BRACE Law Firm presents its regulatory digest of the most significant changes in the pharmaceutical industry for 2019. Notably, the legislator introduced pivotal amendments to the legal framework governing the circulation of medicines, specifically targeting drug labeling, maximum manufacturer prices for Vital and Essential Drugs (VED), market entry regulations for pharmaceuticals, and other critical areas.

In compiling this digest, we evaluated the direct impact of these statutory changes on the life sciences industry and the practical compliance challenges market participants may face.

This digest provides an analytical overview of these milestone amendments and other notable legal developments.

1. The Collegium of the Eurasian Economic Commission Adopts Key Guidelines and Recommendations Governing EAEU Pharmaceutical Activity

Recommendation of the Collegium of the Eurasian Economic Commission No. 2 dated January 29, 2019 “On the Guideline on the Choice of Trade Names for Medicinal Products”

Recommendation of the Collegium of the Eurasian Economic Commission No. 3 dated January 29, 2019 “On the Guideline on the Manufacture of Finished Dosage Forms of Medicinal Products”

Recommendation of the Collegium of the Eurasian Economic Commission No. 6 dated February 12, 2019 “On the Guideline on the Selection of Tests and Acceptance Criteria for the Specification of Herbal Raw Materials, Herbal Pharmaceutical Substances (Herbal Raw Material-Based Preparations), and Herbal Medicinal Products”

Recommendation of the Collegium of the Eurasian Economic Commission No. 24 dated August 6, 2019 “On the Guideline on Microbial Contamination Risk Control for Herbal Raw Materials, Herbal Pharmaceutical Substances (Herbal Raw Material-Based Preparations), and Herbal Medicinal Products”

Recommendation of the Collegium of the Eurasian Economic Commission No. 10 dated March 19, 2019 “On the Updated Information Directory of Concepts Applied Within the Eurasian Economic Union in the Sphere of Medicine Circulation”

Recommendation of the Collegium of the Eurasian Economic Commission No. 8 dated March 12, 2019 “On the Guideline on Dose Selection for Medicinal Products”

The Guideline on the Choice of Trade Names for Medicinal Products establishes an approach for evaluating the trade names of orphan drugs, aligning it with the general assessment framework for non-orphan medicines. For orphan drugs, applicants must submit detailed data regarding the specific conditions of distribution and administration, alongside target population metrics. Notably, if a trade name comprises a newly coined word, it must not cause confusing similarity or mimic any existing international nonproprietary name (INN).

The Guideline on the Manufacture of Finished Dosage Forms mandates that manufacturing process descriptions detail critical stages and intermediate products, establishing a clear link between pharmaceutical development, the proposed control strategy, and process validation.

The Guideline on the Selection of Tests and Acceptance Criteria for Specifications of Herbal Medicinal Products dictates that finished dosage form specifications must include: quality metrics for herbal raw materials and/or herbal pharmaceutical substances; manufacturing process descriptions (covering temperature impacts, residual solvents, etc.); active component profile and stability during packaging; and batch data utilized in preclinical or clinical trials (safety and efficacy assessment), where applicable. Section 5 elaborates on core testing and acceptance criteria, introducing specific additional tests beyond standard metrics.

The Guideline on Microbial Contamination Risk Control for Herbal Raw Materials and Herbal Pharmaceutical Substances requires operators to mitigate risks associated with pH fluctuations and elevated storage humidity, which facilitate microbial proliferation during cultivation, harvesting, processing, manufacturing, storage, and transport. To prevent microbial contamination, companies must implement and monitor optimal cultivation environments.

To harmonize terminology across the EAEU pharmaceutical market, the Commission updated the Information Directory of Concepts Applied Within the Eurasian Economic Union in the Sphere of Medicine Circulation. For instance, the updated directory defines novel concepts such as “bio-batch”, “process validation”, and “dose dumping”.

The Guidelines on Dose Selection for Medicinal Products establish that during drug registration, developers must determine the minimum dose providing a clear therapeutic benefit or the maximum dose beyond which no additional efficacy occurs, thereby reducing instances of over-dosing. Evaluating the shape and position of the population mean dose-response curve for both desired effects and adverse reactions proves critical when selecting a starting dose. The determination of dose-response relationships must incorporate diagnostic and therapeutic approaches that influence standard research protocols across distinct clinical domains.

