Narcotic and Psychotropic Medicinal Products: Legal Regulation in Russia

 

April 25, 2021

Anna Ivanova, Associate at BRACE Law Firm ©

 

Requirements for the Organization of Circulation of Narcotic and Psychotropic Medicinal Products

Federal Law No. 3-FZ dated January 8, 1998, On Narcotic Drugs and Psychotropic Substances (the "Law on Narcotic Drugs") regulates the general procedure for dispensing narcotic medicinal products, packaging and labeling narcotic drugs and psychotropic substances used for medical and (or) veterinary purposes, and the procedure for importing said medicinal products. It also establishes a ban on their free distribution. It is important to note that the term "preparation of narcotic drugs and psychotropic substances" includes actions resulting in obtaining medicinal products containing such substances based on narcotic drugs, psychotropic substances, or their precursors [1].

As a general rule under Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (the "Law on Circulation of Medicinal Products" or "Law No. 61-FZ"), a pharmaceutical substance must be included in the list of narcotic drugs, psychotropic substances, and their precursors subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation, including the Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971 [2].

The Single Convention on Narcotic Drugs of 1961 recognizes that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes. Conversely, it notes that addiction to narcotic drugs constitutes a serious evil for the individual and is fraught with social and economic danger to mankind. In this regard, the parties take such legislative and administrative measures as may be necessary to limit the production, manufacture, export, import, distribution of, trade in, use, and possession of drugs exclusively to medical and scientific purposes [3].

According to the Convention on Psychotropic Substances, concluded in Vienna on February 21, 1971, a general rule is established that a preparation is subject to the same measures of control as the psychotropic substance it contains. If a preparation contains more than one such substance, it is subject to the measures applicable to the most strictly controlled of those substances. If a preparation containing a psychotropic substance is compounded in such a way that it presents no, or a negligible, risk of abuse and the substance cannot be recovered by readily applicable means in a quantity liable to abuse, so that the preparation does not give rise to a public health and social problem, the preparation may be exempted from certain control measures provided in the said Convention [4].

In accordance with Clause 4, Part 5, Article 19 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law on Health Protection"), patients have the right to relief of pain associated with a disease and (or) medical intervention using available methods and medicinal products [5].

Currently, the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors Subject to Control (the "List"), approved by a Resolution of the Government of Russia, is in effect in the Russian Federation. Effectively, this List is divided into 4 lists:

• List I – the list of narcotic drugs, psychotropic substances, and their precursors, the circulation of which is prohibited in the Russian Federation;
• List II – the list of narcotic drugs and psychotropic substances, the circulation of which is limited in the Russian Federation and regarding which control measures are established;
• List III – the list of psychotropic substances, the circulation of which is limited in the Russian Federation and regarding which certain control measures may be excluded;
• List IV – the list of precursors, the circulation of which is limited in the Russian Federation and regarding which control measures are established [6].

Indeed, in the Russian Federation, medicinal products containing narcotic or psychotropic substances are subject to special control during prescribing, dispensing, movement, and storage. Maintaining a balance between legislative restrictions and the timely provision of patients requiring such medicinal products is extremely important. This article reviews the specifics of legal regulation regarding prescribing, dispensing, storage, transportation, return of unused medicinal products containing narcotic or psychotropic substances, as well as other aspects of the circulation of said medicinal products.

Prescribing Medicinal Products Containing Narcotic Drugs and Psychotropic Substances

Issues regarding prescribing medicinal products, including narcotic and psychotropic medicinal products, are regulated by Order of the Ministry of Health of Russia No. 4n dated January 14, 2019, On Approval of the Procedure for Prescribing Medicinal Products, Forms of Prescription Blanks for Medicinal Products, and the Procedure for Filling Out Said Blanks, Their Recording and Storage. An appendix to this document provides a list of medicinal products defining the maximum quantity of the medicinal product (depending on its international nonproprietary name) that may be prescribed in one prescription.

Medical workers are prohibited from issuing prescriptions in the absence of medical indications for the patient for narcotic drugs and psychotropic substances included in List II of the List, registered as medicinal products, for the purpose of treating drug addiction.

It is important to note that the prescribing of said medicinal products is carried out both within inpatient care or primary medical care, and within outpatient treatment. When providing medical care in an inpatient setting, issuing a prescription is not required.

Since the entry into force of Order of the Ministry of Health of Russia No. 4n dated January 14, 2019, the approval of the head of the medical organization is not required for prescribing medicinal products containing narcotic or psychotropic substances. Such medicinal products may be prescribed by the attending physician individually [7].

Furthermore, the head of a medical organization may assign functions regarding prescribing and applying medicinal products, including narcotic medicinal products and psychotropic medicinal products, to a paramedic (feldsher) or midwife in accordance with the requirements of the legislation of the Russian Federation on health protection and on narcotic drugs and psychotropic substances [8].

It is important to note that the procedure for assigning such duties was approved by Order of the Ministry of Health and Social Development of the Russian Federation No. 252n dated March 23, 2012, which contains a reference to the previously effective procedure for prescribing and writing medicinal products approved by the Ministry of Health on December 20, 2012, No. 1175n. We believe that this reference is merely a technical oversight, as the current procedure contains corresponding norms regarding the possibility of transferring said powers to a paramedic or midwife.

Information on the prescribed medicinal product (name of the medicinal product, dosage, method of administration and application, dosing regimen, duration of treatment, and justification for prescribing the medicinal product) shall be entered by the medical worker into the patient's medical documentation.

It is important to note a situation where current legislation lacks clear criteria for patients' indications for prescribing medicinal products containing narcotic or psychotropic substances. The Standing Committee on Drug Control published methodological recommendations on the procedure and terms for prescribing narcotic drugs. It is established that for minor surgical interventions, there is no need to prescribe narcotics; pain relief is achieved with analgesics. In case of insufficient pain relief, a peripheral action analgesic should be combined with a narcologically safe and well-tolerated opioid—tramadol (Tramal). For acute pain syndrome of moderate intensity after major non-cavitary and medium-volume intracavitary operations or traumatic injuries, one of the medium-potency opioids should be used in combination with a peripheral action analgesic. Opioids used in these cases are tramadol and prosidol. The duration of prosidol use should not exceed 3-5 days. For severe acute pain syndrome caused by extensive intracavitary surgical intervention, severe traumatic injuries, and pathological conditions, a potent narcotic analgesic must be combined with an analgesic. Preference should be given to buprenorphine, which differs from morphine and its derivatives (in equianalgesic doses) [9].

