Home Pulpitis Ministry of Health of the Russian Federation.

Ministry of Health of the Russian Federation.

The Ministry of Health has changed the rules for calculating the NMCC for the purchase of medicines. The innovations came into force with the Order of the Ministry of Health of the Russian Federation dated June 26, 2018 No. 386n. The document introduces important changes to Order of the Ministry of Health of the Russian Federation dated October 26, 2017 No. 871n.

What has changed in the calculations

First of all new Order The Ministry of Health cancels footnote 1 in paragraph 2 of Order No. 871n. This means that customers will no longer reject or refuse to enter into a contract with a bidder who has offered a value higher than that indicated in the register of marginal selling prices on medicines, and refuses to omit it (clause 2, part 10, article 31 44-FZ). Let us remind you that this rule applies only to drug manufacturers and is used in the procurement of drugs from the VED register, the NMCC of which at the federal level exceeds 10 million rubles, and at the regional level this threshold is set by the executive authority (the limit should not exceed 10 million rubles. ).

Another important change is that now, when calculating the maximum cost, it will be necessary to take into account not concluded, but state or municipal contracts executed by the government customer. And the application of reference prices was postponed until 01/01/2019.

Now, in the calculations of the NMCC, as the cost of one medication, use the unit price excluding VAT, taken from the concluded contracts. And from July 1, 2019, this data must be determined based on executed contracts and deduct not only VAT, but also the wholesale markup.

The changes also affected the wholesale markups themselves. Their size should not exceed the limits established by the authorities executive power subjects of the Russian Federation. And wholesale markups will be applied if.

"On amendments to the annexes to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175N "On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for processing these forms, their recording and storage"

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER
dated June 30, 2015 N 386n

ON AMENDMENTS TO THE ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION OF DECEMBER 20, 2012 N 1175N “ON APPROVAL OF THE PROCEDURE FOR PRESCRIBING AND PRESCRIPTION OF MEDICINAL DRUGS, AS WELL AS RECEPTION BLA FORMS NKV FOR MEDICINES, THE PROCEDURE FOR REGISTRATION OF THE SPECIFIED FORMS, THEIR ACCOUNTING AND STORAGE

1. Amend the appendices to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for processing these forms, their recording and storage” ( registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration N 28883) as amended by order of the Ministry of Health of the Russian Federation dated December 2, 2013 N 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration N 30714), according to application.

2. Subparagraphs 9 - 12 of paragraph 1, paragraph 2 and subparagraphs 3 and 5 of paragraph 3 of the appendix to this order come into force on January 1, 2016.

Minister
IN AND. SKVORTSOVA

"<2>In relation to the person specified in Part 2 of Article 20 Federal Law dated November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, Art. 3442, 3446; 2013, N 27 , Art. 3459, Art. 4038; Art. 4883; Art. 6951; , 4244, 4257; art. 5798; art. 6927; art. 72, 85; art. N 27, art. 3951; N 29 (part I), art. 4339, 4397, 4356, 4359).

in paragraph one, replace the words “in paragraph 15” with the words “in paragraphs 15 and 23”;

in paragraph two, replace the words “in paragraphs 15 and 23” with the words “in paragraphs 15, 22 and 23”;

the words “when providing palliative medical care to patients” should be replaced with the words “when providing patients in need of long-term treatment, primary health care and palliative care";

add paragraph two with the following content:

“In the cases provided for in the first paragraph of this paragraph, the inscription “According to special purpose", separately signed by the medical worker and the seal of the medical organization "For prescriptions".";

"20. Prescriptions written out on prescription form forms N 148-1/у-88, valid for 15 days from the date of issue.";

in paragraph one, replace the words “one month” with the words “30 days”;

in paragraph two, replace the words “three months” with the words “90 days”;

in paragraph three, replace the words “up to three months” with the words “up to 90 days”;

12) paragraph one of paragraph 23 should be stated as follows:

"23. Prescriptions for barbituric acid derivatives, combination medicinal products containing codeine (its salts), other combined medicinal products subject to subject-quantitative accounting, medicinal products with anabolic activity in accordance with the main pharmacological action, for the treatment of patients with chronic diseases may be discharged for a course of treatment of up to 60 days.";

13) in the first paragraph of clause 25, replace the words “and also with a clinical pharmacologist” with the words “and also, if available, with a clinical pharmacologist”;

add footnote 6 with the following content:

"<6>Order of the Government of the Russian Federation dated December 30, 2014 N 2782-r “On approval of the list of vital and essential drugs for 2015, as well as lists of drugs for medical use and minimum assortment medications necessary to provide medical care" (Collection of Legislation of the Russian Federation 2015, No. 3, Art. 597).";

add subparagraph 4 with the following content:

"4) citizens suffering from life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens and their disability<8>.";

add footnote 8 with the following content:

" <8>Decree of the Government of the Russian Federation of April 26, 2012 N 403 “On the procedure for maintaining the Federal Register of persons suffering from life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens and their disability, and its regional segment” (Collection of Legislation of the Russian Federation Federation, 2012, No. 19, Art. 2428, Art. 5002).";

add position 18 with the following content:

22) in Appendix No. 2 “Recommended quantity of individual medications for prescribing per prescription” to the Procedure for prescribing and prescribing medications, approved by order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n

On amendments to the annexes to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for processing these forms, their recording and storage” (lost force from 04/07/2019 on the basis of the order of the Russian Ministry of Health dated 01/14/2019 N 4n)

Document's name:
Document Number: 386n
Document type: Order of the Russian Ministry of Health
Receiving authority: Ministry of Health of Russia
Status: Inactive
Published:
Acceptance date: June 30, 2015
Start date: August 21, 2015
Expiration date: April 07, 2019

On amendments to the annexes to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for...

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER

On making changes to the annexes to


Lost force on April 7, 2019 on the basis
Order of the Russian Ministry of Health dated January 14, 2019 N 4n
____________________________________________________________________


I order:

1. Amend the appendices to (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration N 28883) with the changes made by order of the Ministry of Health of the Russian Federation dated December 2, 2013 N 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration N 30714), according to the appendix.

2. Subparagraphs 9-12 of paragraph 1, paragraph 2 and subparagraphs 3 and 5 of paragraph 3 of the appendix to this order come into force on January 1, 2016.

Minister
V.I.Skvortsova

Registered
at the Ministry of Justice
Russian Federation
August 6, 2015,
registration N 38379

Application. Changes that are being made to the annexes to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “On approval of the procedure for prescribing and prescribing medications, as well as prescription forms...

