New rules for the destruction of poor-quality, falsified, counterfeit drugs. How to properly write off the drugs with an expired shelf life of the rules for the destruction of poor-quality drugs falsified

Date: 29.06.2020

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

To approve the instructions on the procedure for the destruction of medicines that have come into disrepair, drugs with an expired shelf life and drugs that are fakes or illegal copies of drugs registered in the Russian Federation (Appendix).

Yu. Shevchenko

application

Approved

Order

Ministry of Health

Russian Federation

from 12/15/2002 № 382

Instruction

On the procedure for the destruction of medicines,

Who came into disrepair, medicines

With expired shelf life and drugs,

Who are fakes or illegal copies

Registered in the Russian Federation

Medicines

1. This instruction was developed in accordance with federal laws from 22.06.98 No. 86-ФЗ "On Medicines", from 30.03.99 No. 52-ФЗ "On the sanitary and epidemiological well-being of the population" and determines the procedure for the destruction of medicines that have come to dissent , medicines with an expired shelf life and drugs that are fakes or illegal copies of drugs registered in the Russian Federation.

2. Drugs that have come into disrepair and expired drugs are withdrawn from circulation and subsequent destruction in full. The sale of these medicines is prohibited.

3. Destructuring drugs that are fakes or illegal copies of drugs registered in the Russian Federation discovered and confiscated by the customs authorities of the Russian Federation when importing them into the territory of the Russian Federation.

4. The drugs specified in paragraphs 2 and 3 of these Instructions are confiscated and removed from the conversion of the customs authorities of the Russian Federation, legal entities and individual entrepreneurs who are 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 drug owners, in enterprises with the relevant license, and their subsequent destruction is carried out on a contractual basis.

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

(paragraph 6 as amended. Order of the Ministry of Health and Social Development of the Russian Federation of 05.02.2010 No. 62n)

7. The destruction of drugs confiscated by the customs authorities of the Russian Federation is carried out by enterprises with a relevant license, on specially equipped areas, polygons and premises in accordance with the requirements provided by the legislation of the Russian Federation.

8. Features of the destruction of drugs:

Liquid dosage forms (solutions for injection in ampoules, in packages and vials, in aerosol cylinders, medicines, drops, etc.) are destroyed by crushing (ampoules) with subsequent dilution of the contents of ampoules, packages and bottles with water in a ratio of 1: 100 and a drainage of the resulting solution into industrial sewers (holes are predefined in aerosol cylinders); The remnants of ampoules, aerosol cylinders, packages and vial are exported by the usual order, as a production or household garbage;

Solid dosage forms (powders, tablets, capsules, etc.), containing water-soluble substances of drugs, are subject to water to the powder state of water in a ratio of 1: 100 and a drainage of the resulting suspension (or solution) into industrial sewers;

Solid dosage forms (powders, tablets, capsules, etc.) containing substances of drugs insoluble in water, soft dosage forms (ointments, suppositories, etc.), transdermal forms of drugs, and also pharmaceutical substances are destroyed by burning;

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

Flameless, explosive drugs, radiopharmaceutical preparations, as well as medicinal vegetable raw materials with an increased radionuclide content are destroyed in special conditions according to the special technology available to the organization for destruction, in accordance with the license.

9. In the destruction of drugs, the act is drawn up in which:

(as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of 05.02.2010 No. 62n)

Date, destroying place;

Place of work, position, surname, first name, patronymic of persons who participated in the destruction;

Base for destruction;

Name information (indicating the dosage form, dosage, units of measurement, series) and the number of destroyed drugs, as well as on container or packaging;

Name of the manufacturer of the drug;

Name of the owner or the owner of the drug;

Method of destruction.

The act of destroying medicines is signed by persons who participated in the destruction of medicines, and is bonded by the organization of the organization, which made the destruction of the drug.

(as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of 05.02.2010 No. 62n)

10. Responsibility for the destruction of medicines are subject to the subjects of drug circulation in accordance with the legislation of the Russian Federation.

Article 59. The foundations and procedure for the destruction of medicines

Comment on Article 59

According to the provisions of the commented on, the following drugs are subject to destruction:

— non-free medicines, that is, drugs that do not comply with the requirements of a pharmacopoeia article or in case of its lack of requirements for regulatory documentation or regulatory documents;

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

— counterfeit drugs, that is, drugs that are in circulation with violation of civil legislation.

It should be noted that from July 1, 2015, in accordance with the Federal Law of December 22, 2014, N 429-FZ will be somewhat changing the wording part 1 and part 2 of the commented article. Instead of the concept of "Civil turnover", the term "appeal" will be used.

