Import of Medicinal Products to Russia: Legal Regulations

April 19, 2023

BRACE Law Firm ©

Despite the obvious successes of the import substitution policy implemented in Russia in recent years, domestic manufacturers of medicinal products cannot fully meet the needs of the Russian market. A portion of the necessary drugs and pharmaceutical substances has to be imported from foreign countries. At the same time, the movement of medicinal products across the border is a complex procedure that is strictly regulated by the norms of specialized legislation and customs legislation.

This article examines the rules that legal entities and individuals need to know when importing medicinal products to minimize the risks of being held criminally or administratively liable.

Regulatory Regulation of the Import of Medicinal Products

The main documents regulating the rules for importing medicinal products into Russia are Federal Law No. 61-FZ dated April 12, 2010, "On the Circulation of Medicinal Products" (hereinafter, the "Law on Circulation of Medicinal Products") and Decree of the Government of the Russian Federation No. 853 dated June 1, 2021, "On the Procedure for Importing Medicinal Products for Medical Use into the Territory of the Russian Federation" (hereinafter, "Decree No. 853"), adopted in furtherance thereof.

In accordance with the specified regulatory acts, a limited number of entities possess the right to import medicinal products:

• Manufacturers of medicinal products – for the purposes of their own production;
• Organizations engaged in the wholesale trade of medicinal products.

Based on a permit from the Ministry of Health of Russia, the following are also endowed with such a right:

• Foreign developers and foreign manufacturers of medicinal products – for conducting clinical trials, carrying out expertise and state registration of a medicinal product, including a pharmaceutical substance in the State Register of Medicinal Products (GRLS), and quality control of medicinal products;
• Scientific research organizations, educational organizations of higher education, manufacturers of medicinal products – for development, research, and control of the safety, quality, and efficacy of medicinal products;
• Medical and other aforementioned organizations – for providing medical care based on life-saving indications for a specific patient or a limited group of patients with rare and/or particularly severe pathology;
• State unitary enterprises determined by the Government of Russia – for the purpose of importing unregistered narcotic drugs or psychotropic substances for providing medical care based on life-saving indications for a specific patient or group of patients.

Which Medicinal Products are Prohibited for Import?

According to Part 5 of Article 47 of the Law on Circulation of Medicinal Products, the import into the Russian Federation of the following is prohibited:

• Falsified medicinal products (i.e., accompanied by false information about their composition and/or manufacturer);
• Substandard medicinal products (i.e., not complying with the requirements of a pharmacopoeial monograph or, in its absence, the requirements of normative documentation or a normative document);
• Counterfeit medicinal products (i.e., those in circulation in violation of civil legislation).

Such products are subject to seizure and destruction or export from the country at the expense of the person who carried out their import.

The quality of imported medicinal products must be confirmed by a certificate from their manufacturer certifying compliance with the requirements of pharmacopoeial monographs or, in their absence, normative documentation.

Procedure for Importing Medicinal Products

As a general rule established by Part 2 of Article 47 of the Law on Circulation of Medicinal Products, imported medicinal products must be contained in the State Register of Medicinal Products (hereinafter, "GRLS").

By special permit of the Ministry of Health of Russia, the importation of the following is allowed:

• A specific batch of unregistered and registered medicinal products for conducting clinical trials of medicinal products, conducting expertise and state registration, quality control, as well as for providing medical care based on life-saving indications for a specific patient or a limited group of patients with rare and/or particularly severe pathology;
• A specific batch of unregistered medicinal products containing narcotic drugs or psychotropic substances for providing medical care based on life-saving indications for a specific patient or group of patients;
• Medicinal products registered in the territory of Russia in packaging intended for circulation in foreign countries, in the event of a shortage of medicinal products or the risk of its occurrence due to the introduction of restrictive economic measures against the Russian Federation.

Below, we examine the specifics of importation on each of the indicated grounds.

Specifics of Importing Medicinal Products for Clinical Trials, Expertise, Registration, and Provision of Medical Care Based on Life-Saving Indications

The import of medicinal products for conducting clinical trials, registration and expertise of medicinal products, inclusion of a pharmaceutical substance in the GRLS, quality control of medicinal products, as well as unregistered medicinal products for providing medical care, may be carried out only based on a conclusion (permit) from the Ministry of Health of Russia.