Additionally, the methodological recommendations state that for a safe transition from one narcotic analgesic to another (opioid rotation), the selected equipotential dose of the new product should be reduced by 50% at the first intake, and then, in the absence of adverse effects, gradually increased to the necessary level. A table for converting equipotential doses of narcotic analgesics is also provided, along with criteria for determining the intensity of pain endured by patients [10]. Also, certain criteria for prescribing said medicinal products are introduced at the level of the constituent entities of the Russian Federation, but effectively they correspond to the general criteria established above (these legal acts adopted at the regional level will be discussed in more detail below).

However, these documents are recommendatory in nature.

On the one hand, this is a certain advantage and allows the doctor to act at their own discretion, guided by the patient's condition. On the other hand, far from all medical workers are willing to take the risk of prescribing medicinal products containing narcotic or psychotropic substances to a patient due to the fear of bearing liability for non-compliance with the prescribing procedure.

Recall that currently, Article 228.2 of the Criminal Code of the Russian Federation establishes liability for violation of the rules for the production, preparation, processing, storage, recording, dispensing, sale, distribution, transportation, transfer, acquisition, use, import, export, or destruction of narcotic drugs or psychotropic substances.

At the same time, a bill has currently been prepared proposing to decriminalize cases of violation of the rules for the circulation of narcotic drugs and psychotropic substances committed by negligence during the performance of medical activities, if their loss did not cause harm to interests protected by criminal law [11]. We believe that such an amendment is reasonable and will provide greater freedom of action for medical workers to help patients requiring the prescription of medicinal products containing narcotic substances.

The features of prescribing medicinal products containing narcotic or psychotropic substances to patients undergoing treatment in inpatient medical institutions were discussed above. Next, we will consider the features of prescribing during treatment in outpatient conditions.

As a general rule under Order of the Ministry of Health of Russia No. 4n dated January 14, 2019, the prescription of medicinal products by decision of a medical commission during the provision of primary medico-sanitary care and palliative medical care in outpatient conditions is carried out in cases of primary prescription of narcotic and psychotropic medicinal products of Lists II and III of the List to a patient (if the head of the medical organization decides on the necessity of coordinating the prescription of such medicinal products with the medical commission).

Repeat prescriptions of narcotic and psychotropic medicinal products of Lists II and III of the List are made by the medical worker independently to patients with severe pain syndrome of any genesis, sleep disorders, convulsive states, anxiety disorders, phobias, and psychomotor agitation.

In this case, to prescribe a medicinal product for patients receiving medical care in outpatient conditions, it is necessary to write a prescription using a special form. The forms of prescription blanks were approved by Order of the Ministry of Health of Russia No. 54n dated August 1, 2012 [12]. When prescribing narcotic and psychotropic medicinal products of List II of the List, prescriptions on paper are issued on a prescription blank of Form No. 107/u-NP.

Prescription blank Form No. 148-1/u-88 is issued when prescribing:

• Narcotic and psychotropic medicinal products of List II of the List in the form of transdermal therapeutic systems;
• Narcotic medicinal products of List II of the List containing a narcotic drug in combination with an opioid receptor antagonist;
• Psychotropic medicinal products of List III of the List;
• As well as medicinal products possessing anabolic activity and classified as anabolic steroids (code A14A) according to the anatomical-therapeutic-chemical classification recommended by the World Health Organization [13].

It is prohibited to prescribe narcotic and psychotropic medicinal products to individual entrepreneurs engaged in medical activities.

It is important to note that prescription blanks of Form No. 107/u-NP are important for providing needy patients with necessary medicines containing narcotic substances, including if such provision occurs in an emergency mode. Thus, the Federal State Budgetary Institution "All-Russian Center for Disaster Medicine 'Zashchita'" of the Ministry of Health of the Russian Federation approved the procedure for accounting and storing the reserve stock of said blanks, as well as their release from the reserve stock. The release of prescription blanks from the reserve stock is carried out by a responsible employee based on a decision to release prescription blanks, formalized as a letter signed by the Director of the Department of Drug Supply and Regulation of Circulation of Medical Devices [14].

Prescription blanks have specific filling rules. A blank of Form No. 107/u-NP must be filled out legibly, clearly, with ink or a ballpoint pen, or using printing devices. Corrections are not allowed when filling out a prescription blank. The name of the narcotic (psychotropic) medicinal product (international nonproprietary or chemical, or in their absence – trade name), its dosage, quantity, and method of administration are indicated in Latin. The rule must be observed where one name of a narcotic (psychotropic) medicinal product is written on one prescription blank. The quantity of the prescribed narcotic (psychotropic) medicinal product must be indicated in words. In cases where it is necessary to issue a prescription for a narcotic (psychotropic) medicinal product at home as part of palliative medical care, preliminary certification of the prescription with the stamp of the medical organization, the seal of the medical organization, or the structural unit of the medical organization "For Prescriptions" is allowed. In this case, a note regarding its issuance for completion at home is made in the register of registration and accounting of prescription blanks [15].

Today, the issue of prescribing medicinal products to palliative patients, including outside medical institutions, is particularly acute. Thus, the Ministry of Health of Russia clarifies that pain relief for palliative care patients residing in inpatient social service organizations and requiring the use of narcotic and psychotropic medicinal products in outpatient conditions is carried out in accordance with the legislation of the Russian Federation in the territory of the constituent entity of the Russian Federation where the patient is actually receiving medical care [16].

For example, in the territory of the city of Moscow, the Instruction on the Procedure for Acquisition, Transportation, Storage, Accounting, Dispensing, Use, Destruction, Prescribing, and Writing of Narcotic Drugs and Psychotropic Substances Included in List II of the List, and Psychotropic Substances Included in List III of the List in Medical Organizations of the State Healthcare System of the City of Moscow is in effect. According to said instruction, the primary prescribing and writing of narcotic drugs and psychotropic substances included in List II of the List and psychotropic substances included in List III of the List during the provision of primary medico-sanitary care and palliative medical care in outpatient conditions is performed for patients with severe pain syndrome of any genesis, as well as patients with sleep disorders, convulsive states, anxiety disorders, phobias, and psychomotor agitation. This is carried out independently by a medical worker in cases of a typical course of the disease, based on the severity and nature of the disease, or by a medical worker by decision of a medical commission (if the head of the medical organization decides on the necessity of coordinating the primary prescription with the medical commission). When writing a prescription, it is prohibited to exceed the maximum allowable quantity of the medicinal product for writing on one prescription. On Saturdays, Sundays, and holidays, the writing of special prescription blanks for a narcotic drug or psychotropic substance is carried out by the duty doctor. The administration of narcotic drugs and psychotropic substances at home is carried out by a nurse with a corresponding entry in the procedure sheet indicating the name of the product, quantity, date, time, method of administration, surname, initials of the nurse, and her signature. Upon written application and objective medical indications, the administration of narcotic drugs and psychotropic substances at home by relatives of patients is allowed after appropriate instruction, about which a corresponding entry is made in the medical card of the outpatient [17].