The procedure for the destruction of poor-quality drugs, falsified drugs and counterfeit drugs is established by the rules for the destruction of poor-quality drugs, falsified medicines and counterfeit drugs, approved by the Government Decree of September 3, 2010 N 674.

Foundations of destruction listed categories Medicines are:

- the solution of the owner of medicines;

- the decision of the corresponding authorized federal executive body;

- the court's decision.

Moreover, it should be noted that only the court decision may be in relation to counterfeit drugs.

As an authorized executive body in solving issues of the destruction of poor-quality or falsified drugs, the Federal Service for Supervision of Health, which, in case of identification of imports into the territory of the Russian Federation or the facts of appealing in the territory of the Russian Federation, the listed categories of medicines makes a decision that binds The owner of the specified drugs to make their withdrawal, destruction and export in full from the territory of the Russian Federation. The specified decision must contain information on drugs, the founding of the withdrawal and destruction of drugs, the length of the removal and destruction of medicines, information about the owner of medicines, information about the manufacturer of drugs.

The owner of poor-quality drugs and (or) of falsified drugs in a period not exceeding 30 days from the date of the Federal Health Supplement Service, destruction and export, is obliged to fulfill this decision or report its disagreement with it.

Disagreement of the owner of poor-quality drugs and (or) of falsified drugs with the decision to withdraw, the destruction and export of these drugs, failure to comply with the decision of the Federal Health Supervision Service, the incompleteness of the measures taken are the grounds for the appeal of the Federal Health Supervision Service to Court .

for example, Resolution FAS of the Moscow District dated April 24, 2014 N F05-1931 / 14 in case N A40-76491 / 13 refused to meet the claim for invalidation of the order for the withdrawal and destruction of the drug. According to the circumstances of the case, the challenged order was adopted in connection with the discrepancy between the drug the requirements of the regulatory documentation for packaging and labeling. The court decision was denied the satisfaction of the requirement, since it was proved that in one package there are drugs that cannot be attributed to drugs produced as a result of a single technological cycle using homogeneous source and packaging materials.

Part 3 of the commented article it was established that the costs associated with the destruction of poor-quality drugs, falsified drugs and counterfeit drugs are reimbursed by their owner.

The owner of drugs is not entitled to destroy them on their own. The destruction of poor-quality drugs, falsified drugs and counterfeit drugs is carried out by an organization with a license to collect, use, neutralizing, transporting and placing the waste of I - IV of the hazard class, on specially equipped areas, polygons and specially equipped rooms in compliance with requirements For environmental protection in accordance with the provisions of the Federal Law of January 10, 2002 N 7-FZ "On Environmental Protection".

The owner of poor-quality drugs and (or) falsified drugs, which decided to make up their withdrawal, destruction and export, transmits these drugs of the organization that extends drugs on the basis of the relevant contract.

In turn, the organization extinguishing drugs is an act of destruction of drugs, which indicates:

- date and place of destruction of medicines;

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

- justification for the destruction of medicines;

- information about destroyed medicines (name, dosage form, dosage, units of measure, series) and their number, as well as on container or packaging;

- the name of the manufacturer of medicines;

- information about the owner of medicines;

- The method of destruction of medicines.

The act of destruction of medicines is drawn up on the day of the destruction of poor-quality drugs and (or) falsified drugs. The number of copies of this act is determined by the number of parties participating in the destruction of these drugs, are signed by all persons who participated in the destruction of these drugs, and is assigned to the seal of an organization that carries out the destruction of medicines.

The owner of medicines in accordance with Part 4 of the commented article should submit to an authorized federal executive authority act on the destruction of medicines or its copy, certified in the manner prescribed by Art. 77 Fundamentals of the Russian Federation on the notarity 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, the act 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 owner of the destroyed drugs to the Federal Service for Supervision in the field of health.

In the event that the destruction of poor-quality drugs and (or) of falsified drugs was carried out in the absence of the owner of the destroyed drugs, the act of destruction of medicines or a copy of it, certified in the prescribed manner, within 5 working days from the date of its preparation is sent by the organization engaging medicines, their owner.

Control over the destruction of poor-quality drugs, falsified drugs and counterfeit drugs is carried out by the Federal Service for Supervision of Health.