To obtain it, the applicant submits an application to the Ministry of Health in the form of an electronic document via the "Unified Portal of State Services," indicating information about the medicinal product or pharmaceutical substance planned for import. Supporting documents are attached to it:

• Draft conclusion;
• Justification of the quantity of imported medicinal products. The justification is presented in the form of extracts from the industrial regulation, normative documentation, references to pharmacopoeial monographs, calculations by an expert institution, or other documents confirming the necessity of importing the medicinal product in the declared volume depending on the purpose of import;
• Copies of the contract or other document confirming the intentions of the parties;
• Copies of documents confirming the quality of the medicinal product issued by the manufacturer or authorized organization, indicating the characteristics and place of its production.

Additionally, other documents determined by the purpose of the import of medicinal products are provided.

When importing for conducting clinical trials:

• Mock-ups or photographs of packaging confirming the labeling of medicinal products "exclusively for use in clinical trials".

When importing for providing medical care to patients based on life-saving indications:

• Copy of the patient's passport or birth certificate;
• Medical documents of the patient – in case of import for providing medical care based on life-saving indications.

According to Decree No. 853, the following may be provided as such documents: a protocol of the conclusion of a medical commission of a regional medical institution or a consilium of doctors of a federal institution where medical care is provided to the patient or an appeal from the healthcare management body of the constituent entity with an attached copy of the protocol of the decision of the medical commission or consilium of doctors or a decision of the expert council of the Foundation for the Support of Children with Severe Life-Threatening and Chronic Diseases "Circle of Kindness" regarding a specific citizen with a severe life-threatening and chronic disease whom the Foundation provides with medicinal products.

In case of importing a medicinal product for providing medical care to a limited group of patients with rare and/or particularly severe pathology:

• Copy of the decision of the expert council of the "Circle of Kindness" Foundation on the formation of a reserve of medicinal products for the purpose of immediate provision to an undefined group of children with orphan diseases.

Within 5 business days from the date of receipt of the documents, the Ministry of Health makes a decision to issue a conclusion or a decision to refuse with an indication of the reasons for refusal. The grounds for refusal are the following circumstances:

• The application was submitted by an unauthorized legal entity;
• Presence of incomplete or unreliable information in the documents;
• The medicinal product declared for import is prohibited for medical use in the territory of the Eurasian Economic Union.

Refusal to issue a conclusion does not prevent the re-submission of documents after the elimination of the reasons for refusal.

The conclusion or decision to refuse is sent to the applicant's personal account on the Public Services Portal. The Ministry of Health maintains a register of issued conclusions in electronic form. Information contained in the conclusions is submitted to the customs authorities weekly, no later than the first working day of the calendar week.

Organizations that have imported medicinal products intended for providing medical care shall notify the Ministry of Health of Russia thereof within 10 business days from the date the medicinal products are received by the medical organization where medical care is provided to the patient.

Specifics of Importing Narcotic Medicinal Products and Psychotropic Substances

The import of medicinal products containing narcotic and psychotropic substances is carried out in accordance with Federal Law No. 3-FZ dated January 8, 1998, "On Narcotic Drugs and Psychotropic Substances" and Decree of the Government of the Russian Federation No. 181 dated March 21, 2011, "On the Procedure for Import into the Russian Federation and Export from the Russian Federation of Narcotic Drugs, Psychotropic Substances and Their Precursors" (hereinafter, "Decree No. 181").

Permit documents must be obtained for import, which vary depending on the country from which the export is made. If the import is carried out while conducting foreign trade activities with EAEU states, it will be necessary to obtain:

• A permit from the Ministry of Internal Affairs of the Russian Federation;
• A certificate from the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

When importing from the territory of other countries, a one-time license from the Ministry of Industry and Trade of Russia is additionally issued.

regarding unregistered narcotic medicinal products and psychotropic substances, the procedure for their import is established by Decree of the Government of the Russian Federation No. 230 dated March 5, 2020 [1]. It will be valid until December 31, 2023.

