Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines - Rossiyskaya Gazeta. Destruction of medicines Procedure for recalling counterfeit medicines

What regulatory documents regulate destruction? medicines, placing medicines in a quarantine zone? What is the algorithm of actions? In what cases should the pharmacy destroy the drugs itself, and in what cases can it return them to the supplier? How can you minimize pharmacy disposal costs? In what form should acts of destruction and placement in a quarantine zone be drawn up? How can you force an organization that destroys medicines to draw up a report and provide it to the pharmacy?

Please pay attention to the date of the response - the situation may have changed.

Substandard medicines are destroyed in accordance with the “Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines”, approved by Decree of the Government of the Russian Federation of 09/03/2010 No. 674 (as amended on 09/04/2012).
The concept of a designated quarantine zone for organizations operating in the field of circulation of medicines is not clearly defined by current legislation.
In accordance with paragraph 12 of the “Rules for the storage of medicines” approved by Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 No. 706n (as amended on December 28, 2010), when medicines with expired expiration date, they must be stored separately from other groups of medicines in a specially designated and designated (quarantine) area.
According to clause 4.2 of the Industry Standard “Rules for the dispensing (sale) of medicines in pharmacy organizations. Basic Provisions", approved by Order of the Ministry of Health of the Russian Federation dated 04.03.2003 No. 80 (as amended on 18.04.2007), for medicinal products (medicines) in damaged packaging, without certificates and/or the necessary accompanying documentation, rejected When receiving or dispensing to a patient that does not correspond to the order or has expired, a report is drawn up. Such medications must be properly labeled and placed in a designated area separate from other medications until they are identified, returned to the supplier, or disposed of as required.
The Standard does not establish requirements for the form and content of the act.
Thus, the act on identifying medicines to be placed in the quarantine zone and on their movement to and from the quarantine zone can be drawn up in any form.
In accordance with paragraph 2 of the “Rules for the destruction of substandard medicines, falsified medicines and counterfeit medicines,” substandard medicines and (or) counterfeit medicines are subject to seizure and destruction by decision of the owner of these medicines, the decision of the Federal Service for Surveillance in Healthcare and social development or a court decision.
According to paragraph 4 of these Rules, the owner of substandard medicines and (or) counterfeit medicines within a period not exceeding 30 days from the date of issue Federal service for supervision in the field of health care and social development of a decision on their seizure, destruction and export, is obliged to implement this decision or report his disagreement with it.
The current civil legislation of the Russian Federation does not define the concept of “owner”, however, within the meaning of civil law norms, the owner of a product is a person who owns it on any legal basis, in particular, the owner of a product is its owner if he has not transferred the right of ownership to another person, for example , did not transfer the goods for commission or the item for rent.
Thus, according to the above Rules, the destruction of substandard medicines must be ensured by their owner, i.e. in this case, a pharmacy organization.
At the same time, in accordance with the provisions of Articles 475-477 of the Civil Code of the Russian Federation, the seller (pharmacy) has the right to make claims to the supplier (manufacturer) demanding compensation for expenses and losses incurred if he proves that the goods supplied to him were of poor quality at the time of delivery or that the goods were damaged due to the fault of the supplier, for example, due to violations of transportation conditions, etc.
According to paragraph 8 of the Rules, the destruction of medicines is carried out by an organization that has a license to collect, use, neutralize, transport and dispose of waste of I-IV hazard classes.
In accordance with paragraph 11 of these Rules, the organization carrying out the destruction of 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 who took part 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 measurement, series) and their quantity, as well as containers or packaging;
e) name of the manufacturer of medicines;
f) information about the owner of the medicines;
g) method of destruction of medicines.
An act on the 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 who took part in the destruction of these medicines, signed by all persons who took part in the destruction of these medicines, and certified by the seal of the organization carrying out the destruction of medicines (clause 12 of the Rules).
As can be seen from the legislative norms listed above, the need to draw up an act is established by law, but the strict form of the act on the destruction of medicines has not been established, and a clear composition of persons taking part in the destruction of medicines has not been established.
Thus, the form of the act can be arbitrary, provided it reflects all the positions specified in paragraph 11 of the Rules.
For the destruction of medicines, the organization carrying out the destruction may create an appropriate commission. At the same time, as follows from paragraph 13 of the Rules, participation in the process of destruction of medicines by their owner is not mandatory. In this case, the act of destruction of medicines or its copy, certified in the prescribed manner, is sent to the owner of the destroyed medicines within 5 working days from the date of its preparation.
When concluding a contract for the destruction of medicines, you can additionally specify a list of documents that are used to close the contract.

