Order of the Ministry of Health of the Russian Federation 805 minimum assortment. On approval of the minimum range of medicinal products for medical use required for the provision of medical care

In accordance with Article 55 of the Federal Law of April 12, 2010 N 61-FZ "On Circulation medicines"(Collection of legislation Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161) I order:

1. Approve the minimum assortment drugs for medical userequired to provide medical care, according to the application.

2. To recognize as invalid the Order of the Ministry of Health and Social Development of the Russian Federation of April 29, 2005 N 312 "On the minimum range of medicines" (registered by the Ministry of Justice of the Russian Federation on May 20, 2005 N 6606).

The minister
T.A. GOLIKOVA

application
to the Order
Ministry of Health
and social development
Russian Federation
dated September 15, 2010 N 805n

<*> Medicines for medical use, sold without a doctor's prescription and included in the minimum range of pharmacy kiosks and pharmacy points.

Order of the Ministry of the Russian Federation of September 15, 2010 N 805n

With changes and additions from:

Information about changes:

3. The Federal Service for Supervision in the Sphere of Healthcare and Social Development and its territorial bodies for the constituent entities of the Russian Federation ensure control over the execution of the order.

Registration N 18612

Since September 1, 2010, a new Law on Medicines is in force. They, in particular, are assigned the duty of pharmaceutical organizations and individual entrepreneurs licensed for pharmaceutical activities to provide the minimum range of drugs necessary for the provision of medical care.

Compared to the previously valid minimum list of drugs for pharmacies, this list is greatly reduced. So, it does not include narcotic analgesics and analgesics of mixed action, as well as drugs for the treatment of heart failure from the previous list. Of the vitamins and minerals, for example, only vitamin C, and from antiarrhythmic drugs - only the drug verapamil.

In addition, over-the-counter medications have been identified. They should be included in the minimum assortment of medicines in pharmacy kiosks and points.

Order of the Ministry of Health and Social Development of the Russian Federation of September 15, 2010 N 805n "On approval of the minimum range of drugs for medical use necessary for the provision of medical care"

Registration N 18612

This order comes into force 10 days after the day of its official publication

By order of the Ministry of Health of Russia and the Ministry of Labor of Russia dated July 8, 2015 N 427n / 443n, this order was declared invalid

This document is amended by the following documents:

The changes come into force 10 days after the day of the official publication of the said order

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On inspections of the minimum assortment of medicinal products in organizations and individual entrepreneurs licensed for pharmaceutical activities

By virtue of Part 6 of Article 55 of the Federal Law "On the Circulation of Medicines", organizations and individual entrepreneurs licensed for pharmaceutical activities are required to ensure that their pharmacies have a minimum range of medicines for medical use necessary for the provision of medical care.

On October 24, 2010, the Order of the Ministry of Health and Social Development of the Russian Federation of September 15, 2010 No. 805n came into force, which approved a new minimum range of drugs for medical use required for the provision of medical care (hereinafter - the Minimum Range). The named order, which significantly reduced the list of drugs that pharmacies must have in stock, was adopted taking into account the listed shortcomings and contains only drugs used in outpatient practice and included in treatment standards.

When conducting inspections of the provision of a minimum range of medicines by pharmacies, the regulatory authorities do not accept a reference to clause 2.12. The procedure for dispensing medicines approved by Order of the Ministry of Health and Social Development dated December 14, 2005 No. 785, in accordance with which prescriptions for medicines included in the minimum range of medicines are served within a period not exceeding five working days from the moment the patient contacts a pharmacy. This norm sets only the maximum period for the dispensing of medicines and does not relieve the organization either from the obligation to have such medicines available, or from liability for violation of this obligation.

A similar legal position is set out in the definition of the Supreme Arbitration Court of the Russian Federation dated May 18, 2009 No. 6315/09.

The minimum range of drugs in the pharmacy (Valova S.R.)

Date the article was posted: 17.04.2015

In accordance with paragraph 6 of Art. 55 of the Federal Law of 12.04.2010 N 61-FZ "On the Circulation of Medicines" pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities are obliged to provide the minimum range of medicines required for the provision of medical care approved by the Government of the Russian Federation and formed in accordance with the established procedure ... The article will focus on compliance with this rule by pharmacies.
By Order of the Government of the Russian Federation of December 30, 2014 N 2782-r, the following were approved:
- List of vital and essential medicines for medical use for 2015;
- The list of medicinal products for medical use, including medicinal products for medical use, prescribed by decision of the medical commissions of medical organizations;
- The list of medicinal products intended to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after organ and (or) tissue transplantation;
- The minimum range of drugs required for the provision of medical care.
All listed Lists are applied from March 1, 2015.

