Administrative Liability in Connection with the Circulation of Medicinal Products, Medical Devices, and Dietary Supplements

 

June 29, 2022

BRACE Law Firm ©

 

Administrative liability is a form of legal liability for individuals and legal entities for committing unlawful, culpable acts (actions or omissions) in which the offender is subject to state coercive measures. Liability for such acts is provided for by the Code of Administrative Offenses of the Russian Federation (the "CAO RF"), as well as by the laws of the constituent entities of the Russian Federation on administrative liability.

Administrative liability for violations related to the circulation of medicinal products and medical devices can arise at virtually every stage of their circulation. Pursuant to Clause 1 of Article 1 of Federal Law No. 61-FZ dated April 12, 2010, On Circulation of Medicinal Products (the "Law No. 61-FZ"), the circulation of medicinal products includes development, preclinical studies, clinical trials, expertise, state registration, standardization and quality control, production, manufacturing, storage, transportation, import into the Russian Federation, export from the Russian Federation, advertising, dispensing, sale, transfer, use, and destruction of medicinal products.

Clause 3 of Article 38 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ") defines the concept of medical device circulation, which includes technical testing, toxicological studies, clinical trials, expertise of quality, efficiency, and safety of medical devices, their state registration, production, manufacturing, import into the Russian Federation, export from the Russian Federation, confirmation of conformity, storage, transportation, sale, installation, adjustment, application, operation, including maintenance as provided by the manufacturer’s (producer’s) regulatory, technical, and (or) operational documentation, as well as repair, disposal, or destruction.

General Grounds and Rules for Imposing Administrative Liability

Entities involved in the circulation of medicinal products, medical devices, and dietary supplements may be held liable under various forms of responsibility in the event of legislative violations, including criminal, administrative, and civil liability. Administrative liability is the most frequently applied form. This is due to the fact that companies engaged in the circulation of medicinal products, medical devices, and dietary supplements perform activities directly related to public health. Consequently, oversight of such organizations by control and supervisory authorities and holding them accountable for legislative violations are vital aspects of their functioning.

Often, administrative liability is imposed for the following violations:

• Violation of licensing legislation;
• Circulation of falsified, counterfeit, substandard, or unregistered medicinal products and medical devices, and the circulation of falsified dietary supplements;
• Production or sale of medicinal products without labeling, or the untimely submission of data to the system for monitoring the movement of medicinal products for medical use, or the submission of unreliable data thereto, etc.

The measure of liability depends directly on the elements of the offense and the consequences of the violation. Frequently, when imposing administrative liability, executive authorities act to prevent more serious offenses in cases where no actual harm has been caused to public health.

If it is necessary to establish all circumstances of an administrative offense requiring significant time for clarification, an administrative investigation is applied. The procedure for conducting an administrative investigation is defined in Article 28.7 of the "CAO RF", which provides that an administrative investigation is conducted in cases where, following the identification of an administrative offense in the field of legislation of the Russian Federation on the circulation of medicinal products, an expertise or other procedural actions requiring significant time are carried out, as well as in cases of administrative offenses provided for by Articles 6.1.1, 7.27, 13.41, and 20.6.1 of the "CAO RF". An administrative investigation constitutes a complex of time-consuming procedural actions aimed at clarifying all circumstances of the administrative offense, recording them, establishing the legal classification, and completing the procedural documentation. The conduct of an administrative investigation must consist of actual actions aimed at obtaining the necessary information, including by conducting an expertise, identifying victims and witnesses, and questioning persons residing in other localities.[1] At the same time, procedural actions performed in accordance with the norms of the Criminal Procedure Code of the Russian Federation within the framework of a preliminary investigation in a criminal case initiated against a person being held administratively liable, and subsequently terminated, do not constitute an administrative investigation.