Recall that in 2019, the Ministry of Health established a procedure for providing care to palliative patients, which includes, among other things, prescribing medicinal products, including narcotic medicinal products and psychotropic medicinal products [18].

Also, the Ministry of Health recommends organizing places for their centralized storage with ensuring the accounting of such products to ensure the safety and security of the use of narcotic and psychotropic medicinal products purchased by citizens residing (staying) in inpatient social service organizations, by decision of the head of the organization or the head of the social protection body (healthcare management) of the constituent entity of the Russian Federation. Metal containers (safe deposit boxes) or containers made of other high-strength materials permitted for storing narcotic drugs and psychotropic substances may be used for centralized storage.

Thus, prescribing narcotic medicinal products to outpatients in need of them, as well as to patients in inpatient social service organizations, is permissible subject to compliance with the necessary conditions specified above.

Procedure for Acquisition of Narcotic Medicinal Products by Medical and Pharmacy Organizations

In accordance with Article 24 of the Law on Narcotic Drugs, the acquisition of narcotic drugs and psychotropic substances is carried out by legal entities holding licenses. The license for activities related to the circulation of narcotic drugs, psychotropic substances, and their precursors, and the cultivation of narcotic-containing plants must specify works and services for the acquisition of narcotic drugs and psychotropic substances included in Lists II and III of the List [19]. At the same time, suppliers of narcotic and psychotropic medicinal products (as well as other medicinal products) to a pharmacy or medical organization may be manufacturers of medicinal products and organizations engaged in the wholesale trade of medicines.

In accordance with the Methodological Recommendations on the Organization of Circulation of Narcotic and Psychotropic Medicinal Products for Medical Use in Medical and Pharmacy Organizations (Letter of the Ministry of Health of the Russian Federation No. 25-4/10/1-1221 dated February 27, 2018), the acceptance of narcotic and psychotropic medicinal products from a supplier is carried out by a commission approved by the order of the head of the pharmacy organization or medical organization, consisting of a chairman and at least two members of the commission who are financially responsible persons of the pharmacy or medical organization. Upon acceptance of narcotic and psychotropic medicinal products, all transport packaging is subject to opening and checking for compliance of the quantity of narcotic and psychotropic medicinal products with the data indicated in the receipt documents, and the integrity of the primary packaging, regarding which an acceptance act is drawn up. If shortages, surpluses, spoilage, breakage, or labeling violations are detected, the commission draws up an additional act signed by the members of the commission who performed the acceptance of narcotic and psychotropic medicinal products and representatives of the supplier.

The distribution of narcotic drugs and psychotropic substances is carried out in accordance with the applications of legal entities for receiving specific narcotic drugs and psychotropic substances.

When submitting applications for receiving narcotic medicinal products and psychotropic medicinal products intended for medical use, the calculation of the need for said products is carried out by legal entities based on the standards approved by Order of the Ministry of Health of Russia No. 917n dated December 1, 2016. This order specifies the names of medicinal products and their standard per 1,000 people per year, established both for organizations providing medical care on an outpatient basis and for organizations conducting inpatient monitoring of patients (for them, the standards are distributed by the profile of the medical organization's work). At the same time, the standard for calculating the need for narcotic medicinal products for ambulance organizations is indicated based on 1,000 ambulance calls [20].

The application is signed by the head of the legal entity, certified by a seal, and submitted to the authorized organization no later than September 15. The authorized organization, in accordance with the submitted applications, forms a consolidated application and submits it to the federal executive body under whose jurisdiction it falls, or to the authorized executive body of the constituent entity of the Russian Federation in whose territory the applicant legal entities are registered. The consolidated application is signed by the head of the federal executive body or the authorized executive body of the constituent entity of the Russian Federation and submitted to the Ministry of Industry and Trade of the Russian Federation no later than October 15. Based on the consolidated applications and information on planned volumes, the Ministry of Industry and Trade of the Russian Federation forms a distribution plan and approves it no later than December 1 [21].

The Ministry of Health of Russia has developed methodological recommendations providing a formula for calculating needs, which includes established consumption standards and the number of patients who received medical care under the corresponding profile. At the same time, it is recommended to calculate the actual need for specific names of narcotic medicinal products based on the calculated need or based on the calculated need taking into account comparison with data on actual or maximum actual consumption of narcotic medicinal products for the previous year(s). It is recommended to form regional needs from:

• The total need for narcotic and psychotropic medicinal products used in the provision of specialized, including high-tech, medical care, palliative medical care, ambulance, including specialized ambulance, medical care, in inpatient conditions and day hospital conditions;
• The total need for narcotic and psychotropic medicinal products used in the provision of primary medico-sanitary medical care and palliative medical care in outpatient conditions;
• The total need for narcotic and psychotropic medicinal products used in the provision of ambulance, including specialized ambulance, medical care outside a medical organization [22].

Also, the Ministry of Health of Russia clarifies the necessity for healthcare management bodies of the constituent entities of the Russian Federation and each medical organization to carefully approach the issue of forming real needs for opioid analgesics and deliberately draw up applications for narcotic and psychotropic medicinal products to prevent a decrease in the percentage of sampling of these medicinal products and the level of availability of opioid analgesics, including in non-invasive dosage forms [23].

Dispensing of Narcotic Medicinal Products, Including Combined Medicinal Products

Current legislation does not provide a definition of the concept of "dispensing medicinal products." However, the Rules for Determining Categories of Medicinal Products Dispensed Without a Prescription and by Prescription, approved by Decision of the Board of the Eurasian Economic Commission No. 178 dated December 29, 2015, provide a classification of medicinal products depending on the procedure for their dispensing. Thus, medicinal products dispensed by prescription are medicinal products the dispensing of which to a patient is carried out only after the patient presents a prescription to a pharmacy employee [24].

Effectively, dispensing medicines implies the main type of activity of pharmacy organizations. There are also specific rules for dispensing medicinal products by medical organizations.

Medicinal products containing narcotic drugs, psychotropic substances, and their precursors (their salts, isomers, stereoisomers) and included in Lists II, III, IV of the List, including in combination with pharmacologically inactive substances, as well as medicinal products containing narcotic drugs, psychotropic substances, and their precursors in combination with pharmacologically active substances are subject to subject-quantitative accounting [25]. Dispensing of medicinal products containing narcotic substances is carried out exclusively by prescription.