The conditions for import are:

• The existence of a decision of the medical commission of a medical organization regarding the ineffectiveness or impossibility of using registered medicinal products by the patient, and regarding the necessity of importing a specific unregistered medicinal product;
• The import of such a medicinal product is dictated by life-saving indications for a specific patient or group of patients;
• The medicinal products are included in the list approved by the Ministry of Health of Russia.

The list of diseases (conditions), as well as drugs permitted for import, was approved by Order of the Ministry of Health of Russia No. 80n dated February 13, 2020 [2]. Currently, it contains only 3 diseases (conditions): epilepsy, status epilepticus, and palliative care, and 2 names of medicinal products: Lorazepam solution in ampoules and Phenobarbital elixir, solution for injection.

To provide for these categories of patients, regional healthcare bodies form a consolidated application for a batch of narcotic or psychotropic medicinal products, if necessary with a 25 percent increase to form a reserve, submit it to the Ministry of Industry and Trade of Russia and the Ministry of Health of Russia, and also inform about the unclaimed quantity. The Ministry of Industry and Trade ensures the monitoring of received applications and the distribution of the purchased batch among the constituent entities of the Russian Federation.

The direct import of drugs is carried out by the Federal State Unitary Enterprise "Moscow Endocrine Plant". For import, permit documents provided for by Decree No. 181 must also be obtained.

Specifics of Importing Medicinal Products in Case of Shortage or Risk Thereof

In connection with the introduction of economic sanctions against Russia, until December 31, 2024, the import of registered medicinal products in packaging intended for circulation in foreign countries is permitted. This is possible only in the event of a shortage of medicinal products or the risk of its occurrence due to restrictive measures.

Let us clarify that the concept of "shortage" (defectura) is not directly defined in either the Law on Circulation of Medicinal Products or in the Decrees of the Government of Russia. In practice, shortage is understood as the absence of medicinal products.

The specifics of importing medicinal products are regulated by Decree of the Government of the Russian Federation No. 593 dated April 5, 2022 (hereinafter, "Decree No. 593") [3].

The import of medicinal products is allowed based on the conclusion of an interdepartmental commission created under the Ministry of Health of Russia regarding the presence of a shortage or the risk of its occurrence. To obtain it, it is necessary to submit an application and the documents listed in Clause 36 of Decree No. 593 to the Ministry of Health of Russia.

Import conditions:

• The medicinal product must comply with the requirements established during registration, with the exception of requirements for primary and secondary (consumer) packaging;
• A self-adhesive label containing information about the drug in Russian must be affixed to the consumer and primary packaging;
• Each package of the series (batch) of the medicinal product must be accompanied by instructions for medical use translated into Russian, approved by the authorized body of the manufacturing country or the marketing authorization holder;
• Marking (two-dimensional barcode) must be applied to the secondary packaging.

Furthermore, Decree No. 593 allows, upon establishing a shortage or the risk thereof, the import of a specific batch of medicinal products unregistered in the territory of Russia, provided that:

• This drug is authorized for medical use in the territory of foreign states by the relevant authorized bodies;
• There are analogues registered in the Russian Federation by international nonproprietary name.

To import such a drug, it is required to obtain a permit from the Ministry of Health of Russia for temporary circulation, which is issued based on a conclusion regarding the presence of a shortage. To obtain it, the applicant must submit an application and the package of documents listed in Clause 24 of Decree No. 593.

Within 10 business days from the day of receipt of the documents, the Ministry of Health makes a decision to grant or refuse to grant the permit. The register of issued permits is posted on the official website of the Ministry of Health of Russia on the "Internet".

The imported medicinal product must also have instructions for medical use in Russian, a self-adhesive label with information about the medicinal product in Russian, and identification means.

Customs Clearance and Documents Necessary for Import

When importing medicinal products for commercial use, a customs declaration must be processed – a document containing information about the imported goods. It will also be necessary to provide the following documents to the customs authorities:

• Contract (international contract) confirming the fact of purchase and sale, the subject of the contract, the value of the goods, and the liability of the parties;
• Invoice (bill for payment);
• Transport documents;
• Certificate from the manufacturer of the medicinal product certifying the compliance of the imported medicinal product with the requirements of the pharmacopoeial monograph or normative documentation;
• Permit documents from the Ministry of Health of Russia for the import of a specific batch of the medicinal product (if required in accordance with the Law on Circulation of Medicinal Products);
• Other documents that may be required to confirm the transaction and customs declaration.

