New rules for the destruction of substandard, falsified, counterfeit medicines. New rules for the destruction of drugs that are not subject to use Destruction of substandard drugs, counterfeit and co

On Approval of the Rules for the Destruction of Substandard Medicines, Counterfeit Medicines and Counterfeit Medicines

Decree of September 3, 2010 No. 674 On the approval of the Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines

In accordance with Articles 47 and 59 of the Federal Law "On the Circulation of Medicines", the Government of the Russian Federation decides:

Approve the attached Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines.

Prime Minister Russian Federation V.Putin

APPROVED

Government Decree

Russian Federation

REGULATIONS

destruction of substandard medicines, counterfeit medicines and counterfeit medicines

1. These Rules determine the procedure for the destruction of substandard medicines, falsified medicines and counterfeit medicines, with the exception of issues related to the destruction of narcotic medicines and their precursors, psychotropic medicines and radiopharmaceutical medicines.

2. Substandard medicines and (or) falsified medicines are subject to seizure and destruction by decision of the owner of the said medicines, decision of the Federal Service for Surveillance in Healthcare and social development or a court decision.

3. The Federal Service for Supervision in the Sphere of Health Care and Social Development, in the event of detection of facts of importation into the territory of the Russian Federation or facts of circulation in the territory of the Russian Federation of substandard medicines and (or) falsified medicines, makes a decision obliging the owner of these medicines to withdraw them, destruction and removal in full from the territory of the Russian Federation. The said decision must contain:

a) information about medicines;

b) grounds for seizure and destruction of medicines;

c) the term for the withdrawal and destruction of medicines;

d) information about the owner of medicines;

e) information about the manufacturer of medicines.

4. The owner of substandard medicines and (or) falsified medicines, within a period not exceeding 30 days from the date of the decision by the Federal Service for Surveillance in Health and Social Development to withdraw, destroy and export them, is obliged to execute this decision or report its disagree with him.

5. If the owner of poor-quality medicines and (or) falsified medicines does not agree with the decision to withdraw, destroy and export these medicines, and also if he did not comply with this decision and did not report on the measures taken, the Federal Supervision Service in health and social development goes to court.

6. Substandard medicines and counterfeit medicines that are under the customs regime of destruction are subject to destruction in the manner prescribed by the customs legislation.

7. Substandard medicines, counterfeit medicines and counterfeit medicines are subject to destruction on the basis of a court decision.

8. Destruction of substandard medicines, falsified medicines and counterfeit medicines is carried out by an organization licensed to collect, use, neutralize, transport and dispose of waste of I-IV hazard class (hereinafter referred to as the organization that destroys medicines), on a specially equipped sites, landfills and in specially equipped premises in compliance with the requirements for protection environment in accordance with the legislation of the Russian Federation.

9. Expenses associated with the destruction of substandard medicines, counterfeit medicines and counterfeit medicines shall be reimbursed by their owner.

10. The owner of poor-quality medicines and (or) counterfeit medicines, who has made a decision on their withdrawal, destruction and export, transfers the said medicines to the organization that destroys medicines, on the basis of the relevant agreement.

11. The organization that destroys medicines draws up an act on the destruction of medicines, which indicates:

a) date and place of destruction of medicines;

b) last name, first name, patronymic of the persons involved in the destruction of medicines, their place of work and position;

c) justification for the destruction of medicines;

d) information about destroyed medicines (name, dosage form, dosage, units of measure, series) and their quantity, as well as tare or packaging;

e) name of the drug manufacturer;

f) information about the owner of medicines;

g) method of destruction of medicines.

12. The act of destruction of medicines is drawn up on the day of destruction of substandard medicines and (or) counterfeit medicines. The number of copies of this act is determined by the number of parties involved in the destruction of these medicinal products, signed by all persons involved in the destruction of these medicinal products, and certified by the seal of the organization that destroys the medicinal products.