Administrative Liability in Connection with the Circulation of Medicinal Products, Medical Devices, and Dietary Supplements

In general terms, administrative liability in connection with the circulation of medicinal products, medical devices, and dietary supplements can be presented in the following table:

No.	Article of the CAO RF	Violation	Sanction
1.	14.1	Engaging in entrepreneurial activity without state registration or without a special permit (license)	For engaging in entrepreneurial activity without registration: an administrative fine of 500 to 2,000 rubles.   For engaging in entrepreneurial activity without a license:   - For individuals: 2,000 to 2,500 rubles, with or without confiscation of manufactured products, production tools, and raw materials;   - For officials: 4,000 to 5,000 rubles, with or without confiscation of manufactured products, production tools, and raw materials;   - For legal entities: 40,000 to 50,000 rubles, with or without confiscation of manufactured products, production tools, and raw materials.
2.	6.28	Violation of established rules in the sphere of medical device circulation	Administrative fine:   - For individuals: 2,000 to 4,000 rubles;   - For officials: 5,000 to 10,000 rubles;   - For legal entities: 30,000 to 50,000 rubles.
3.	6.33	Circulation of falsified, counterfeit, substandard, and unregistered medicinal products and medical devices, and circulation of falsified dietary supplements	Administrative fine:   - For individuals: 70,000 to 100,000 rubles;   - For officials: 100,000 to 600,000 rubles;   - For individual entrepreneurs: 100,000 to 600,000 rubles or administrative suspension of activity for up to 90 days;   - For legal entities: 1 million to 5 million rubles or administrative suspension of activity for up to 90 days.
4.	6.34	Production or sale of medicinal products for medical use without identification means, or with violation of the established procedure for their application, or untimely entry of data into the medicinal product movement monitoring system, or entry of unreliable data	Production or sale without labeling:   - For officials: 5,000 to 10,000 rubles with confiscation of the objects of the offense;   - For legal entities: 50,000 to 100,000 rubles with confiscation of the objects of the offense.   Untimely entry of data or entry of unreliable information:   - For officials: 5,000 to 10,000 rubles;   - For legal entities: 50,000 to 100,000 rubles.
5.	14.16	Violation of the rules for the sale of ethyl alcohol, alcohol, and alcohol-containing products	Retail sale of ethyl alcohol (including ethanol API), alcohol-containing flavoring dietary supplements, or wine materials:   - For officials: 10,000 to 15,000 rubles with confiscation of products;   - For legal entities: 200,000 to 300,000 rubles with confiscation of products.
6.	14.3	Violation of advertising legislation	Violation of requirements for the advertising of medicinal products, medical devices, medical services (including treatment methods), and dietary supplements:   - For individuals: 2,000 to 2,500 rubles;   - For officials: 10,000 to 20,000 rubles;   - For legal entities: 200,000 to 500,000 rubles.
7.	14.4.2	Violation of legislation on the circulation of medicinal products	Violation of wholesale trade rules or retail sale procedures (except for cases under Art. 6.33 and Part 4 of this article):   - For individuals: 1,500 to 3,000 rubles;   - For officials: 5,000 to 10,000 rubles;   - For legal entities: 20,000 to 30,000 rubles.   Sale of products in violation of price mark-up limits:   - For officials: 250,000 to 500,000 rubles;   - For individual entrepreneurs and legal entities: double the amount of excess revenue obtained due to unlawful price inflation for the entire period of the violation (not exceeding one year).

Liability of Legal Entities and Their Officers

The activities of organizations engaged in the circulation of medicines, medical devices, and dietary supplements are inextricably linked with strict compliance with numerous regulatory documents, instructions, and rules for storage and transportation, as they can potentially impact human health. Consequently, the level of liability for such organizations is quite high. However, a legal entity or the head of an organization is not always held administratively liable. This is because a specific officer may commit the offense; if the employee's liability is specified in their employment contract or the employer's local act, that specific employee will be held administratively liable.

Pursuant to Clause 2 of Article 2.1 of the "CAO RF", a legal entity is found guilty of an administrative offense if it is established that it had the opportunity to comply with the rules and norms for the violation of which administrative liability is provided, but failed to take all measures within its power to ensure compliance. However, a legal entity shall not be subject to administrative liability for an offense for which an officer or other employee has been held administratively liable, provided the legal entity took all measures prescribed by the legislation of the Russian Federation to comply with the rules and norms.

