ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of December 16, 2019 No. 1683

About introduction of amendments to some acts of the Government of the Russian Federation regarding state registration and marginal re-registration of selling prices on the medicines included in the list of vital and essential drugs

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to acts of the Government of the Russian Federation regarding state registration and marginal re-registration of selling prices on the medicines included in the list of vital and essential drugs.

2. Marginal selling prices of producers on the medicines included in the list of vital and essential drugs (further - marginal selling prices) which are registered before entry into force of this resolution and are re-registered without fail in 2019 - 2020 according to the 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 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" (in edition of this resolution) (further - Rules of obligatory re-registration), can be re-registered according to Items 32 and 34 of Rules of state registration and marginal re-registration of 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" (in edition of this resolution) (further - Rules of registration).

3. Determine that:

subitems "v" and "g" of Item 42 of Rules of registration are not applied to the marginal selling prices on medicines re-registered in 2019 - 2020 according to Rules of obligatory re-registration;

since January 1, 2021 realization by producers of medicines on which marginal selling prices are not re-registered in 2019 - 2020 according to Rules of obligatory re-registration is not allowed.

4. The medicines realized by their producers in the territory of the Russian Federation about day of entry into force of the order of the Ministry of Health of the Russian Federation on obligatory re-registration in marginal 2019 - 2020 of selling price of the producer can be in circulation before the expiration of their validity taking into account the actual selling price of the producer which is not exceeding the marginal selling price applied for date of their realization.

5. From the date of entry into force of this resolution state registration and marginal re-registration of selling prices on the reproduced, bioanalog (biosimilar) medicines according to Rules of registration can be performed after decision making about obligatory re-registration in marginal 2019 - 2020 of selling prices on the reference medicines corresponding to them.

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

Approved by the Order of the Government of the Russian Federation of December 16, 2019 No. 1683

Changes which are made to acts of the Government of the Russian Federation regarding state registration and marginal re-registration of selling prices on the medicines included in the list of vital and essential drugs

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" (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, Art. 5302; 2016, No. 6, Art. 853; 2018, No. 43, Art. 6597):

a) in Item 1:

state paragraph two in the following edition:

"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;";

after paragraph two to add with the paragraph of the following content:

"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;";

b) in 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 the vital and essential drugs approved by the specified resolution:

state the name in the following edition:

"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";

state Item 1 in the following edition:

"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 which is annually approved by the Government of the Russian Federation (further - medicines).";

in Item 5:

state the subitem "an" in the following edition:

"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);";

in the subitem "g":

to state paragraphs of the first and second in the following edition:

"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;";

in paragraphs seven and the eighth words of "producers of state members" shall be replaced with words "the producer of state member";

in paragraph nine of the word "on medicine of the foreign producers performing including primary and (or) secondary package of medicine" shall be replaced with words "medicine of foreign production, including primary and (or) secondary package of which is performed or planned to be performed";

Item 7 after words "the copy of the registration certificate of medicine" to add with words ", and also the copy of form No. 2-LEK (pry) "Data on production, shipment and the prices of medicines";

in Item 22:

the paragraph one of the subitem "a" to state in the following edition:

"a) for medicine of the producer of state member of the Eurasian Economic Union, and also medicine of foreign production which primary and (or) secondary package is performed or planned to be performed in the Russian Federation:";

in the subitem "b" of the word "foreign producers" shall be replaced with words "for medicine of foreign production";

in Item 24:

in the paragraph the second words of "producers of state member" shall be replaced with words "the producer of state member", shall be replaced with words words of "state members" "state member";

word in paragraph three of "the foreign producer" shall be replaced with words "foreign production";

in paragraph one of Item 25 of the word "in the foreign states specified" shall be replaced with words "in one of foreign states specified";

state Item 27 in the following edition:

"27. If within one registration certificate of medicine the reproduced, bioanalog (biosimilar) medicine of the producer of state member of the Eurasian Economic Union and foreign production is registered, the price for such medicine is calculated as for medicine of production of state member of the Eurasian Economic Union or medicine of foreign production taking into account the corresponding decreasing coefficient according to technique.";

in Item 29:

exclude the words "according to national calendar of preventive inoculations";

add with the paragraph of the following content:

"If for date of giving in the Ministry of Health of the Russian Federation of the statement for state registration on the medicine applied in pediatric practice (based on data of the instruction on medical application of medicine), marginal selling price on medicine in the dosages applied in pediatric practice within one international non-proprietary name (is not registered in case of its lack of the chemical or grouping name) and dosage form, calculation is perfromed according to the requirements established for reference medicines. At the same time the maximum difference between the minimum registered marginal selling price on medicine and the selling price provided for marginal state registration on medicine calculated proceeding from the cost of unit of active ingredient cannot exceed 90 percent.";

in Item 32:

word in paragraph one of "producers of state members" shall be replaced with words "the producer of state member";

in the subitem "an" of the word "to 50 rubles" shall be replaced with words "up to 100 rubles";

in subitems "b" and "v" of the word "from 50 rubles" shall be replaced with words "from 100 rubles";

in paragraph one of Item 33 of the word of "producers of state members" shall be replaced with words "the producer of state member";

in paragraphs one and the second Item 34 of the word "on medicine of the foreign producer performing including primary and (or) secondary package of medicine" shall be replaced with words "medicine of foreign production, including primary and (or) secondary package of which is performed";

in Item 35:

in paragraph one of the subitem "an" and in paragraph one of the subitem "b" of the word "producers from state members" shall be replaced with words "for medicine of the producer of state member";

in the subitem "v":

