Transportation of Medicinal Products

 

June 30, 2022

BRACE Law Firm ©

 

The transportation of medicinal products is an integral part of the circulation of medicinal products and is a licensed type of pharmaceutical activity. The significance of this standard procedure cannot be understated; failure to comply with requirements during transit may lead to the circulation of substandard medicinal products and significant losses for pharmaceutical organizations.

The primary regulatory documents governing medication transportation requirements include:

• Rules for Good Practice of Storage and Transportation of Medicinal Products for Medical Use, approved by Order of the Ministry of Health of the Russian Federation No. 646n dated August 31, 2016 (the "Rules for Storage and Transportation");
• Rules of Good Distribution Practice within the Eurasian Economic Union, approved by Decision of the Council of the Eurasian Economic Commission No. 80 dated November 3, 2016 (the "EAEU GDP Rules").

These rules apply to all medicinal product circulation entities (the "Pharma Organization"), specifically:

• manufacturers of medicinal products;
• wholesale organizations for medicinal products;
• pharmacy organizations;
• individual entrepreneurs holding a pharmaceutical license;
• medical organizations and their separate subdivisions (outpatient clinics, paramedic and obstetric stations, centers or departments of general medical or family practice) located in rural settlements where no pharmacy organizations exist.

This article examines who is entitled to transport medicinal products and the specific requirements for the transportation process.

Who Is Entitled to Transport Medicinal Products?

The transportation of medicinal products is a type of work comprising pharmaceutical activity and, pursuant to the Regulations on Licensing of Pharmaceutical Activity approved by Decree of the Government of the Russian Federation No. 1081 dated December 22, 2011 (the "Licensing Regulations"),[1] is subject to licensing.

Judicial practice confirms that for the independent delivery of medicinal products, a pharmacy organization must hold a pharmaceutical license specifying transportation as a type of work. This requirement also applies to transportation between a pharmacy’s own structural subdivisions.[2] In such cases, the regulatory authority will verify how the Pharma Organization performs this process, including compliance with requirements for vehicles and equipment. The list of control questions is included in the Checklists[3] used by Roszdravnadzor when exercising control over the circulation of medicinal products.

What if transportation is outsourced to a transport company? In accordance with Clause 6 of the Rules for Storage and Transportation, the Pharma Organization must define, agree upon, and monitor any transportation activity transferred to a third party to avoid discrepancies that could lead to unsatisfactory quality of medicinal products or work performed. Thus, the Pharma Organization bears responsibility for transportation activities even when outsourced.

To minimize the risks of violations, the Pharma Organization must verify the competence of its counterparty. This should be done as follows:

First, conduct a legal capacity check of the contractor and its ability to fulfill contractual obligations, ensuring the counterparty holds the necessary permits (including any license required under Russian legislation).

Whether a transport company must hold a pharmaceutical license remains a debated issue. On one hand, the Licensing Regulations list transportation as an independent type of pharmaceutical activity alongside "wholesale trade of medicinal products" and "retail trade of medicinal products". The necessity for all persons performing such activities to hold a license is supported by judicial practice[4] and Clause 6 of the Rules for Storage and Transportation. On the other hand, Roszdravnadzor has stated on its official website that a pharmaceutical license is not required for the sole purpose of transporting medicinal products. This argument is supported by the fact that the Licensing Regulations do not specify separate requirements for persons performing only transportation, implying this activity can only be licensed in conjunction with other types of pharmaceutical activity.

In this situation, pharmacy organizations are recommended to license this activity, as the absence of a transportation license for both the Pharma Organization and the transport company will be qualified as a violation in any event.[5]

It is also recommended to check the counterparty for:

• absence of tax and fee arrears;
• absence of pending liquidation or bankruptcy proceedings;
• absence of decisions by authorized state bodies to suspend activities;
• absence of criminal records for persons in management positions;
• absence of supplies of counterfeit, falsified, or substandard medicinal products;
• absence from the Register of Unscrupulous Suppliers.

In addition to legal capacity checks, the Rules for Storage and Transportation require an assessment of the counterparty's reliability and reputation, as well as its ability to fulfill the outsourcing agreement regarding experienced personnel, premises, and equipment.