Thus, the Minimum Assortment of Medicines Required for the Provision of Medical Care, currently approved by Order of the Ministry of Health and Social Development of Russia dated September 15, 2010 N 805n, will expire from that date.
Note that, as before, the new list of the Minimum Range of Medicines Required for the Provision of Medical Care is divided into two sections:
- sect. I - for pharmacies (ready-made dosage forms, production, production with the right to manufacture aseptic drugs);
- sect. II - for pharmacy points, pharmacy kiosks and individual entrepreneurs licensed for pharmaceutical activities.
Let us recall that the absence of medicines, which are included in the list of the mandatory Minimum Range of Medicines required for the provision of medical care, is a gross violation of licensed activities, for which Art. 14.1 of the Administrative Code of the Russian Federation established administrative responsibility.

For reference. Carrying out entrepreneurial activities in gross violation of the conditions provided for by a special permit (license) shall entail the imposition of an administrative fine:
- for persons engaged in entrepreneurial activities without forming a legal entity - in the amount of 4000 to 5000 rubles. (or administrative suspension of activities for up to 90 days);
- for officials - from 4000 to 5000 rubles;
- for legal entities - from 40,000 to 50,000 rubles. (or administrative suspension of activities for up to 90 days).

According to the footnote to Art. 14.1 of the Administrative Code of the Russian Federation, the concept of gross violation is established by the Government of the Russian Federation in relation to a specific licensed type of activity. Decree of the Government of the Russian Federation of December 22, 2011 N 1081 approved the Regulation on the licensing of pharmaceutical activities (hereinafter - Regulation N 1081), carried out by legal entities, including pharmacy organizations.

Subparagraph "d" of clause 5 of Regulation N 1081, the failure of a pharmacy organization to provide a minimum range of medicines necessary for the provision of medical care is attributed to gross violations of licensing requirements and conditions. For this violation, the pharmacy will be brought to administrative responsibility. As an example of such involvement, consider the Resolution of the CA SZO of 09/29/2014 in case N A56-8450 / 2014. It, in particular, notes that at the time of the check, the pharmacy was not provided with the minimum range of medicines required for the provision of medical care established by Order of the Ministry of Health and Social Development of Russia N 805n, namely, there were no medicines, which, among other things, contained the following medicines:
- algeldrat + magnesium hydroxide (tablets, oral suspension);
- acetylcysteine \u200b\u200b(granules for preparation of oral solution);
- bisacodyl (rectal suppositories, tablets);
- loratadine (oral syrup);
- levomenthol solution in menthil isovalerate (tablets);
- peppermint oil + phenobarbital + ethyl bromisovalerinate (drops for oral administration);
- sennoside A + B (tablets);
- tetracycline (eye ointment).
In accordance with Part 2 of Art. 2.1 of the Administrative Code of the Russian Federation, a legal entity is found guilty of committing an administrative offense if it is established that:
- he had the opportunity to comply with the rules and regulations, for violation of which the Code of Administrative Offenses of the Russian Federation or the laws of a constituent entity of the Russian Federation provides for administrative liability,
- this person has not taken all measures in his control to comply with them.
Since the very fact of the absence at the time of the check in the pharmacy of medicines included in the minimum list of medicines necessary for the provision of medical care was confirmed in court and was not refuted by the audited organization, the court concluded that there was an administrative offense in the actions of the pharmacy organization under Part 4 Art. 14.1 of the Administrative Code of the Russian Federation.
Similar decisions were made earlier in the Resolutions of the FAS VSO of February 15, 2011 in case N A33-8013 / 2010, FAS ZSO of 24.01.2011 in case N A03-9869 / 2010, FAS ZSO of 19.10.2010 in case N A02-1935 / 2009.
We would like to draw the attention of readers that the possibility of recognizing the absence of medicines included in the Minimum Range of Medicines Needed for the Provision of Medical Care as a minor violation was not confirmed by a higher court. Thus, the issue of liability for violation of the rules on the named Minimum Range was touched upon in the Ruling of the Supreme Arbitration Court of the Russian Federation of February 24, 2011 N BAC-1599/11. During the inspection of the organization, it was found that the pharmacy does not have drugs included in the Minimum Range of Medicines Necessary for the Provision of Medical Care: arbidol (tablets), acyclovir (tablets, lyophilisate for preparing a solution for infusion), rimantadine (tablets). The pharmacy admitted the revealed violation and asked to mitigate the punishment regarding the penalties, but the higher court refused the pharmacy organization to satisfy its request to recognize this offense as insignificant.
At the same time in jurisprudence there are decisions when the violation was considered insignificant. In the Decree of the Federal Antimonopoly Service of the UO of 10.06.2010 N F09-4409 / 10-C1, the court recognized the violation as insignificant, since the drugs were partially absent due to their absence from wholesale suppliers. Some of the drugs were prescription drugs, were in the company's warehouse and could be provided by prescription on time. Similar decisions were made in the Resolutions of the Federal Antimonopoly Service of the UO of 21.04.2010 N Ф09-1793 / 10-С1, of 25.05.2010 N Ф09-3923 / 10-С1.

