ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION, MINISTRY OF INDUSTRY AND TRADE OF THE RUSSIAN FEDERATION AND FEDERAL CUSTOMS SERVICE OF THE RUSSIAN FEDERATION

of December 25, 2009 No. 1035n/1203/2377

About submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation, and also about the actual selling prices, production volumes and shipments of vital and major medicines of the Russian producers

According to Item 2 of the order of the Government of the Russian Federation of August 8, 2009 N 654 "About enhancement of state regulation of the prices of vital and major medicines" (The Russian Federation Code, 2009, N 33, 4086) we order to the Art.:

Approve:

single form of submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation, and also of the actual selling prices, production volumes and shipments of vital and major medicines of the Russian producers in electronic form according to the appendix N 1;

Procedure for submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation, and also about the actual selling prices, production volumes and shipments of vital and major medicines of the Russian producers according to the appendix N 2;

Procedure for filling of single form of submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation, and also about the actual selling prices, production volumes and shipments of vital and major medicines of the Russian producers according to the appendix N 3.

 

Minister of Health and social development Russian Federation

T. A. Golikova

Minister of Industry and Trade Russian Federation

V. B. Khristenko

Head Federal Customs Service

A.Yu.Belyaninov

Appendix №1

to the order of the Ministry of Health and Social Development of the Russian Federation, Ministry of Industry and Trade of the Russian Federation and Federal Customs Service of the Russian Federation of December 25, 2009 N 1035n/1203/2377

Single form of submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation, and also of the actual selling prices, production volumes and shipments of vital and major medicines of the Russian producers in electronic form

 _________________________________________________________________
         (наименование федерального органа исполнительной власти,
                       представляющего сведения)
                 за _________________________ 20__ г.
 
+--+--------+-------+--------+--------+-------+--------+-------+-------+---------+-------+-------+----------
¦N ¦N и дата¦  N и  ¦Междуна-¦Торговое¦Лекарс-¦Дозиров-¦Количе-¦  Вид  ¦Владелец ¦Страна ¦Упаков-¦ Страна
¦п/¦сертифи-¦ дата  ¦ родное ¦наимено-¦твенная¦ка ЖНВЛС¦ ство  ¦упаков-¦регистра-¦владе- ¦  щик  ¦упаковщи-
¦п ¦  ката  ¦лицен- ¦непатен-¦ вание  ¦ форма ¦(гр, мл,¦  доз  ¦  ки   ¦ционного ¦ льца  ¦ ЖНВЛС ¦ка ЖНВЛС
¦  ¦(декла- ¦зии на ¦тованное¦ ЖНВЛС  ¦ ЖНВЛС ¦ ед. и  ¦ЖНВЛС в¦ ЖНВЛС ¦удостове-¦  РУ   ¦       ¦
¦  ¦ рации) ¦ ввоз  ¦наимено-¦        ¦       ¦  др.)  ¦упаков-¦       ¦  рения  ¦ ЖНВЛС ¦       ¦
¦  ¦соответ-¦ ЖНВЛС ¦ вание  ¦        ¦       ¦        ¦  ке   ¦       ¦  (РУ)   ¦       ¦       ¦
¦  ¦ ствия  ¦       ¦ ЖНВЛС  ¦        ¦       ¦        ¦ (шт.) ¦       ¦  ЖНВЛС  ¦       ¦       ¦
+--+--------+-------+--------+--------+-------+--------+-------+-------+---------+-------+-------+----------
¦1 ¦   2    ¦   3   ¦   4    ¦   5    ¦   6   ¦   7    ¦   8   ¦   9   ¦   10    ¦  11   ¦  12   ¦   13
+--+--------+-------+--------+--------+-------+--------+-------+-------+---------+-------+-------+----------