Application
to the order
Ministry of Health
Russian Federation
dated June 30, 2015 N 386n

Changes made to the annexes

1. In Appendix No. 1 “Procedure for prescribing and prescribing medications” to the order:

1) in paragraph 3, delete the words “and indicating your position”;

2) add clause 3.1 with the following content:

"3.1. Prescribing and prescribing medications when providing medical care in inpatient conditions carried out under an international non-proprietary, group or trade name."

3) in paragraph 5 footnote 2

"In relation to the person specified in part 2 of Article 20 of the Federal Law of November 21, 2011 N 323-FZ "On the fundamentals of protecting the health of citizens in the Russian Federation" (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, Art. 3442, 3446; 27, Art. 3459, 3477; No. 39, Art. 4883; Art. 6165; 23, art. 2930; no. 4106, 4206, 4247, 4257; no. 43, art. 5798; 2015, no. 72, 85, art. .1403, 1425; No. 14, Art. 2018; No. 27, Art. 3951 (Part I), Art. 4339, 4397, 4356, 4359).";

4) clause 6.2 should be stated as follows:

"6.2. individual entrepreneurs carrying out medical activities, for narcotic drugs and psychotropic substances included in lists II and III of the List of lists II and III of the List).";

5) in paragraph 8, replace the words “List II of the List” with the words “List II of the List (hereinafter referred to as narcotic and psychotropic drugs of List II of the List), with the exception of drugs in the form of transdermal therapeutic systems,";

6) in paragraph 9:

subparagraph 1 should be stated as follows:

"1) narcotic and psychotropic drugs of List II of the List in the form of transdermal therapeutic systems, psychotropic substances included in List III of the List, registered in the prescribed manner as medicinal products (hereinafter referred to as psychotropic drugs of List III of the List);";

subparagraph 2 after the words “subject-quantitative accounting” should be supplemented with the words “(except for over-the-counter drugs)”;

subparagraph 3 after the words “anabolic activity” is added with the words “(in accordance with the main pharmacological action)”;

7) in paragraph 13:

in paragraph one, replace the words “in paragraph 15” with the words “in paragraphs 15 and 23”;

in paragraph two, replace the words “in paragraphs 15 and 23” with the words “in paragraphs 15, 22 and 23”;

8) in paragraph 15:

the words “when providing palliative care to patients” should be replaced with the words “when providing primary health care and palliative care to patients in need of long-term treatment”;

add paragraph two with the following content:

“In the cases provided for in the first paragraph of this paragraph, the inscription “For special purposes” is written on the prescriptions, separately signed by the medical worker and the seal of the medical organization “For prescriptions.”;

9) paragraph 20 should be stated as follows:

"20. Prescriptions written out on prescription form form N 148-1/у-88 are valid for 15 days from the date of prescription.";

10) in paragraph 21:

in paragraph one, replace the words “one month” with the words “30 days”;

in paragraph two, replace the words “three months” with the words “90 days”;

in paragraph three, replace the words “up to three months” with the words “up to 90 days”;

11) in paragraph 22, replace the words “two months” with the words “60 days”;

12) paragraph one of paragraph 23 should be stated as follows:

"23. Prescriptions for barbituric acid derivatives, combination drugs containing codeine (its salts), other combination drugs subject to subject-quantitative accounting, drugs with anabolic activity in accordance with the main pharmacological action, for the treatment of patients with chronic diseases may be discharged for a course of treatment of up to 60 days.";

13) in the first paragraph of clause 25, replace the words “and also with a clinical pharmacologist” with the words “and also, if available, with a clinical pharmacologist”;

14) in paragraph 26, replace the words “in paragraph 25” with the words “in paragraphs 25 and 27”;

15) in paragraph 29, after the words “lists II and III of the List”, add the words “potent drugs”;

16) subclause 3 of clause 31 should be stated as follows:

“3) the initial prescription of narcotic and psychotropic medications to a patient on lists II and III of the List (if the head of a medical organization makes a decision on the need to coordinate the prescription of such medications with a medical commission).”;

17) paragraph 32 should be stated as follows:

"32. Prescription and prescription of narcotic and psychotropic drugs of lists II and III of the List is carried out to patients with severe pain syndrome of any origin, as well as for patients with sleep disorders, convulsive conditions, anxiety disorders, phobias, psychomotor agitation on one's own medical worker or by a medical worker by decision of the medical commission (if the head of the medical organization decides on the need to coordinate the primary prescription of such medications with the medical commission).";

18) in paragraph 34:

subparagraph 1 should be stated as follows:

"1) certain categories of citizens entitled to receive state social assistance as a set social services, in accordance with the list of drugs for medical use, including drugs for medical use prescribed by decision of medical commissions medical organizations;";

add footnote 6 with the following content:

"Order of the Government of the Russian Federation dated December 30, 2014 N 2782-r "On approval of the list of vital and essential drugs for 2015, as well as lists of drugs for medical use and the minimum range of drugs necessary to provide medical care" (Meeting Legislation of the Russian Federation, 2015, No. 3, Art. 597).";

in subparagraph 3, footnote 6 is considered footnote 7;

in subparagraph 3 the words “dated July 30, 1994 N 890.” replace with the words “dated July 30, 1994 N 890;”;

add subparagraph 4 with the following content:

“4) citizens suffering from life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens and their disability.”;

add footnote 8 with the following content:

"Resolution of the Government of the Russian Federation of April 26, 2012 N 403 "On the procedure for maintaining the Federal Register of persons suffering from life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens and their disability, and its regional segment" (Collection of Legislation of the Russian Federation Federation, 2012, N 19, Art. 2428; N 37, Art. 5002).";

19) paragraph 38 should be stated as follows:

"38. On the prescription form of form N 148-1/u-04 (l) and form N 148-1/u-06 (l), the prescription is written out by a medical worker in two copies, with one copy of which the patient applies to pharmacy organization. The second copy of the recipe is attached to medical card patient.";

20) in paragraphs 39 and the words “in 3 copies” should be replaced with the words “in duplicate”;

21) in Appendix No. 1 “Maximum permissible quantity of certain narcotic and psychotropic drugs for prescribing per prescription” to the Procedure for prescribing and prescribing drugs, approved by:

position 5 should be stated as follows:

"

Solution for injection, solution for subcutaneous administration,
ampoules 10 mg/ml 1 ml

";

positions 7, 8, 9 should be stated as follows:

"

Promedol (trimepyridine)

Tablets for oral administration 25 mg

50 tablets

Promedol (trimepyridine)

Solution for injection, ampoules (syringe tubes) 10 mg/ml 1 ml, 20 mg/ml 1 ml

20 ampoules (syringe tubes)

Morphine (MCT continuus or other analogues

Extended-release tablets (capsules) for oral administration

lasting at least 12 hours)

180 tab. (caps.)