Nevertheless, the imposition of an administrative penalty on a legal entity does not exempt the guilty individual from administrative liability for the same offense, just as holding an individual administratively or criminally liable does not exempt the legal entity from administrative liability for the same offense.

Regarding legal entities, liability arises if they failed to take all measures prescribed by the legislation of the Russian Federation to comply with the rules and norms. As for officers of pharmaceutical companies, the job description of the pharmaceutical employee plays an important role. Although there is no legislative obligation for an employer to draft such a document, it is often decisive in determining the employee's degree of guilt and the measure of liability. The rules for drafting a job description are not regulated by labor law norms, but generally, it should reflect: general provisions, job duties, rights, liability, etc. The more clearly a job description is drafted, the clearer the legal relationship between the employee and the employer will be, thereby allowing for the liability of not only the legal entity and its head but also the organization's employees.

Administrative Liability in the Sphere of Circulation of Medicinal Products for Veterinary Use

Medicinal products for veterinary use are a vital component affecting the life and health of animals surrounding humans. The life and health of humans themselves depend on the quality of these products and compliance with established norms for their application, as animals can become carriers and spreaders of various diseases. Given this circumstance, control in the sphere of circulation of medicinal products for veterinary use is a necessary means of ensuring vital activity.

Federal state control (supervision) in the sphere of circulation of medicinal products for veterinary use is carried out by the Federal Service for Veterinary and Phytosanitary Surveillance.[2]

Federal Law No. 336-FZ dated November 27, 2017, On Amendments to the Code of the Russian Federation on Administrative Offenses Regarding Counteracting the Circulation of Falsified, Counterfeit, Substandard, and Unregistered Medicinal Products for Veterinary Use, introduced Article 23.14.1 into the "CAO RF". Under this norm, the federal executive body exercising state control (supervision) in the sphere of circulation of medicinal products for veterinary use and its territorial bodies consider cases of administrative offenses provided for by Article 14.4.2 of the "CAO RF" (in the part concerning the circulation of medicinal products for veterinary use).

The following persons are authorized to consider administrative offense cases in this regard:

1. The head of the federal executive body exercising state control (supervision) in the sphere of circulation of medicinal products for veterinary use and their deputies;
2. The heads of territorial bodies of the federal executive body exercising state control (supervision) in the sphere of circulation of medicinal products for veterinary use and their deputies.

Applying this norm, executive authorities hold entrepreneurs administratively liable. For example, an individual entrepreneur was held administratively liable by a decision of the Department of Rosselkhoznadzor for the Kirov Region, the Udmurt Republic, and the Perm Territory. As a result of the case review, the individual entrepreneur was sentenced to an administrative fine of 4,000 rubles and the goods were confiscated.[3]

Distinction Between Administrative and Criminal Liability

Depending on the consequences, the liability of pharmaceutical organizations and their employees can be administrative or criminal. An act committed by employees of pharmaceutical organizations that triggers criminal liability must possess all elements of a crime as provided for by the Criminal Code of the Russian Federation.

In the context of violations related to the circulation of medicinal products, medical devices, and dietary supplements, the elements of a criminal offense are:

• Object (life and health of the patient);
• Subject (e.g., a pharmaceutical worker who committed the crime);
• Objective side (the unlawful action of the worker and its consequences);
• Subjective side (proven guilt, often of a mixed nature). Guilt in this case may take the form of direct or indirect intent.

Criminal liability arises only if all four elements of the crime listed above are present. If at least one element is missing, criminal liability does not arise. Furthermore, criminal liability is imposed only for offenses expressly provided for by the Criminal Code of the Russian Federation.

If liability under criminal legislation does not arise, the guilty parties are generally held administratively liable.

The imposition of administrative liability is, in essence, a prevention of offenses that could affect the life and health of citizens. The main criterion for distinguishing administrative liability from criminal liability is that criminal liability arises when harm to life and health has already been caused by the unlawful acts of pharmaceutical employees.