Let's summarize the main conclusions:
1.From March 1, 2015, the list of the Minimum Range of Medicines Required for the Provision of Medical Care, approved by the Order of the Government of the Russian Federation of December 30, 2014 N 2782-r, has been applied.
2. The absence of medicines included in this list is a gross violation of licensing requirements and conditions, for which administrative liability is provided under Part 4 of Art. 14.1 Administrative Code of the Russian Federation.
3. In the event of a dispute between the control body and the pharmacy, it cannot be guaranteed that the organization will win the case by applying to the arbitration court to cancel the penalties established by Part 4 of Art. 14.1 of the Administrative Code of the Russian Federation. The arbitrators make decisions based on the specific situation.
4. Regarding the recognition of the violation as insignificant, the court should submit as evidence a correspondence with the supplier about the lack of necessary drugs at the time of the appeal. In case of official confirmation of non-delivery of the necessary drugs by different suppliers, the specified document will be the justification for the absence of the fault of the pharmacy organization.

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Order of the Ministry of Health "On approval of the minimum range of drugs for medical use, necessary for the provision of medical care"

Order of the Ministry of Health and Social Development of the Russian Federation (Ministry of Health and Social Development of Russia) of September 15, 2010 N 805n Moscow
"On approval of the minimum range of medicinal products for medical use required for the provision of medical care"
Date of official publication: October 13, 2010
Published: October 13, 2010 in "RG" - Federal issue No. 5310
Effective: October 24, 2010
Registered with the Ministry of Justice of the Russian Federation on October 4, 2010 Registration N 18612

In accordance with article 55 of the Federal Law of April 12, 2010 N 61-FZ "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161) I order:

1. To approve the minimum range of medicinal products for medical use required for the provision of medical care, according to the annex.

2. To recognize as invalid the order of the Ministry of Health and Social Development of the Russian Federation of April 29, 2005 N 312 "On the minimum range of medicines" (registered by the Ministry of Justice of the Russian Federation on May 20, 2005 N 6606).

On approval of the minimum range of medicinal products for medical use

MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT
RUSSIAN FEDERATION

About making changes

to the Order of the Ministry of Health and Social Development of the Russian Federation dated September 15, 2010 No. 805N "On approval of the minimum range of drugs for medical use necessary for the provision of medical care"

I order:

To amend the Order of the Ministry of Health and Social Development of the Russian Federation dated September 15, 2010 No. 805n "On approval of the minimum range of drugs for medical use necessary for the provision of medical care" (registered by the Ministry of Justice of the Russian Federation on October 4, 2010, No. 18612 ) according to the Appendix.

application
to the Order of the Ministry
health and social development
Russian Federation
dated 26.04.2011 No.351n

CHANGES,
SUBMITTED TO THE ORDER OF THE MINISTRY OF HEALTH
AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION
OF SEPTEMBER 15, 2010 № 805N "ON THE APPROVAL OF THE MINIMUM
ASSORTMENT OF MEDICINAL PRODUCTS FOR MEDICAL
APPLICATIONS REQUIRED FOR PROVIDING MEDICAL CARE "

1. Supplement the Order with clause 3 as follows:
"The Federal Service for Supervision in the Sphere of Healthcare and Social Development and its territorial bodies in the constituent entities of the Russian Federation ensure control over the execution of the Order."
2. The appendix to the Order shall be stated as follows:

application
to the Order of the Ministry
health and social development
Russian Federation
dated September 15, 2010 No.805n