60 tab. (caps.)

30 tab. (caps.)

20 tab. (caps.)

20 tab. (caps.)

";

position 11 should be stated as follows:

"

";

add position 18 with the following content:

"

22) in Appendix No. 2 “Recommended quantity of individual medications for prescribing per prescription” to the Procedure for Prescribing and Prescribing Medicines, approved by Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1175n, position 11 is declared invalid.

2. In Appendix No. 2 “Forms of prescription forms” to the order:

1) in the prescription form "Form N 148-1/у-88":

the words “N of the medical record of the outpatient __________ (history of the child’s development)” should be replaced with the words “the medical record number of the patient receiving medical care V outpatient setting";

the words “10 days” should be replaced with the words “15 days”;

2) in the prescription form “Form N 107-1/u” replace the words “2 months” with the words “60 days”;

3) in the prescription form "Form N 148-1/у-04 (l)":

the words “Address or N of the medical record of an outpatient patient __________ (history of the child’s development)” should be replaced with the words “Medical record number of a patient receiving medical care on an outpatient basis”;

the words “10 days, 1 month, 3 months” are replaced with the words “, 15 days, 30 days, 90 days”;

4) in the prescription form "Form N 148-1/у-06 (l)":

the words “10 days, 1 month, 3 months” should be replaced with the words “15 days, 30 days, 90 days”;

the words “N of the medical record of an outpatient patient (history of the child’s development)” should be replaced with the words “Number of the medical record of a patient receiving medical care on an outpatient basis.”
2) all details (except for the details “Signature of the attending physician”) of prescription forms of form N 148-1/у-88 and form N 107-1/у (not having a number and (or) series, place for applying a barcode) using printing devices.";

2) in paragraph 8, after the word “(SNILS)”, add the words “(if available)”;

3) point 9:

to read as follows:

"9. In prescription forms of form N 148-1/у-88 in the column "Address or medical card number of a patient receiving medical care on an outpatient basis" the full postal address of the patient's place of residence (place of stay or place of actual residence) and the medical number cards of a patient receiving medical care on an outpatient basis.

In prescription forms of form N 148-1/у-04(l) and form N 148-1/у-06 (l) in the column “Medical card number of the patient receiving medical care on an outpatient basis” indicate the medical card number of the patient receiving medical care on an outpatient basis.";

add footnote 2 with the following content:

"Order of the Ministry of Health of the Russian Federation dated December 15, 2014 N 834n "On approval of unified forms of medical documentation used in medical organizations providing medical care on an outpatient basis, and procedures for filling them out" (registered by the Ministry of Justice of the Russian Federation on January 20, 2015, registration N 36160).";,

Document's name: On amendments to the annexes to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for processing these forms, their recording and storage” (lost force from 04/07/2019 on the basis of the order of the Russian Ministry of Health dated 01/14/2019 N 4n)
Document Number: 386n
Document type: Order of the Russian Ministry of Health
Receiving authority: Ministry of Health of Russia
Status: Inactive
Published: Official Internet portal of legal information www.pravo.gov.ru, 08/10/2015, N 0001201508100053
Acceptance date: June 30, 2015
Start date: August 21, 2015
Expiration date: April 07, 2019

Order of the Ministry of Health of the Russian Federation dated June 30, 2015 No. 386n “On amendments to the annexes to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications , the procedure for completing the specified forms, their recording and storage” (has not entered into force)

1. Amend the annexes to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for processing these forms, their recording and storage” ( registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration No. 28883) as amended by the Russian Federation on December 2, 2013 No. 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration No. 30714), according to the appendix.

2. Subparagraphs 9-12 of paragraph 1, paragraph 2 and subparagraphs 3 and 5 of paragraph 3 of the appendix to this order come into force on January 1, 2016.

Changes,
which are included in the annexes to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for processing these forms, their recording and storage”

1. In Appendix No. 1 “Procedure for prescribing and prescribing medications” to the order:

1) in paragraph 3, delete the words “and indicating your position”;

2) add clause 3.1. the following content:

"3.1. Prescription and prescription of medications when providing medical care in inpatient settings is carried out according to the international nonproprietary, group or trade name.”

3) in paragraph 5, footnote 2 should be stated as follows:

“(2) In relation to the person specified in part 2 of Article 20 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724 ; 2012, art. 3446; 27, art. 3477; no. 4038; ; 2014, No. 2930; 2015, No. 4247, 4257; No. 10, Art. 1403, 1425; No. 27, Art. 3951 (Part I), Art.

4) clause 6.2 should be stated as follows:

"6.2. individual entrepreneurs carrying out medical activities for narcotic drugs and psychotropic substances included in lists II and III of the List (hereinafter referred to as narcotic and psychotropic drugs of lists II and III of the List).”;

5) in paragraph 8, the words “List II of the List” should be replaced with the words “List II of the List (hereinafter referred to as narcotic and psychotropic drugs of List II of the List), with the exception of drugs in the form of transdermal therapeutic systems,”;

subparagraph 1 should be stated as follows:

“1) narcotic and psychotropic drugs of List II of the List in the form of transdermal therapeutic systems, psychotropic substances included in List III of the List, registered in the prescribed manner as medicinal products (hereinafter referred to as psychotropic drugs of List III of the List);”;

subparagraph 2 after the words “subject-quantitative accounting” should be supplemented with the words “(except for over-the-counter drugs)”;

subparagraph 3 after the words “anabolic activity” is added with the words “(in accordance with the main pharmacological action)”;

in paragraph one, replace the words “in paragraph 15” with the words “in paragraphs 15 and 23”;

in paragraph two, replace the words “in paragraphs 15 and 23” with the words “in paragraphs 15, 22 and 23”;

the words “when providing palliative care to patients” should be replaced with the words “when providing primary health care and palliative care to patients in need of long-term treatment”;

add paragraph two with the following content:

“In the cases provided for in the first paragraph of this paragraph, the inscription “For special purposes” is written on prescriptions, separately signed by a medical worker and the seal of the medical organization “For prescriptions.”;

9) paragraph 20 should be stated as follows:

"20. Prescriptions written out on the prescription form form No. 148-1/u-88 are valid for 15 days from the date of prescription.”;

in paragraph one, replace the words “one month” with the words “30 days”;

in paragraph two, replace the words “three months” with the words “90 days”;

in paragraph three, replace the words “up to three months” with the words “up to 90 days”;

11) in paragraph 22, replace the words “two months” with the words “60 days”;

12) paragraph one of paragraph 23 should be stated as follows:

"23. Prescriptions for barbituric acid derivatives, combination drugs containing codeine (its salts), other combination drugs subject to subject-quantitative recording, drugs that have anabolic activity in accordance with the main pharmacological action, for the treatment of patients with chronic diseases can be prescribed to course of treatment up to 60 days.”;

13) in the first paragraph of clause 25, replace the words “as well as with a clinical pharmacologist” with the words “and also, if available, with a clinical pharmacologist”;

14) in paragraph 26, replace the words “in paragraph 25” with the words “in paragraphs 25 and 27”;

15) in paragraph 29, after the words “lists II and III of the List”, add the words “potent drugs”;

16) subclause 3 of clause 31 should be stated as follows:

“3) the initial prescription of narcotic and psychotropic medications to a patient on lists II and III of the List (if the head of a medical organization makes a decision on the need to coordinate the prescription of such medications with a medical commission)”;

17) paragraph 32 should be stated as follows:

"32. The prescription and prescription of narcotic and psychotropic drugs of lists II and III of the List is carried out to patients with severe pain syndrome of any origin, as well as to patients with sleep disorders, convulsive conditions, anxiety disorders, phobias, psychomotor agitation independently by a medical worker or by a medical worker by decision of a medical commission ( if the head of a medical organization decides on the need to coordinate the primary prescription of such medications with a medical commission).”;

“1) certain categories of citizens entitled to receive state social assistance in the form of a set of social services, in accordance with the list of medicines for medical use, including medicines for medical use prescribed by decision of medical commissions of medical organizations (6); ";

add footnote 6 with the following content:

“(6) Order of the Government of the Russian Federation dated December 30, 2014 No. 2782-r “On approval of the list of vital and essential medicines for 2015, as well as lists of medicines for medical use and the minimum range of medicines necessary for the provision of medical care assistance" (Collected Legislation of the Russian Federation 2015, No. 3, Art. 597)";

in subparagraph 3 the words “dated July 30, 1994 No. 890.” replace with the words “dated July 30, 1994 No. 890;”;

add subparagraph 4 with the following content:

“4) citizens suffering from life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens and their disability (8)”;

add footnote 8 with the following content:

“(8) Decree of the Government of the Russian Federation of April 26, 2012 No. 403 “On the procedure for maintaining the Federal Register of persons suffering from life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens and their disability, and its regional segment” (Collected Legislation of the Russian Federation, 2012, No. 19, Art. 2428; No. 37, Art. 5002).”;

19) paragraph 38 should be stated as follows:

"38. On the prescription form of form No. 148-1/u-04(l) and form No. 148-1/u-06(l), the prescription is written by a medical professional in two copies, with one copy of which the patient applies to the pharmacy. The second copy of the prescription is attached to the patient’s medical record.”;

20) in paragraphs 39 and 40, replace the words “in 3 copies” with the words “in duplicate”;

21) in Appendix No. 1 “Extremely permissible quantity individual narcotic and psychotropic medications for one prescription" to the Procedure for Prescribing and Prescribing Medicines, approved by Order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n:

Order mz 386n

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for completing these forms, their recording and storage


Document with changes made:
by order of the Ministry of Health of Russia dated December 2, 2013 N 886n ( Russian newspaper, N 294, December 27, 2013) (came into force on January 1, 2014);
by order of the Ministry of Health of Russia dated June 30, 2015 N 386n (Official Internet portal of legal information www.pravo.gov.ru, 08/10/2015, N 0001201508100053) (for the procedure for entry into force, see paragraph 2 of the order of the Ministry of Health of Russia dated June 30, 2015 N 386n);
by order of the Ministry of Health of Russia dated April 21, 2016 N 254n (Official Internet portal of legal information www.pravo.gov.ru, July 19, 2016, N 0001201607190020) (for the procedure for entry into force, see paragraph 2 of the order of the Ministry of Health of Russia dated April 21, 2016 N 254n);
by order of the Ministry of Health of Russia dated October 31, 2017 N 882n (Official Internet portal of legal information www.pravo.gov.ru, 01/09/2018, N 0001201801090027).
____________________________________________________________________

the procedure for prescribing and prescribing medications in accordance with Appendix No. 1;

forms of prescription forms according to Appendix No. 2;

the procedure for preparing prescription forms, recording and storing them in accordance with Appendix No. 3.

Registered
at the Ministry of Justice
Russian Federation
June 25, 2013,
registration N 28883

Appendix No. 1. Procedure for prescribing and prescribing medications

I. General provisions

3. Medical professionals write prescriptions for medications under their own signature.

The prescription and prescription of medications is carried out by a medical professional using the international nonproprietary name, and in its absence, the generic name. In the absence of international generic name and group name medicinal product, the drug is prescribed and prescribed by a medical professional by trade name.

If there are medical indications (individual intolerance, vital signs) by decision of the medical commission of a medical organization, medications are prescribed and prescribed: those that are not included in the standards of medical care; by trade names. The decision of the medical commission of the medical organization is recorded in medical documents patient and the medical commission journal.
(Paragraph as amended, put into effect on January 1, 2014 by order of the Ministry of Health of Russia dated December 2, 2013 N 886n.

Medical workers prescribe and prescribe medications that are subject to manufacture and dispensing by pharmacies (hereinafter referred to as individually manufactured medications).

3.1. Prescribing medications when providing medical care in a hospital setting and prescribing them in invoice requests in accordance with the Instructions on the procedure for prescribing medications and issuing prescriptions and invoice requests, approved by order of the Ministry of Health and social development Russian Federation dated February 12, 2007 N 110 “On the procedure for prescribing and prescribing medications and products medical purposes and specialized products therapeutic nutrition", carried out under an international non-proprietary, group or trade name.
(The paragraph was additionally included on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n; as amended, put into effect on July 30, 2016 by order of the Ministry of Health of Russia dated April 21, 2016 N 254n.
_______________
Registered by the Ministry of Justice of the Russian Federation on April 27, 2007, registration N 9364, as amended by orders of the Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 N 560 (registered by the Ministry of Justice of the Russian Federation on September 14, 2007, registration N 10133), dated September 25, 2009 N 794н (registered by the Ministry of Justice of the Russian Federation on November 25, 2009, registration N 15317), dated January 20, 2011 N 13н (registered by the Ministry of Justice of the Russian Federation on March 15, 2011, registration N 20103), by orders of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration N 25190), dated February 26, 2013 N 94n (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration N 28881).
(Footnote additionally included from July 30, 2016 by order of the Russian Ministry of Health dated April 21, 2016 N 254n)

4. A prescription issued in violation of the requirements established by this Procedure is considered invalid.

5. Information about the prescribed and discharged medicinal product (name of the medicinal product, single dose, method and frequency of administration or administration, duration of the course, rationale for prescribing the medicinal product) is indicated in the patient’s medical record.