The aforementioned instruments effectively regulate these and other paramount legal issues within the enforcement landscape of EAEU member states.

2. The Eurasian Economic Commission Issues Recommendations on Preclinical and Clinical Trials, R&D Frameworks, and Drug Expertise

Recommendation of the Collegium of the Eurasian Economic Commission No. 25 dated September 2, 2019 “On the Guideline on the Preclinical and Clinical Development of Combination Medicinal Products”

Recommendation of the Collegium of the Eurasian Economic Commission No. 28 dated September 10, 2019 “On the Guideline on Determining the Scope of Laboratory Testing During Drug Expertise”

Decision of the Collegium of the Eurasian Economic Commission No. 202 dated November 26, 2019 “On Approving the Guideline on Preclinical Safety Studies for the Purpose of Conducting Clinical Trials and Drug Registration”

Recommendation of the Collegium of the Eurasian Economic Commission No. 42 dated December 17, 2019 “On the Guideline on the Selection of Non-Investigational Medicinal Products for the Purpose of Conducting Clinical Trials”

The Guideline on the Preclinical and Clinical Development of Combination Medicinal Products outlines methodologies for developing fixed-dose combinations containing two or more active substances in a single dosage form. The scope and design of preclinical studies depend on existing data for individual active ingredients and the intended therapeutic indications. The document further classifies various active substance combination profiles.

The Guideline on Determining the Scope of Laboratory Testing During Drug Expertise advises on the volume of sample testing required to verify compliance with quality regulatory documents and analytical methodology validation during drug registration or variations. These procedures follow the Rules of Drug Registration and Expertise for Human Use (Decision of the EAEU Council No. 78). Regulators determine laboratory testing parameters based on the specific manufacturing characteristics of each drug. However, for biological medicinal products, testing must encompass all quality indicators across all manufacturing sites and utilize all declared active pharmaceutical substance (API) manufacturers.

The Guideline on Preclinical Safety Studies for the Purpose of Conducting Clinical Trials and Drug Registration states that clinical trials must expand once preceding data confirms sufficient safety profiles, incorporating cumulative preclinical safety data as clinical development progresses. The core safety pharmacology battery evaluates impacts on the cardiovascular, central nervous, and respiratory systems, and operators must conduct these evaluations prior to initiating clinical development, pursuant to human drug safety pharmacology guidelines.

The Guideline on the Selection of Non-Investigational Medicinal Products for the Purpose of Conducting Clinical Trials defines the term “non-investigational medicinal product” (NIMP). A medicine is classified as non-investigational if its administration does not constitute the direct objective of the clinical trial. The document establishes NIMP selection criteria and outlines the data package required within clinical trial applications. Sponsors primarily utilize NIMPs registered under the Rules of Registration and Expertise, or authorized by a member state hosting the trial, in compliance with EAEU legal frameworks.

These instruments play a critical role in structuring the regulatory framework for preclinical and clinical trials, as well as drug expertise, across the EAEU.

3. The Russian Government Enacts New Market Entry Regulations for Pharmaceuticals, Supported by Roszdravnadzor Clarifications

Decree of the Government of the RF No. 1510 dated November 26, 2019 “On the Procedure for Introducing Medicinal Products for Human Use into Commercial Circulation” (together with the Rules for Submitting Documents and Information on Medicinal Products for Human Use Introduced into Commercial Circulation; the Rules for Issuing Testing Protocols Confirming Compliance for the First Three Batches or Lots of a Medicinal Product for Human Use (Excluding Immunobiological Medicinal Products) First Manufactured in the Russian Federation or First Imported into the Russian Federation with Quality Indicators Provided by Regulatory Documentation; the Rules for Issuing Market Entry Permits for a Batch or Lot of an Immunobiological Medicinal Product and Issuing a Statement of Compliance of a Batch or Lot of an Immunobiological Medicinal Product with the Requirements Established Upon its State Registration; and the Rules for Revoking Commercial Circulation Permits for a Batch or Lot of a Medicinal Product for Human Use)