The dispensing of combined medicinal products is regulated by a separate procedure. In particular, the procedure for dispensing medicinal products for medical use containing, in addition to small quantities of narcotic drugs, psychotropic substances, and their precursors included in Lists II, III, and IV of the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors, other pharmacologically active substances, provides lists of medicinal products dispensed by prescription. For these purposes, the dispensing of such medicines must be carried out by a pharmacy organization holding a corresponding license for pharmaceutical activities, according to prescriptions written on prescription blanks of forms No. 107-1/u and No. 148-1/u-88 [26]. At the same time, combined medicinal products containing narcotic drugs, psychotropic substances, and their precursors in a quantity not exceeding the maximum allowable quantity of a narcotic drug, psychotropic substance, and their precursor contained in products that contain small quantities of narcotic drugs, psychotropic substances, and their precursors included in Lists II, III, and IV of the List, established by the Ministry of Health of Russia, are subject to dispensing [27]. In the event that the quantity of a combined medicinal product written in a prescription of Form No. 107-1/u exceeds the maximum allowable or recommended quantity for writing on one prescription, the medicinal product is dispensed in a quantity not exceeding the maximum allowable. If the prescription indicates the periodicity of dispensing the medicinal product, then a corresponding note on the date of dispensing is made on such prescription at each dispensing of the medicine.

It is important to note that with the development of remote trade, one must still not violate the requirements regarding the ban on mailing products with a small quantity of narcotic drugs, psychotropic substances, and their precursors included in Lists II, III, IV of the List in postal items, including international ones, and under the guise of humanitarian aid (except for emergency situations when said products are sent to the constituent entities of the Russian Federation by decisions of the Government of the Russian Federation) [28].

Upon expiration of the validity period, a prescription of Form No. 107-1/u is canceled with the stamp "Medicinal Product Dispensed" and returned to the patient. Prescriptions written on a blank of Form No. 148-1/u-88, after the dispensing of a combined medicinal product, are subject to storage in the pharmacy for 3 years. Upon expiration of this time, they are subject to destruction. In addition to the above requirements, special requirements are imposed on persons and organizations authorized to dispense medicinal products containing narcotic drugs, psychotropic substances, and their precursors.

As a general rule under the Law on Narcotic Drugs, dispensing of narcotic medicinal products and psychotropic medicinal products to individuals is performed only in pharmacy organizations or in medical organizations or separate subdivisions of medical organizations located in rural settlements and remote localities where there are no pharmacy organizations, provided that the pharmacy organizations, medical organizations, and their separate subdivisions hold a license provided for by the legislation of the Russian Federation on licensing certain types of activities. Legal entities have the right to dispense narcotic and psychotropic substances if they hold a license for activities related to the circulation of narcotic drugs, psychotropic substances, and their precursors, and the cultivation of narcotic-containing plants, specifying works and services for said type of activity [29]. The list of medical organizations and separate subdivisions of medical organizations located in rural settlements and remote localities where there are no pharmacy organizations, and the list of narcotic medicinal products and psychotropic medicinal products, the dispensing of which to individuals may be carried out by said medical organizations and their separate subdivisions, are established by the Governments of the constituent entities of the Russian Federation. For example, such a list is in effect in the Sverdlovsk Region (it includes the Garinsky urban district, the Makhnevskoye municipal formation, etc.) [30].

In addition to the medical or pharmaceutical organization holding the relevant license, current legislation establishes a list of positions of employees of such organizations authorized to dispense said medicinal products. Such positions among pharmaceutical workers include: director (head, chief) of a pharmacy organization, deputy director (head, chief) of a pharmacy organization, head (chief) of a structural unit (department) of a pharmacy organization, pharmacist (provizor), pharmacist-technologist, senior pharmacist (provizor), senior pharmacist (farmatsevt), pharmacist (farmatsevt); positions of medical workers include: specialist doctor, head nurse (head midwife, head paramedic), midwife, head of a health post – paramedic (nurse), head of a feldsher-midwife post – paramedic (midwife, nurse), nurse, general practitioner's (family doctor's) nurse, senior nurse (midwife, paramedic), paramedic [31].

The aforementioned persons, whose activities are directly related to the dispensing of narcotic and psychotropic medicinal products, require a special permit (a certificate of the absence of drug addiction, substance abuse, and chronic alcoholism among employees who, in accordance with their labor duties, must have access to narcotic drugs and psychotropic substances). The issuance of the certificate is carried out by medical organizations holding a license for medical activities providing for the performance of works (provision of services) in "psychiatry-narcology" and "laboratory diagnostics" or "clinical laboratory diagnostics" [32].

Storage of Narcotic and Psychotropic Medicinal Products

The storage conditions for medicinal products containing narcotic and psychotropic substances are determined by establishing appropriate requirements for premises and storage regimes.

Thus, premises for storing said medicinal products are divided into 5 categories.

The 1st category includes premises of manufacturers and compounders (excluding pharmacy organizations) of narcotic drugs, psychotropic substances, and precursors intended for storing starting materials and finished products (excluding products in work-in-progress), premises of organizations engaged in the wholesale trade of narcotic drugs and psychotropic substances and (or) the processing of narcotic drugs, psychotropic substances, and precursors intended for storing narcotic drugs, psychotropic substances, and precursors, as well as premises of organizations storing narcotic drugs and psychotropic substances intended for liquidation of medico-sanitary consequences of natural and man-made emergencies or for mobilization needs.

The 2nd category includes premises of pharmacy organizations intended for storing a 3-month or 6-month stock (for pharmacy organizations located in rural settlements and remote localities) of narcotic drugs and psychotropic substances, as well as premises of veterinary pharmacy organizations intended for storing a 3-month stock of narcotic drugs and psychotropic substances.

The 3rd category includes premises of medical and veterinary organizations intended for storing a 15-day stock of narcotic drugs and psychotropic substances included in List II of the List, and a monthly stock of psychotropic substances included in List III of the List, premises of medical organizations intended for storing narcotic medicinal products and psychotropic medicinal products dispensing said medicinal products to individuals.

The 4th category includes premises of medical and veterinary organizations intended for storing a daily stock of narcotic drugs and psychotropic substances included in List II of the List, and a three-day stock of psychotropic substances included in List III of the List, as well as premises of medical organizations intended for storing unused narcotic drugs received from relatives of deceased patients.

The 5th category includes premises of separate subdivisions of medical organizations intended for storing a monthly stock of narcotic medicinal products and psychotropic medicinal products dispensing said medicinal products to individuals [33].