Article 14.1 of the "CAO RF" and Article 235 of the Criminal Code of the Russian Federation both provide for liability for engaging in pharmaceutical activities without a special permit (license). However, these articles, which are similar in composition, differ in that the criminal legislation contains the critical addition: "if this has resulted in the negligent cause of harm to human health or death". This is the distinction between administrative and criminal liability: in the first case, the proven fact alone is sufficient for liability to arise; in the second, the cause of harm to health or the death of a person is a necessary condition for liability.

Violation of Legislation on the Circulation of Medicinal Products

Pursuant to Article 14.4.2 of the "CAO RF", an administrative fine is provided for the violation of established rules for the wholesale trade of medicinal products and the procedure for the retail sale of medicinal products. The rules for wholesale trade and the procedure for retail sale are provided for by Articles 54 and 55 of the "Law No. 61-FZ", respectively.

Liability for the violation of established rules and procedures was introduced into the "CAO RF" in 2013 by Federal Law No. 317-FZ dated November 25, 2013, On Amendments to Certain Legislative Acts of the Russian Federation and the Recognition as Void of Certain Provisions of Legislative Acts of the Russian Federation on Health Protection of Citizens in the Russian Federation.

Liability under Article 14.4.2 of the "CAO RF" is encountered quite frequently. For instance, a limited liability company was held administratively liable for the systematic non-prescription dispensing of codeine-containing medicinal products to minors. Following the review of the case, a penalty in the form of a fine of 30,000 rubles was imposed.[4]

Administrative Liability for the Unlawful Circulation of Falsified, Counterfeit, Substandard, and Unregistered Medicinal Products, Medical Devices, and the Circulation of Falsified Dietary Supplements

On January 23, 2015, Federal Law No. 532-FZ dated December 31, 2014, On Amendments to Certain Legislative Acts of the Russian Federation Regarding Counteracting the Circulation of Falsified, Counterfeit, Substandard, and Unregistered Medicinal Products, Medical Devices, and Falsified Dietary Supplements (the "Law No. 532-FZ") entered into force, introducing significant changes to the legislation regarding the circulation of these products.

The definitions of falsified, substandard, and counterfeit medicinal products are reflected in Article 4 of the "Law No. 61-FZ", according to which:

• Falsified medicinal product: a medicinal product accompanied by false information about its composition and (or) manufacturer;
• Substandard medicinal product: a medicinal product that does not meet the requirements of the pharmacopoeial monograph or, in its absence, the requirements of the regulatory documentation or regulatory document;
• Counterfeit medicinal product: a medicinal product in circulation in violation of civil legislation.

Falsified, substandard, and counterfeit medical devices are defined by the norms of Article 38 of the "Law No. 323-FZ", based on which:

• Falsified medical device: a medical device accompanied by false information about its characteristics and (or) manufacturer (producer);
• Substandard medical device: a medical device that does not meet the safety and efficiency requirements for medical devices, requirements for their labeling, regulatory, technical, and operational documentation, and which cannot be safely used for its intended purpose as established by the manufacturer (producer);
• Counterfeit medical device: a medical device in circulation in violation of civil legislation.

Pursuant to Article 1 of Federal Law No. 29-FZ dated January 2, 2000, On Quality and Safety of Food Products, dietary supplements are categorized as food products. At the same time, falsified dietary supplements are supplements that are intentionally altered (fake) and (or) have hidden properties and quality and (or) information about which is knowingly incomplete and (or) unreliable.

The main changes regarding administrative liability in the sphere of circulation of falsified, counterfeit, substandard, and unregistered medicinal products, medical devices, and the circulation of falsified dietary supplements were introduced by Article 4 of the "Law No. 532-FZ". Chapter 6 of the "CAO RF" was supplemented with Article 6.33, titled Circulation of Falsified, Counterfeit, Substandard, and Unregistered Medicinal Products, Medical Devices, and Circulation of Falsified Dietary Supplements, which defines the measure of administrative liability for the specified offenses.

The object of the offense under Article 6.33 of the "CAO RF" is public relations in the field of circulation of medicinal products, medical devices, and dietary supplements.