Memo on the Acceptance of Medicinal Products in Connection with the Entry into Force of the New Market Entry Procedure for Medicinal Products on November 29, 2019

Letter of Roszdravnadzor No. 01I-2906/19 dated November 28, 2019 “On Introduction into Commercial Circulation”

Federal Law No. 449-FZ “On Amending Certain Legislative Acts of the Russian Federation regarding the Introduction of Medicinal Products for Human Use into Commercial Circulation” introduced Article 52.1 into Federal Law No. 61-FZ “On the Circulation of Medicines”. For medicines entering commercial circulation after November 29, 2019, manufacturers must submit a quality certificate along with an authorized person's confirmation that the product meets state registration requirements to the Federal Service for Surveillance in Healthcare (Roszdravnadzor). This statutory instrument effectively abolishes mandatory drug certification.

The Government Decree enacted in November 2019 specifies that prior to introducing a batch or lot into commercial circulation, the manufacturer must upload the quality certificate and the authorized person's compliance statement to Roszdravnadzor's automated information system (AIS) via their secure online portal for each corresponding batch or lot.

Similarly, prior to market entry, importers must submit the following documentation to Roszdravnadzor's AIS portal for every batch or lot: a manufacturer's certificate attesting that the imported drug complies with the relevant pharmacopoeia monograph (or quality documentation if no monograph exists), and a compliance confirmation executed by an importer's representative authorized by the foreign manufacturer.

Failure to submit these documents triggers a revocation of the drug's commercial circulation permit. Roszdravnadzor issues the corresponding administrative order within five business days from receiving data that confirms the batch or lot is physically present in the market.

Roszdravnadzor clarified that starting November 29, 2019, domestic manufacturing facilities and importers must log all relevant data through the AIS Roszdravnadzor external portal.

Applicants possessing an active AIS Roszdravnadzor account do not require additional registration.

Stakeholders can verify the regulatory compliance of any medicine batch or lot on Roszdravnadzor's official website, utilizing search parameters such as trade name, batch number, manufacturer, and country of origin.

Roszdravnadzor publishes data concerning market entry permits for immunobiological batches or lots under the “Electronic Services” / “Information on Medicines Entered into Commercial Circulation in the Russian Federation” section.

If the website lacks information regarding the commercial introduction of a specific batch or lot, market participants should contact Roszdravnadzor's territorial body to initiate necessary enforcement or control measures.

4. The Russian Government Approves Compliance Assessment and Recognition Procedures for GLP Testing Laboratories Under OECD Standards

Decree of the Government of the RF No. 1227 dated September 20, 2019 “On the Recognition and Compliance Assessment of Testing Laboratories (Centers) with Good Laboratory Practice Principles Aligned with the Good Laboratory Practice Principles of the Organisation for Economic Co-operation and Development”

Testing laboratories performing non-clinical (preclinical) studies on objects contained in pesticides, cosmetics, human and veterinary medicines, food and feed additives, and industrial chemicals may voluntarily apply to the monitoring authority to obtain or renew Good Laboratory Practice (GLP) compliance status.

The monitoring body grants GLP compliance recognition based on the findings of preliminary and full inspections.

A multi-agency framework oversees these GLP recognition and compliance assessment procedures aligned with OECD standards, comprising the Ministry of Health, the Ministry of Industry and Trade, the Ministry of Agriculture, the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor), the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor), Roszdravnadzor, the Federal Medical-Biological Agency (FMBA), and the Federal Agency for Technical Regulation and Metrology (Rosstandart).

5. Roszdravnadzor Establishes the Immunobiological Quality Commission, Permitting Forms, and Quality Testing Assessment Procedures

Order of Roszdravnadzor No. 8967 dated November 29, 2019 “On the Commission of the Federal Service for Surveillance in Healthcare on the Quality of Immunobiological Medicinal Products” (together with the “Regulations on the Commission of the Federal Service for Surveillance in Healthcare on the Quality of Immunobiological Medicinal Products”)

Order of Roszdravnadzor No. 8966 dated November 29, 2019 “On Approving the Market Entry Permit Form for Immunobiological Batches or Lots Manufactured in or Imported into the Russian Federation, and the Statement Form of Compliance of an Immunobiological Batch or Lot with the Requirements Established Upon its State Registration”

Order of Roszdravnadzor No. 9452 dated December 17, 2019 “On Approving the Procedure for Assessing the Volume of Quality Testing of Immunobiological Medicinal Products by the Commission of the Federal Service for Surveillance in Healthcare on the Quality of Immunobiological Medicinal Products”

The Head of Roszdravnadzor appoints the Quality Commission for Immunobiological Medicinal Products (the “Commission”), which must consist of at least 10 members.