Import of Medicinal Products for Personal or Other Non-Commercial Use

Article 50 of the Law on Circulation of Medicinal Products establishes a list of cases where the import of medicinal products, including unregistered ones, is allowed without special permits and without compliance with the procedures discussed above.

A simplified import regime for medicinal products is established in the following cases:

• For personal use by individuals (exception – medicinal products containing potent or poisonous substances included in the List of Potent Substances and the List of Poisonous Substances for the purposes of the criminal legislation of the Russian Federation [4], the import of which is permitted only if there are medical documents confirming their prescription to the person, except for those registered and dispensed in Russia without a prescription; confirming documents (their certified copies or certified extracts from them) must contain information on the name and quantity of the prescribed medicinal product, and if composed in a foreign language, a notarized translation must be attached to them);
• Use by employees of the diplomatic corps or representatives of international organizations accredited in the Russian Federation;
• Treatment of passengers and crew members of transport vehicles arriving in the Russian Federation;
• Treatment of participants in international cultural and sports events and participants in international expeditions;
• Treatment of specific animals in zoos, circuses, oceanariums, etc., treatment of wild animals inhabiting the territory of the Russian Federation belonging to species listed in the Red Book, as well as animals imported into the Russian Federation for participation in sports and entertainment events;
• Use in the territory of an international medical cluster.

Let us clarify that a medical cluster is a collection of medical organizations, educational and research centers, and other organizations created in a territory for the purpose of developing medicine. Currently, one has been created in the territory of "Skolkovo".

Additionally, Decree of the Government of Russia No. 675 dated September 3, 2010, defines the rules for importing into the territory of the Russian Federation medicinal products intended for providing humanitarian aid or assistance in emergency situations [5]. The import of medicinal products for providing humanitarian aid is carried out based on a permit from the Ministry of Health of Russia.

However, the procedure for obtaining a permit and the list of submitted documents differ from those discussed above. In particular, a copy of the document confirming the humanitarian nature of the cargo (deed of gift, agreement), a letter from the executive authority of the constituent entity regarding support for the humanitarian action with an obligation to exercise control over the targeted non-commercial use of the cargo, and a copy of the plan for the targeted distribution of medicinal products indicating the full data of recipients and the quantity of transferred cargo are provided as supporting documents.

Liability for Violation of Rules for Importing Medicinal Products

Persons who have imported medicinal products into the Russian Federation in violation of the rules established by law may be held administratively or criminally liable.

Thus, Article 238.1 of the Criminal Code of the Russian Federation provides for criminal liability for the import into the territory of Russia of falsified, substandard medicinal products or the illegal import of unregistered medicinal products for the purpose of sale on a large scale. In this case, a large scale is recognized as the value of medicinal products exceeding 100,000 rubles.

A mandatory condition for liability is the presence of the purpose of selling the imported drugs. Furthermore, Note 3 to the article allows the import into the territory of Russia for the purpose of sale of medicinal products unregistered in the RF if they are not produced in Russia or are recommended for use by the World Health Organization (hereinafter, "WHO"). Note that currently, the State Duma has adopted amendments to Article 238.1 of the Criminal Code in the first reading, which change Note 3. As indicated in the explanatory note to the bill, the current wording effectively decriminalizes the import into Russia and subsequent sale of drugs whose safety has not been confirmed, since the WHO does not maintain lists that would have the identical name "medicinal products recommended by the WHO" [6].

The maximum punishment for a crime committed without aggravating circumstances is imprisonment for a term of up to 6 years. Additionally, supplementary punishments may be imposed: a fine in the amount of up to 2,500,000 rubles or wages for a period of up to 2 years, as well as deprivation of the right to hold certain positions or engage in certain activities for a term of up to 4 years.