13. The certificate of destruction of medicines or its duly certified copy shall be sent by the owner of the destroyed medicines to the Federal Service for Supervision of Health and Social Development within 5 working days from the date of its preparation.

If the destruction of substandard medicines and (or) falsified medicines was carried out in the absence of the owner of the destroyed medicines, the certificate of destruction of medicines or its copy, certified in the prescribed manner, within 5 working days from the date of its preparation, is sent by the organization carrying out the destruction medicines, their owner.

14. Control over the destruction of substandard medicines, counterfeit medicines and counterfeit medicines is carried out by the Federal Service for Supervision in Health and Social Development.

In order to implement the Federal Law of June 22, 1998 No. 86-FZ "On Medicines" (Collected Legislation of the Russian Federation, 1998, No. 26, Art. 3006; 2000, No. 2, Art. 126; 2002, No. 1 (part I), Article 2) I order:

Approve the Instruction on the procedure for the destruction of medicines that have become unusable, medicines with expired validity and medicines that are fakes or illegal copies of medicines registered in the Russian Federation (Appendix).

Y. Shevchenko

Application

Approved

by order

Ministry of Health

Russian Federation

dated December 15, 2002 No. 382

INSTRUCTIONS

ON THE PROCEDURE FOR THE DESTRUCTION OF MEDICINES,

WRONG, MEDICINES

EXPIRED AND MEDICINES,

BEING FAKE OR ILLEGAL COPIES

REGISTERED IN THE RUSSIAN FEDERATION

MEDICINES

1. These Instructions were developed in accordance with Federal Laws No. 86-FZ of June 22, 1998 "On Medicines", No. 52-FZ of March 30, 1999 "On the Sanitary and Epidemiological Welfare of the Population" and determines the procedure for the destruction of drugs that have become unusable , expired medicines and medicines that are fakes or illegal copies of medicines registered in the Russian Federation.

2. Medicinal products that have become unusable and expired medicinal products are subject to withdrawal from circulation and subsequent destruction in full. The sale of these medicines is prohibited.

3. Medicinal products that are fakes or illegal copies of medicinal products registered in the Russian Federation, discovered and confiscated by the customs authorities of the Russian Federation when they are imported into the territory of the Russian Federation, are subject to destruction.

4. The medicines specified in paragraphs 2 and 3 of this Instruction are confiscated and withdrawn from circulation by the customs authorities of the Russian Federation, legal entities and individual entrepreneurs who are the owners or owners of these medicines.

5. The transfer of medicines by the customs authorities of the Russian Federation, legal entities and individual entrepreneurs who are owners or owners of medicines to enterprises that have the appropriate license, and their subsequent destruction is carried out on a contractual basis.

6. The destruction of medicines is carried out in compliance with the mandatory requirements of regulatory documents on environmental protection and is carried out in the presence of the owner or possessor of medicines to be destroyed.

(clause 6 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation dated February 5, 2010 No. 62n)

7. The destruction of medicines confiscated by the customs authorities of the Russian Federation is carried out by enterprises that have the appropriate license on specially equipped sites, landfills and premises in accordance with the requirements provided for by the legislation of the Russian Federation.

8. Features of the destruction of medicines:

Liquid dosage forms (solutions for injection in ampoules, in bags and vials, in aerosol cans, medicines, drops, etc.) are destroyed by crushing (ampoules) followed by dilution of the contents of ampoules, bags and vials with water in a ratio of 1:100 and draining the resulting solution into an industrial sewer (holes are pre-made in aerosol cans); the remains of ampoules, aerosol cans, bags and vials are taken out in the usual manner as industrial or household waste;

Solid dosage forms (powders, tablets, capsules, etc.) containing water-soluble substances of medicinal products, after crushing to a powdery state, are diluted with water in a ratio of 1:100 and the resulting suspension (or solution) is drained into an industrial sewer;