The Commission holds the authority to engage independent experts in immunobiological manufacturing and quality control. It can also request and obtain necessary operational data from federal executive bodies, domestic manufacturers, importers, and other entities operating within the medicine circulation sphere.

The Commission determines the specific scope of quality testing for a given drug name and manufacturer (factoring in dosage form and strength) pursuant to the established immunobiological quality testing assessment procedure.

The Commission adopts resolutions via open ballot by a simple majority vote.

The testing assessment procedure mandates that from January 12, 2020, quality evaluations target immunobiological drugs registered in the State Register of Medicines, entered into Russian commercial circulation, and recorded within Roszdravnadzor's AIS.

The Commission determines testing volumes based on an annual drug quality analysis submitted to the Commission by March 1 each year.

Utilizing available data, the Commission convenes annually no later than April 1 to determine the exact quality testing scope and frequency for specific drug products and manufacturers across all parameters of the approved quality specification documents.

6. FAS Russia Issues Guidance on New Statutory Obligations for VED Manufacturers to Reduce Maximum Manufacturer Prices

Federal Law No. 134-FZ dated June 6, 2019 “On Amending the Federal Law 'On the Circulation of Medicines' Regarding State Price Regulation for Medicinal Products Included in the List of Vital and Essential Drugs”

Clarification on Pricing Mechanisms for Narcotic and Psychotropic VED Supplied to Medical Organizations by Wholesalers with Retail Subdivisions (FAS Russia Letters No. RP/15603/19 dated February 28, 2019 and No. TSA/36600/19 dated April 29, 2019)

Decree of the Government of the RF No. 1683 dated December 16, 2019 “On Amending Certain Acts of the Government of the Russian Federation Regarding State Registration and Re-registration of Maximum Manufacturer Prices for Medicinal Products Included in the List of Vital and Essential Drugs”

Federal Law No. 134-FZ introduced a legal mandate requiring manufacturers to lower maximum manufacturer prices for drugs included in the Vital and Essential Drugs (VED) list.

Price reductions are mandatory under the following conditions:

• a reduction in the foreign-currency price of the drug within its country of origin and/or countries where the manufacturer holds registrations or delivers supplies;

• a price drop for reference products affecting corresponding generic or biosimilar drugs within the manufacturing country or supply destinations;

• instances where the maximum manufacturer price of the initial foreign-manufactured generic or biosimilar exceeds that of a subsequent generic or biosimilar calculated via the Russian Government's approved methodology;

• situations where the maximum manufacturer price of an initial generic or biosimilar from an EAEU member state exceeds the methodology-calculated price of a secondary EAEU-produced generic or biosimilar.

FAS Russia clarified that applicable legislation governing medicine circulation and public procurement prohibits the inclusion of retail markups in VED prices supplied directly to medical organizations. Medical institutions lacking internal pharmacies receive narcotic and psychotropic drugs via requisition invoices. In such cases, wholesalers operating an internal pharmacy unit through which these products are dispensed via requisition invoices may account for their operating costs.

Significantly, December 2019 amendments to the VED Price Registration Rules dictate that mandatory re-registration preserves the latest registered maximum manufacturer prices for EAEU-produced immunobiologicals, narcotics, psychotropics, and medicines priced below 100 rubles.

Marketing authorization holders or owners of reference drugs must submit mandatory price re-registration applications for 2019–2020 within 40 business days from the effective date of Government Decree No. 1683.

For unregistered pediatric medicines, the price calculation follows the criteria established for reference drugs. Crucially, the maximum variance between the lowest registered maximum price and the newly submitted price—calculated per active ingredient unit—cannot exceed 90 percent.