A prescription for a drug is written in the name of the patient for whom the drug is intended.

A prescription for a drug can be obtained by the patient or his legal representative. The fact of issuing a prescription for a drug to a legal representative is recorded in the patient’s medical record.
________________
In relation to the person specified in part 2 of Article 20 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26 , art. 3442, 3446; 2013, art. 3459, 3477; , Art. 2930, Art. 4106, 4244, 4257; N 43, Art. 5798; 2015, Art. 72, 85; 1403, 1425; N 14, art. 2018; N 27, art. 3951; N 29 (part I), art. 4339, 4397, 4356, 4359).
(Footnote as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

6.1. medical workers:

in the absence of medical indications;

for medicinal products not registered in the Russian Federation;

for medicines that, in accordance with the instructions for medical use, are used only in medical organizations;

for narcotic drugs and psychotropic substances included in List II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (hereinafter referred to as the List), registered as medicinal products , for the purpose of use for the treatment of drug addiction;
(Paragraph as amended, put into effect on January 20, 2018 by order of the Ministry of Health of Russia dated October 31, 2017 N 882n.
___________________
Collection of Legislation of the Russian Federation, 1998, No. 27, Art. 3198; 2004, N 8, art. 663, N 47, art. 4666; 2006, N 29, art. 3253; 2007, N 28, art. 3439; 2009, N 26, art. 3183, N 52, art. 6572; 2010, N 3, Art. 314, N 17, Art. 2100, N 24, Art. 3035, N 28, Art. 3703, N 31, Art. 4271, N 45, Art. 5864, N 50, Art. 6696 , art. 6720; 2011, N 10, Art. 1390, N 12, Art. 1635, N 29, Art. 4466, Art. 4473, N 42, Art. 5921, N 51, Art. 7534; 2012, N 10, Art. 1232, N 11, Art. 1295, N 19, Art. 2400, N 22, Art. 2864, N 37, Art. 5002, N 48, Art. 6686, N 49, Art. 6861 .

6.2. individual entrepreneurs carrying out medical activities for narcotic drugs and psychotropic substances included in lists II and III of the List (hereinafter referred to as narcotic and psychotropic drugs of lists II and III of the List).

7. Prescriptions for medications are written out on prescription forms according to forms N 148-1/u-88, N 148-1/u-04 (l), N 148-1/u-06 (l) and N 107-1/ 1*, approved by this order.
________________
*Probably an error in the original. It should read: “N 107-1/u”. — Note from the database manufacturer.

8. Narcotic and psychotropic drugs of List II of the List (hereinafter referred to as narcotic and psychotropic drugs of List II of the List), with the exception of drugs in the form of transdermal therapeutic systems, and drugs containing narcotic in combination with an opioid receptor antagonist are prescribed on a special prescription form in the form approved by Order of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules" (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration N 25190).
(Clause as amended, put into effect on August 21, 2015, by order of the Ministry of Health of Russia dated June 30, 2015 N 386n; as amended, put into effect on January 20, 2018 by order of the Ministry of Health of Russia dated October 31, 2017 N 882n.

9. Prescription form N 148-1/у-88 is intended for prescribing:

1) narcotic and psychotropic drugs of List II of the List in the form of transdermal therapeutic systems, narcotic drugs of List II of the List containing a narcotic drug in combination with an opioid receptor antagonist, psychotropic substances included in List III of the List, registered in the prescribed manner as drugs (hereinafter referred to as psychotropic drugs of list III of the List);
(Subparagraph as amended, put into effect on August 21, 2015, by order of the Ministry of Health of Russia dated June 30, 2015 N 386n; as amended, put into effect on January 20, 2018 by order of the Ministry of Health of Russia dated October 31, 2017 N 882n.

2) other medicinal products subject to subject-quantitative accounting (with the exception of over-the-counter medicinal products);

3) drugs with anabolic activity (in accordance with the main pharmacological action);
(Subparagraph as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

5) individually manufactured medicinal products containing a narcotic drug or psychotropic substance of List II of the List, and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combination medicinal product is not a narcotic or psychotropic medicinal product of schedule II of the List.

10. Prescription forms N 148-1/у-04 (l), N 148-1/у-06 (l) are intended for prescribing medications to citizens entitled to free receipt medications or receiving medications at a discount.

11. Prescription form form N 107-1/у is intended for prescribing:

other medications not specified in paragraphs 8-10 of this Procedure.

12. When writing a prescription for an individually manufactured medicinal product, the names of narcotic and psychotropic medicinal products of Lists II and III of the List, and other medicinal products subject to subject-quantitative accounting are written at the beginning of the prescription, then all other ingredients.

13. When writing a prescription, it is prohibited to exceed the maximum permissible quantity of a medicinal product for prescribing per prescription, installed by application No. 1 to this Procedure, except for the case specified in paragraphs 15 and 23 of this Procedure.
(Paragraph as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

It is not recommended to exceed the recommended amount of the drug for prescribing per prescription, established by Appendix No. 2 to this Procedure, except for the cases specified in paragraphs 15, 22 and 23 of this Procedure.
(Paragraph as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

14. When prescribing narcotic and psychotropic drugs of lists II and III of the List, other drugs subject to subject-quantitative recording, the dose of which exceeds the highest single dose, the medical worker writes the dose of this drug in words and puts an exclamation point.

15. The number of prescribed narcotic and psychotropic drugs of lists II and III of the List, other drugs subject to subject-quantitative recording,  when providing patients in need of long-term treatment, primary health care and palliative care may be increased by no more than 2 times compared to the maximum permissible number of medications for prescribing per prescription, established by Appendix No. 1 to this Procedure, or the recommended number of medications for prescribing per prescription, established by Appendix No. 2 to this Procedure.
(Paragraph as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

In the cases provided for in the first paragraph of this paragraph, the inscription “For special purposes” is written on the prescriptions, separately signed by the medical worker and the seal of the medical organization “For prescriptions”.
(Paragraph additionally included from August 21, 2015 by order of the Russian Ministry of Health dated June 30, 2015 N 386n)

16. Composition of the combined medicinal product, designation dosage form and an appeal from a medical worker to a pharmacist about the manufacture and dispensing of a medicinal product is written out in Latin.

The prescription abbreviations allowed for use are provided in Appendix No. 3 to this Procedure.

It is not allowed to abbreviate the ingredients that make up the medicinal product with similar names, which do not make it possible to determine which medicinal product is prescribed.

