Among the most significant regulatory updates in the Russian life sciences and pharmaceutical sector during the first quarter of 2023, the following developments stand out:

1. Within the Eurasian Economic Union (EAEU), regulatory bodies refined the rules governing bioequivalence studies for medicinal products. Specifically, the updated framework details the evaluation protocols for demonstrating the therapeutic equivalence of local-action gastrointestinal drugs and topical dermatological medicines. It also introduces stringent clinical trial requirements for formulations containing well-established active pharmaceutical ingredients (APIs) designed for localized therapeutic effects.
2. The government established a transitional legal framework to integrate the pharmaceutical markets of the Donetsk People's Republic, Luhansk People's Republic, Zaporozhye Oblast, and Kherson Oblast into the broader Russian regulatory environment.
3. Legislators clarified the protocols for transferring donor blood to pharmaceutical manufacturers, introducing enhanced compliance mechanisms to ensure end-to-end transparency at every stage of the supply chain.
4. As part of the ongoing pilot program for the remote retail distribution of prescription-only medicines, regulatory bodies enacted specific eligibility criteria to govern the inclusion of drugs within the authorized online sales registry.
5. The Ministry of Health of the Russian Federation proposed implementing an experimental legal regime that permits healthcare providers to prescribe medicinal products via advanced telemedicine technologies.
6. A new draft bill proposes specialized administrative fines reaching up to RUB 200,000 to penalize pharmacies for dispensing prescription-only medications without a valid prescription.
7. Amendments introduce additional restrictive criteria for single-source public procurement contracts involving medicinal products under state tender frameworks.

1. Statutes, Regulations, and Legal Developments

1.1 EAEU Revises Bioequivalence Study Rules for Medicinal Products

Decision of the Council of the Eurasian Economic Commission No. 22 dated February 15, 2023, "On Amending the Rules for Bioequivalence Studies of Medicinal Products Within the Eurasian Economic Union"

The amendments supplement the Rules with the following three new annexes.

The updates establish precise requirements for clinical trials of medicinal products containing well-established active substances in local-action dosage forms. This category covers dermatological creams, ointments, inhalation powders or aerosols, eye and ear drops, and nasal formulations.

The updated framework stipulates that if an applicant cannot evaluate the bioavailability of a medicinal product using pharmacokinetic, pharmacodynamic, or in vitro endpoints, regulatory authorities will bar the drug from being classified as a generic medicinal product. However, the scope of pharmaceutical development for these products matches the requirements for an abbreviated dossier. When filing a marketing authorization application for such drugs, applicants must designate them as hybrid medicinal products. Manufacturers may justify the safety and local tolerability of topical formulations by submitting data on the properties of the active substance and the choice of well-known excipients. In specific cases, the regulations demand additional animal studies on the finished product (the combination of the active substance and all excipients), alongside further clinical trials involving human subjects.

The guidelines introduce new requirements for trials verifying the therapeutic equivalence of local-action medicinal products within the gastrointestinal tract. To substantiate equivalence, applicants must utilize the following data categories, structured in increasing order of preference: pharmaceutical quality data exclusively; a combination of pharmaceutical quality and in vitro model data; pharmaceutical quality coupled with in vivo pharmacokinetic data; or an integrated set of pharmaceutical quality, in vitro model, and in vivo pharmacokinetic data.

An additional annex establishes strict quality and bioequivalence requirements for topical medicinal products applied directly to the skin. Under these provisions, the physical state and saturation level of the active substance within the formulation (e.g., whether dissolved or suspended) constitute critical quality attributes. Manufacturers must justify these metrics from safety and efficacy standpoints, providing robust evidence demonstrating how the target state of the active substance is achieved during manufacturing and maintained throughout its shelf life.

The revised rules introduce extensive additions regarding the compliance criteria for the aforementioned medicinal products. These regulatory modifications take effect on August 28, 2023.

1.2 Transitional Framework Enacted for Medicine Circulation in New Territories

Federal Law No. 16-FZ dated February 17, 2023, "On the Peculiarities of Legal Regulation of Relations in the Spheres of Health Protection, Compulsory Health Insurance, Circulation of Medicines, and Circulation of Medical Devices in Connection with the Admission of the Donetsk People's Republic, the Luhansk People's Republic, Zaporozhye Oblast, and Kherson Oblast into the Russian Federation"

Following the integration of the new federal subjects into the Russian Federation, a transitional legal regime has taken effect to manage and resolve integration matters across these jurisdictions.