Solid dosage forms (powders, tablets, capsules, etc.) containing water-insoluble drug substances, soft dosage forms (ointments, suppositories, etc.), transdermal forms of drugs, as well as pharmaceutical substances are destroyed by incineration;

Narcotic drugs and psychotropic substances included in lists II and III of the List of narcotic drugs, psychotropic substances and their precursors, the further use of which in medical practice is recognized as inappropriate, are destroyed in accordance with the legislation of the Russian Federation;

Flammable, explosive drugs, radiopharmaceuticals, as well as medicinal plant materials with a high content of radionuclides are destroyed under special conditions using a special technology available to the destruction organization, in accordance with a license.

9. When destroying medicines, an act is drawn up, which indicates:

(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation dated February 5, 2010 No. 62n)

Date, place of destruction;

Place of work, position, surname, name, patronymic of the persons who took part in the destruction;

Reason for destruction;

Information about the name (indicating the dosage form, dosage, unit of measurement, series) and the quantity of the destroyed medicinal product, as well as about the container or packaging;

Name of the manufacturer of the medicinal product;

Name of the owner or owner of the medicinal product;

Destruction method.

The act on the destruction of medicines is signed by the persons who took part in the destruction of medicines, and sealed with the seal of the organization that carried out the destruction of the medicine.

(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation dated February 5, 2010 No. 62n)

10. Responsibility for the destruction of medicinal products shall be borne by the subjects of circulation of medicinal products in accordance with the legislation of the Russian Federation.

Article 59. Grounds and procedure for the destruction of medicines

Commentary on article 59

According to the provisions of the commented article, the following medicines are subject to destruction:

— substandard medicines, that is, medicinal products that do not meet the requirements of a pharmacopoeial article or, in its absence, the requirements of regulatory documentation or normative document;

— counterfeit medicines, that is, medicines accompanied by false information about their composition and (or) manufacturer;

— counterfeit medicines, that is, medicines that are in circulation in violation of civil law.

Note that from July 1, 2015, in accordance with the Federal Law of December 22, 2014 N 429-FZ, the wording of parts 1 and 2 of the commented article will be slightly changed. Instead of the concept of "civil circulation" the term "circulation" will be used.

The procedure for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines is established by the Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines, approved by Decree of the Government of the Russian Federation of September 3, 2010 N 674.

Grounds for destruction listed categories medicines are:

— the decision of the owner of medicines;

- decision of the relevant authorized federal executive body;

- the court's decision.

Moreover, it should be noted that in relation to counterfeit medicines, only a court decision can be the basis for destruction.

The Federal Service for Surveillance in the Sphere of Health Care acts as an authorized executive body when deciding on the destruction of substandard or counterfeit medicines, which, in the event of detection of facts of importation into the territory of the Russian Federation or facts of circulation in the territory of the Russian Federation of the listed categories of medicines, makes a decision obliging the owner of the said medicines to carry out their withdrawal, destruction and export in full from the territory of the Russian Federation. The said decision shall contain information about the medicinal products, the grounds for the seizure and destruction of the medicinal products, the term for the seizure and destruction of the medicinal products, information about the owner of the medicinal products, information about the manufacturer of the medicinal products.

The owner of substandard medicines and (or) counterfeit medicines, within a period not exceeding 30 days from the date of the decision by the Federal Service for Surveillance in Health Care to withdraw, destroy and export them, is obliged to comply with this decision or report his disagreement with it.

Disagreement of the owner of low-quality medicines and (or) counterfeit medicines with the decision to withdraw, destroy and export these medicines, failure to comply with the decision of the Federal Service for Surveillance in Healthcare, failure to report on the measures taken are the grounds for the Federal Service for Surveillance in Healthcare to go to court .

