The composition of the commission for the destruction of counterfeit drugs. Destruction of medicines. What medicines are subject to destruction

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

Destruction of substandard medicines, counterfeit 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), at specially equipped sites , landfills and in 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.

10. The owner of poor-quality medicines and (or) falsified 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 medicinal products (name, dosage form, dosage, units of measure, 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.

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 medicines, signed by all persons involved in the destruction of these medicines, and certified by the seal of the organization that destroys the medicines.

13. The certificate of destruction of medicines or its copy certified in accordance with the established procedure shall be sent by the owner of the destroyed medicines to the authorized body 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 authorized body.

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

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) 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.

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 substandard medicines and (or) counterfeit medicines does not agree with the decision to confiscate, 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 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.

10. The owner of poor-quality medicines and (or) falsified 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 medicinal products (name, dosage form, dosage, units of measure, 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.

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 medicines, signed by all persons involved in the destruction of these medicines, and certified by the seal of the organization that destroys the medicines.

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.

The activities of some organizations, for example, pharmacies, clinics, private medical offices, etc., are associated with the use and sale of medicines (MPs). Like any product, they must be sold or used on time, the manufacturer indicates a valid expiration date for this. However, situations are inevitable in which part of the drugs will remain on the shelves or in the warehouse after this period has expired. How to act correctly in such cases, how to write them off and what to do with expired drugs later, we understand in this article.

Expired means poor quality.

The number on the packaging of medicines indicating the end date for its use is very important. Even if, in fact, nothing happens to the contents of the vial or box in the extra few days after the specified date, it is no longer possible to sell or take such medicines.

Art. 59 of the Law "On the Circulation of Medicines" equates drugs with an expired shelf life to substandard ones, removing them from the pharmacopeia regulations. In Art. 31 of Federal Law No. 86-FZ of July 22, 1998, their sale is directly and categorically prohibited.

From the designated date, they cease to be medicines, but are considered to be recyclable goods that have lost their consumer properties. How to deal with them further is stated in the Instruction approved by the Order of the Ministry of Health of Russia No. 382 of December 15, 2002. It is valid for the following medicines:

  • whose expiration date has expired;
  • which for any reason have become unusable;
  • falsifications;
  • counterfeit medicinal products;
  • fakes officially registered in the Russian Federation medicinal trademarks.

The regulation on the destruction of such drugs is approved by the legislation of the Russian Federation:

  • in Decree of the Government of the Russian Federation of September 03, 2010 No. 674 - for most medications;
  • in the Order of the Ministry of Health of the Russian Federation of November 12, 1997 No. 330 - if the drugs are psychotropic or narcotic drugs.

Responsibilities of Owners of Substandard Medicinal Products

Those legal entities or individual entrepreneurs who own or manage medicinal products, in accordance with paragraph 2 of the above Instruction, must perform the following operations with them without fail:

  1. Timely conduct an inventory and identify drugs that lose their consumer qualities or do not meet them initially.
  2. Immediately withdraw such drugs from circulation and formalize this in accordance with the established documentary procedure.
  3. Send the withdrawn medicines for disposal in full to special enterprises licensed for their destruction.
  4. Be present in person or send your representative to the procedure for the destruction of drugs (as part of a specially created commission).

NOTE! Disposal of expired drugs can be initiated not only by the goodwill of the owner, but also by instructions from regulatory authorities or a court decision.

How to write off medicines correctly

The procedure for write-off and subsequent disposal of medicinal products is associated with a fairly extensive documentary support. The main paper is the Write-off Act, which will become the basis for the transfer of spoiled or expired medicines for destruction. The process of identifying and writing off such medicines involves several important steps:

  1. Inventory:
    • identification and fixation of substandard drugs;
    • entering information into inventory sheets (with signatures of members of the inventory commission and persons with financial responsibility);
    • reflection of these data in the accounting documentation.
  2. The following forms can be used to record data on damage to drugs:

  • No. TORG-15 and No. TORG-16, approved by the Decree of the State Statistics Committee of Russia No. 132 of December 25, 1998 "On approval of unified forms of primary accounting documentation for accounting for trade operations";
  • forms from the Guidelines for practitioners and researchers, approved by the Order of the Ministry of Health of Russia No. 98/124 dated May 14, 1998.
  • Activation. The act of damage to inventory items in the form No. A-2.18 is filled out by members of the inventory commission at the moment when this damage is detected. A separate act is drawn up for each group of damaged assets (for example, for medicines, containers, etc.). This document should indicate the reasons for the damage found and the persons responsible for it. The book value of spoiled medicines and medical containers is indicated. Explanatory statements of those responsible for the damage are added to it (if such are established). This document is drawn up in 3 copies: one copy of the act will have to remain with the financially responsible person and be used to attach to the report when writing off the assets.
  • Separation. Medicinal products selected for write-off can no longer be stored together with benign ones. They need to be transferred to a special “quarantine zone” - a separate designated place (clause 12 of Order No. 706 n).
  • IMPORTANT! The write-off act is the main document for the disposal of spoiled or expired medicines. On its basis, they are transferred to special organizations for destruction.

    Lawful destruction of medicines

    Medications that have become substandard cannot simply be thrown into the trash. They must be handed over for legally regulated destruction to special firms that have permission to do so.

    Financial accounting for the disposal of medicines

    The owner concludes a service agreement with such an organization - it will serve as a document confirming the costs.

    ATTENTION! Disposal costs depend not only on the company's tariffs, but also on the specifics of the disposal of certain drugs: for example, tablets are much easier to destroy than aerosol drugs, hence the higher cost of disposal of the latter. The cost of destruction also affects the packaging of medicines, their weight, volume.

    After direct destruction, the contractor issues an invoice for services to the customer, after which an Acceptance Certificate for the work performed is issued (it is usually standard).

    The Tax Code prescribes that these expenses be taken into account when calculating income tax (clause 1, article 264 of the Tax Code of the Russian Federation).

    Is it possible to destroy medicines yourself

    The law allows self-disposal of medicinal products by their owners, subject to the following conditions:

    • the owner is not a drug manufacturer;
    • the batch to be disposed of is small in volume.

    Most often this situation occurs in pharmacies.

    It is necessary to dispose of medicinal products in the order established by the Instruction, determined for each type of destroyed medicinal products:

    • liquid medicines must be strongly diluted with water (not less than 1:100) and poured into sewers;
    • tablets that dissolve in water must be ground into powder, which is also dissolved in water and poured;
    • ointments and insoluble dosage forms must be burned;
    • fragments of ampoules, boxes, convoys, vials, etc. are disposed of as household waste (thrown away)

    FOR YOUR INFORMATION! If the substances to be destroyed are explosive or flammable, their self-disposal is prohibited.

    Destruction act

    After disposal, members of the commission fill out a special act. It should include the following information:

    • date of disposal;
    • the place where it happened;
    • data of all members of the destruction commission (name, position, place of work);
    • reasons why drugs are sent for disposal;
    • a list of destroyed medicines (name, number of units, features of packaging, containers);
    • the name of the owner of the assets being disposed of (company or individual entrepreneur) and his data;
    • rationale for the method of disposal (for each medicine from the list).

    ATTENTION! The act of destruction must be signed by all members of the commission and affixed with the seal of the liquidation enterprise.

    After drawing up, within 5 days, this document or its certified copy is sent to the Federal Service for Supervision in Health and Social Development.

    What threatens negligent drug owners

    If in the arsenal of an organization or an individual entrepreneur, medicines that have lost their condition are not disposed of on time, for unscrupulous owners of Art. 14.1 of the Code of Administrative Offenses of the Russian Federation provides for serious liability:

    • for an organization - a fine in the amount of 40,000 to 50,000 rubles;
    • it is possible to suspend core activities for up to 3 months;
    • for an official caught in the sale of medicinal "delay" - a fine of 4,000 to 5,000 rubles.

    The "bonus" will be the loss of the institution's reputation and, as a result, a drop in demand and respect from customers.

    It is on this day that the Federal Law of December 31, 2014 "On Amendments to Certain Legislative Acts of the Russian Federation in the Part of Counteracting the Turnover of Counterfeit, Counterfeit, Substandard and Unregistered Medicines, Medical Devices and Counterfeit Dietary Supplements" will enter into force.

    But before we talk about the changes themselves, let's define some terms. They have already been included in federal laws and have a specific meaning, that is, they are not subject to ambiguous interpretation.

    The Federal Law of November 21, 2011 "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation" amended Article 38, it was supplemented with the following definitions:

    Counterfeit medical device- a medical device accompanied by false information about its characteristics and (or) manufacturer (manufacturer).

