secondary (consumer) package without release form, except as specified, of stipulated in Item 25 these rules is established.

25. If the minimum level of the prices of reference medicine of different forms of release (the syringe handle, cartridges or other forms of release compatible to devices of introduction (application) or being devices of introduction (application) in the foreign states specified in table 1 of the Section II of appendix No. 3 to technique differs more than for 10 percent, it is allowed to establish marginal selling prices on each of such forms of release of medicine. Marginal selling price on reference medicine in such forms of release is established based on the minimum selling prices of the producer (without the production sites participating in production process) on the corresponding forms of release of such medicine in the foreign states specified in table 1 of the Section II of appendix No. 3 to technique (taking into account the expenses connected with customs clearance).

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info