For example, Decree The Federal Antimonopoly Service of the Moscow District dated April 24, 2014 N F05-1931/14 in case N A40-76491/13 denied the request to invalidate the order to withdraw and destroy the medicinal product. According to the circumstances of the case, the disputed order was adopted in connection with the non-compliance of the medicinal product with the requirements of regulatory documentation for packaging and labeling. By a court decision, the claim was denied, since it was proved that one package contains medicines that cannot be attributed to medicines produced as a result of one technological cycle using homogeneous starting and packaging materials.

Part 3 of the commented article establishes that the costs associated with the destruction of substandard medicines, counterfeit medicines and counterfeit medicines are reimbursed by their owner.

The owner of medicinal products is not entitled to destroy them independently. The destruction of substandard medicines, counterfeit medicines and counterfeit medicines is carried out by an organization that has a license to collect, use, neutralize, transport and dispose of waste of I-IV hazard class, at specially equipped sites, landfills and in specially equipped rooms in compliance with the requirements on environmental protection in accordance with the provisions of the Federal Law of January 10, 2002 N 7-FZ "On Environmental Protection".

The owner of substandard medicines and (or) counterfeit medicines, who has made a decision on their withdrawal, destruction and export, transfers the said medicines to the organization that destroys medicines, on the basis of the relevant agreement.

In turn, the organization carrying out the destruction of medicines draws up an act on the destruction of medicines, which indicates:

— date and place of destruction of medicines;

- surname, name, patronymic of the persons who took part in the destruction of medicines, their place of work and position;

- justification for the destruction of medicines;

— information about destroyed medicinal products (name, dosage form, dosage, units of measurement, series) and their quantity, as well as container or packaging;

— name of the drug manufacturer;

- information about the owner of medicines;

- a method of destruction of medicines.

The act of destruction of medicines is drawn up on the day of destruction of substandard medicines and (or) counterfeit medicines. The number of copies of this act is determined by the number of parties involved in the destruction of these medicinal products, signed by all persons involved in the destruction of these medicinal products, and certified by the seal of the organization that destroys the medicinal products.

The owner of medicines, in accordance with Part 4 of the commented article, must submit to the authorized federal executive body an act on the destruction of medicines or a copy certified in the manner prescribed by Art. 77 Fundamentals of the legislation of the Russian Federation on notaries, approved by the Supreme Court of the Russian Federation on February 11, 1993 N 4462-1.

In accordance with the Rules approved by Decree of the Government of the Russian Federation of September 3, 2010 N 674, an act on the destruction of medicines or a duly certified copy thereof, within 5 working days from the date of its compilation, is sent by the owner of the destroyed medicines to the Federal Service for health supervision.

Control over the destruction of substandard medicines, counterfeit medicines and counterfeit medicines is carried out by the Federal Service for Surveillance in Healthcare.

Part 7 of the commented article establishes a special procedure for the destruction of the following categories of medicines:

— narcotic drugs, that is medications and pharmaceutical substances containing narcotic drugs and included in 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;

— psychotropic medicines, i.e. medicines and pharmaceutical substances containing psychotropic substances and included in 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;

— radiopharmaceutical medicines, i.e. medicines that contain one radionuclide or several radionuclides (radioactive isotopes) in a ready-to-use form.

The destruction of the listed categories of medicines is carried out in accordance with the provisions of the Federal Law of January 8, 1998 N 3-FZ "On Narcotic Drugs and Psychotropic Substances", as well as Decree of the Government of the Russian Federation of June 18, 1999 N 647 "On the procedure for further use or destruction of narcotic drugs, psychotropic substances and their precursors, plants containing narcotic drugs or psychotropic substances or their precursors, or parts thereof containing narcotic drugs or psychotropic substances or their precursors, as well as tools and equipment that have been confiscated or withdrawn from illicit circulation or further use of which is recognized as inappropriate.

It should be noted that the destruction of narcotic drugs, psychotropic substances and their precursors, drug-containing plants seized from illegal circulation, the further use of which is recognized as inappropriate by the authorities that seized or confiscated them, is carried out by state unitary enterprises or institutions if they have a license for this type of activity.