    Poor quality medical device- a medical device that does not comply with the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer) or, in its absence, the requirements of other regulatory documentation.

    counterfeit medical device- a medical product that is in circulation in violation of civil law.

    And now I will give examples from our industry. This is about the products that I met in my practice when checking beauty salons and clinics.

    Fake medical products are mesothreads, the sellers of which claim that thread lifting has a therapeutic effect. The term itself - therapeutic effect - means the dynamics in the development of a certain disease after the application of a certain therapeutic method. So far, none of these manufacturers has identified a disease according to ICD-10 that can be cured by thread lifting, and, accordingly, have not conducted clinical trials (for all) for positive dynamics.

    Poor quality medical device. In Russia, as in many European countries, fillers are registered as medical devices (although their pharmacokinetics still proves that these fillers are closer to medicines, since they enter into biochemical reactions with body tissues and are excreted through the excretory systems). But since they are registered as medical devices, then clinical trials are not as rigorous as when putting a drug into circulation. Moreover, some of them are generally registered as products of only the second risk class, although in all respects they are closer to the third. Why? We read: "Medical devices, the components of which include a substance that is a drug or other biologically active agent and affects the human body in addition to the effects of a medical device, belong to class 3."

    So it's hard to talk about quality... And not only for me. Thus, according to Medikforum, over the past three years, the number of complications in contour plastic surgery has tripled.

    A completely legal and high-quality medical device can also turn out to be of poor quality if, for example, it is transported or stored incorrectly. I remember a case when fillers were smuggled across the Finnish border in the undercarriage of a car in winter...

    Well, counterfeit - that's all clear. The two main violations are smuggling and lack of registration with Roszdravnadzor.

    No wonder Roszdravnadzor now, when checking cosmetic equipment, also checks the serial number (the practice of "catching" stolen cars from Europe came in handy in this department as well).

    The lack of registration is already familiar to visitors to our portal, we have discussed this more than once.

    One can speculate about substandard medicines on the example of drugs that are not used for their intended purpose. For example, one drug recommended by cosmetologists as an anti-aging agent, according to the instructions for use, is prescribed for the following diseases (according to ICD-10): B00.9 Herpes infection, unspecified, K70.0 Alcoholic fatty degeneration of the liver [fatty liver], K76.0 Fatty liver, not elsewhere classified, K76.9 Liver disease, unspecified, L20 Atopic dermatitis. The drug itself is quite possible and good if it is used according to indications, but its appointment in the office of a cosmetologist does not meet the requirements of a pharmacopoeial article in any way.

    Counterfeit drugs include a large group of mesotherapeutic cocktails that do not have a drug registration, but are imported into the country as cosmetics for external use. Moreover, in this case, not only those who imported the meso-cocktail, but also those who conducted its clinical trials, although they did not have the right to do so, fall under the law.

    And who can conduct such tests? They are established by Decree of the Government of the Russian Federation of September 3, 2010 N 683 "On Approval of the Rules for the Accreditation of Medical Organizations for the Right to Conduct Clinical Trials of Medicinal Products for Medical Use". And now, if you check the register of issued permits for conducting clinical trials of medicinal products for medical use (and such a register is maintained in accordance with the requirements of the Order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 N 754n "On approval of the procedure for maintaining, publishing and posting on the official website on the network" Internet"), it turns out that some institutes and scientific organizations did not have the right to conduct such research in many cases.

    By the way, the same applies to clinical trials of medical devices. They are carried out in accordance with the conformity assessment of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of honey. products.

    In Russia, not only the rules for importation, registration and use (which we have already proved above) are violated, but also the rules for the sale of medicines and medical devices, which were approved by the Government Decree of January 19, 1998.

    By the way, there are also changes in the legislation to it, which came into force in 2015. They were introduced by the Decree of the Government of the Russian Federation of 01/05/2015 "On Amendments to the Rules for the Sale of Certain Types of Goods". We will reproduce this part in full:

    Information about medical devices (instruments, devices, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, restoring, replacing, changing the anatomical structure or physiological functions of the body, preventing or terminating pregnancy, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body) in addition to the information specified in paragraphs 11 and 12 of these Rules, must contain information about the number and date of the registration certificate for a medical device issued by Federal Service for Surveillance in Healthcare in accordance with the established procedure, as well as taking into account the characteristics of a particular type of product, information about its purpose, method and conditions of use, action and effect, restrictions (contraindications) for use.