The objective side of the offense under Part 1 of the article includes:

• Production, sale, or import into the Russian Federation of falsified medicinal products;
• Production, sale, or import into the Russian Federation of falsified medical devices;
• Sale or import into the Russian Federation of counterfeit medicinal products;
• Sale or import into the Russian Federation of counterfeit medical devices;
• Circulation of falsified dietary supplements.

Exceptions include actions that do not constitute a criminally punishable act and cases provided for by Part 3 of Article 6.33 of the "CAO RF".

The subjects of the offense are individuals, officials, individual entrepreneurs, and legal entities.

Regarding the subjective side of the offense, it can be committed either intentionally or through negligence.

The measure of liability under this article is the imposition of an administrative fine:

• For individuals: 70,000 to 100,000 rubles;
• For officials: 100,000 to 600,000 rubles;
• For individual entrepreneurs: 100,000 to 600,000 rubles or administrative suspension of activity for up to 90 days;
• For legal entities: 1 million to 5 million rubles or administrative suspension of activity for up to 90 days.
• The objective side of the offense under Part 2 of Article 6.33 of the "CAO RF" includes:
• Sale or import into the Russian Federation of substandard medicinal products;
• Sale or import into the Russian Federation of substandard medical devices;
• Unlawful production, sale, or import into the Russian Federation of unregistered medicinal products.

Similar to Part 1, exceptions apply to actions that do not constitute a criminally punishable act and cases provided for by Part 3 of Article 6.33 of the "CAO RF".

The objective side of the offense under Part 3 of Article 6.33 of the "CAO RF" includes:

• Sale of falsified, counterfeit, substandard, or unregistered medicinal products, or falsified dietary supplements;
• Sale of falsified, counterfeit, or substandard medical devices committed using mass media or information and telecommunications networks, including the Internet.

The measure of liability under Parts 2 and 3 of Article 6.33 of the "CAO RF" also varies among the subjects of the offense.

For example, in a case considered by an arbitration court, Rospotrebnadzor filed an application against an LLC to hold it administratively liable under Part 1 of Article 6.33 of the "CAO RF" with an administrative penalty of a 1 million ruble fine. During a planned on-site inspection, it was established that a sample of dietary supplements contained "tadalafil", a pharmaceutical substance not declared during state registration. Tadalafil is a synthetic phosphodiesterase-5 inhibitor, is not an essential nutritional factor, and is prohibited for use in dietary supplements and food. The courts established that the company violated Article 1 of Federal Law No. 29-FZ dated January 2, 2000, Clause 1.4 of Appendix 7 of TR CU 021/2011, Article 4 of TR CU 022/2011, Clauses 2.2 and 7.4.3 of SanPiN 2.3.2.1290-03, and Clauses 4.11 and 4.17 of MUK 2.3.2.721-98.[5]

If the sale and (or) import of unregistered medicinal products or medical devices is permitted in accordance with the legislation on the circulation of medicinal products and health protection legislation, and (or) said products/devices are not manufactured in the Russian Federation, and (or) they are recommended for use by the World Health Organization, then the actions provided for by Part 2 or 3 do not constitute an administrative offense.

In addition to the legal norms reflected in the "CAO RF", the legislation expressly provides for prohibitions on actions related to medicinal products. For example, pursuant to Clause 5 of Article 47 of the "Law No. 61-FZ", the import of falsified, substandard, and counterfeit medicinal products into the Russian Federation is prohibited. Furthermore, falsified and substandard medicinal products are subject to seizure and subsequent destruction or export from the Russian Federation, while counterfeit medicinal products are subject to seizure and subsequent destruction.[6]

Additionally, the sale of falsified, substandard, and counterfeit medicinal products is prohibited.[7]

Legislation also provides for the possibility of withdrawal from circulation. For example, substandard and falsified medicinal products are subject to withdrawal from circulation and destruction in the manner established by the Government of the Russian Federation. The basis for the destruction of medicinal products is a decision by the owner, the relevant authorized federal executive body, or a court.[8]

Counterfeit medicinal products are subject to withdrawal from circulation and destruction by court decision. The procedure for the destruction of counterfeit medicinal products is established by the Government of the Russian Federation.[9]

Administrative Liability for the Production or Sale of Medicinal Products Without Labeling or Untimely Entry of Data into the Monitoring System

Pursuant to Decree of the Government of the Russian Federation No. 515 dated April 26, 2019, On the System of Labeling Goods by Identification Means and Traceability of the Movement of Goods, the labeling of goods is carried out by generating and applying identification means (machine-readable labeling codes) to the goods, their packaging, or another material carrier intended for identification means at the sites of their production, packaging (repackaging), or storage. The labeling of medicinal products is carried out in accordance with the requirements of Article 46 of the "Law No. 61-FZ".