17. The method of use of the drug is indicated indicating the dose, frequency, time of administration relative to sleep (morning, at night) and its duration, and for drugs that interact with food, the time of their use relative to meals (before meals, during meals , after meal).

18. If it is necessary to immediately or urgently dispense a medicinal product to the patient, the designations “cito” (urgent) or “statim” (immediate) are placed at the top of the prescription.

19. When writing a prescription for a custom-made medicinal product, the amount of liquid pharmaceutical substances is indicated in milliliters, grams or drops, and for other pharmaceutical substances - in grams.

20. Prescriptions written out on prescription form Form N 148-1/у-88 are valid for 15 days from the date of prescription.
(Clause as amended, put into effect on January 1, 2016 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

21. Prescriptions for medications written out on prescription forms Form N 148-1/u-04 (l) and Form N 148-1/u-06 (l) are valid for 30 days from the date of prescription.

Prescriptions for medications written out on prescription forms Form N 148-1/u-04 (l) and Form N 148-1/u-06 (l), for citizens who have reached retirement age, disabled people of the first group, disabled children, as well as citizens suffering from chronic diseases requiring long-term course of treatment, are valid for 90 days from the date of issue.
(Paragraph as amended, put into effect on July 30, 2016 by order of the Ministry of Health of Russia dated April 21, 2016 N 254n.

For the treatment of chronic diseases, the specified categories of citizens can be issued prescriptions for medications for a course of treatment of up to 90 days.
(Paragraph as amended, put into effect on January 1, 2016 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

22. Prescriptions for medications written out on prescription forms of form N 107-1/u are valid for 60 days from the date of prescription.
(Paragraph as amended, put into effect on January 1, 2016 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

When a medical professional prescribes prescriptions for finished medicinal products and individually manufactured medicinal products for patients with chronic diseases on prescription forms of form N 107-1/u, it is allowed to set the validity period of the prescription within up to one year and exceed the recommended amount of the medicinal product for prescribing per prescription, established by Appendix No. 2 to this Procedure.

When writing such prescriptions, the medical worker makes a note “For a patient with a chronic disease”, indicates the validity period of the prescription and the frequency of dispensing medications from a pharmacy organization or an individual entrepreneur licensed to pharmaceutical activities(weekly, monthly and other periods), certifies this instruction with his signature and personal seal, as well as the seal of the medical organization “For prescriptions”.

23. Prescriptions for barbituric acid derivatives, combination drugs containing codeine (its salts), other combination drugs subject to subject-quantitative accounting, drugs with anabolic activity in accordance with the main pharmacological action, for the treatment of patients with chronic diseases may be discharged for a course of treatment up to 60 days.
(Paragraph as amended, put into effect on January 1, 2016 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

In these cases, the prescriptions are marked “For special purposes”, separately signed by the medical worker and the seal of the medical organization “For prescriptions”.

II. Prescribing medications when providing medical care in inpatient settings

24. When providing medical care to a patient in a hospital setting, medications are prescribed by a medical worker alone, except for the cases specified in subparagraphs 1-2 of paragraph 25 of this Procedure, without issuing a prescription.

25. Coordination of the prescription of medications with the head of the department or the responsible doctor on duty or another person authorized by order of the chief physician of the medical organization, as well as, if available, with a clinical pharmacologist, is necessary in the following cases:
(Paragraph as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

1) simultaneous prescription of five or more drugs to one patient;

2) prescribing medications that are not included in the list of vital and essential medications in case of an atypical course of the disease, the presence of complications of the underlying disease and (or) concomitant diseases, when prescribing medications, the interaction and compatibility features of which, according to the instructions for their use, lead to a decrease in the effectiveness and safety of pharmacotherapy and (or) create a potential danger to the life and health of the patient.
____________________
Order of the Government of the Russian Federation of December 7, 2011 N 2199-r (Collection of Legislation of the Russian Federation, 2011, N 51, Art. 7544; 2012, N 32, Art. 4588).

In these cases, the prescription of medications is recorded in the patient’s medical documents and certified by the signature of the medical worker and the head of the department (responsible doctor on duty or other authorized person).

26. Medical worker of a medical organization located in a rural locality or a populated area located in remote and hard-to-reach areas, prescribes medications in the cases specified in paragraphs 25 and 27 of this Procedure, individually.
(Clause as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

27. By decision of the medical commission, when providing medical care in a hospital setting, patients are prescribed medications that are not included in the list of vital and essential medications, in case of their replacement due to individual intolerance, for health reasons.

The decision of the medical commission is recorded in the patient’s medical documents and the medical commission’s journal.

29. In some cases, by decision of the head of a medical organization, upon discharge from a medical organization of a patient who has appropriate medical indications and is sent to continue treatment on an outpatient basis, narcotic and psychotropic drugs of lists II and III of the List may be prescribed or issued simultaneously with an extract from the medical history , potent medications for the patient to take for up to 5 days.
(Clause as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

III. Prescribing and prescribing medications in primary health care, emergency care and palliative care

30. When providing primary health care and palliative care in an outpatient setting, the prescription and prescription of medications is carried out by a medical professional in cases of the typical course of the patient’s disease based on the severity and nature of the disease.

31. Prescribing and prescribing medications by decision of the medical commission when providing primary health care and palliative care in an outpatient setting is carried out in the following cases:

1) simultaneous prescription of five or more medications to one patient within one day or more than ten items within one month;

2) prescribing medications for an atypical course of the disease, the presence of complications of the underlying disease and (or) concomitant diseases, when prescribing medications, the interaction and compatibility features of which, according to the instructions for their use, lead to a decrease in the effectiveness and safety of pharmacotherapy and (or) create a potential danger for the life and health of the patient;

3) the initial prescription of narcotic and psychotropic medications to the patient on lists II and III of the List (if the head of the medical organization decides on the need to coordinate the prescription of such medications with a medical commission).
(Subparagraph as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

32. The prescription and prescription of narcotic and psychotropic drugs of lists II and III of the List is carried out to patients with severe pain syndrome of any origin, as well as to patients with sleep disorders, convulsive conditions, anxiety disorders, phobias, psychomotor agitation independently by a medical worker or by a medical worker by decision of a doctor commission (if the head of a medical organization decides on the need to coordinate the primary prescription of such medications with a medical commission).
(Clause as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

33. When providing emergency medical care, medications are prescribed by a medical professional visiting team ambulance, medical worker of a medical organization when providing medical care to citizens in case of diseases, accidents, injuries, poisoning and other conditions requiring urgent medical intervention.