At the same time, narcotic drugs, psychotropic substances and their precursors, drug-containing plants seized from illicit circulation, the process of destruction of which, in accordance with the conclusion of the commission, consisting of representatives of the bodies for controlling the circulation of narcotic drugs and psychotropic substances, health and environmental protection, do not requires technological processing, can be destroyed by the body that ensures their storage.

When narcotic drugs, psychotropic substances and their precursors are destroyed, a commission consisting of representatives of the authorities that carried out their seizure or confiscation, health and environmental protection authorities draws up an act that indicates:

- date and place of drawing up the act;

- place of work, position, surname, name, patronymic of the persons participating in the destruction;

- grounds for destruction;

- information on the name and quantity of the narcotic drug, psychotropic substance and its precursors to be destroyed, as well as on the container or packaging in which they were stored;

"Budget healthcare institutions: accounting and taxation", 2010, N 11

In accordance with Art. Art. 47 and 59 of the Federal Law of 12.04.2010 N 61-FZ "On the Circulation of Medicines" (hereinafter - Law N 61-FZ) Decree of the Government of the Russian Federation of 03.09.2010 N 674 approved the Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines funds (hereinafter referred to as the Rules). The document enters into force seven days after its official publication.<1>.

Law N 61-FZ establishes a ban on the circulation of counterfeit, substandard, counterfeit medicines. In Art. 4 of this Law provides the terminology of this category of medicines:

falsified medicinal product - a medicinal product accompanied by false information about its composition and (or) manufacturer;
low-quality medicinal product - a medicinal product that does not meet the requirements of a pharmacopoeial article or, in its absence, the requirements of regulatory documentation or a regulatory document;
counterfeit drug - a drug that is in circulation in violation of civil law.

All listed medicines are subject to immediate destruction.

Making a decision on the destruction of medicines excluded from circulation

In accordance with paragraph 2 of the Rules, substandard and (or) counterfeit medicines are subject to seizure and destruction by decision of their owner, Roszdravnadzor or the court.

According to clause 5.2 of the Regulations on the Federal Service for Supervision in Healthcare and Social Development, approved by Decree of the Government of the Russian Federation of June 30, 2004 N 323, the examination of the quality, efficacy and safety of medicines is organized by Roszdravnadzor.

Clause 1.2 of the Administrative Regulations<2>it has been established that if there is a need for an examination of the quality, efficacy and safety of medicines in the course of carrying out measures to state control in the field of drug circulation, it is organized by the Federal Service for Supervision in Healthcare and Social Development in accordance with the requirements of the legislation of the Russian Federation.

<2>Administrative regulations of the Federal Service for Supervision of Health and Social Development for the performance of the state function of organizing the examination of the quality, efficacy and safety of medicines, approved. Order of the Ministry of Health and Social Development of Russia dated October 30, 2006 N 734.

The organization of the examination of the quality, efficacy and safety of medicines includes such administrative procedures as (clause 1.13 of the Administrative Regulations):

organization of the examination of quality, efficiency and safety, carried out in the course of reviewing documents and making a decision on state registration medicinal product (when registering medicinal products);
collection and analysis of information about side effects the use of medicines;
organization of preliminary state control of the quality and safety of medicines;
organization of the quality examination in the implementation of selective state control of medicines;
organization of the quality examination in the implementation of repeated selective state control of medicines;
collection and analysis of information on the quality of medicines.

The document reflecting the result of the examination of the quality, efficacy and safety of the medicinal product is an expert opinion issued by Roszdravnadzor when it performs control procedures (clause 2.1.1 of the Administrative Regulations).