Order of the Ministry of Health of Russia No. 484n dated July 24, 2015, established that in a pharmacy, medical organization, or organization for wholesale trade in medicinal products, narcotic and psychotropic medicinal products for parenteral, internal, and external use must be stored separately, including on a separate shelf of a cabinet. At the end of the working day, narcotic and psychotropic medicinal products must be returned to the main storage place for narcotic and psychotropic medicinal products.

Storage of narcotic and psychotropic medicinal products in premises belonging to the 4th category, or in temporary storage places, is carried out in safes (containers) located in the corresponding premises or places.

Special requirements are imposed on the storage of medicinal products requiring compliance with a temperature regime. Namely, the storage of narcotic and psychotropic medicinal products requiring protection from elevated temperatures in pharmacy, medical, research, educational organizations, and organizations for wholesale trade in medicinal products is carried out:

• In premises specially equipped with engineering and technical security means belonging to the 1st and 2nd categories – in lockable refrigerators (refrigerated chambers) or in a special zone for placing refrigerators (refrigerated chambers) separated from the main storage place by a metal grate with a lockable grated door;
• In premises belonging to the 3rd category – in a special zone for placing refrigerators (refrigerated chambers) separated from the main storage place by a metal grate with a lockable grated door;
• In premises belonging to the 4th category – in thermal containers placed in safes;
• In temporary storage places – in thermal containers placed in safes, or in metal containers or containers made of other high-strength materials placed in thermal containers.

Storage of pharmaceutical substances used for compounding narcotic and psychotropic medicinal products in the form of finished dosage forms in pharmacy organizations must be carried out in glass jars (shtanglas) placed in safes (metal cabinets) indicating the maximum single and maximum daily doses.

In pharmacy and medical organizations, lists of stored narcotic and psychotropic medicinal products indicating their maximum single and maximum daily doses must be posted on the inner sides of the doors of safes or metal cabinets where narcotic and psychotropic medicinal products are stored.

Additionally, in medical organizations, tables of antidotes for poisoning with said substances must be placed in storage places for narcotic and psychotropic medicinal products [34].

Special requirements for the storage of medicinal products containing narcotic and psychotropic substances are established for control and analytical laboratories. There, medicinal products must be stored in closed sealed safes. Narcotic drugs or medicines containing them issued to a pharmacist-analyst for analysis are stored separately under lock and key by the chemist-analyst. Narcotic drugs and psychotropic substances arriving for analysis from pharmaceutical organizations (pharmacy warehouses, bases, pharmacies) are stored for 3 months after the analysis, after which their residues are returned to the pharmaceutical organizations.

The person responsible for storing narcotic drugs and psychotropic substances is the head of the laboratory (center) or a deputy who keeps the keys to the safe where narcotic drugs are stored.

Rejected narcotic drugs and psychotropic substances are destroyed after the expiration of the storage period. All said substances are subject to subject-quantitative accounting in a special transaction log. Documents on narcotic drugs must be kept by the head of the laboratory for 3 years [35].

Substandard narcotic and psychotropic medicinal products identified in a pharmacy, medical organization, or organization for wholesale trade in medicinal products, as well as narcotic or psychotropic medicinal products surrendered by relatives of deceased patients to a medical organization, are subject to identification and storage on a separate shelf or in a separate compartment of a safe or metal cabinet until they are written off and destroyed [36].

Next, we will consider the procedure for destroying substandard medicines containing narcotic and psychotropic substances.

Return of Unused Narcotic Medicinal Products by Relatives of Deceased Patients and Destruction of Narcotic Medicinal Products

The procedure for accepting unused narcotic drugs from relatives of deceased patients was approved by Order of the Ministry of Health of Russia No. 23n dated January 15, 2016. Said procedure was developed due to the urgency of the issue regarding the further fate of medicinal products remaining after deceased patients.

The acceptance of unused narcotic medicinal products from relatives of deceased patients is carried out by an authorized employee of the medical organization at the place of residence (stay) of the patient, which issued prescriptions for these products. Relatives of the deceased patient are obliged to surrender medicinal products within 3 days from the date of receipt of the medical death certificate.

Primary and (or) secondary (consumer) packaging, for example, empty ampoules, vials, blisters, boxes, used transdermal therapeutic systems of used narcotic medicinal products, are not subject to return. An act is drawn up upon acceptance of narcotic medicinal products. Prior to the destruction of medicinal products, they are stored in a safe [37].

The Law on Narcotic Drugs establishes that narcotic drugs, psychotropic substances, and their precursors, as well as tools or equipment, the further use of which is deemed inexpedient, are subject to destruction. Destruction of narcotic and psychotropic medicinal products included in List II of the List is carried out by:

• State unitary enterprises and state institutions;
• Municipal unitary enterprises and municipal institutions when providing medical care to citizens in the Russian Federation by medical organizations of the municipal healthcare system.

Destruction of psychotropic medicinal products included in List III of the List is carried out by organizations regardless of the form of ownership.

To destroy narcotic and psychotropic medicinal products, a pharmacy or medical organization must hold a license for activities related to the circulation of narcotic drugs, psychotropic substances, and their precursors. In the absence of such a license, transfer for destruction to another legal entity holding the relevant license is required based on an agreement and a transfer and acceptance act. For destruction, it is necessary to issue an order to write off narcotic and psychotropic medicinal products, and commissions are created in pharmacy and medical organizations [38].

The write-off of narcotic drugs and psychotropic substances subject to destruction is performed no later than the last working day of the calendar month. Destruction of narcotic drugs and psychotropic substances is carried out as they accumulate, but at least once a quarter.

Destruction of narcotic and psychotropic medicinal products is carried out at specially equipped sites (landfills) and in specially prepared premises.

Liquid dosage forms in glass ampoules, vials are destroyed by crushing the primary packaging; liquid dosage forms in plastic ampoules, syringe tubes are destroyed by crushing the primary packaging followed by dilution of the resulting contents with water in a ratio of 1:100 and draining the resulting solution into the sewer.

Solid dosage forms containing water-soluble pharmaceutical substances of narcotic drugs and psychotropic substances are subject to dilution with water in a ratio of 1:100 after crushing to a powdery state and draining the resulting suspension (solution) into the sewer.

Water-soluble pharmaceutical substances are destroyed by dilution with water in a ratio of 1:100 and draining the resulting solution into the sewer.

Solid dosage forms containing water-insoluble pharmaceutical substances of narcotic drugs and psychotropic substances, soft dosage forms, and transdermal dosage forms are destroyed by burning [39].