    As we remember, since 2014 the Code of Administrative Offenses has been introduced by the Federal Law:

    Article 14.4.2. Violation of the legislation on the circulation of medicines

    Article 6.28 Violation of the established rules in the field of circulation of medical devices

    now added to it:

    Article 6.33. Circulation of falsified, counterfeit, substandard and unregistered medicines, medical devices and circulation of falsified dietary supplements.

    Well, now we just have to bring new articles of laws on criminal liability. We will not comment on them, we will only refer to the definition of what "treatment" is and we will italicize the word "application", which is directly related to cosmetologists. So, federal law:

    "Circulation of medicines - development, preclinical studies, clinical studies, examination, state registration, standardization and quality control, production, manufacture, storage, transportation, import into the territory of the Russian Federation, export from the territory of the Russian Federation, advertising, dispensing, sale, transfer , application destruction of medicines.

    And this is from federal law:

    "The circulation of medical devices includes technical tests, toxicological studies, clinical trials, "examination" of the quality, efficacy and safety of medical devices, their state registration, production, manufacture, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of conformity, state control, storage, transportation, sale, installation, adjustment, application, operation, including maintenance, provided for by the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer), as well as repair, disposal or destruction.


    And, having realized everything written above, we read the new articles of the Criminal Code of the Russian Federation, which come into force on January 23, 2015. There are no comments for now:

    Article 235.1. Illicit production of medicines and medical devices

    1. Manufacture of medicines or medical devices without a special permit (license), if such a permit (such a license) is obligatory (mandatory), - shall be punishable by imprisonment for a term of three to five years with a fine of five hundred thousand to two million rubles, or in the amount of wages or other income of the convicted person for a period of six months to two years or without it.

    2. The same acts committed: a) by an organized group; b) on a large scale, are punishable by deprivation of liberty for a term of five to eight years, with or without a fine in the amount of one million to three million rubles, or in the amount of the wage or other income of the convicted person for a period of one to three years.

    Note. The large amount in this article is the cost of medicines or medical devices in excess of one hundred thousand rubles.

    Article 238.1. Circulation of counterfeit, substandard and unregistered medicines, medical devices and circulation of counterfeit dietary supplements.

    1. Manufacture, sale or import into the territory of the Russian Federation of counterfeit medicines or medical devices, or sale or import into the territory of the Russian Federation of substandard medicines or medical devices, or illegal production, sale or import into the territory of the Russian Federation for the purpose of marketing unregistered medicines or medical devices, or the production, sale or import into the territory of the Russian Federation of falsified biologically active additives containing pharmaceutical substances not declared during state registration, committed on a large scale - shall be punishable by compulsory labor for a term of three to five years with deprivation of the right to hold certain positions or engage in certain activities for up to three years or without it, or by imprisonment for a term of three to five years with a fine in the amount of five hundred thousand to two million rubles or in the amount of wages or other dismissal of the convicted person for a period of six months to two years or without it and with deprivation of the right to occupy certain positions or engage in certain activities for a period of up to three years or without it.

    2. The same acts, if they: a) are committed by a group of persons by prior agreement or by an organized group; b) negligently caused grievous bodily harm or death to a person, are punishable by deprivation of liberty for a term of five to eight years, with a fine in the amount of one million to three million rubles, or in the amount of the wage or other income of the convicted person for a period of one year to three years or without it and with deprivation of the right to hold certain positions or engage in certain activities for up to five years or without it.

    3. The acts provided for by paragraphs 1 or 2 of this Article, which negligently caused the death of two or more persons, are punishable by deprivation of liberty for a term of eight to twelve years, with a fine in the amount of two million to five million rubles, or in the amount of wages, or another the income of the convicted person for a period of two to five years or without it and with or without deprivation of the right to occupy certain positions or engage in certain activities for a period of up to ten years.

    Notes.
    1. This article does not apply to cases of illegal sale and import into the territory of the Russian Federation of narcotic drugs, psychotropic substances, their precursors, potent or poisonous substances, as well as illegal production of narcotic drugs, psychotropic substances or their precursors.
    2. A large amount in this article is the cost of medicines, medical devices or biologically active additives in an amount exceeding one hundred thousand rubles.