During this transitional window, the territories of the Donetsk People's Republic, Luhansk People's Republic, Zaporozhye Oblast, and Kherson Oblast permit the market circulation of:

• Medicinal products registered under Russian legislation in the State Register of Medicines, and/or drugs listed in the EAEU Unified Register of Registered Medicinal Products pursuant to applicable international treaties and EAEU law;
• Medicinal preparations exempt from registration in Russia under domestic statutory frameworks or EAEU legal acts;
• Unregistered medicinal products authorized for import into the Russian Federation in compliance with domestic legislation or EAEU international agreements;
• Medicines, including medicinal preparations for medical use, manufactured within the territories of the Donetsk People's Republic, Luhansk People's Republic, Zaporozhye Oblast, and Kherson Oblast prior to January 1, 2025.

Manufacturers may produce the aforementioned medicinal products without additional confirmation from Russian federal authorities, provided operations rely upon:

• Permits and authorizations issued prior to the effective date of this Federal Law by the state authorities of the Donetsk People's Republic, Luhansk People's Republic, Zaporozhye Oblast, Kherson Oblast, or Ukraine;
• Authorizations issued by the regional state bodies of the Donetsk People's Republic, Luhansk People's Republic, Zaporozhye Oblast, and Kherson Oblast based on applications submitted before this Federal Law entered into force.

These inherited permits shall remain valid until January 1, 2025.

Until January 1, 2025, the regional regulatory frameworks of the Donetsk People's Republic, Luhansk People's Republic, Zaporozhye Oblast, and Kherson Oblast shall govern price controls for medicinal preparations.

Furthermore, until January 1, 2025, pharmacies operating in these new federal subjects must execute all retail sales of non-VED (Vital and Essential Drugs) medicines in Russian rubles if the wholesale supply pricing was originally denominated in foreign currency. Retailers must convert the acquisition price of these medications, medical devices, and related goods into rubles using the official exchange rate of the Central Bank of the Russian Federation fixed on the delivery date.

1.3 Revisions Enacted for the VED Registry and Minimum Pharmacy Stock Requirements

Government of the Russian Federation Regulation No. 4173-r dated December 24, 2022

Effective February 28, 2023, the government expanded the Vital and Essential Drugs (VED) list to include several new therapeutic options: ramipril (capsules, tablets) for renin-angiotensin system modulation; the combination formula tenofovir + elsulfavirine + emtricitabine (coated tablets) for HIV therapeutics; and calcium polystyrene sulfonate (powder for oral suspension) to treat hyperkalemia and hyperphosphatemia.

The updated registry also incorporates bacterial diphtheria and tetanus vaccines.

Concurrently, the mandatory minimum pharmacy stock regulations clarify that single-component sorbed probiotics derived from bifidobacterium bifidum fall under the official anti-diarrheal drug classification.

1.4 Inclusion Criteria and Approved Registry for E-Pharmacy Prescription Sales Established

Government of the Russian Federation Decree No. 2465 dated December 28, 2022, "On Approving the Criteria for Including Medicinal Products and Pharmacotherapeutic Groups within the List of Medicines Authorized for Sale Under the Retail E-Commerce Prescription Drug Pilot Program," and Ministry of Health of the Russian Federation Order No. 36n dated February 1, 2023, "On Approving the List of Medicinal Products and Pharmacotherapeutic Groups Authorized for Sale Under the Retail E-Commerce Prescription Drug Pilot Program"

The regulatory criteria dictate that to qualify for remote online retail distribution, prescription-only medicinal products must satisfy the following negative clearances:

• Do not contain narcotic drugs, psychotropic substances, or their immediate precursors;
• Are free from potent or restricted substances;
• Contain no toxic or poisonous compounds;
• Exclude radiopharmaceuticals, immunobiological drugs, products requiring strict cold-chain storage below 15°C, or alcohol-containing formulations with an ethyl alcohol volume fraction exceeding 25%;
• Are not extemporaneously compounded directly within pharmacy laboratories;
• Are absent from the official registry of drugs subject to mandatory subject-to-quantitative accounting;
• Do not fall under the therapeutic classification of anabolic steroids;
• Exclude antipsychotics, anxiolytics, antidepressants, hypnotics, and sedatives;
• Are not indicated or utilized for the medical termination of pregnancy.