+-------+-------+-------+--------+--------+--------+--------+---------+--------+---------+--------+---------
¦Юриди- ¦Количе-¦Статис-¦ Общая  ¦  Дата  ¦Органи- ¦ Страна ¦Количест-¦ Общая  ¦Количест-¦Фактиче-¦ Общая
¦ческое ¦ ство  ¦тичес- ¦ стои-  ¦выпуска ¦ зация- ¦органи- ¦   во    ¦ стои-  ¦   во    ¦  ская  ¦ стои-
¦ лицо, ¦ввезен-¦  кая  ¦ мость  ¦ товара ¦произво-¦ зации- ¦произве- ¦ мость  ¦отгружен-¦отпуск- ¦ мость
¦ввозя- ¦  ных  ¦ стои- ¦ввезен- ¦        ¦ дитель ¦произво-¦ денных  ¦произве-¦   ных   ¦  ная   ¦отгруже-
¦  щее  ¦ЖНВЛС в¦ мость ¦  ных   ¦        ¦ ЖНВЛС  ¦ дителя ¦упаковок ¦ денных ¦упаковок ¦  цена  ¦  нных
¦ ЖНВЛС ¦допол- ¦ ЖНВЛС ¦ ЖНВЛС  ¦        ¦        ¦ ЖНВЛС  ¦  ЖНВЛС  ¦упаковок¦  ЖНВЛС  ¦ ЖНВЛС  ¦упаковок
¦       ¦нитель-¦ (дол. ¦ (руб.) ¦        ¦        ¦        ¦  (шт.)  ¦ ЖНВЛС  ¦  (шт.)  ¦ (руб.) ¦ ЖНВЛС
¦       ¦  ной  ¦ США)  ¦        ¦        ¦        ¦        ¦         ¦ (тыс.  ¦         ¦        ¦ (тыс.
¦       ¦единице¦       ¦        ¦        ¦        ¦        ¦         ¦ руб.)  ¦         ¦        ¦ руб.)
¦       ¦измере-¦       ¦        ¦        ¦        ¦        ¦         ¦        ¦         ¦        ¦
¦       ¦  ния  ¦       ¦        ¦        ¦        ¦        ¦         ¦        ¦         ¦        ¦
+-------+-------+-------+--------+--------+--------+--------+---------+--------+---------+--------+---------
¦  14   ¦  15   ¦  16   ¦   17   ¦   18   ¦   19   ¦   20   ¦   21    ¦   22   ¦   23    ¦   24   ¦   25
+-------+-------+-------+--------+--------+--------+--------+---------+--------+---------+--------+---------
 

Head of the structural unit

federal executive body,

the representing data ________________________________________

                            (initials, surname)

Contractor of ___________ _________________________ ______________

           (position)    (initials, surname)      (phone)

"__" _______________________ 20 __ (date of filling of form)

Appendix № 2

to the order of the Ministry of Health and Social Development of the Russian Federation, Ministry of Industry and Trade of the Russian Federation and Federal Customs Service of the Russian Federation of December 25, 2009 N 1035n/1203/2377

Procedure for submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation, and also about the actual selling prices, production volumes and shipments of vital and major medicines of the Russian producers

1. This Procedure establishes rules of data presentation, including data on the actual prices of vital and major medicines (further - VED) foreign producers and amounts of their import to the territory of the Russian Federation, and also about the actual selling prices, production volumes and shipments of VED of the Russian producers, for monitoring of assortment and the prices of VED.

2. The Federal Service on Surveillance in Healthcare and Social Development sends to the Ministry of Industry and Trade of the Russian Federation of the conclusion about possibility of issue of licenses for VED import, drawn up separately on each name VED of one dosage, dosage form and form of release, with the mark "Permission Is Issued on VED Import".

3. After receipt of the conclusions about possibility of issue of licenses for import of VED provided by Federal Service on Surveillance in Healthcare and Social Development, the Ministry of Industry and Trade of the Russian Federation grants the separate licenses for VED import which are drawn up on each name VED of one dosage, dosage form and form of release with indication of in VED code license number.

4. The Ministry of Industry and Trade of the Russian Federation provides information on number and date of the license for import of VED of the foreign producers imported on the territory of the Russian Federation, corresponding column 3 of single form of submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation and also on the actual selling prices, production volumes and the shipment of vital and major medicines of the Russian producers in electronic form (further - the Single form) provided by the appendix N 1:

in the Ministry of Health and Social Development of the Russian Federation - monthly, no later than the 10th following for reporting, on paper;

in Federal Service on Surveillance in Healthcare and Social Development - monthly, no later than the 5th following for reporting, in electronic form in dbf-file format;

in the Federal Customs Service - monthly, no later than the 5th following for reporting, in electronic form in dbf-file format.