    Article 327.2. Forgery of documents for medicines or medical devices or packaging of medicines or medical devices

    1. Production for the purpose of use or sale or use of knowingly forged documents for medicines or medical devices (registration certificate, certificate or declaration of conformity, instructions for use of a medicinal product or regulatory, technical and operational documentation of the manufacturer (manufacturer) of a medical device), - shall be punishable by a fine in the amount of five hundred thousand to one million rubles, or in the amount of the wage or salary, or any other income of the convicted person for a period of one to two years, or by compulsory labor for a term of up to three years, or by deprivation of liberty for the same term.

    2. Manufacture for the purpose of use or sale, or use of knowingly counterfeit primary packaging and (or) secondary (consumer) packaging of a medicinal product - year to two years, or forced labor for up to three years, or imprisonment for the same period.

    3. Commitment of the deeds provided for by paragraphs 1 or 2 of this article by an organized group, is punishable by imprisonment for a term of five to ten years, with deprivation of the right to hold certain positions or engage in certain activities for a term of up to three years.

    Any company whose activities are related to the production of any product is faced with the problem of waste disposal. As production volumes only increase from year to year, the existing problem is becoming more acute and global. Regardless of the amount of accumulated waste, their removal from the territory of the enterprise must be regular and strictly adhere to the rules and regulations established by the legislation of the Russian Federation. Any waste requires an attentive attitude, but expired pharmaceuticals require special responsibility and conscientious disposal, which, if handled carelessly, can cause harm to the environment in general and human health in particular.

    Under no circumstances should pharmaceutical products be simply disposed of in a landfill. Transportation of expired medicinal products should be carried out by specialized companies that have at their disposal the appropriate technical and intellectual base and the necessary permits.

    The legislation of the Russian Federation defines the procedure for the destruction of expired, counterfeit and counterfeit medicines. The exception is narcotic, psychotropic and radiopharmaceutical drugs.

    Medicines are subject to disposal by the decision of the owner of these drugs, the court or the order of the oversight services in the field of health and social development.

    The decision taken by the Federal Service to confiscate, export and dispose of medicines must be supported by the following information:

    • information about medicines;
    • grounds for seizure and destruction of medicinal products;
    • information about the owner of the medicinal products;
    • the established period for the withdrawal and destruction of medicines;
    • information about the manufacturer of medicinal products.

    After the federal service makes a decision to liquidate medicines, the owner of low-quality products is obliged to comply with this decision or report his disagreement with it within thirty days.

    Substandard medicinal products under the customs regime are subject to destruction in accordance with the rules established by the customs legislation.

    Liquidation of low-quality, falsified or counterfeit medicines is carried out by an organization on the basis of a license that gives the right to collect, sort, disinfect, transport and dispose of waste of various hazard classes in specially equipped areas, premises or landfills in compliance with the requirements for environmental protection in the given territory. The owner, who made the decision to dispose of medicines, transfers them to the organization providing these services on the basis of a concluded contract.

    In turn, the organization providing services for the destruction of medicines draws up an act on the destruction of medicines, which indicates:

    • date and place of disposal of medicines;
    • surnames and initials of persons present at the destruction of medicinal products, their positions and places of work;
    • the reason for the destruction of medicinal products;
    • information about utilized medicines: name, dosage form, dosage, series. It is also necessary to indicate their quantity, attach a description of the container or packaging;
    • the name of the pharmaceutical manufacturer;
    • information about the owner of medicinal products;
    • manufactured method of destruction of medicines.

    The act of destruction of medicinal products is drawn up on the day of their destruction. The number of required copies of each act depends on the number of parties involved in the destruction of drugs. Each copy is signed by all persons who were present at the disposal of medical products, certified by the seal of the organization that carries out the destruction of pharmaceutical products.

    The certificate of destruction of medicinal products, certified in accordance with the existing procedure, is sent by the owner of the disposed funds to the Federal Service for Supervision of Health and Social Development within five working days from the date of its preparation.

    If the disposal procedures were carried out in the absence of the owner of the medicinal products, the certificate of destruction of the medicinal products or its copies certified in accordance with the existing procedure, within 5 working days from the date of its preparation, is sent by the institution that destroys the medicinal products to their owner.

    The disposal of pharmaceuticals is controlled by the Federal Service for Supervision of Health and Social Development.