Second, the outsourcing agreement must specify the duties of each party, the procedure for actions, and the responsibility of the parties (Clause 6 of the Rules for Storage and Transportation).

Third, the Pharma Organization must monitor and analyze the contractor's performance, including systematic checks of its authority and the implementation of necessary improvement measures (Clause 111 of the EAEU GDP Rules).

Failure to verify a counterparty is qualified by the regulatory authority as the performance of pharmaceutical activity with a gross violation of licensing requirements. For example, during an inspection, Roszdravnadzor found that transportation activities were outsourced to transport companies. However, at the time of the check, the Pharma Organization lacked documents confirming an assessment of the contractors' ability to fulfill obligations (availability of vehicles, ability to maintain temperature regimes). The outsourcing agreements lacked information on monitoring the carrier's compliance with transportation rules. Transit times were not monitored. The regulatory authority concluded that the outsourced transportation was not controlled. The Pharma Organization was held administratively liable under Part 4 of Article 14.1 of the CAO RF with a fine of 50,000 rubles.[6]

Requirements for the Transportation of Medicinal Products

The following requirements apply to the transportation of medications:

1. Transport and Equipment Requirements.

Specialized vehicles and equipment should be used for the transportation of medicinal products whenever possible. If non-specialized vehicles and equipment are used, procedures must be developed to ensure the quality of the medicinal products is maintained.

The vehicle must be equipped with all necessary systems. Pursuant to Clause 37 of the Rules for Storage and Transportation, such equipment includes:

• air conditioning systems;
• refrigeration chambers and/or refrigerators;
• access control systems;
• ventilation systems;
• equipment used for recording temperature and humidity. Equipment for maintaining and recording temperature regimes must be listed in the State Register of Measuring Instruments and undergo periodic maintenance, verification, and calibration.

When transporting thermolabile medicinal products, specialized equipment (isothermal packaging, containers) that maintains the required storage temperature regimes must be used. Coolant elements in isothermal containers must be placed to avoid direct contact with medications. The reuse of insufficiently cooled and/or damaged coolant elements is prohibited.

Vehicles and equipment must be kept clean and undergo cleaning as necessary in accordance with sanitary norms.

2. Packaging Requirements.

Transportation is carried out in containers selected by the Pharma Organization based on:

• requirements for storage and transportation conditions;
• the volume of transported medications;
• the duration of transportation;
• environmental conditions and possible temperature fluctuations.

The chosen packaging must not affect the quality or safety of the medicinal products and must provide reliable protection from environmental factors.

Transport packaging not intended for the final consumer must be labeled with the name, batch number, release date, number of secondary (consumer) packages, and the manufacturer's name and address, as well as the expiration date and storage/transportation conditions, including necessary warning labels and handling marks (Clause 71 of the Rules for Storage and Transportation).

3. Expiration Date Requirements.

When preparing for transportation, the residual shelf life of the medications must be agreed upon with the recipient. Upon request, the recipient must be provided with information regarding compliance with the temperature regime during transit.

4. Route Requirements.

The transportation route must be planned in advance based on a risk analysis and assessment. Medicinal products must be delivered to the address specified in the shipping documents.

5. Storage Condition Requirements.

Required storage conditions must be maintained throughout the entire transportation period. In the event of deviations, such as temperature violations or damage to medications during transit, this information must be reported to the sender and recipient.

In cases where transportation involves unloading and reloading or includes transit storage, proper environmental conditions and storage security at transit warehouses must be ensured. Measures must be taken to minimize the duration of temporary storage before the next stage of transportation.

Features of Transporting Specific Types of Medicinal Products

Requirements for transporting specific types of medicinal products are also contained in other regulatory acts.

The procedure for transporting immunobiological medicinal products is regulated by SanPiN 3.3686-21 Sanitary and Epidemiological Requirements for the Prevention of Infectious Diseases. The key requirement is maintaining the "cold chain" at all levels of transportation. Consequently, SanPiN 3.3686-21 details requirements for equipment supporting the "cold chain" (thermal containers, coolant elements, refrigerated trucks, etc.), temperature control equipment (thermal recorders, indicators, thermographs, etc.), and the registration of product arrivals and departures.