As a regulatory baseline, this remote prescription drug sales pilot project runs from March 1, 2023, through March 1, 2026, across the territories of Moscow, Moscow Oblast, and Belgorod Oblast.

1.5 Rules for Transferring Donor Blood to Pharmaceutical Manufacturers Approved

Government of the Russian Federation Decree No. 153 dated February 2, 2023, "On Approving the Rules for the Transfer of Donor Blood and/or Its Components to Organizations Engaged in the Manufacture of Medicines and/or Medical Devices"

Pursuant to this Decree, supplying organizations must maintain comprehensive data traceability regarding donors, individual donations, harvested blood components, operational consumables, donor blood samples, and specific technicians. This measure aims to safeguard the biological safety of donor blood and its components prior to transfer to manufacturing entities.

The system achieves end-to-end traceability by deploying unique identifiers at every operational stage—from the donor’s initial medical screening through final distribution, including temporary storage and disposal. Staff must systematically log this information across medical documentation and the central blood donor safety registry. Recipient manufacturing organizations must maintain internal traceability for every unit of donor blood received.

Suppliers shall deliver donor blood materials to manufacturing organizations based on executed agreements, specifically:

• A compensated service contract for the collection, harvesting, and storage of donor blood and/or its components;
• A specialized processing contract stipulating the transfer of blood components for refinement, manufacturing, and the subsequent return or delivery of finished medicinal products and medical devices to state or municipal entities.

Recipient manufacturers possess the right to conduct risk-based compliance audits of the suppliers' harvesting and storage infrastructure, capped at one audit per calendar year.

Should a supplier identify markers of bloodborne infections, it must notify the recipient manufacturer in writing (via facsimile or electronic communication) within three business days, covering a look-back window of 12 months from the transfer date.

Conversely, if a recipient manufacturer detects bloodborne pathogens within the transferred components, it must issue a written notification to the supplier within three business days of discovery.

Regulatory compliance mandates the immediate withdrawal from circulation and subsequent destruction of any blood units or components testing positive for bloodborne pathogens.

Furthermore, the manufacturer must recall any commercial batch or lot of a medicinal product or medical device that incorporates blood components flagged with such pathogens.

1.6 Regulatory Amendments Implemented for the National Medicine Track-and-Trace System

Government of the Russian Federation Decree No. 468 dated March 24, 2023, "On Amending Decree of the Government of the Russian Federation No. 1556 dated December 14, 2018, and Repealing Certain Provisions of Selected Acts of the Government of the Russian Federation"

Effective September 1, 2023, the regulation shortens the mandatory timeframe for the system operator to deliver emission recording devices and cryptographic decommissioning equipment to market participants, reducing the window from 45 down to 30 calendar days.

Additionally, the track-and-trace serialization platform will integrate digital patient package inserts. Pharmaceutical manufacturers must fully upload these electronic instructions to the system by June 30, 2024.

1.7 Licensing Framework Modified for Remote Retail Distribution of Medicines

Government of the Russian Federation Decree No. 272 dated February 18, 2023, "On Amending the Rules for Issuing Permits to Conduct Remote Retail Sales of Medicinal Products for Medical Use, Executing Such Trade, and Delivering Said Medicines to Citizens"

The amendments expand the list of mandatory documentation required to accompany an application for a remote retail sales permit. Specifically, applicants must now submit:

• Documentation confirming compliance of storage facilities and order-assembly areas with Good Storage and Distribution Practices (GSDP);
• Evidence of an internal courier infrastructure or an active third-party logistics contract, verified to use specialized climate-controlled transport equipment to safeguard the cold chain for thermolabile medications;
• Proof of integrated electronic payment systems or mobile point-of-sale (POS) terminals deployed to process digital and bank card transactions directly at the point of delivery.

The Decree further mandates that applicants submit all registry modification filings, supporting data, and contract copies electronically through the Unified State Services Portal, authenticated via an enhanced qualified or unqualified electronic signature.