Furthermore, the Ministry of Health and the Federal Antimonopoly Service now hold autonomous authority to mandate the re-registration of a drug's maximum manufacturer price.

While these statutory amendments aim to lower consumer drug prices, the aggressive implementation timelines could prompt certain international manufacturers to exit the Russian market.

7. Statutory Amendments Revamp the Regulatory Landscape for Special Investment Contracts (SPIC)

Federal Law No. 290-FZ dated August 2, 2019 “On Amending the Federal Law 'On Industrial Policy in the Russian Federation' Regarding the Regulation of Special Investment Contracts”

Federal Law No. 269-FZ dated August 2, 2019 “On Amending Parts One and Two of the Tax Code of the Russian Federation”

The Special Investment Contract (SPIC) framework mandates that investors establish, modernize, or scale industrial production within the territory, continental shelf, or exclusive economic zone of the Russian Federation. In return, federal or regional authorities guarantee specific industrial incentives throughout the contract's duration.

The amendments insert Chapter 2.1 into the Federal Law “On Industrial Policy in the Russian Federation”, specifying that SPICs govern the deployment or R&D-driven implementation of technologies necessary for manufacturing operations. The Russian Government maintains and updates the approved list of advanced technologies. SPICs must explicitly detail the industrial incentives available to the investor upon fulfilling contract milestones. However, contracts exclude standard statutory incentives that investors can access independently of the SPIC. Furthermore, bidding participants must secure location clearance from regional and municipal authorities regarding the proposed manufacturing site prior to submitting their applications, embedding this clearance within the selection dossier.

The statutory duration for investment contracts below 50 billion rubles is extended to 15 years, while projects exceeding this threshold can secure terms up to 20 years.

Taxpayers participating in SPICs benefit from a 0 percent federal corporate income tax rate during the application period of reduced regional tax rates. As a general rule, investors qualify for zero-rate incentives if the SPIC generates over 90% of their total revenue. The Tax Code amendments introduce separate accounting options for investor income streams.

Regional authorities may likewise reduce their budget allocation tax rates down to 0 percent. This preferential rate applies from the tax period in which the investment project yields its initial profit until the entity loses its SPIC participant status, capped at the tax period where the total value of incentives and foregone budget revenues exceeds 50 percent of the contractually specified capital expenditure.

We anticipate that these measures will successfully attract major institutional investors, particularly within the pharmaceutical sector.

8. Law Expands Authorized Wholesale Drug Purchasers and Extends International Medical Cluster Status

Federal Law No. 240-FZ dated July 26, 2019 “On Amending Certain Legislative Acts of the Russian Federation”

This statute amends Item 6, Part 1, Article 53 of Federal Law No. 61-FZ “On the Circulation of Medicines”. Wholesalers may now legally sell or transfer drugs to medical organizations established by foreign legal entities from OECD member states, as well as individual entrepreneurs participating as project entities under Federal Law No. 160-FZ “On the International Medical Cluster and Amending Certain Legislative Acts of the Russian Federation”.

The International Medical Cluster integrates physical infrastructure, project participants, and specific cooperation mechanisms. A “project” encompasses all activities designed to achieve the cluster's operational objectives. The highest executive authority of Moscow designates the cluster's territory, aiming to enhance healthcare delivery, elevate quality standards, and facilitate drug development.

The amendment extends the project participant status for legal entities and individual entrepreneurs to 20 years (up from 10 years) from the agreement date, unless terminated earlier due to liquidation, reorganization, or cessation of business operations. Additionally, the federal law prohibits cluster participants from delivering medical services funded by the Russian budget system. Previously, participants holding domestic medical licenses could provide such services.

9. Digital Infrastructure Enables Electronic Prescriptions for Narcotic and Psychotropic Medications

Federal Law No. 242-FZ dated July 29, 2017 “On Amending Certain Legislative Acts of the Russian Federation Regarding the Application of Information Technologies in Healthcare”

Physicians may now issue prescriptions for narcotic or psychotropic substances either on specialized paper forms or, with the consent of the patient or their legal representative, as electronic documents. These digital prescriptions require an advanced qualified electronic signature from the attending physician (or authorized healthcare professional) and the issuing medical institution.