Pursuant to Article 21 of Federal Law No. 3-FZ dated January 8, 1998, On Narcotic Drugs and Psychotropic Substances, the right to transport narcotic drugs, psychotropic substances, and List I precursors is granted to legal entities holding a license for the circulation of such substances with an indication of transportation work.

Specific requirements for transporting narcotic drugs, psychotropic substances, and their precursors, including documentation, vehicles, and packaging, are determined by Decree of the Government of the Russian Federation No. 449 dated June 12, 2008.[7] All requirements aim to ensure security. Thus, during transportation, the following must be guarded by units of the National Guard, departmental guards of federal state bodies, or a legal entity licensed for private security:

• narcotic drugs and psychotropic substances listed in List I, as well as precursors;
• narcotic drugs and psychotropic substances listed in Lists II and III intended for further production, manufacturing (except for manufacturing by pharmacy organizations), processing, and distribution;
• narcotic drugs and psychotropic substances listed in Lists II and III sold to wholesale organizations or organizations storing them for emergency response or mobilization needs.

In other cases of transporting narcotic drugs and psychotropic substances from Lists II and III, the head of the legal entity decides on the necessity of security.

Vehicles must be enclosed, equipped with locking devices, and have space for persons responsible for transportation and security. An instruction on the transportation procedure must be developed, and for substances requiring guards, a specific route must be established.

The transportation of the pharmaceutical substance of ethyl alcohol (ethanol) is carried out in compliance with the requirements established by the fourth paragraph of Clause 3 of Article 9 of Federal Law No. 171-FZ dated November 22, 1995, On State Regulation of Production and Circulation of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products and on Restricting Consumption (Drinking) of Alcoholic Products.

Documentation of the Medication Transportation Procedure

Regulatory acts govern not only transportation requirements but also the quality system and documentation of the process.

First, the circulation entity must have an approved SOP "Transportation of Medicinal Products" and monitor compliance (Clause 3 of the Rules for Storage and Transportation). An SOP is a list of step-by-step actions to be performed. Developing SOPs aims to minimize violations by providing employees with clear algorithms instead of requiring them to study complex regulations.

The head of the Pharma Organization appoints a person responsible for implementing the quality system and updating SOPs. The duties of employees, including the responsible person, are fixed in job descriptions.

Second, a document analyzing and assessing potential risks during transportation must be developed (Clause 60 of the Rules for Storage and Transportation). This may be an internal order evaluating risks such as vehicle repairs, stops, long-distance transit, and transit storage.

Third, personnel must be briefed on the procedure for preparing isothermal containers and the reuse of coolant elements. It is recommended to maintain a briefing schedule and log.

Fourth, a procedure must be developed for actions and investigations in the event of deviations, such as temperature violations or product damage (Clause 124 of the EAEU GDP Rules).

Fifth, procedures for the maintenance and operation of vehicles and equipment, including cleaning and safety measures, must be regulated (Clause 125 of the EAEU GDP Rules).

The existence of these documents is subject to Roszdravnadzor’s control, and their absence is qualified as a violation of licensing requirements under Part 4 of Article 14.1 of the CAO RF.

Liability for Violation of Medication Transportation Rules

Violations of transportation rules may result in criminal, administrative, or civil liability.

Criminal liability may arise for violations regarding substances under special control: narcotics, psychotropic substances, potent substances, and poisonous substances under the following articles:

• Article 228 of the Criminal Code of the Russian Federation ("Illegal Acquisition, Storage, Transportation, Manufacturing, or Processing of Narcotic Drugs, Psychotropic Substances, or Their Analogs");
• Article 234 of the Criminal Code of the Russian Federation ("Illegal Circulation of Potent or Poisonous Substances for the Purpose of Sale");
• Article 228.2 of the Criminal Code of the Russian Federation ("Violation of Rules for the Circulation of Narcotic Drugs or Psychotropic Substances").