Part 7 of the commented article establishes a special order to destroy the following categories of drugs:

— narcotic drugs, that is, drugs and pharmaceutical substances containing narcotic drugs and included in the list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation, approved by the Decree of the Government of the Russian Federation of June 30, 1998 N 681;

— psychotropic drugs, that is, drugs and pharmaceutical substances containing psychotropic substances and included in the list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation, approved by the Decree of the Government of the Russian Federation of June 30, 1998 N 681;

— radiopharmaceutical Drugs, that is, drugs that contain one radionuclide or several radionuclides (radioactive isotopes) in ready-to-use form.

The destruction of the listed categories of drugs 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 decisions of the Government of the Russian Federation of June 18, 1999 N 647 "On the procedure for further use or The destruction of narcotic drugs, psychotropic substances and their precursors, plants containing narcotic drugs or psychotropic substances or their precursors, or their parts containing narcotic drugs or psychotropic substances or their precursors, as well as tools and equipment that were confiscated or withdrawn from illegal turnover Either the further use of which is recognized in impractical. "

It should be noted that the destruction of drugs seized from the illegal trafficking, psychotropic substances and their precursors, drug-containing plants, the further use of which is recognized as inexpedient bodies that made their withdrawal or confiscation are carried out by state unitary enterprises or institutions if they have licenses for the specified type of activity.

At the same time, narotic drugs, psychotropic substances and their precursors, drug-containing plants, the destruction process, in accordance with the conclusion of the Commission, consisting of representatives of drug control agencies and psychotropic substances, health care and environmental protection, not Requires technological processing, can be destroyed by the body ensuring their storage.

In the destruction of narcotic drugs, psychotropic substances and their precursors by the Commission consisting of representatives of bodies that made their withdrawal or confiscation, health and environmental bodies are drawn up with an act in which:

- date and place of drawing up an act;

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

- grounds for destruction;

- information on the name and number of destroyed narcotic drugs, psychotropic substance and its precursors, as well as about the packaging or the packaging, in which they were stored;

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

Approve the accompanying rules for the destruction of poor-quality drugs, falsified medicines and counterfeit drugs.

Chairman of the Government of the Russian Federation V. Putin

Rules for the destruction of poor-quality drugs, falsified medicines and counterfeit drugs

1. These rules determine the procedure for the destruction of poor-quality drugs, falsified medicines and counterfeit drugs, with the exception of issues related to the destruction of narcotic drugs and their precursors, psychotropic drugs and radiopharmaceutical drugs.

2. Non-free drugs and (or) Falsified drugs are subject to withdrawal and destruction to solve the owner of these drugs, the decision of the Federal Service for Supervision of Health and Social Development or a court decision.

3. The Federal Service for Supervision in Health and Social Development In the event of identifying the facts of importation into the territory of the Russian Federation or the facts of circulation on the territory of the Russian Federation, poor-quality drugs and (or) of falsified drugs makes a decision that binds the owner of the specified drugs to make their withdrawal, Destruction and export in full from the territory of the Russian Federation. The specified decision must contain:

a) information about medicines;

b) the founding of the withdrawal and destruction of drugs;

c) the period of seizure and destruction of drugs;

d) information about the owner of medicines;

e) information about the manufacturer of medicines.

4. The owner of the poor-quality drugs and (or) of falsified drugs in a period not exceeding 30 days from the date of the Federal Health and Social Development Service and Social Development Service, the Decision, Destruction and Export, is obliged to fulfill this decision or report its disagreement with him.

6. Non-qualitative drugs and falsified drugs under the customs regime of destruction are to be destroyed in the manner prescribed by customs legislation.

7. Non-qualitative drugs, falsified drugs and counterfeit drugs are subject to destruction on the basis of a court decision.

8. The destruction of poor-quality drugs, falsified drugs and counterfeit drugs is carried out by an organization that has a license to collect, use, neutralizing, transporting and placing the waste of I - IV hazard class (hereinafter - an organization that extends drugs), on specifically equipped with venues, polygons and specially equipped rooms in compliance with environmental protection requirements in accordance with the legislation of the Russian Federation.

9. The costs associated with the destruction of poor-quality drugs, falsified medicines and counterfeit drugs are reimbursed by their owner.

10. The owner of poor-quality drugs and (or) falsified drugs, which decided to make up their withdrawal, destruction and export, transfers the specified drugs of the organization to destroy drugs on the basis of the relevant contract.

11. The organization exercising the destruction of drugs is an act of the destruction of drugs in which:

a) the date and place of the destruction of medicines;

b) surname, first name, patronymic of persons who participated in the destruction of medicines, their place of work and position;

c) the rationale for the destruction of medicines;

d) information about the destroyed drugs (name, dosage form, dosage, units of measure, series) and their quantity, and also on container or packaging;

e) the name of the manufacturer of medicines;

e) information about the owner of medicines;

g) a way to destroy medicines.

