Legal Liability for Violation of Medicinal Product Storage Rules within the EAEU

June 10, 2022

BRACE Law Firm ©

Ensuring the quality, safety, and efficacy of medicinal products is a fundamental objective of state policy in the field of healthcare. One of the most critical stages in the circulation of medicinal products is their storage, as violations of storage conditions can lead to changes in the physico-chemical and pharmacological properties of preparations, rendering them ineffective or even dangerous for patients.

Within the Eurasian Economic Union (the "EAEU"), unified requirements for the storage of medicinal products have been established to ensure their quality throughout the entire distribution chain. This article examines the legal requirements for storage and the liability for their violation.

Regulatory Framework for Storage Rules

The storage of medicinal products in the Russian Federation is regulated by both national legislation and the acts of the EAEU. The key regulatory acts include:

• Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products.
• The Rules of Good Distribution Practice within the EAEU, approved by Decision of the Council of the Eurasian Economic Commission No. 80 dated November 3, 2016 (the "GDP Rules").
• The Rules of Good Storage and Distribution Practice for Medicinal Products for Human Use, approved by Order of the Ministry of Health of Russia No. 646n dated August 31, 2016.
• The Rules for the Storage of Medicinal Products, approved by Order of the Ministry of Health and Social Development of Russia No. 706n dated August 23, 2010.

According to these acts, entities engaged in the circulation of medicinal products (manufacturers, wholesalers, and pharmacies) must provide storage conditions that ensure the preservation of the quality, safety, and efficacy of the medicinal products.

Monitoring Compliance with Storage Rules

Roszdravnadzor (the Federal Service for Surveillance in Healthcare) exercises state control over compliance with medicinal product storage rules. During inspections, Roszdravnadzor officials verify:

1. The availability of premises suitable for storage and their compliance with technical requirements.
2. The presence of necessary equipment for maintaining and monitoring temperature and humidity conditions (refrigerators, air conditioners, hygrometers, thermometers).
3. Compliance with the storage conditions specified by the manufacturer on the primary and secondary packaging of the medicinal product.
4. The maintenance of logs for recording parameters of the storage environment.
5. The availability of Standard Operating Procedures (SOPs) regulating the storage process.

Legal Liability for Violations

Violations of medicinal product storage rules entail various types of legal liability depending on the severity and consequences of the offense.

Administrative Liability

Administrative liability is the most common consequence for violating storage rules. The Code of Administrative Offenses of the Russian Federation (the "CAO RF") contains several articles under which an organization or its officials may be held liable:

• Article 14.43 of the CAO RF: Violation of the requirements of technical regulations or mandatory requirements for products by a manufacturer, performer, or seller. This article is applied if the storage violation led to the circulation of substandard products.
• Article 14.1 of the CAO RF: Carrying out entrepreneurial activity in violation of the requirements and conditions provided for by a special permit (license). Since compliance with storage rules is a licensing requirement, its violation may be classified under this article.
• Article 19.7.8 of the CAO RF: Failure to provide information or providing deliberately false information to the body authorized to exercise state control in the field of healthcare. This may apply if an organization conceals facts of storage condition violations or provides false temperature logs.

Sanctions under these articles range from administrative fines to the administrative suspension of the organization's activities for up to 90 days.

Civil Liability

If a violation of storage rules led to the sale of a low-quality medicinal product that caused harm to a consumer's life or health, the victim has the right to demand compensation for damages. According to the Civil Code of the Russian Federation (the "Civil Code"), harm caused to a citizen's life or health as a result of structural, manufacturing, or other defects in a product is subject to full compensation by the seller or manufacturer, regardless of their fault.

Criminal Liability

In cases where a violation of storage rules leads to the circulation of a large volume of substandard or falsified medicinal products, or if such violation causes death or serious harm to health, criminal liability may arise.

• Article 238.1 of the Criminal Code of the Russian Federation: Circulation of falsified, substandard, or unregistered medicinal products.
• Article 238 of the Criminal Code of the Russian Federation: Production, storage, transportation, or sale of products that do not meet safety requirements.

Judicial Practice

Analysis of judicial practice shows that courts consistently support the position of Roszdravnadzor regarding the mandatory nature of storage requirements. Even minor deviations from the temperature regime or the absence of a calibration certificate for a measuring device are recognized as significant licensing violations.

In one case, an Arbitration Court upheld a fine against a wholesale organization for storing thermolabile medicinal products outside a refrigerator during the acceptance process. The court pointed out that the GDP Rules require maintaining the cold chain at all stages, including acceptance and loading.

In another instance, the Supreme Court of the Russian Federation confirmed the legality of bringing a pharmacy to administrative liability for failing to monitor humidity in the storage room. The court noted that the lack of proper documentation (logs) prevents the objective verification of compliance with storage conditions.

Conclusion

Compliance with medicinal product storage rules is not merely a bureaucratic requirement but a vital necessity for protecting public health. Legal entities and individual entrepreneurs must pay special attention to the technical equipment of their warehouses and pharmacies, as well as the training of personnel and the development of internal quality control systems. Given the tightening of control by Roszdravnadzor and the transition to EAEU standards, the risks associated with storage violations significantly increase both legally and reputationally.

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References

1. Decision of the Council of the Eurasian Economic Commission No. 80 dated November 3, 2016, On the Approval of the Rules of Good Distribution Practice within the Eurasian Economic Union.
2. Order of the Ministry of Health of Russia No. 646n dated August 31, 2016, On the Approval of the Rules of Good Storage and Distribution Practice for Medicinal Products for Human Use.
3. Letter of Roszdravnadzor No. 04I-1270/15 dated August 6, 2015, On Compliance with Legislation in the Activities of Pharmacy Organizations.
4. Ruling of the Supreme Court of the Russian Federation No. 309-AD17-19255 dated February 1, 2018.
5. Ruling of the Supreme Court of the Russian Federation dated June 1, 2017, in Case No. A56-52545/2016.