IV. Prescribing and prescribing medications to citizens entitled to receive medications free of charge or to receive medications at a discount as part of the provision of primary health care to them

34. Prescription and prescription of medicines to citizens entitled to receive medicines free of charge or to receive medicines at a discount when providing them with primary health care is carried out by a medical worker in cases of the typical course of the patient’s disease based on the severity and nature of the disease as approved in the established in accordance with medical care standards, including:

2) citizens suffering malignant neoplasms lymphoid, hematopoietic and related tissues, hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, multiple sclerosis, as well as citizens after organ and (or) tissue transplantation, in accordance with the list of drugs centrally purchased at the expense of the federal budget, approved by the Government of the Russian Federation;

4) citizens suffering from life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens and their disability.
(The subparagraph was additionally included on August 21, 2015 by order of the Russian Ministry of Health dated June 30, 2015 N 386n)
________________
Decree of the Government of the Russian Federation of April 26, 2012 N 403 “On the procedure for maintaining the Federal Register of persons suffering from life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens and their disability, and its regional segment” (Collected Legislation of the Russian Federation , 2012, N 19, Art. 2428; N 37, Art. 5002).
(Footnote additionally included from August 21, 2015 by order of the Russian Ministry of Health dated June 30, 2015 N 386n)

35. The right to write prescriptions for medicines to citizens who have the right to receive medicines free of charge or to receive medicines at a discount also have:

1) medical workers working part-time in a medical organization (within their competence);

2) medical workers inpatient institutions social services And correctional institutions(regardless of departmental affiliation);

3) medical workers of medical organizations providing medical care in inpatient settings, in the case provided for in paragraph 29 of this Procedure;

4) medical workers of medical organizations providing primary health care, subordinate to federal executive authorities or executive authorities of constituent entities of the Russian Federation:

a) citizens, expenses for free drug provision which, in accordance with the legislation of the Russian Federation, are covered from the federal budget;

b) other categories of citizens whose costs for free drug provision, in accordance with the legislation of the Russian Federation, are covered by funds from budgets of various levels and compulsory medical insurance;

5) individual entrepreneurs, engaged in private medical practice and included in the register of medical organizations operating in the field of compulsory health insurance.

36. It is not permitted for medical workers to write prescriptions for medications for the treatment of citizens entitled to receive medications free of charge or to receive medications at a discount. health resort organizations, medical workers of medical organizations providing medical care inpatiently or in day hospital, except for the case provided for in paragraph 29 of this Procedure.

37. When writing prescriptions for medications for the treatment of citizens who have the right to receive medications free of charge or to receive medications at a discount, a telephone number is indicated by which an employee of a pharmacy organization, if necessary, can agree with a medical worker on a synonymous replacement of the drug.

38. On the prescription form of form N 148-1/у-04 (l) and form N 148-1/у-06 (l), the prescription is written by a medical professional in two copies, with one copy of which the patient applies to the pharmacy. A second copy of the prescription is attached to the patient’s medical record.
(Clause as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n.

39. Narcotic and psychotropic drugs of List II of the List (with the exception of drugs in the form of transdermal therapeutic systems, as well as drugs containing a narcotic drug in combination with an opioid receptor antagonist) for the treatment of citizens entitled to receive free drugs or receive drugs drugs at a discount, are prescribed on a special prescription form for narcotic drugs and psychotropic substances, for which prescriptions are additionally issued in duplicate on the prescription form Form N 148-1/у-04 (l) or Form N 148-1/у-06 ( l).

40. Narcotic and psychotropic drugs of List II of the List in the form of transdermal therapeutic systems, narcotic drugs of List II of the List containing a narcotic drug in combination with an opioid receptor antagonist, psychotropic drugs of List III of the List, other drugs subject to subject-quantitative accounting, medicines with anabolic activity, combination medicines specified in subparagraph 4 of clause 9 of this procedure, intended for the treatment of citizens entitled to receive medicines free of charge or to receive medicines at a discount, are prescribed on prescription form N 148-1/u- 88, to which prescriptions are additionally written in two copies on the prescription form Form N 148-1/у-04 (l) or Form N 148-1/у-06 (l).
(Clause as amended, put into effect on August 21, 2015 by order of the Ministry of Health of Russia dated June 30, 2015 N 386n; as amended by order of the Ministry of Health of Russia dated April 21, 2016 N 254n; as amended by effective from January 20, 2018 by order of the Russian Ministry of Health dated October 31, 2017 N 882n.

Appendix No. 1. Maximum permissible quantity of certain narcotic and psychotropic drugs for prescribing per prescription

Maximum permissible quantity of individual narcotic and psychotropic drugs for prescribing per prescription

Order of the Ministry of Health of the Russian Federation dated June 26, 2018 No. 386n

Ministry of Health

Russian Federation

(Ministry of Health of Russia)

Order

On amendments to the Procedure for determining the initial (maximum) price of a contract, the price of a contract concluded with a single supplier (contractor, performer), when purchasing medicines for medical use, approved by order of the Ministry of Health of the Russian Federation dated October 26, 2017 No. 871n

APPROVED
by order of the Ministry of Health
Russian Federation
dated June 26, 2018 No. 386n

Changes made to the Procedure
determining the initial (maximum) contract price, the contract price concluded with a single supplier (contractor, performer), when purchasing medicines for medical use, approved by order of the Ministry of Health of the Russian Federation dated October 26, 2017 N 871n

2. Add paragraph 21 with the following content:

"21. When calculating NMCC, wholesale markups, the amount of which should not exceed size limits wholesale markups established by the executive authorities of the constituent entities of the Russian Federation (Article 63 of the Federal Law of April 12, 2010 N 61-FZ “On circulation medicines"(Collected Legislation of the Russian Federation, 2010, No. 16, Art. 1815; 2015, No. 29, Art. 4367) are used when purchasing medicines that are included in the list of vital and essential medicines (except for cases of purchasing from drug manufacturer):

a) to meet federal needs, if the NMCC does not exceed ten million rubles, and also if the NMCC exceeds ten million rubles, provided that the price of a unit of a medicinal product planned for purchase does not exceed the price of such a medicinal product contained in the state register of maximum selling prices of manufacturers for medicinal products drugs included in the list of vital and essential drugs;

a) replace the word “calculation” with the word “calculation4.1”;

“Until July 1, 2019, data from concluded contracts excluding VAT are taken into account when calculating the price per unit of a medicinal product; after this date, data from executed contracts excluding VAT and wholesale markup are taken into account.”