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

Expired means poor quality

The number on the packaging of medications indicating the end date for its use is very important. Even if in fact nothing happens to the contents of the bottle or box in the extra few days after the specified date, such medicines can no longer be sold or taken.

Art. 59 of the Law “On the Circulation of Medicines” equates drugs with an expired shelf life to poor quality, removing them from the pharmacopoeia 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 a product subject to disposal that has lost its consumer properties. How to proceed with them is stated in the Instructions approved by Order of the Russian Ministry of Health 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;
• counterfeits;
• counterfeit medicinal products;
• counterfeits of officially registered medicinal brands in the Russian Federation.

The regulations regarding the destruction of such drugs are approved by the legislation of the Russian Federation:

• in Decree of the Government of the Russian Federation of September 3, 2010 No. 674 - for most medications;
• in Order of the Ministry of Health of the Russian Federation of November 12, 1997 No. 330 - if the medications are classified as psychotropic drugs or narcotic drugs.

Responsibilities of owners of substandard medicines

Those legal entities or individual entrepreneurs who own or manage medicinal products, in accordance with paragraph 2 of the above-mentioned Instructions, must mandatory perform the following operations with them:

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

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

How to write off medications correctly

The procedure for write-off and subsequent disposal of medicines is associated with fairly extensive documentary support. The main document is the Write-off Certificate, which will become the basis for transferring 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 this data in accounting documentation.

To record data on drug damage, the following forms can be used:

• No. TORG-15 and No. TORG-16, approved by Resolution of the State Statistics Committee of Russia No. 132 of December 25, 1998 “On approval of unified forms of primary accounting documentation for recording trade operations”;
• shapes from Methodological recommendations for practical and scientific workers approved by Order of the Ministry of Health of Russia No. 98/124 of May 14, 1998.

IMPORTANT! The write-off act is the main document when disposing of spoiled or expired medicines. On its basis, they are transferred to special organizations for destruction.

Lawful destruction of medicines

Medicines that have become of poor quality cannot simply be thrown into the trash. They must be handed over for legally regulated destruction to special companies that have permission to do so.

Financial accounting of drug disposal

The owner enters into a service agreement with such an organization - it will serve as a document confirming expenses.

ATTENTION! Disposal costs depend not only on the company’s tariffs, but also on the features of disposal of certain medications: for example, tablets are much easier to destroy than medications in aerosol form, hence the higher cost of disposal of the latter. The cost of destruction is also affected by the packaging of drugs, their weight, and volume.

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

The Tax Code requires 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 the independent disposal of medicines by their owners, subject to the following conditions:

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

Most often this situation occurs in pharmacies.

Medicines must be disposed of in the order established by the Instructions, defined for each type of medicine being destroyed:

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

NOTE! If the substances being destroyed are explosive or flammable, their independent disposal is prohibited.

Destruction Act

After disposal, members of the commission fill out a special act. It needs to reflect 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;
• list of medications to be destroyed (name, number of units, packaging features, containers);
• name of the owner of the assets being disposed of (company or individual entrepreneur) and his data;
• justification for the disposal method (for each drug on the list).

ATTENTION! The act of destruction must be signed by all members of the commission and sealed 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 Surveillance in Healthcare and Social Development.

What threatens negligent drug owners

If the organization has in its arsenal or 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 convicted of selling overdue medications - a fine of 4,000 to 5,000 rubles.

A “bonus” will be the loss of the institution’s reputation and, as a result, a drop in demand and respect among clients.

Article 59. Grounds and procedure for destruction of medicines

Commentary on Article 59

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

— substandard medicines, that is, medicines that do not meet the requirements pharmacopoeial monograph or in the absence of it, 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.

Please note that from July 1, 2015, in accordance with Federal law dated December 22, 2014 N 429-FZ, the wording of Part 1 and Part 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:

— decision of the owner of the medicines;

— decision of the relevant authorized federal executive body;

- court decision.

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

The Federal Service for Surveillance in Healthcare acts as the authorized executive body when resolving issues of the destruction of substandard or falsified medicines, which, in the event of detection of facts of import into the territory Russian Federation or facts of circulation of the listed categories of medicines on the territory of the Russian Federation, makes a decision obliging the owner of these medicines to carry out their seizure, destruction and export in full from the territory of the Russian Federation. The said decision must contain information about the medicines, the grounds for the seizure and destruction of the medicines, the period for the seizure and destruction of the medicines, information about the owner of the medicines, information about the manufacturer of the medicines.