1.8 Operational Scope of the "Circle of Kindness" Orphan Disease Foundation Refined

Government of the Russian Federation Decree No. 229 dated February 15, 2023, "On Amending Certain Acts of the Government of the Russian Federation Regarding the Operations of the 'Circle of Kindness' Foundation for the Support of Children with Severe Life-Threatening and Chronic Diseases, Including Rare (Orphan) Diseases"

The amendments clarify the financial architecture governing medicine procurement for patients under the age of 18 suffering from hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, hemolytic uremic syndrome, systemic juvenile arthritis, mucopolysaccharidosis Types I, II, and VI, unspecified aplastic anemia, and hereditary deficiencies of factors II, VII, and X, as well as pediatric post-transplant care. Beginning in 2023, federal budget appropriations allocated to the Ministry of Health specifically earmarked for the "Circle of Kindness" Foundation (the Foundation) shall serve as the primary funding source.

A specialized Ministry of Health commission shall formally approve all pediatric medicine supply volumes. Within three business days of finalizing procurement needs, the commission must transmit these figures to the Foundation and the state contractor to initiate procurement.

2. Draft Legislation and Regulatory Proposals

2.1 Experimental Legal Regime Proposed for Telemedicine Prescriptions

Draft Decree of the Government of the Russian Federation "On Establishing an Experimental Legal Regime in the Field of Digital Innovation and Approving the Program for the Experimental Legal Regime in Digital Innovations Regarding Medical Activities Utilizing Telemedicine Technologies"

This draft initiative proposes establishing an experimental legal sandbox to expand regular outpatient consultation capabilities. Under a single continuous course of treatment, a patient (or their legal representative) may transition from an initial in-person physician visit to subsequent remote consultations with a different healthcare professional. This secondary practitioner can leverage telemedicine technologies to manage the case, alter treatment courses, and issue electronic prescriptions.

The text of the project explicitly enables telemedicine physicians to adjust current therapies or formulate entirely new digital prescriptions, provided the initial diagnosing physician established the clinical diagnosis and baseline treatment plan during a prior face-to-face physical examination.

2.2 Draft Bill Introducing Heavy Fines for Over-the-Counter Sales of Prescription Drugs Approved

Draft Federal Law "On Amending the Code of the Russian Federation on Administrative Offenses"

The bill introduces targeted administrative liability for violations concerning the retail dispensing of monitored substances subject to subject-to-quantitative accounting. Specifically, selling these drugs over-the-counter without a valid prescription will incur substantial penalties, provided the actions do not rise to criminal misconduct. The draft escalates administrative fines to the following thresholds: RUB 10,000 to RUB 20,000 for licensed pharmacists and corporate officers; RUB 50,000 to RUB 100,000 for sole proprietors; and RUB 150,000 to RUB 200,000 for corporate legal entities.

The explanatory note emphasizes the principle of proportionality, seeking to punish non-compliance without imposing an excessive regulatory burden on small and medium-sized enterprises. To achieve this, draft legislators explicitly omitted administrative suspension of activities from the available sanctions, ensuring that retail pharmacy operations face no threats of forced operational shutdown.

2.3 Single-Source Public Procurement and Medicine Selection Criteria Formulated

"On Approving the List of Criteria for Single-Source Procurement of Medicinal Products for Medical Use and the Selection Criteria for Medicinal Products for Medical Use"

The proposed framework introduces the following mandatory compliance requirements for sole-source state procurement contracts:

• The designated sole supplier must maintain valid corporate legal entity status;
• The single source must operate as the direct manufacturer, executing all production stages—including active pharmaceutical ingredient (API) chemical synthesis—strictly within EAEU member states;
• The supplier must remain completely free from the direct or indirect control of foreign investors or foreign groups of persons;
• The contractor must demonstrate a verified three-year history of executing public medicine procurement contracts under Federal Laws No. 44-FZ or No. 223-FZ prior to petitioning the Government of the Russian Federation, accounting for corporate succession;
• The entity must hold exclusive patent rights protecting the underlying chemical compound of the active substance, with a patent duration matching or exceeding the single-source appointment term.

Concurrently, the selection criteria prioritize medicines whose entire manufacturing cycle occurs within the EAEU and whose active chemical structures are protected by valid Russian patents held by the sole supplier during state procurement tenders, with a duration matching the procurement term.