In addition to labeling, information regarding the movement of a medicinal product must be entered into the system for monitoring the movement of medicinal products for medical use. This system is a federal state information system for monitoring the movement of medicinal products for medical use from the manufacturer to the final consumer using identification means.[10]

The production or sale of medicinal products for medical use without identification means, or in violation of the established procedure for their application, or the untimely entry of data into the medicinal product movement monitoring system, or the entry of unreliable data constitutes an administrative offense under Article 6.34 of the "CAO RF". This article consists of two parts with different offense elements. Part 1 of Article 6.34 provides for administrative liability for violating labeling rules during production or sale, or violating the procedure for applying identification means. Under Part 2 of this article, the offense is the untimely entry of data into the monitoring system or the entry of unreliable data.

Liability under Article 6.34 of the "CAO RF" applies to officials and legal entities. In the case of Part 1, liability includes the confiscation of the objects of the administrative offense.

The provisions of Article 6.34 of the "CAO RF" (in the version effective at the time the violation was identified) provide for the untimely entry of data into the monitoring system or the entry of unreliable data. Cases under Article 6.34 of the "CAO RF" also occur where the party found guilty of an administrative offense disagrees with the supervisory authority's decision and applies to an arbitration court to resolve the dispute.

For example, in one case, it was established that the storage of the medicinal product "Gam-COVID-Vac" with unique labeling codes took place. Information regarding the receipt of the product was entered by the medical organization into the MDLP System 31 days after the actual delivery. In violation of Part 7 of Article 67 of the "Law No. 61-FZ", the LLC failed to ensure the timely entry of information into the MDLP System. No evidence confirming that the LLC took measures to comply with the legislation or prevent/eliminate the identified violations prior to the discovery date was presented during the case review or the appeal.[11]

Administrative Liability for Violation of the Rules of Medical Device Circulation

The concept of "circulation of medical devices" is defined by Clause 3 of Article 38 of the "Law No. 323-FZ". Furthermore, regarding the circulation of medical devices intended for use in combat, emergency situations, prevention of emergencies, and the treatment of diseases posing a danger to others or those resulting from unfavorable chemical, biological, or radiation factors, the provisions of Decree of the Government of the Russian Federation No. 430 dated April 3, 2020, On the Specifics of the Circulation of Medical Devices, Including the State Registration of a Series (Batch) of a Medical Device, are taken into account.

Administrative liability for the violation of established rules in the sphere of medical device circulation is established by Article 6.28 of the "CAO RF" and entails an administrative fine:

• For individuals: 2,000 to 4,000 rubles;
• For officials: 5,000 to 10,000 rubles;
• For legal entities: 30,000 to 50,000 rubles.

The object of the offense in this case is public relations arising in the sphere of public health protection.

The objective side of this article is the violation of established rules in the sphere of medical device circulation, provided these actions do not constitute a criminally punishable act. Criminally punishable acts in this regard are provided for by the Criminal Code of the Russian Federation under Article 235.1 (Unlawful Production of Medicinal Products and Medical Devices) and Article 238.1 (Circulation of Falsified, Substandard, and Unregistered Medicinal Products and Medical Devices, and Circulation of Falsified Dietary Supplements).

The subjects of the offense are:

• An individual who has reached the age of 16;
• An official;
• A legal entity.

Regarding the subjective side, the offense can be committed either intentionally or through negligence.