The owner of substandard medicines and (or) counterfeit medicines, within a period not exceeding 30 days from the date of the Federal Service for Surveillance in Healthcare making a decision on their seizure, destruction and export, is obliged to comply with this decision or report his disagreement with it.

Disagreement of the owner of substandard medicines and (or) falsified medicines with the decision to confiscate, destroy and export these medicines, failure to comply with the decision of the Federal Service for Surveillance in Healthcare, failure to report measures taken are grounds for the Federal Service for Surveillance in Healthcare to go to court.

For example, Resolution FAS Moscow District dated April 24, 2014 N F05-1931/14 in case N A40-76491/13 refused to satisfy the request to invalidate the order for seizure and destruction medicinal product. According to the circumstances of the case, the contested order was adopted due to the non-compliance of the medicinal product with the requirements of regulatory documentation for packaging and labeling. The court decision rejected the claim, since it was proven that one package contains medicines that cannot be classified as medicines produced as a result of one technological cycle, using homogeneous starting and packaging materials.

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

The owner of medicines does not have the right to destroy them himself. The destruction of substandard medicines, falsified medicines 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 premises in compliance with the requirements on protection environment 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) falsified medicines, who has made a decision on their seizure, destruction and export, transfers these medicines to the organization carrying out the destruction of medicines on the basis of an appropriate 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;

- last name, first 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 the destroyed medicines (name, dosage form, dosage, units of measurement, series) and their quantity, as well as about the container or packaging;

— name of the manufacturer of the medicines;

— information about the owner of the medicines;

— a method of destroying medicines.

An act on the 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 who took part in the destruction of the specified medicinal products, is signed by all persons who took part in the destruction of the specified medicinal products, and is certified by the seal of the organization carrying out the destruction of the medicinal products.

1. 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 thereof, certified in the manner established 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, the act on the destruction of medicines or its copy, certified in the prescribed manner, is sent by the owner of the destroyed medicines to the Federal Service for supervision in the healthcare sector.

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

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

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

— narcotic medicines, that is, medicines 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 medicinal products, that is, drugs 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 medicinal products, that is, medicinal products 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 the 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 their parts containing narcotic drugs or psychotropic substances or their precursors, as well as tools and equipment that were confiscated or seized from illegal trafficking or the further use of which is considered inappropriate.”

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

At the same time, narcotic drugs, psychotropic substances and their precursors, narcotic plants seized from illicit trafficking, the process of destruction of which, in accordance with the conclusion of a commission consisting of representatives of the authorities for control over the circulation of narcotic drugs and psychotropic substances, health care and environmental protection, is not requires technological processing, can be destroyed by the body providing their storage.

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

— date and place of drawing up the act;

— place of work, position, last name, first name, patronymic of the persons taking part in the destruction;

— grounds for destruction;

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

It is on this day that the Federal Law of December 31, 2014 “On Amendments to Certain legislative acts of the Russian Federation in terms of combating the circulation of falsified, counterfeit, substandard and unregistered medicines, medical devices and biologically falsified active additives".

But before we talk about the changes themselves, let's define the 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 and added the following definitions:

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

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

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

Now I’ll give examples from our industry. This is about the products that I have encountered in my practice when checking beauty salons and clinics.

Counterfeit medical products - mesothreads, whose sellers claim that thread lifting has therapeutic effect. The term itself - therapeutic effect - means the dynamics in the development of a certain disease after the use of a certain therapeutic method. So far, none of these manufacturers have 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 product. In Russia, as in many European countries, fillers are registered as medical products (although their pharmacokinetics still prove that these fillers are closer to drugs, 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 not as scrupulous as when introducing 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 products, the components of which include a substance that is a drug or other biological active agent and affecting human body in addition to the impact medical device, belong to class 3".

So it’s difficult to talk about quality... And not only for me. Thus, according to MedicForum, over the past three years the number of complications with contour plastic surgery has tripled.

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

Well, counterfeit ones - everything is clear with that. The two main violations are contraband supplies and lack of registration with Roszdravnadzor.

It is not for nothing that Roszdravnadzor now also checks the serial number when checking cosmetology equipment (the practice of “catching” stolen cars from Europe has also come in handy in this department).

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

Poor quality medicines can be discussed using the example of drugs that are used for other purposes. For example, one drug that is recommended to cosmetologists as a means for rejuvenation, according to the instructions for use, is prescribed for the following diseases(according to ICD-10): B00.9 Herpetic infection unspecified, K70.0 Alcoholic fatty liver [fatty liver], K76.0 Fatty liver degeneration, not elsewhere classified, K76.9 Liver disease, unspecified, L20 Atopic dermatitis. The drug itself is quite possible and good if used according to indications, but prescribing it in a cosmetologist’s office does not in any way meet the requirements of the pharmacopoeial monograph.