In accordance with clause 2.2 of the Administrative Regulations, the organization of the examination of the quality of the medicinal product in the form of:

preliminary state control is carried out, but not more than 50 days from the date of receipt of a set of relevant documents and data (excluding the time spent by the applying organization for the development of three pilot batches of the medicinal product), subject to compliance with the requirements for their composition and content;
repeated selective state control is carried out within a period not exceeding 40 days from the date of sampling, but not more than 50 days from the date of receipt of a set of relevant documents and data, subject to compliance with the requirements for their composition and content.

As for the measures of selective state control of the quality of medicines, in order to increase the effectiveness of these measures, Roszdravnadzor annually informs domestic manufacturing organizations, foreign manufacturing companies and importing organizations of medicines about the list of medicines subject to selective state control. For 2010, such a List was completed by the Letter of Roszdravnadzor dated 02.02.2010 N 01I-68/10 "On selective quality control of medicines".

For reference. In 2010, the List of drugs subject to selective control included:

eye medicines;
drugs obtained from donor blood and plasma;
preparations of injectable forms of heparin and chondroitin-containing preparations;
antibiotics and antimicrobials;
medicinal herbal raw materials and medicinal preparations from medicinal herbal raw materials;
insulins;
medicines for parenteral nutrition, infusion solutions and blood substitutes;
alcohol-containing medicines (solutions for external and internal use);
medicines for the treatment of cardiovascular diseases;
pharmaceutical substances;
drugs that have comparison spectra for determining authenticity by non-destructive express methods.

In accordance with paragraph 3 of the Rules, in the event that substandard and (or) falsified medicines are imported into the Russian Federation or circulated in the Russian Federation, Roszdravnadzor makes a decision obliging the owner of these medicines to withdraw, destroy and export them in full from the territory of the Russian Federation . The decision must contain:

information about medicines;
grounds for seizure and destruction of medicines;
term for withdrawal and destruction of medicines;
information about the manufacturer of medicines.

Owner of substandard and (or) counterfeit medicines within a period not exceeding 30 days from the date of the decision by Roszdravnadzor on their withdrawal, destruction and export, is obliged to comply with this decision or report his disagreement with it. If he does not agree with the decision, and also if he did not comply with this decision and did not report on the measures taken, Roszdravnadzor goes to court. In the future, the dispute is resolved by the court. He makes a decision regarding the seizure and destruction of substandard and (or) falsified medicines (clauses 4, 5 and 7 of the Rules).

Substandard and counterfeit medicines that are under the customs regime of destruction are subject to destruction in the manner prescribed by the customs legislation (clause 6 of the Rules).

Destruction of medicines that have not passed quality control

By virtue of clause 8 of the Rules, the destruction of poor-quality, falsified and counterfeit medicines is carried out by an organization that has a license to collect, use, neutralize, transport and dispose of waste of hazard class I - IV, at specially equipped sites, landfills and in specially equipped rooms with compliance with the requirements for environmental protection in accordance with the legislation of the Russian Federation.

The owner of medicinal products, in respect of which a decision has been made to destroy them, transfers them to a specialized organization on the basis of an appropriate agreement (clause 10 of the Rules).

Features of the destruction of medicines are given in clause 8 of the Instruction on the procedure for the destruction of medicines, approved by Order of the Ministry of Health of Russia dated December 15, 2002 N 382 (currently in force as amended by the Order of the Ministry of Health and Social Development of Russia dated February 5, 2010 N 62n):

liquid dosage forms (solutions for injection in ampoules, in bags and vials, in aerosol cans, medicines, drops, etc.) are destroyed by crushing (ampoules) followed by dilution of the contents of ampoules, bags and vials with water in a ratio of 1:100 and draining the resulting solution into an industrial sewer (holes are pre-made in aerosol cans); the remains of ampoules, aerosol cans, bags and vials are taken out in the usual manner as industrial or household waste;
solid dosage forms (powders, tablets, capsules, etc.) containing water-soluble substances of medicines, after crushing to a powdery state, are diluted with water in a ratio of 1:100 and the resulting suspension (or solution) is drained into an industrial sewer;
solid dosage forms (powders, tablets, capsules, etc.) containing water-insoluble drug substances, soft dosage forms (ointments, suppositories, etc.), transdermal forms of drugs, as well as pharmaceutical substances are destroyed by incineration;
narcotic drugs and psychotropic substances included in Lists II and III of the List of narcotic drugs, psychotropic substances and their precursors, the further use of which in medical practice is recognized as inappropriate, are destroyed in accordance with the legislation of the Russian Federation;
flammable, explosive drugs, radiopharmaceuticals, as well as medicinal plant materials with a high content of radionuclides are destroyed under special conditions using a special technology available to the destruction organization, in accordance with a license.