Thus, when destroying narcotic medicinal products, it is important to observe the procedure for their write-off and subject-quantitative accounting, as well as strict adherence to the disposal procedure depending on the dosage form.

Import, Export, and Transportation of Narcotic Medicinal Products Across the State Border

According to the Law on Narcotic Drugs, the import (export) of narcotic drugs and psychotropic substances included in Lists I and II, and the import (export) of precursors included in List I and Table I of List IV of the List, are carried out by Lomonosov Moscow State University for use in scientific, educational purposes and in expert activities, as well as by state unitary enterprises in the procedure established by the Government of the Russian Federation, subject to a license for the right to import (export) narcotic drugs, psychotropic substances, and their precursors.

The import (export) of psychotropic substances included in List III, as well as the import (export) of precursors included in Table II and Table III of List IV, is carried out by legal entities regardless of their form of ownership in the procedure established by the Government of the Russian Federation, subject to a license.

To carry out the import (export) of narcotic drugs, psychotropic substances, or precursors, if they are medicinal products, a certificate from the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for the right to import (export) must be obtained [40].

The decision to issue (or refuse to issue) and send the permit is made within 5 working days from the date of receipt of the application containing:

• Name of the legal entity – applicant, OGRN, INN;
• Address of the applicant and its structural subdivisions;
• Addresses of places for carrying out retail trade in medicinal products;
• Information on the license for pharmaceutical activities;
• Address of the applicant's website and information on the mobile application (if any).

The application shall be accompanied by copies of documents (information) confirming the existence of at least 10 places for carrying out pharmaceutical activities in the territory of the Russian Federation, as well as information confirming the availability of equipped premises (places) for storing formed orders in accordance with the Rules of Good Practice for Storage and Transportation of Medicinal Products for Medical Use, approved by Order of the Ministry of Health of the Russian Federation No. 646н dated August 31, 2016. Additionally, it is necessary to provide confirmation of the existence of a website or mobile application, the existence of an own courier service having equipment ensuring the maintenance of the necessary temperature regime for the delivery of thermolabile medicinal products, or an agreement with a courier delivery service having such equipment, and the presence of an electronic payment system and (or) mobile payment terminals directly at the place of provision of the state service [41].

Recall that in 2019, the issue of importing unregistered medicinal products into Russia became particularly acute. Problems were aggravated by the fact that a number of citizens who were relatives of seriously ill patients were held liable for ordering medicines restricted in circulation that were not registered in Russia [42]. In this regard, amendments were adopted to the Law on the Circulation of Medicinal Products, according to which, from March 1, 2020, the import into the Russian Federation of a specific batch of unregistered medicinal products containing narcotic drugs or psychotropic substances is allowed in the procedure established by the Government of the Russian Federation for the provision of medical care based on life indications of a specific patient or a group of patients in case there is a decision of the medical commission of a medical organization regarding the ineffectiveness or impossibility of using other registered medicinal products in a specific patient, including those containing other active substances, and the necessity of importing a certain unregistered medicinal product specifying its international nonproprietary (or chemical, or grouping) name, form of issue, and quantity [43].

We believe that these innovations are justified and provide an opportunity to improve the quality of medical care for patients requiring the prescription of medicinal products containing narcotic substances, even if such medicines are not registered in Russia.

The procedure for moving medicinal products containing narcotic substances across the border of the Russian Federation by individuals is regulated separately. Often, citizens, due to ignorance of the established requirements, may face problems when transporting medicines when crossing the Russian border.

The movement of medicinal products by individuals for personal use is carried out in accordance with Appendix No. 10 to Decision of the Board of the Eurasian Economic Commission No. 30 dated April 21, 2015, On Non-Tariff Regulation Measures, according to which, if medicinal products contain narcotic and psychotropic substances, their import into the Russian Federation and export from the Russian Federation by individuals for personal use is carried out based on medical indications subject to supporting medical documents indicating the name and quantity of the goods. At the same time, supporting medical documents (their certified copies) shall be drawn up in Russian, or their notarized translation into Russian shall be attached [44].

Such products are subject to mandatory customs declaration in written form using a passenger customs declaration. The form and procedure for filling out the declaration were approved by Decision of the Customs Union Commission No. 287 dated June 18, 2010, according to which, upon submission of the declaration, all copies of the declaration are signed by the declarant, or by an authorized person of the customs representative, or by a person acting on behalf of and under the instruction of the declarant, and the date of completion of the declaration is affixed to them [45].

Thus, it is important for citizens transporting medicinal products for personal needs across the Russian border to clarify the composition of said medicines, as well as data on their registration in the State Register of Medicinal Products (GRLS), posted on the official website of the Ministry of Health of the Russian Federation.

It is also recommended to obtain appropriate consultation regarding the rules for import (export) in the territories of other countries for said medicinal products.

In the absence of appropriate permits, an individual may be held criminally liable under Article 229.1 of the Criminal Code of the Russian Federation for smuggling narcotic drugs, psychotropic substances, and their precursors.

Transportation and Movement of Narcotic Medicinal Products Within the Russian Federation

The rules for transporting narcotic drugs, psychotropic substances, and their precursors in the territory of the Russian Federation, as well as processing the documents necessary for this, were approved by Resolution 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 in the Territory of the Russian Federation, as well as Processing Documents Necessary for This, according to which the following are subject to guarding during transportation:

• Narcotic drugs and psychotropic substances included in List I of the List, as well as precursors;
• Narcotic drugs and psychotropic substances included in Lists II and III of the List intended for further production, manufacture (excluding compounding by pharmacy organizations), processing, and distribution;
• Narcotic drugs and psychotropic substances included in Lists II and III of the List sold to organizations engaged in the wholesale trade of narcotic drugs and psychotropic substances, as well as to organizations storing narcotic drugs and psychotropic substances intended for liquidation of medico-sanitary consequences of natural and man-made emergencies or for mobilization needs.

Guarding is ensured by:

• Units of the National Guard Troops of the Russian Federation (Rosgvardiya) or an organization subordinate to the Federal Service of National Guard Troops of the Russian Federation;
• Departmental security of federal state bodies and organizations;
• Legal entities holding a license for private security activities [46].

Currently, FSUE "Okhrana" provides transportation services in all constituent entities of Russia. Also, for example, within the framework of trilateral agreements concluded by FSUE "Okhrana" of Rosgvardiya, FSUE "Main Center for Special Communications," and FSUE "Moscow Endocrine Plant," the Rosgvardiya enterprise fulfills contractual obligations for guarding narcotic and psychotropic medicinal products during their transportation. The transportation itself is performed by employees of FSUE "Main Center for Special Communications" [47].