Counterfeit drugs include: large group mesotherapy cocktails, which do not have drug registration, but are imported into the country as cosmetics for external use. Moreover, in this case, the law covers not only those who imported the mesococktail, but also those who conducted its clinical trials, although they did not have the right to do so.

Who can conduct such tests? They were established by Decree of the Government of the Russian Federation dated 09/03/2010 N 683 “On approval of the Rules for accreditation of medical organizations for the right to conduct clinical trials of medicinal products for medical use". And if you check the register of issued permits to conduct clinical trials of medicinal products for medical use (and such a register is maintained in accordance with the requirements of Order of the Ministry of Health and Social Development of the Russian Federation dated August 26, 2010 N 754n "On approval of the procedure for maintaining, publishing and posting on the official website in Internet), it turns out that some institutions 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 products in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical products. products.

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

By the way, there are also changes in legislation that came into force in 2015. They were introduced by the Decree of the Government of the Russian Federation dated January 5, 2015 “On Amendments to the Rules for the Sale of Certain Types of Goods.” We will present this part in full:

Information about medical products (instruments, devices, instruments, equipment, materials and other products used in 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 prevention, diagnosis, treatment and medical rehabilitation diseases, monitoring the condition of the human body, conducting medical research, restoration, replacement, change in anatomical structure or physiological functions organism, prevention or termination of 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 registration certificate for a medical product issued by the Federal Service for Surveillance in Healthcare in the prescribed manner, 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 Federal Law has introduced into the Code of Administrative Offenses:

Article 14.4.2. Violation of legislation on the circulation of medicines

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

Now it is added to it:

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

Well, now all we have to do is bring up new articles of the laws on criminal liability. We will not comment on them, we will only refer to the definition of what “treatment” is and we will highlight in italics the word “application”, which is directly related to cosmetologists. So, the Federal Law:

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

And this is from the Federal Law:

"The circulation of medical devices includes technical tests, toxicological studies, clinical trials, “examination” of the quality, effectiveness and safety of medical devices, their state registration, production, manufacturing, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of conformity, state control, storage, transportation, sales, 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. No comments needed for now:

Article 235.1. Illegal production of medicines and medical devices

1. Production of medicines or medical devices without a special permit (license), if such a permit (such license) is mandatory (mandatory), is punishable 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 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 - shall be punishable by imprisonment 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 wages or other income of the convicted person for a period of one to three years.

Note. Large size This article recognizes the cost of medicines or medical devices exceeding one hundred thousand rubles."

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

1. Production, 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 selling unregistered medicines or medical products, or the production, sale or import into the territory of the Russian Federation of counterfeit biologically active additives containing pharmaceutical substances not declared at state registration, committed on a large scale - is punishable by forced labor for a term of three to five years with deprivation of the right to hold certain positions or engage in certain activities for a term of up to three years or without it, or 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 income of the convicted person for a period of six months to two years or without it and with or without deprivation of the right to hold certain positions or engage in certain activities for a period of up to three years.

2. The same acts, if they: a) were committed by a group of persons by prior conspiracy or by an organized group; b) caused by negligence the infliction of serious harm to health or the death of a person, - shall be punishable by imprisonment 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 wages or other income of the convicted person for a period of one year to three years or without it and with or without deprivation of the right to hold certain positions or engage in certain activities for a period of up to five years.

3. Acts provided for in parts one or two of this article, resulting through negligence in the death of two or more persons, are punishable by imprisonment 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 other 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 toxic substances, as well as illegal production of narcotic drugs, psychotropic substances or their precursors.
2. In this article, a large amount is recognized as the cost of medicines, medical devices or dietary supplements 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. Manufacturing for the purpose of use or sale or use of deliberately counterfeit documents for medicines or medical devices (registration certificate, certificate or declaration of conformity, instructions for use of a medicine 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 wages or other income of the convicted person for a period of one to two years, or by forced labor for a term of up to three years, or by imprisonment for the same term.

2. Manufacturing for the purpose of use or sale or using knowingly counterfeit primary packaging and (or) secondary (consumer) packaging of a medicinal product - is punishable by a fine in the amount of five hundred thousand to one million rubles or in the amount of the wages or other income of the convicted person for a period of one year. one year to two years, or forced labor for a term of up to three years, or imprisonment for the same period.

3. Committing acts provided for in parts of the first or second of this article, organized by a 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.