2.4 Ministry of Health Proposes Updated Compounding Rules for Licensed Pharmacies

Draft Order of the Ministry of Health of the Russian Federation "On Approving the Rules for Compounding and Dispensing Medicinal Products for Medical Use by Pharmacy Organizations Holding a Pharmaceutical Activity License"

This regulatory act will supersede Ministry of Health Order No. 751n dated October 26, 2015, which previously governed pharmacy and sole proprietor compounding practices.

The draft order excludes individual entrepreneurs from the authorized list of entities permitted to compound prescription drugs or fulfill medical facility orders. Conversely, the text grants licensed pharmacy organizations the right to utilize registered commercial medicines during the compounding process and establishes clear manufacturing protocols for radiopharmaceutical compounding.

2.5 Expansion of Interdepartmental Commission's Discretion to Mitigate Drug Shortages Contemplated

Draft Order "On Amending Paragraph 3 of the Regulations on the Interdepartmental Commission for Determining Drug Shortages or the Risk of Shortages of Medicinal Products in Connection with the Introduction of Economic Restrictive Measures Against the Russian Federation, Approved by Ministry of Health of the Russian Federation Order No. 339n dated May 19, 2022"

The draft order amends Ministry of Health Order No. 339n, which dictates the administrative procedures of the interdepartmental commission tasked with assessing drug shortages or supply chain risk profiles. It also governs the formal authorization templates enabling the temporary market circulation of unregistered foreign-label drug batches or commercial lots originally packaged for foreign jurisdictions.

The Ministry expects the draft order to mitigate the risk of drug stockouts and absolute shortages within the domestic market, particularly regarding critical items on the VED list, amid ongoing economic sanctions.

Substantively, the draft order empowers the interdepartmental commission throughout 2023 to authorize the importation and sale of foreign-packaged medicinal lots, including determining whether such products must undergo additional localized laboratory quality testing.

2.6 Roszdravnadzor Formulates Compliance Documentation List for Online Retail Prescription Drug Sales

Draft Order of Roszdravnadzor "On Approving the List of Documents Confirming the Compliance of a Pharmacy Organization with the Requirements Granting the Right to Conduct Remote Retail Sales of Prescription Medicinal Products for Medical Use"

Under the proposed rules, a pharmacy organization must maintain robust compliance records proving the availability of specialized order-storage and assembly areas, specifically including:

• Proof of ownership, leasehold, or other lawful possessory rights over specific storage units, individual rooms, or facility locations, detailed by room numbers matching official BTI (Bureau of Technical Inventory) floor plans;
• Verification of functional climate-control infrastructure, including air conditioning systems, industrial refrigeration chambers, ventilation systems, and calibrated psychrometric hygrometers or equivalent digital environmental logging equipment.

The regulation mandates that pharmacies provide verified domain ownership records for websites and mobile applications or present active commercial agreements executed with online marketplace aggregators. Additionally, operators must present proof of an internal courier department with compliant cold-chain gear or a binding contract with certified third-party fulfillment logistics providers.

3. Judicial and Enforcement Practice

3.1 Commercial Court Imposes Administrative Liability and Severe Fine on Pharmacy for Subsidized Drug Violations

Decision of the Commercial Court of the City of Moscow dated January 31, 2023, in Case No. A40-235026/22-94-1789

During a compliance inspection of a commercial pharmacy trading floor located at 5 Nizhnyaya Street, Moscow, inspectors from the Territorial Organ of Roszdravnadzor discovered high-value medications inside storage bags and refrigerators. The packages bore retail price tags displaying the pharmacy’s corporate name, yet several units exhibited intentionally scratched and tampered cryptographic track-and-trace codes. Consequently, the inspectors could not verify the lawful origin of the medicines due to the unidentifiable status of the mandatory tracking codes.

Furthermore, Roszdravnadzor identified medicines previously dispensed to patients under state-subsidized prescriptions, as well as products marked within the national track-and-trace database as 'withdrawn for medical use' by external clinics.

The Court ruled in favor of the regulatory body, finding the pharmacy liable for gross licensing violations and imposing an administrative fine of RUB 1,000,000. The appellate court subsequently affirmed the decision, leaving the fine intact.

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