12. The act of destroying medicines is drawn up on the day of the destruction of poor-quality drugs and (or) falsified drugs. The number of copies of this act is determined by the number of parties participating in the destruction of these drugs, are signed by all persons who participated in the destruction of these drugs, and is assigned to the seal of an organization that carries out the destruction of medicines.

13. Act on the destruction of medicines or a copy of it, certified in the prescribed manner, within 5 working days from the date of its preparation is sent by the owner of the destroyed drugs to the Federal Health and Social Development Service.

14. Control over the destruction of poor-quality drugs, falsified drugs and counterfeit drugs is carried out by the Federal Service for Supervision of Health and Social Development.

Government of the Russian Federation

Decision

On approval of rules for the destruction of poor-quality drugs, falsified medicines and counterfeit drugs

Document with changes made by:
resolution of the Government of the Russian Federation of September 4, 2012 N 882 (Meeting of the legislation of the Russian Federation, N 37, 09/10/2012);
(Official Internet portal of legal information www.pravo.gov.ru, 01/19/2016, N 0001201601190006).
____________________________________________________________________

In accordance with and 59 of the federal law "On the circulation of drugs" Government of the Russian Federation

decides:

Approve the accompanying rules for the destruction of poor-quality drugs, falsified medicines and counterfeit drugs.

Chairman of the government
Russian Federation
V.Putin

Rules for the destruction of poor-quality drugs, falsified medicines and counterfeit drugs

Approved
decree of Government
Russian Federation
from September 3, 2010 N 674

2. Non-qualitative drugs and (or) falsified drugs are subject to withdrawal and destruction by decision of the owner of these drugs, the decision of the Federal Health Supervision Service for Medicines for Medical Applications or the Federal Service for Veterinary and Phytosanitary Supervision for Medicines For veterinary applications (hereinafter referred to as an authorized body) or a court decision.
Decree of the Government of the Russian Federation of January 16, 2016 N 8.

3. The authorized body in the event of identifying the facts of importation into the territory of the Russian Federation or the facts of circulation on the territory of the Russian Federation of poor-quality drugs and (or) of falsified drugs makes a decision that binds the owner of the specified drugs to make their withdrawal, destruction and export in full from the territory Russian Federation. The specified decision must contain:
Resolution of the Government of the Russian Federation of September 4, 2012 N 882; As amended, entered into force from January 27, 2016 by the Decree of the Government of the Russian Federation of January 16, 2016 N 8.

a) information about medicines;

b) the founding of the withdrawal and destruction of drugs;

c) the period of seizure and destruction of drugs;

d) information about the owner of medicines;

e) information about the manufacturer of medicines.

4. The owner of poor-quality drugs and (or) of falsified drugs in a period not exceeding 30 days from the date of the authorized authority of the decision on their withdrawal, destruction and export, is obliged to fulfill this decision or inform about his disagreement with him.
(The point in the editorial office entered into force from September 18, 2012 by the Decree of the Government of the Russian Federation of September 4, 2012 No. 882; as amended by the Decree of the Government of the Russian Federation of January 16, 2016 No. 8.

5. In the event that the owner of poor-quality drugs and (or) of falsified drugs does not agree with the decision to withdraw, the destruction and export of these drugs, and also if he did not fulfill this decision and did not report the measures taken, the authorized body appeals to the court .
(The point in the editorial office entered into force from September 18, 2012 by the Decree of the Government of the Russian Federation of September 4, 2012 No. 882; as amended by the Decree of the Government of the Russian Federation of January 16, 2016 No. 8.

6. Non-qualitative drugs and falsified drugs under the customs regime of destruction are to be destroyed in the manner prescribed by customs legislation.

7. Non-qualitative drugs, falsified drugs and counterfeit drugs are subject to destruction on the basis of a court decision.

8. The destruction of poor-quality drugs, falsified drugs and counterfeit drugs is carried out by an organization that has a license to collect, use, neutralizing, transporting and placing the waste of the I-IV hazard class (hereinafter - an organization extinguishing drugs), on specifically equipped with venues, polygons and specially equipped rooms in compliance with environmental protection requirements in accordance with the legislation of the Russian Federation.

9. The costs associated with the destruction of poor-quality drugs, falsified medicines and counterfeit drugs are reimbursed by their owner.