Also, the Ministry of Health of Russia clarifies that for the purpose of providing its structural subdivisions with narcotic drugs, psychotropic substances, and precursors, a legal entity may carry out the transportation of narcotic drugs, psychotropic substances, and precursors without concluding an agreement.

For each transportation, the head of the legal entity carrying out the transportation issues an order appointing persons responsible for their receipt, delivery, transfer, and safety, who are admitted in the established procedure to work with narcotic drugs, psychotropic substances, and precursors.

During transportation, it is mandatory to have bills of lading, invoices, invoices (factures), an approved transportation route (approved for a period of up to 1 year), and documents confirming the authority for transportation [48].

This article has reviewed the main features of the circulation of narcotic medicinal products in the territory of Russia. Currently, there is a trend toward gradual improvement of legislation in this area aimed at ensuring the timely provision of medicines to patients requiring the prescription of such medicines; however, a number of serious problems identified above still exist.

___________________________

References

[1] Federal Law No. 3-FZ dated January 8, 1998, On Narcotic Drugs and Psychotropic Substances.

[2] Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products.

[3] Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol Amending the Single Convention on Narcotic Drugs, 1961 (Concluded in New York on March 30, 1961).

[4] Convention on Psychotropic Substances (Concluded in Vienna on February 21, 1971).

[5] Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation.

[6] Resolution of the Government of the Russian Federation No. 681 dated June 30, 1998, On Approval of the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors Subject to Control in the Russian Federation.

[7] Order of the Ministry of Health of Russia No. 4n dated January 14, 2019, On Approval of the Procedure for Prescribing Medicinal Products, Forms of Prescription Blanks for Medicinal Products, and the Procedure for Filling Out Said Blanks, Their Recording and Storage.

[8] Order of the Ministry of Health and Social Development of the Russian Federation No. 252n dated March 23, 2012, On Approval of the Procedure for Assigning Certain Functions of an Attending Physician to a Paramedic or Midwife by the Head of a Medical Organization When Organizing the Provision of Primary Medico-Sanitary Care and Ambulance Care for the Direct Provision of Medical Care to a Patient During the Period of Observation and Treatment, Including Prescribing and Applying Medicinal Products, Including Narcotic Medicinal Products and Psychotropic Medicinal Products.

[9] Methodological Recommendations "On the Procedure and Terms for Prescribing Narcotic Drugs," adopted by the Protocol of the Standing Committee on Drug Control No. 2/71-99 dated April 14, 1999.

[10] Letter of the Ministry of Health of Russia No. 17-7/10/1-797 dated February 26, 2015, On Sending Methodological Recommendations "Pharmacotherapy of Chronic Pain Syndrome in Adult Patients When Providing Palliative Medical Care in Inpatient and Outpatient Polyclinic Conditions".

[11] Bill No. 01/05/01-20/00099106 dated January 31, 2020, On Amendments to Article 228.2 of the Criminal Code of the Russian Federation.

[12] Order of the Ministry of Health of Russia No. 54n dated August 1, 2012, On Approval of the Form of Prescription Blanks Containing a Prescription for Narcotic Drugs or Psychotropic Substances, the Procedure for Their Manufacture, Distribution, Registration, Accounting, and Storage, as well as Rules for Processing.

[13] Order of the Ministry of Health of Russia No. 4n dated January 14, 2019, On Approval of the Procedure for Prescribing Medicinal Products, Forms of Prescription Blanks for Medicinal Products, and the Procedure for Filling Out Said Blanks, Their Recording and Storage.

[14] Order of the Ministry of Health of Russia No. 377 dated June 17, 2013, On Approval of the Procedure for Registration, Accounting, and Storage of the Reserve Stock of Special Prescription Blanks for a Narcotic Drug or Psychotropic Substance of the Ministry of Health of the Russian Federation and Carrying Out the Dispensing of Special Prescription Blanks for a Narcotic Drug or Psychotropic Substance from the Reserve Stock.

[15] Order of the Ministry of Health of Russia No. 54n dated August 1, 2012, On Approval of the Form of Prescription Blanks Containing a Prescription for Narcotic Drugs or Psychotropic Substances, the Procedure for Their Manufacture, Distribution, Registration, Accounting, and Storage, as well as Rules for Processing.

[16] Letter of the Ministry of Health of Russia No. 25-4/i/1-6953 dated August 1, 2019, On the Procedure for Prescribing, Storing, and Using Medicinal Products Containing Narcotic Drugs and Psychotropic Substances Used for Treating Patients Residing in Inpatient Social Service Organizations.

[17] Order of the Department of Healthcare of the City of Moscow No. 1077 dated December 11, 2015, On the Procedure for Acquisition, Transportation, Storage, Accounting, Dispensing, Use, Destruction, Prescribing, and Writing of Narcotic Drugs and Psychotropic Substances Included in List II of the List, Psychotropic Substances Included in List III of the List in Medical Organizations of the State Healthcare System of the City of Moscow.

[18] Order of the Ministry of Health of the Russian Federation and the Ministry of Labor and Social Protection of the Russian Federation No. 345n/372n dated May 31, 2019, On Approval of the Regulation on the Organization of Provision of Palliative Medical Care, Including the Procedure for Interaction of Medical Organizations, Social Service Organizations, and Public Associations, Other Non-Profit Organizations Carrying Out Their Activities in the Sphere of Health Protection.

[19] Letter of the Ministry of Health of the Russian Federation No. 25-4/10/1-1221 dated February 27, 2018, On Methodological Recommendations on the Organization of Circulation of Narcotic and Psychotropic Medicinal Products for Medical Use in Medical and Pharmacy Organizations.

[20] Order of the Ministry of Health of Russia No. 917n dated December 1, 2016, On Approval of Standards for Calculating the Need for Narcotic and Psychotropic Medicinal Products Intended for Medical Use.

[21] Resolution of the Government of the Russian Federation No. 558 dated July 26, 2010, On the Procedure for Distribution, Dispensing, and Sale of Narcotic Drugs and Psychotropic Substances, as well as Dispensing and Sale of Their Precursors (together with the Rules for Distribution, Dispensing, and Sale of Narcotic Drugs and Psychotropic Substances, as well as Dispensing and Sale of Their Precursors).

[22] Order of the Ministry of Health of Russia No. 913 dated November 16, 2017, On Approval of Methodological Recommendations on Determining the Need for Narcotic Drugs and Psychotropic Substances Intended for Medical Use.

[23] Letter of the Ministry of Health of Russia No. 346/25-4 dated February 13, 2017, On Determining the Need for Narcotic Medicinal Products Intended for Medical Use.