"producers of state members" shall be replaced with words words "for medicine of the producer of state member";

after words "the subitem "g" of Item 32 of these rules, -" to add with the words "the copy of form No. 2-LEK (pry) " data on production, shipment and the prices of medicines " (for domestic manufacturers), and also";

in paragraph one of the subitem "g" of the word "the foreign producers performing primary and (or) secondary package of medicine" shall be replaced with words "for medicine of foreign production which primary and (or) secondary package is performed or planned to be performed";

in paragraph one of the subitem "d" of the word "foreign producers" shall be replaced with words "for medicine of foreign production";

in Item 36 of the word of "producers of state members" shall be replaced with words "the producer of state member";

in Item 41 of the word of "Item 40" shall be replaced with words "Items 40 and 45";

add with Items 42 - 45 following contents:

"42. The holder or the owner of the registration certificate of medicine (person authorized by it) shall submit the application for re-registration towards decrease in case of approach of the following cases:

a) if as a result of decrease in selling price by the producer in foreign currency on the specified medicine in the foreign states specified in appendix No. 2 to technique the selling price of the producer on medicine in rubles calculated according to technique (taking into account expenses on customs clearance), below the registered marginal selling price of the producer on the specified medicine, - within 30 calendar days from the date of when the decision on reduction of prices of authorized bodies in the foreign states specified in appendix No. 2 to technique became effective;

b) if marginal selling price on the reproduced, bioanalog (biosimilar) medicine above marginal selling price on the corresponding reference medicine in connection with the decrease provided by the subitem "an" of this Item - within 30 calendar days from the date of decision making about re-registration towards decrease in the registered marginal selling price of the producer on reference medicine;

c) if the registered marginal selling price on the first reproduced, bioanalog (biosimilar) medicine of foreign production, including primary and (or) secondary package of which is performed or planned to be performed in the Russian Federation, above the marginal selling price of the producer calculated taking into account the decreasing coefficient specified in appendix No. 9 to technique, after marginal state registration of selling price of the producer on the second reproduced, bioanalog (biosimilar) medicine matching according to the international non-proprietary name (in case of its absence - to the grouping or chemical name), dosage form and dosage, - within 30 calendar days from the date of decision making about marginal state registration of selling price of the producer on the second reproduced, bioanalog (biosimilar) medicine;

d) if the registered marginal selling price on the first reproduced, bioanalog (biosimilar) medicine of the producer of state member of the Eurasian Economic Union above marginal selling price of the producer of the state member of the Eurasian Economic Union calculated taking into account the decreasing coefficient specified in appendix No. 9 to technique, after marginal state registration of selling price on the second reproduced, bioanalog (biosimilar) medicine of the producer of state member of the Eurasian Economic Union matching according to the international non-proprietary name (in case of its absence - grouping or chemical), dosage form and dosage, - within 30 calendar days from the date of decision making about marginal state registration of selling price of the producer on second reproduced, bioanalog (biosimilar) medicine of the producer of state member of the Eurasian Economic Union.

43. The re-registration of the registered marginal selling price of the reproduced, bioanalog (biosimilar) medicine towards decrease in the cases provided by subitems "v" and "g" of Item 42 of these rules is performed if within the international non-proprietary name (in case of its absence - the grouping or chemical name) and dosage form marginal selling price of the producer on the corresponding reference medicine is registered.

44. In case of re-registration of the registered marginal selling price of the producer towards decrease based on the statement of the holder or the owner of the registration certificate of the medicine (authorized by it persons), provided according to Item 42 of these rules, the price of such medicine cannot be declared within calendar year on re-registration towards increase according to Items 32 and 34 of these rules.

45. Federal Antimonopoly Service in writing notifies the holder or the owner of the registration certificate of medicine (person authorized by it) on need of re-registration of the registered marginal selling price on medicine towards decrease if the holder or the owner of the registration certificate of medicine (person authorized by it) did not submit the application for re-registration towards decrease according to Item 42 of these rules.

The holder or the owner of the registration certificate of medicine (person authorized by it) within 20 working days after receipt of the notification of Federal Antimonopoly Service brings the registered marginal selling price into accord with the price calculated according to these rules and technique taking into account information specified in the notification of Federal Antimonopoly Service.

Federal Antimonopoly Service within 5 working days after the expiration specified in the paragraph the second this Item cancels the decision on marginal approval of selling price of the producer on medicine in case of not reduction by the holder or owner of the registration certificate of medicine (authorized by it person) of the registered marginal selling price in compliance with these rules and technique taking into account information specified in the notification of Federal Antimonopoly Service within one month from the date of receipt of the notification of Federal Antimonopoly Service.";

appendices No. 1 and 2 to the specified Rules to state in the following edition:

"Appendix No. 1

to 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
(in edition of the Order of the Government of the Russian Federation of December 16, 2019 No. 1683)

(form)

The statement for marginal state registration of selling prices of producers on the medicines included in the list of vital and essential drugs

 

Applicant _________________________________________________________________

                          (name, postal address, e-mail address)

Holder  or  owner of the registration certificate medicinal

medicine _________________________________________________________________

                         (name, postal address, e-mail address)

 

№ of payment order	Production stage	Producer (name)	Address	Country	For the Russian legal entities - identification taxpayer number, for foreign legal entities - code of the taxpayer in country of incorporation (incorporation) or its analog	Name of registering body	Registration number

 

№ of payment order	Number of the registration certificate	International unlicensed, either the grouping, or chemical name <*>	Trade name	Dosage form, dosage, completeness <**>	Total quantity in secondary (consumer) package	Marginal selling price of the producer for consumer packaging <**> excluding VAT (rubles)	The bar code applied on secondary (consumer) package	ATH code	Code of the CN FEA EEU
1	2	3	4	5	6	7	8	9	10

 

Authorized person

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