10. The Russian Government Modifies Licensing Requirements for Alcohol-Containing Pharmaceuticals

Decree of the Government of the RF No. 201 dated February 28, 2019 “On Approving the Rules for Forming the List of Alcohol-Containing Medicinal Products Exempt from the Federal Law 'On State Regulation of Production and Circulation of Ethyl Alcohol, Alcohol, and Alcohol-Containing Products and on Limiting Alcohol Consumption'”

Decree of the Government of the RF No. 217 dated February 28, 2019 “On Amending the Regulations on Licensing of Pharmaceutical Manufacturing”

The Ministry of Health (for human medicines) and the Ministry of Agriculture (for veterinary medicines) compile the list of exempt alcohol-containing products based on written submissions and electronic copies requesting inclusion or exclusion.

Products failing to meet the statutory criteria or those subject to marketing authorization revocation are removed from the exempt list.

License applicants for alcohol-containing pharmaceutical manufacturing face enhanced compliance standards, including requirements:

• to equip ethyl alcohol (ethanol) receiving tanks with automated measurement devices that log anhydrous alcohol concentration, total volume, and fluid levels pursuant to Federal Alcohol Market Regulatory Service tech-specs;

• to install automated telemetry systems that record utilization data and transmit manufacturing volumes directly into the Unified State Automated Information System (EGAIS).

11. New Administrative Penalties Targeting Non-Compliance in Track-and-Trace Reporting Systems

Federal Law No. 58-FZ dated April 15, 2019 “On Amending the Code of the Russian Federation on Administrative Offenses”

Federal Law No. 180-FZ dated July 18, 2019 “On Amending the Code of the Russian Federation on Administrative Offenses”

The legislature introduced Article 6.34 into the Administrative Code, imposing fines on corporate officers (5,000 to 10,000 rubles) and legal entities (50,000 to 100,000 rubles) for late or inaccurate data entry into the human medicine track-and-trace monitoring system. Individual entrepreneurs bear the same liability exposure as corporate entities for these violations.

The statute stipulates that distributing drugs lacking proper identification markings (QR codes) triggers fines between 5,000 and 10,000 rubles for officers, and 50,000 to 100,000 rubles for corporations. Alongside monetary fines, regulators may confiscate the non-compliant inventory.

This Federal Law enters into force on January 1, 2020.

Roszdravnadzor acts as the competent authority for enforcement. Additionally, an amendment to Article 24.81 empowers Roszdravnadzor to adjudicate violations under Article 9.13 (failure to ensure disabled accessibility), specifically targeting medical and pharmaceutical facilities. Violations trigger fines of 2,000 to 3,000 rubles for officers and 20,000 to 30,000 rubles for legal entities. These amendments took effect on July 29, 2019.

12. New Standardized Prescription Forms Take Effect Following Ministry of Health Guidance

Letter of the Ministry of Health of Russia No. 25-4/I/2-2885 dated April 4, 2019 “On New Prescription Forms for Medicinal Products Approved by Order of the Ministry of Health of Russia No. 4n dated January 14, 2019”

The Ministry of Health recognized that manufacturing new templates requires significant lead time. Consequently, the mandatory transition to the new prescription forms is deferred until January 1, 2020.

13. Regulatory Authorities Clarify Drug Marking Pilot Frameworks and Establish Code Generation Fees

Recommendations for Participants in the Identification Marking and Track-and-Trace Pilot Program for Certain Types of Medicinal Products for Human Use (together with “Identification Mark Characteristics, Structure, and Format Requirements, Including Procedures for Requesting and Deploying Serialization Codes and Generating Aggregation Codes” and “Data Transmission Integration Specifications Between Federal Information Systems and the Monitoring System”), Approved by Roszdravnadzor on October 2, 2019

Decree of the Government of Russia No. 577 dated May 8, 2019 “On Approving Fees for Track-and-Trace Code Services Required for Identification Mark Generation and Product Movement Verification Subject to Mandatory Serialization, and the Corresponding Collection Procedures”

Entities operating within the drug supply chain join the track-and-trace pilot program on a voluntary basis via registration in the monitoring system.