It should be noted that there is judicial practice of prosecution under Article 238.1 of the Criminal Code of the Russian Federation. Thus, citizen R., while in the Republic of Egypt, purchased medicinal products of various names unregistered in the territory of the Russian Federation in the amount of about 700 blisters and more than 160 jars. During the customs inspection of baggage, customs officers discovered and seized the aforementioned medicinal products among other personal items. According to the expert's conclusion, their market value in the domestic market of the Russian Federation amounted to more than 3,000,000 rubles. The court found R. guilty of committing a crime provided for by Part 1 of Article 238.1 of the Criminal Code of the Russian Federation and imposed a punishment in the form of imprisonment for a term of 3 years conditionally with a probation period of 3 years [7].

If similar actions were committed in the absence of signs of a criminal offense (for example, not on a large scale), the person may be held administratively liable under Article 6.33 of the Code of Administrative Offenses of the Russian Federation. The punishment imposed under this article: for citizens – a fine in the amount of up to 100,000 rubles; for officials and individual entrepreneurs – up to 600,000 rubles; for legal entities – up to 5,000,000 rubles. Legal entities and individual entrepreneurs may incur punishment in the form of administrative suspension of activity for a period of up to 90 days instead of a fine.

When importing medicinal products for personal use, there is also a risk of criminal liability if the rules for importing potent and poisonous substances are violated. Such actions are qualified by law enforcement practice under Article 226.1 of the Criminal Code of the Russian Federation "Smuggling of potent, poisonous substances". For the commission of the specified crime without qualifying signs, punishment of up to 7 years of imprisonment with a fine in the amount of up to 1,000,000 rubles or wages for a period of up to 5 years is provided.

Thus, in 2019 – 2020, several criminal cases were initiated against parents of seriously ill children for attempting to import into the territory of Russia unregistered medicinal products containing potent substances. These cases caused a wide resonance in society, and only the intervention of high-level officials led to their termination.

At the same time, cases of criminal prosecution under this article for the import of potent medicinal products are not uncommon in judicial practice, and repeated attempts by convicted persons to challenge in the Constitutional Court of Russia the legality of applying this norm to actions for the import of medicinal products purchased for personal use for various motives have not been successful [8].

Summarizing, we note that the procedure for importing medicinal products into the territory of Russia requires serious preparation, during which it is necessary to collect a package of documents. Otherwise, the actions of a legal entity or individual may be recognized as illegal and entail adverse consequences in the form of administrative or criminal liability.

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References

[1] Decree of the Government of the Russian Federation No. 230 dated March 5, 2020, "On the import into the Russian Federation of a specific batch of unregistered medicinal products containing narcotic drugs or psychotropic substances for the provision of medical care based on life-saving indications for a specific patient or group of patients" (together with the Rules for the import into the Russian Federation of a specific batch of unregistered medicinal products containing narcotic drugs or psychotropic substances for the provision of medical care based on life-saving indications for a specific patient or group of patients).

[2] Order of the Ministry of Health of Russia No. 80n dated February 13, 2020, "On approval of the list of diseases and conditions and corresponding medicinal products containing narcotic drugs or psychotropic substances for the purpose of carrying out their import into the territory of the Russian Federation for the provision of medical care based on life-saving indications for a specific patient or group of patients."

[3] Decree of the Government of the Russian Federation No. 593 dated April 5, 2022, "On the specifics of the circulation of medicinal products for medical use in the event of a shortage or the risk of a shortage of medicinal products due to the introduction of restrictive economic measures against the Russian Federation".

[4] Decree of the Government of the Russian Federation No. 964 dated December 29, 2007, "On approval of lists of potent and poisonous substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as the large scale of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation".

[5] Decree of the Government of the Russian Federation No. 675 dated September 3, 2010, "On approval of the Rules for importing into the territory of the Russian Federation medicinal products intended for providing humanitarian aid (assistance) or assistance in emergency situations".

[6] Bill No. 103499-8.

[7] Verdict of the Solntsevsky District Court of Moscow dated September 29, 2022, in case No. 1-480/2022.

[8] Ruling of the Constitutional Court of the Russian Federation No. 1636-O dated July 19, 2016, Ruling of the Constitutional Court of the Russian Federation No. 1177-O dated April 25, 2019.