5. Clause 5 should be stated as follows:

Ministry of Health of Russia Order of June 26, 2018 N 386n

ABOUT MAKING CHANGES

IN THE ORDER OF DETERMINING THE INITIAL (MAXIMUM) PRICE

CONTRACT, PRICE OF THE CONTRACT CONCLUDED WITH THE ONLY

BY THE SUPPLIER (CONTRACTOR, PERFORMER), WHEN IMPLEMENTING

PROCUREMENT OF MEDICINAL DRUGS FOR MEDICAL

APPLICATIONS APPROVED BY ORDER OF THE MINISTRY

HEALTH CARE OF THE RUSSIAN FEDERATION

Approve the attached changes that are made to the Procedure for determining the initial (maximum) price of a contract, the price of a contract concluded with a single supplier (contractor, performer) when purchasing medicines for medical use, approved by order of the Ministry of Health of the Russian Federation dated October 26, 2017. N 871н (registered by the Ministry of Justice of the Russian Federation on November 27, 2017, registration N 49016).

by order of the Ministry of Health

CHANGES,

WHICH ARE INTRODUCED IN THE ORDER OF DETERMINING THE INITIAL

(MAXIMUM) PRICE OF THE CONTRACT, PRICE OF THE CONTRACT CONCLUDED

WITH A SINGLE SUPPLIER (CONTRACTOR, PERFORMER),

WHEN PURCHASING MEDICINES

FOR MEDICAL USE, APPROVED BY ORDER

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

1. In paragraph 2, the footnote is declared invalid.

2. Add clause 2.1 with the following content:

"2.1. When calculating the NMCC, wholesale markups, the amount of which should not exceed the maximum amounts of wholesale markups established by the executive authorities of the constituent entities of the Russian Federation (Article 63 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collection of Legislation of the Russian Federation, 2010, No. 16, Art. 1815; 2015, No. 29, Art. 4367), are used when purchasing medicines that are included in the list of vital and essential medicines (except for cases of purchase from the manufacturer of medicines):

b) to meet the needs of a constituent entity of the Russian Federation, municipal needs, if the NMCC does not exceed the size established by the highest executive body state power of a constituent entity of the Russian Federation and amounts to no more than ten million rubles, and also if the NMCC exceeds the amount established by the highest executive body of state power of a constituent entity of the Russian Federation or exceeds ten million rubles, provided that the price of a unit of the medicinal product planned for purchase does not exceed the price of such a medicinal product, contained in the state register of maximum selling prices of manufacturers for medicines included in the list of vital and essential medicines.”

a) in subparagraph “b”, replace the word “prisoners” with the word “executed”;

4. In paragraph four of paragraph 4:

a) replace the word “calculation” with the word “calculation 4.1”;

b) add a footnote with the following content:

“Until July 1, 2019, data from concluded contracts excluding VAT are taken into account when calculating the price per unit of a medicinal product; after this date, data from executed contracts excluding VAT and wholesale markup are taken into account.”

"5. For the price of a unit of a medicinal product planned for purchase, the customer accepts the minimum price value from the prices calculated by him while simultaneously using the methods provided for in paragraph 3 of this Procedure.”

6. In paragraph 9, the words “maximum price provided” should be replaced with the words “price is not higher than the maximum price provided.”

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MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ABOUT MAKING CHANGES
IN THE ORDER OF DETERMINING THE INITIAL (MAXIMUM) PRICE
CONTRACT, PRICE OF THE CONTRACT CONCLUDED WITH THE ONLY
BY THE SUPPLIER (CONTRACTOR, PERFORMER), WHEN IMPLEMENTING
PROCUREMENT OF MEDICINAL DRUGS FOR MEDICAL
APPLICATIONS APPROVED BY ORDER OF THE MINISTRY
HEALTH CARE OF THE RUSSIAN FEDERATION
DATED OCTOBER 26, 2017 N 871N

I order:

Approve the attached changes that are made to the Procedure for determining the initial (maximum) price of a contract, the price of a contract concluded with a single supplier (contractor, performer) when purchasing medicines for medical use, approved by order of the Ministry of Health of the Russian Federation dated October 26, 2017. N 871н (registered by the Ministry of Justice of the Russian Federation on November 27, 2017, registration N 49016).

Minister
V.I.SKVORTSOVA

Approved
by order of the Ministry of Health
Russian Federation
dated June 26, 2018 N 386n

CHANGES,
WHICH ARE INTRODUCED IN THE ORDER OF DETERMINING THE INITIAL
(MAXIMUM) PRICE OF THE CONTRACT, PRICE OF THE CONTRACT CONCLUDED
WITH A SINGLE SUPPLIER (CONTRACTOR, PERFORMER),
WHEN PURCHASING MEDICINES
FOR MEDICAL USE, APPROVED BY ORDER
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
DATED OCTOBER 26, 2017 N 871N

1. In paragraph 2, the footnote is declared invalid.

2. Add clause 2.1 with the following content:

"2.1. When calculating the NMCC, wholesale markups, the amount of which should not exceed the maximum amounts of wholesale markups established by the executive authorities of the constituent entities of the Russian Federation (Article 63 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collected Legislation Russian Federation, 2010, N 16, Art. 1815; 2015, N 29, Art. 4367), are used when purchasing medicines that are included in the list of vital and essential medicines (except for cases of purchase from the manufacturer of medicines) :

a) to meet federal needs, if the NMCC does not exceed ten million rubles, and also if the NMCC exceeds ten million rubles, provided that the price of a unit of a medicinal product planned for purchase does not exceed the price of such a medicinal product contained in the state register of maximum selling prices of manufacturers for medicinal products drugs included in the list of vital and essential drugs;

b) to meet the needs of a constituent entity of the Russian Federation, municipal needs, if the NMCC does not exceed the amount established by the highest executive body of state power of the constituent entity of the Russian Federation and is no more than ten million rubles, and also if the NMCC exceeds that established by the supreme executive body of state power of the constituent entity of the Russian Federation size or more than ten million rubles, provided that the price of a unit of a medicinal product planned for purchase does not exceed the price of such a medicinal product contained in the state register of maximum selling prices of manufacturers for medicinal products included in the list of vital and essential medicinal products."

3. In paragraph 3:

a) in subparagraph "b" the word "prisoners" is replaced with the word "executed";

4. In paragraph four of paragraph 4:

a) replace the word “calculation” with the word “calculation”;

b) add a footnote with the following content:

"Until July 1, 2019, data from concluded contracts excluding VAT are taken into account when calculating the price per unit of a medicinal product; after this date, data from executed contracts excluding VAT and wholesale markup are taken into account."

5. Clause 5 should be stated as follows:

"5. For the price of a unit of a medicinal product planned for purchase, the customer accepts the minimum price value from the prices calculated by him while simultaneously using the methods provided for in paragraph 3 of this Procedure."

6. In paragraph 9, the words “the maximum price provided” should be replaced with the words “the price is not higher than the maximum price provided.”



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