MINIMUM RANGE OF MEDICINAL PREPARATIONS FOR MEDICAL APPLICATIONS REQUIRED FOR PROVIDING MEDICAL CARE

I. For pharmacies: finished dosage forms, production, production with the right to manufacture
aseptic drugs.

Algeldrat + Magnesium tablets;

Amoxicillin capsules or tablets;
suspension powder
for oral administration

Acetylsalicylic tablets
acid
or powder for oral solution

Acyclovir cream for external use
pills

Beclomethasone inhalation aerosol

Betaxolol eye drops

Bisacodyl rectal suppositories;
pills

Hydrocortisone cream for external use
or topical ointment

Dexamethasone eye drops

Diclofenac gel for external use
or cream for external use
or an ointment for external use;
eye drops;
pills;
rectal suppositories

Doxycycline capsules
or pills

Zanamivir powder for inhalation metered dose

Ibuprofen capsules or tablets;
oral suspension

Isosorbide mononitrate capsules or tablets

Isosorbide dinitrate tablets

Clotrimazole cream or ointment for external use;
vaginal pills

Co-trimoxazole oral suspension;
pills

Loratadine syrup for oral administration;
pills

Levomenthol tablet solution
in mentil isovalerate

Methylphenylthiomethyl - capsules or tablets
dimethylaminomethyl-
hydroxybromindole
carboxylic acid
ethyl ether

Phenobarbital +
Ethyl bromisovalerinate

Nitrogolycerin spray sublingual metered dose;
pills

Omeprazole capsules or tablets

Oseltamivir powder for oral suspension

Paracetamol oral suspension;
rectal suppositories;
pills

Pilocarpine eye drops

Salbutamol inhalation aerosol
or solution for inhalation

Sennoside A + B tablets

Spironolactone capsules or tablets

Tetracycline eye ointment

Timolol eye drops

Ciprofloxacin eye drops;
ear drops
or eye and ear drops;
pills

II. For pharmacies, pharmacy kiosks and individual entrepreneurs licensed for pharmaceutical activities.

Activated charcoal capsules or tablets

Algeldrat + Magnesium tablets;
hydroxide oral suspension

Ascorbic acid dragees or tablets

Acetylsalicylic acid tablets

Acetylcysteine \u200b\u200bgranules for oral solution
or powder for oral solution

Bisacodyl rectal suppositories; pills

Brilliant green solution for external use alcohol

Hydrocortisone topical cream or topical ointment

Diclofenac gel for external use or cream for external use
or an ointment for external use; rectal suppositories;
pills; eye drops

Ibuprofen capsules or tablets; oral suspension

Iodine + [Potassium iodide + Ethanol] solution for external use alcohol

Clotrimazole cream or ointment for external use; vaginal pills

Loperamide capsules or tablets

Loratadine syrup for oral administration; pills

Levomenthol tablet solution
in mentil isovalerate

Peppermint oil + drops for oral administration
Phenobarbital +
Ethyl bromisovalerinate

Nitroglycerin spray sublingual metered

Pancreatin capsules or tablets

Paracetamol oral suspension; rectal suppositories; pills

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MINISTRY OF LABOR AND SOCIAL PROTECTION OF THE RUSSIAN FEDERATION

I order:

1. To include in Appendix No. 2 to the order of the Ministry of Health and Social Development of the Russian Federation of December 17, 2010 No. 1122n "On the approval of standard standards for the free issuance of flushing and (or) detoxifying agents and the occupational safety standard" Provision of workers with flushing and (or ) neutralizing agents "(registered by the Ministry of Justice of the Russian Federation on April 22, 2011, registration N 20562) as amended by orders of the Ministry of Labor and Social Protection of the Russian Federation of February 7, 2013 N 48n (registered by the Ministry of Justice of the Russian Federation on March 15, 2013 ., registration N 27700), dated February 20, 2014 N 103n (registered by the Ministry of Justice of the Russian Federation on May 15, 2014, registration N 32284), the following changes:

a) Clause 9 shall be stated as follows:

"9. The norms for the issuance of flushing and (or) neutralizing agents, corresponding to the working conditions at the employee's workplace, are specified in the employee's employment contract or in the employer's local regulatory act, communicated to the employee in writing or electronically in a manner that allows the employee to confirm that the employee is familiar with the specified norms. ";

b) the third paragraph of clause 24 after the words "Issuance of washing and (or) neutralizing agents" to the workers shall be supplemented with the words "except for the agents specified in clause 7 of the Model Norms,".