Administrative liability is the most common form of liability. Typically, such violations are qualified under Part 4 of Article 14.1 of the CAO RF as the performance of entrepreneurial activity with a gross violation of requirements. Fines include: for individual entrepreneurs—from 4,000 to 8,000 rubles or administrative suspension of activities for up to 90 days; for officials—from 5,000 to 10,000 rubles; for legal entities—from 100,000 to 200,000 rubles or administrative suspension of activities for up to 90 days.

For example, during an inspection, Roszdravnadzor found that a Pharma Organization failed to protect medicinal products from temperature extremes during loading, lacked specialized equipment (coolant elements, freezing equipment) for thermolabile products, failed to develop an SOP, and conducted no risk analysis. The organization was fined 50,000 rubles under Part 4 of Article 14.1 of the CAO RF.[8]

Additionally, practice includes liability under Article 14.43 of the CAO RF for violations of technical regulations by manufacturers or sellers. Fines range from 10,000 to 20,000 rubles for officials, 20,000 to 30,000 rubles for individual entrepreneurs, and 100,000 to 300,000 rubles for legal entities.

The carrier faces civil liability in the form of damages and penalties. Most disputes involve damages caused by improper transportation, often involving significant sums. For instance, a Pharma Organization sued a carrier for over 19 million rubles in damages after a customer refused medications due to temperature violations. The court granted the claim in full. The decisive factor was the carrier’s failure to provide temperature sensors or record readings during delivery. A temperature violation is grounds for declaring a medicinal product substandard and prohibiting its further use.[9]

Losses may also arise if a regulatory authority demands the destruction of medicinal products for which storage regimes were not maintained during transit.[10]

Finally, cases occur involving challenges to procurement documentation[11] and tender results. In one case, a Pharma Organization challenged tender results, arguing that requirements for the supplier to provide temperature indicator cards and transit documents from the manufacturer restricted competition. The court concluded that the customer’s requirements complied with Good Distribution Practice and dismissed the claim.[12]

In conclusion, strict compliance with medication transportation rules is essential. Judicial analysis shows that the risks of liability are high, and the penalties are significant. However, it should be noted that the regulatory acts governing transportation can be vague and use subjective terms, which complicates law enforcement practice.

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References

[1] Decree of the Government of the Russian Federation No. 1081 dated December 22, 2011, On Licensing of Pharmaceutical Activity.

[2] Resolution of the Sixteenth Arbitration Appeal Court No. 16AP-1388/20 dated May 28, 2020, in Case No. A63-172/2020.

[3] Order of the Federal Service for Surveillance in Healthcare No. 1185 dated February 19, 2022, On Approval of Checklist Forms used by the Federal Service for Surveillance in Healthcare and Its Territorial Bodies when Exercising Federal State Control (Surveillance) over the Circulation of Medicinal Products.

[4] Resolution of the Fifth Arbitration Appeal Court No. 05AP-6051/20 dated November 10, 2020, in Case No. A51-4172/2020.

[5] Decision of the Arbitration Court of the Sverdlovsk Region dated June 4, 2021, in Case No. A60-18195/2021.

[6] Resolution of the Seventeenth Arbitration Appeal Court No. 17AP-6953/19 dated July 2, 2019.

[7] Decree of the Government of the Russian Federation No. 449 dated June 12, 2008, On the Procedure for Transporting Narcotic Drugs, Psychotropic Substances, and Their Precursors on the Territory of the Russian Federation, and on the Execution of Documents Necessary for This Purpose.

[8] Resolution of the Twentieth Arbitration Appeal Court No. 20AP-865/18 dated April 1, 2018.

 [9] Resolution of the Ninth Arbitration Appeal Court No. 09AP-17750/22 dated April 22, 2022, in Case No. A40-171829/2021.

[10] Resolution of the Arbitration Court of the North Caucasus District No. F08-1210/21 dated March 4, 2021, in Case No. A32-38705/2020.

[11] Decision of the Office of the Federal Antimonopoly Service for the Perm Territory dated October 4, 2021.

[12] Resolution of the Fourteenth Arbitration Appeal Court No. 14AP-3865/20 dated June 23, 2020, in Case No. A52-5073/2019.