[24] Decision of the Board of the Eurasian Economic Commission No. 178 dated December 29, 2015, On Rules for Determining Categories of Medicinal Products Dispensed Without a Prescription and by Prescription.

[25] Order of the Ministry of Health of Russia No. 183n dated April 22, 2014, On Approval of the List of Medicinal Products for Medical Use Subject to Subject-Quantitative Accounting.

[26] Procedure for Dispensing Medicinal Products for Medical Use to Individuals Containing, in Addition to Small Quantities of Narcotic Drugs, Psychotropic Substances, and Their Precursors Included in Lists II, III, and IV of the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors, Other Pharmacologically Active Substances, approved by Order of the Ministry of Health and Social Development of Russia No. 562n dated May 17, 2012.

[27] Order of the Ministry of Health and Social Development of Russia No. 157n dated March 16, 2010, On Approval of the Maximum Allowable Quantity of a Narcotic Drug, Psychotropic Substance, and Their Precursor Contained in Preparations.

[28] Resolution of the Government of the Russian Federation No. 599 dated July 20, 2011, On Measures of Control Regarding Preparations Containing Small Quantities of Narcotic Drugs, Psychotropic Substances, and Their Precursors Included in the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors Subject to Control in the Russian Federation.

[29] Resolution of the Government of the Russian Federation No. 1085 dated December 22, 2011, On Licensing Activities Related to the Circulation of Narcotic Drugs, Psychotropic Substances, and Their Precursors, and Cultivation of Narcotic-Containing Plants.

[30] List of Medical Organizations and Separate Subdivisions of Medical Organizations Located in Rural Settlements and Remote Localities Where There Are No Pharmacy Organizations, and the List of Narcotic Medicinal Products and Psychotropic Medicinal Products, the Dispensing of Which to Individuals May Be Carried Out by Medical Organizations and Separate Subdivisions of Medical Organizations Located in Rural Settlements and Remote Localities Where There Are No Pharmacy Organizations, approved by Resolution of the Government of the Sverdlovsk Region No. 704-PP dated August 5, 2015.

[31] Order of the Ministry of Health of Russia No. 681n dated September 7, 2016, On the List of Positions of Pharmaceutical and Medical Workers in Organizations Granted the Right to Dispense Narcotic Medicinal Products and Psychotropic Medicinal Products to Individuals.

[32] Order of the Ministry of Health of Russia No. 988n dated December 22, 2017, On the Procedure for Issuing a Certificate of Absence of Drug Addiction, Substance Abuse, Chronic Alcoholism Among Employees Who, in Accordance with Their Labor Duties, Must Have Access to Narcotic Drugs, Psychotropic Substances Included in List I and Table I of List IV of the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors Subject to Control in the Russian Federation, Precursors, or Cultivated Narcotic-Containing Plants.

[33] Resolution of the Government of the Russian Federation No. 1148 dated December 31, 2009, On the Procedure for Storage of Narcotic Drugs, Psychotropic Substances, and Their Precursors.

[34] Order of the Ministry of Health of Russia No. 484n dated July 24, 2015, On Approval of Special Requirements for Storage Conditions of Narcotic Drugs and Psychotropic Substances Registered in the Established Procedure as Medicinal Products Intended for Medical Use in Pharmacy, Medical, Research, Educational Organizations, and Organizations for Wholesale Trade in Medicinal Products.

[35] Rules for Storage and Accounting of Narcotic Drugs in Control and Analytical Laboratories, approved by Order of the Ministry of Health of the Russian Federation No. 330 dated November 12, 1997.

[36] Resolution of the Government of the Russian Federation No. 1148 dated December 31, 2009, On the Procedure for Storage of Narcotic Drugs, Psychotropic Substances, and Their Precursors.

[37] Order of the Ministry of Health of the Russian Federation No. 23n dated January 15, 2016, On Approval of the Procedure for Accepting Unused Narcotic Drugs from Relatives of Deceased Patients.

[38] Letter of the Ministry of Health of Russia No. 25-4/10/1-1221 dated February 27, 2018, On Sending Methodological Recommendations on the Organization of Circulation of Narcotic and Psychotropic Medicinal Products for Medical Use in Medical and Pharmacy Organizations.

[39] Order of the Ministry of Health of Russia No. 127 dated March 28, 2003, On Approval of the Instruction on Destruction of Narcotic Drugs and Psychotropic Substances Included in Lists II and III of the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors Subject to Control in the Russian Federation, the Further Use of Which in Medical Practice Is Deemed Inexpedient.

[40] Resolution 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 (together with the "Regulation on Import into the Russian Federation and Export from the Russian Federation of Narcotic Drugs, Psychotropic Substances, and Their Precursors When Carrying Out Foreign Trade Activities with Member States of the Eurasian Economic Union," the "Regulation on Import into the Russian Federation and Export from the Russian Federation of Narcotic Drugs, Psychotropic Substances, and Their Precursors When Carrying Out Foreign Trade Activities with States That Are Not Members of the Eurasian Economic Union").

[41] Order of Roszdravnadzor No. 3588 dated May 15, 2019, On Approval of the Administrative Regulation of the Federal Service for Surveillance in Healthcare for Providing State Services for Issuing a Certificate for the Right to Import (Export) Narcotic Drugs, Psychotropic Substances, and Their Precursors, If They Are Medicinal Products.

[42] A law permitting the import of medicines with narcotic substances into Russia has entered into force. The new law also improves the procedure for interchangeability of medicinal products // TASS. March 1, 2020.

[43] Federal Law No. 475-FZ dated December 27, 2019, On Amendments to the Federal Law "On the Circulation of Medicinal Products" and the Federal Law "On Amendments to the Federal Law 'On the Circulation of Medicinal Products'".

[44] Decision of the Board of the Eurasian Economic Commission No. 30 dated April 21, 2015, On Non-Tariff Regulation Measures.

[45] Decision of the Customs Union Commission No. 287 dated June 18, 2010, On Approval of the Form of the Passenger Customs Declaration and the Procedure for Filling Out the Passenger Customs Declaration.

[46] Resolution 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 in the Territory of the Russian Federation, as well as Processing Documents Necessary for This.

[47] Rosgvardiya clarifies. Press service of Rosgvardiya. February 7, 2018.

[48] Letter of the Ministry of Health of Russia No. 25-4/I/1-6872 dated July 31, 2019, On the Procedure for Transporting Medicinal Products Containing Narcotic Drugs and Psychotropic Substances to Medical and Pharmacy Organizations.