The organization that destroys medicines draws up an act on the destruction of medicines, which indicates (clause 11 of the Rules):

date and place of destruction of medicines;
FULL NAME. persons involved in the destruction of medicines, their place of work and position;
justification for the destruction of medicines;
information about the destroyed medicinal products (name, dosage form, dosage, units of measurement, series) and their quantity, as well as container or packaging;
name of the manufacturer of medicines;
information about the owner of medicines;
method of destroying medicines.

Note! The costs associated with the destruction of substandard medicines, counterfeit medicines and counterfeit medicines are reimbursed by their owner (clause 9 of the Rules).

Drug Destruction Act

An act on the destruction of medicines (hereinafter referred to as the act) is drawn up on the day of their destruction. The number of copies of the act is determined by the number of parties involved in this operation. The act is signed by all persons who took part in the destruction, and certified by the seal of the organization.

In the event that the destruction of substandard and (or) falsified medicines was carried out in the absence of their owner, the act or its copy within five working days from the date of its compilation is sent by the organization that destroys the medicines to their owner.

Note! Control over the destruction of poor-quality, falsified and counterfeit medicines is carried out by Roszdravnadzor (clause 14 of the Rules).

M. Zaripova

Journal Expert

"Budget healthcare institutions:

accounting and taxation"

In accordance with Articles 47 and 59 of the Federal Law "On the Circulation of Medicines", the Government of the Russian Federation decides:

Approve the attached Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines.

Prime Minister of the Russian Federation V. Putin

Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines

2. Substandard medicines and (or) counterfeit medicines are subject to seizure and destruction by decision of the owner of the said medicines, decision of the Federal Service for Surveillance in Health and Social Development or a court decision.

a) information about medicines;

b) grounds for seizure and destruction of medicines;

c) the term for the withdrawal and destruction of medicines;

d) information about the owner of medicines;

e) information about the manufacturer of medicines.

6. Substandard medicines and counterfeit medicines that are under the customs regime of destruction are subject to destruction in the manner prescribed by the customs legislation.

7. Substandard medicines, counterfeit medicines and counterfeit medicines are subject to destruction on the basis of a court decision.

8. Destruction of substandard medicines, falsified medicines and counterfeit medicines is carried out by an organization licensed to collect, use, neutralize, transport and dispose of waste of I-IV hazard class (hereinafter referred to as the organization that destroys medicines), on a specially equipped sites, landfills and specially equipped premises in compliance with environmental protection requirements in accordance with the legislation of the Russian Federation.

9. Expenses associated with the destruction of substandard medicines, counterfeit medicines and counterfeit medicines shall be reimbursed by their owner.

11. The organization that destroys medicines draws up an act on the destruction of medicines, which indicates:

a) date and place of destruction of medicines;

b) last name, first name, patronymic of the persons involved in the destruction of medicines, their place of work and position;

c) justification for the destruction of medicines;

d) information about destroyed medicinal products (name, dosage form, dosage, units of measurement, series) and their quantity, as well as container or packaging;

e) name of the drug manufacturer;

f) information about the owner of medicines;

g) method of destruction of medicines.

14. Control over the destruction of substandard medicines, counterfeit medicines and counterfeit medicines is carried out by the Federal Service for Supervision in Health and Social Development.