Often, guilty parties do not agree with the supervisory authority's decision to impose administrative liability and appeal it in court. However, when considering such cases, courts generally leave the decisions of control authorities unchanged, with the payment of fines for violations of the legislation of the Russian Federation.[12]

Engaging in Entrepreneurial Activity Without State Registration or a Special Permit (License)

One of the most common violations of law related to the circulation of medicinal products and medical devices is engaging in entrepreneurial activity without state registration or a special permit (license). For example, pursuant to Clauses 17 and 47 of Article 12 of Federal Law No. 99-FZ dated May 4, 2011, On Licensing of Certain Types of Activities, the maintenance of medical devices and pharmaceutical activities are subject to licensing.

Engaging in entrepreneurial activity without a special permit (license), when such a permit (license) is mandatory, entails an administrative fine:

• For individuals: 2,000 to 2,500 rubles, with or without confiscation of manufactured products, production tools, and raw materials;
• For officials: 4,000 to 5,000 rubles, with or without confiscation of manufactured products, production tools, and raw materials;
• For legal entities: 40,000 to 50,000 rubles, with or without confiscation of manufactured products, production tools, and raw materials.[13]

As an example where a legal entity was held liable for lacking a reissued pharmaceutical license, a police department applied to an arbitration court to hold an LLC administratively liable under Article 14.1 of the "CAO RF". During inspections at a pharmacy, department employees identified the storage and sale of medicinal products by the LLC in the absence of a license for pharmaceutical activity. The arbitration court found that the evidence proved the elements of the administrative offense, saw no grounds to classify it as minor, and fined the LLC 40,000 rubles.[14] Possession of a pharmaceutical license signifies that the legal entity has passed all relevant procedures, and the executive body responsible for licensing has verified the entity's compliance with all requirements for such activity. In essence, a license held by a pharmaceutical company serves as a guarantee of safety for the final consumer.

Administrative liability in connection with the circulation of medicinal products, medical devices, and dietary supplements is a vital element in providing high-quality medical care to citizens. This is due to the direct correlation between the quality of these products and the results of patient treatment. Consequently, the relevant executive bodies conduct control and audit activities, identify violations, and hold the respective parties administratively liable. Administrative liability arises only if the offense does not show signs of a criminally punishable act.

The established practice of court reviews of administrative liability cases for legislative violations during the circulation of medicinal products, medical devices, and dietary supplements demonstrates the importance of legislative changes in this field. Despite the understanding of the link between product quality and patient outcomes, and the severity of the sanctions applied, violations in this sphere do not decrease.

Given that human lives may depend on the quality of the medicinal products, medical devices, and dietary supplements used, the imposition of administrative liability plays a crucial role in the work of supervisory authorities.

_____________

References

[1] Resolution of the Plenum of the Supreme Court of the Russian Federation No. 5 dated March 24, 2005, On Certain Issues Arising for Courts in the Application of the Code of the Russian Federation on Administrative Offenses.

[2] Decree of the Government of the Russian Federation No. 327 dated June 30, 2004, On the Approval of the Regulations on the Federal Service for Veterinary and Phytosanitary Surveillance.

[3] Decision of the Arbitration Court of the Udmurt Republic dated August 19, 2021, in Case No. A71-10511/2021.

[4] Appellate Ruling of the Voronezh Regional Court dated January 22, 2019, in Case No. 33-321/2019.

[5] Decree of the Arbitration Court of the Moscow District dated November 3, 2020, No. F05-16322/2020 in Case No. A40-5109/2020.

[6] Clause 6 of Article 47 of the "Law No. 61-FZ".

[7] Ibid., Article 57.

[8] Ibid., Clause 1 of Article 59.

[9] Ibid., Clause 2 of Article 59.

[10] Ibid., Clause 56 of Article 4.

[11] Decision of the Koptevo District Court of Moscow dated April 27, 2022, No. 12-297/2022.

[12] Decision of the Arbitration Court of the Krasnoyarsk Territory dated July 9, 2021, in Case No. A33-1873/2021.

[13] Clause 2 of Article 14.1 of the "CAO RF", Engaging in Entrepreneurial Activity Without State Registration or a Special Permit (License).

[14] Decree of the Arbitration Court of the Volga-Vyatka District dated December 27, 2019, No. F01-7255/2019 in Case No. A43-21645/2019.