2. This order comes into force six months after its official publication.

Minister
M.A.Topilin

Registered
at the Ministry of Justice
Russian Federation
December 7, 2017
registration N 49173



Electronic text of the document
prepared by Kodeks JSC and verified by:
Official Internet Portal
legal information
www.pravo.gov.ru, 11.12.2017,
N 0001201712110018

On amendments to Appendix No. 2 to the order of the Ministry of Health and Social Development of the Russian Federation of December 17, 2010 No. 1122n "On Approval of Standard Norms of Free Issuance of Washing and (or) Neutralizing Products to Employees and Labor Safety Standard" ) neutralizing agents "

MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION

ORDER

On approval of the minimum range of medicinal products for medical use required for the provision of medical care

Document with changes made:
by order of the Ministry of Health and Social Development of Russia dated April 26, 2011 N 351n ( Russian newspaper, N 177, 12.08.2011).
____________________________________________________________________

In accordance with Article 55 of the Federal Law of April 12, 2010 N 61-FZ "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2010, N 16, Article 1815; N 31, Article 4161)

i order:

1. Approve the minimum range of medicinal products for medical use required for the provision of medical care, according to the annex.
2. To recognize as invalid the order of the Ministry of Health and Social Development of the Russian Federation of April 29, 2005 N 312 "On the minimum range of medicines" (registered by the Ministry of Justice of the Russian Federation on May 20, 2005 N 6606).
3. The Federal Service for Surveillance in Healthcare and Social Development and its territorial bodies in the constituent entities of the Russian Federation ensure control over the execution of the order (the item was additionally included from August 23, 2011 by order of the Ministry of Health and Social Development of Russia dated April 26, 2011 N 351n).

Minister
T. Golikova

Registered
at the Ministry of Justice
Russian Federation
October 4, 2010
registration N 18612

Application. The minimum range of medicinal products for medical use required for the provision of medical care

application
to order
Ministry of Health
and social development
Russian Federation
dated September 15, 2010 N 805n
(as amended on August 23, 2011
by order of the Ministry of Health and Social Development of Russia
from April 26, 2011 N 351n)

The minimum range of medicinal products for medical use required for the provision of medical care

I. For pharmacies: finished dosage forms, production, production with the right to manufacture aseptic drugs

II. For pharmacies, pharmacy kiosks and individual entrepreneurs licensed for pharmaceutical activities

MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION

ORDER

On approval of the minimum range of medicinal products for medical use required for the provision of medical care

(modified as of April 26, 2011)

Abolished from August 16, 2015 on the basis of
joint order of the Ministry of Health of Russia and the Ministry of Labor of Russia
dated July 8, 2015 N 427n / 443n
____________________________________________________________________

____________________________________________________________________
Document with changes made:
(Russian newspaper, N 177, 12.08.2011).
____________________________________________________________________

In accordance with Article 55 of the Federal Law of April 12, 2010 N 61-FZ "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2010, N 16, Article 1815; N 31, Article 4161)

i order:

1. To approve the minimum range of medicinal products for medical use required for the provision of medical care, according to the annex.

2. To declare invalid the order of the Ministry of Health and Social Development of the Russian Federation of April 29, 2005 N 312 "On the minimum range of medicines" (registered by the Ministry of Justice of the Russian Federation on May 20, 2005 N 6606).

3. The Federal Service for Surveillance in Healthcare and Social Development and its territorial bodies in the constituent entities of the Russian Federation ensure control over the execution of the order (the item has been additionally included from August 23, 2011 by order of the Ministry of Health and Social Development of Russia dated April 26, 2011 N 351n).

Minister
T. Golikova

Registered
at the Ministry of Justice
Russian Federation
October 4, 2010
registration N 18612

Application. The minimum range of medicinal products for medical use required for the provision of medical care

application
to order
Ministry of Health
and social development
Russian Federation
dated September 15, 2010 N 805n
(as amended on August 23, 2011
by order of the Ministry of Health and Social Development of Russia
dated April 26, 2011 N 351н, -
see previous edition)

The minimum range of medicinal products for medical use required for the provision of medical care

I. For pharmacies: finished dosage forms, production, production with the right to manufacture aseptic drugs

II. For pharmacies, pharmacy kiosks and individual entrepreneurs licensed for pharmaceutical activities

Document revision taking into account
changes and additions prepared
CJSC "Codex"