5. The Federal Customs Service on the basis of the licenses for import of VED granted by the Ministry of Industry and Trade of the Russian Federation creates and provides information corresponding to columns 14, of 15, of 16, of 17, 18 Single forms:

in the Ministry of Health and Social Development of the Russian Federation - monthly, no later than the 10th following for reporting, in electronic form;

in Federal Service on Surveillance in Healthcare and Social Development - monthly, no later than the 5th following for reporting, in electronic form.

6. The Federal Service on Surveillance in Healthcare and Social Development places information corresponding to columns 1, of 2, of 4, of 5, of 6, of 7, of 8, of 9, of 10, of 11, of 12, of 13, of 19, of 20, of 21, of 22, of 23, of 24, 25 Single forms according to data from the State register of medicines, generalizes the data obtained from the Ministry of Industry and Trade of the Russian Federation and the Federal Customs Service and posts the Single form in electronic form on the official site of Federal Service on Surveillance in Healthcare and Social Development no later than the 10th following reporting in time.

7. The procedure for information exchange between Federal Service on Surveillance in Healthcare and Social Development and the Ministry of Industry and Trade of the Russian Federation, between Federal Service on Surveillance in Healthcare and Social Development and the Federal Customs Service, and also between the Ministry of Industry and Trade of the Russian Federation and the Federal Customs Service is determined by data exchange agreements.

Appendix №. 3

to the order of the Ministry of Health and Social Development of the Russian Federation, Ministry of Industry and Trade of the Russian Federation and Federal Customs Service of the Russian Federation of December 25, 2009 N 1035n/1203/2377

Procedure for filling of single form of submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation, and also about the actual selling prices, production volumes and shipments of vital and major medicines of the Russian producers

When filling single form of submission of data on the actual prices of vital and major medicines of foreign producers and amounts of their import to the territory of the Russian Federation, and also about the actual selling prices, production volumes and shipments of vital and major medicines of the Russian producers in electronic form (further - the Single form):

1) in the corresponding lines the name of federal executive body and the period (month) for which information is provided are specified;

2) in column 1 the sequence number of record is specified;

3) in column 2 number and date of the certificate (declaration) of compliance are specified;

4) in column 3 number and date of the license for import of vital and major medicines (further - VED) issued by the Ministry of Industry and Trade of the Russian Federation is specified;

5) in column 4 the international non-proprietary name VED according to the List of vital and major medicines approved in accordance with the established procedure is specified;

6) in column 5 the trade name VED under which it is registered is specified;

7) in column 6 the dosage form of VED is specified (solutions for injections, tablet, tinctures, suppositories, etc.);

8) in column 7 VED dosage is specified;

9) in column 8 the quantity of doses of VED in consumer packaging is specified;

10) in column 9 VED type of packaging is specified (ampoules, blisters, bottles, packs cardboard, etc.);

11) in column 10 the owner of the registration certificate of VED - the name and the address of the legal entity addressed to which the registration certificate is issued is specified;

12) in column 11 the state in the territory of which the owner of the registration certificate of VED is registered is specified;

13) in column 12 the packer of VED - the legal entity performing packaging of medicine in primary and/or secondary consumer package is specified;

14) in column 13 the state in the territory of which the packer of VED is registered is specified;

15) in column 14 the name of the legal entity performing import of VED to the territory of the Russian Federation is specified;

16) in column 15 the amount of the imported VED in additional unit of measure is specified;

17) in column 16 the statistical cost ЖНВЛСстоимость of the declared medicines intended for the purposes of forming of customs statistics of foreign trade is specified;

18) in column 17 the total cost of the imported VED is specified (is calculated as the amount of customs value, customs duties for customs clearance of goods and import customs duty);

19) in column 18 date of issue of goods is specified;

20) in column 19 the organization - the producer Zhnvlsorganization, performing production of VED according to requirements of the legislation of the Russian Federation is specified;

21) in column 20 the state in the territory of which the organization - VED producer is registered is specified;

22) in column 21 the number of the made VED packagings in kind is specified;

23) in column 22 the total cost of the made packagings of VED in value term is specified;

24) in column 23 the number of the shipped VED packagings in kind is specified;

25) in column 24 the actual selling price of VED is specified;

26) in column 25 the total cost of the shipped packagings of VED in value term is specified (the number of the shipped packagings the X actual selling price);

27) in the Single form initials, surname of the head of the structural unit of the federal executive body representing data and the worker, the filled form, and also the worker's position, number of its contact telephone number and date of filling of form are specified.

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