11. The organization exercising the destruction of drugs is an act of the destruction of drugs in which:

a) the date and place of the destruction of medicines;

b) surname, first name, patronymic of persons who participated in the destruction of medicines, their place of work and position;

c) the rationale for the destruction of medicines;

d) information about the destroyed drugs (name, dosage form, dosage, units of measure, series) and their quantity, and also on container or packaging;

e) the name of the manufacturer of medicines;

e) information about the owner of medicines;

g) a way to destroy medicines.

13. ACT on the 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 owner of the destroyed medicines in the authorized body.
(Abzatz, as amended from September 18, 2012, by Decree of the Government of the Russian Federation dated September 4, 2012 N 882; as amended, entered into force from January 27, 2016 by the Decree of the Government of the Russian Federation of January 16, 2016 N 8.

In the event that the destruction of poor-quality drugs and (or) of falsified drugs was carried out in the absence of the owner of the destroyed drugs, the act of destruction of medicines or a copy of it, certified in the prescribed manner, within 5 working days from the date of its preparation is sent by the organization engaging medicines, their owner.

14. Control over the destruction of poor-quality drugs, falsified drugs and counterfeit drugs carries out an authorized body.
(The point in the editorial office entered into force from September 18, 2012 by the Decree of the Government of the Russian Federation of September 4, 2012 No. 882; as amended by the Decree of the Government of the Russian Federation of January 16, 2016 No. 8.

Editorial Document Taking into account
changes and additions prepared
JSC "Codex"

Any company whose activities are associated with the production of any products facing the problem of waste disposal. Since the year from year, production volumes only increase, the existing problem is becoming more acute and global. Regardless of the volume of accumulated waste, their elimination from the territory of the enterprise should be regular and strictly adhere to the rules and norms established by the legislation of the Russian Federation. Any waste requires attentive to themselves, but of special responsibility and conscientiousness of disposal require overdue pharmaceutical preparations, which in case of negligent circulation can cause harm to the environment as a whole and the health of people in particular.

Under no circumstances allowed a simple removal of pharmaceutical products to the landfill. Transportation of overdue drugs should produce specialized companies, which have an appropriate technical and intellectual base and necessary permits.

The legislation of the Russian Federation identifies the procedure for the destruction of overdue, counterfeit and falsified drugs. The exception is narcotic, psychotropic and radiopharmaceutical drugs.

Drugs are subject to disposal to solve the data owner of drugs, judicial instance or the order of supervisory services in the field of health and social development.

The decision taken by the Federal Service for withdrawal, export and disposal of medicines should be supported by the following information:

reduced medicines;
the basis for the withdrawal and destruction of drugs;
information about the owner of drugs;
deadline for the withdrawal and destruction of medicines;
information about the manufacturer of drugs.

After the federal service decision on the liquidation of drugs, the owner of poor-quality products is obliged to fulfill this decision on a thirty-day period or report his disagreement with it.

Non-qualitative drugs under the customs regime are subject to destruction according to the rules established by customs legislation.

The elimination of poor-quality, falsified or counterfeit drugs is carried out by the organization on the basis of a license that gives the right to collect, sort, disinfection, transportation and placement of waste of different hazards, on specially equipped areas, premises or polygons in compliance with the requirements for environmental protection in this area. The owner who has decided to dispose of drugs transfers their organizations providing these services on the basis of a concluded agreement.

In turn, the organization providing services for the destruction of drugs is an act of the destruction of drugs, which indicates:

date and place of disposal of medicines;
surnames and initials of persons who were present in the destruction of drugs, their positions and place of work;
the cause of the destruction of drugs;
information about disposal medicines: name, dosage form, dosage, series. It is also necessary to specify their number, attach a description of the container or packaging;
the name of the manufacturer of pharmaceuticals;
information about the owner of drugs;
produced method for the destruction of medicines.

The act of destroying drugs is on the day of their destruction. The number of necessary specimens of each act depends on the number of parties participating in the destruction of drugs. Each copy is signed by all persons who were present in the elimination of medical drugs, the organization is assigned to the organization that exercises the destruction of pharmaceuticals.

The act of destroying drugs, certified in the existing order, within five working days from the date of its preparation is sent by the owner of disposal funds to the Federal Health and Social Development Service.

If utilization procedures passed in the absence of the owner of drugs, the act on the destruction of drugs or its copies, certified in the existing order, within 5 working days from the date of its preparation, is sent by the institution producing the destruction of medicines, their owner.

The control of the disposal of pharmaceutical preparations is carried out by the Federal Service for Supervision of Health and Social Development.