The monitoring system interchanges data with federal databases through secure electronic infrastructure. It integrates directly with multiple platforms: the single register of pharmaceutical manufacturing licenses; the single register of healthcare licenses; the unified state healthcare information system; the Unified State Register of Legal Entities; the Unified State Register of Individual Entrepreneurs; the registry of accredited foreign corporate branches; Roszdravnadzor's AIS; the automated customs database; and internal IT systems of supply chain participants.

Sponsors submit pilot program participation requests electronically within the tracking platform.

When transferring medicine inventories, either the dispatching or the receiving entity may log the transaction details into the monitoring system.

The service fee for generating track-and-trace identification codes is set at 50 kopecks per code, excluding VAT. Notably, the system waives fees for VED medicines with a maximum manufacturer price below 20 rubles.

14. New Public Procurement Rules Permit Drug Purchasing Without Ex-Ante NMCC Determinations

Federal Law No. 71-FZ dated May 1, 2019 “On Amending the Federal Law 'On the Contract System in the Procurement of Goods, Works, and Services for Public and Municipal Needs'”

Where public or municipal procurement authorities cannot predetermine exact pharmaceutical volumes, bidding documentation may specify a maximum contract value. Under these terms, payment reflects the actual unit price of delivered goods up to the designated contract ceiling.

Furthermore, the statute dictates that if an auction or tender targets critical goods (such as emergency medical supplies or essential drugs) and a bidder offers a price 25 percent or more below the initial maximum contract price (NMCC), that participant must provide a comprehensive cost justification to the buyer. Valid justifications include manufacturer warranty letters confirming price and volume metrics, inventory verification documents, or other instruments proving delivery capability at the proposed discount rate.

15. Tax Code Adjustments Expand Social Tax Deductions for Out-of-Pocket Outpatient Medicine Costs

Federal Law No. 147-FZ dated June 17, 2019 “On Amending Part Two of the Tax Code of the Russian Federation”

Letter of the Ministry of Finance of Russia No. 03-04-05/43139 dated June 13, 2019

Previously, taxpayers could only claim social tax deductions for out-of-pocket expenses on medicines explicitly listed in Government Decree No. 201.

The amended framework removes these list-based restrictions, extending tax deductions to any prescription medicine ordered by an attending physician.

The Ministry of Finance clarified that Form No. 107-1/u, bearing an official stamp for Russian tax authorities along with the taxpayer's TIN, serves as the mandatory supporting document for claiming this deduction.

16. The Russian Government Standardizes Quality and Tracking Rules for the Clinical Use of Donor Blood

Decree of the Government of the RF No. 797 dated June 22, 2019 “On Approving the Rules for the Procurement, Storage, Transport, and Clinical Use of Donor Blood and its Components, and Repealing Certain Acts of the Government of the Russian Federation”

The regulations explicitly prohibit introducing any medicinal substances or solutions into donor blood containers other than a 0.9 percent sterile sodium chloride solution.

To safeguard clinical applications, operators must ensure robust data traceability encompassing donor records, donation sessions, processed blood components, consumables (bags, reagents, solutions), donor and recipient blood samples, processing logs, and safety compliance metrics across the entire procurement and transport chain.

17. Ministry of Health Issues Compliance Guidance for Procuring Unregistered Psychotropic Medicines for Pediatric Care

Guidance published on the official website of the Ministry of Health of the Russian Federation

The guidance targets two distinct categories: parents whose children already possess medical commission approvals and federal hospital consultation protocols for unregistered psychotropics (such as diazepam, clobazam, midazolam, phenobarbital); and parents whose children require these medications due to the clinical failure of registered therapies, but who have not yet secured formal institutional consensus.

When transporting these substances, guardians must carry either the commission's formal ruling, the federal consultation protocol, or an official drug receipt. The state dispenses a three-month supply; thus, parents should notify their physician 2.5 months into the cycle to secure the subsequent allocation. Guardians lacking a medical board approval must contact their local outpatient clinic or a specialized pediatric neurology/palliative care facility to initiate the evaluation. If required, local primary care physicians can refer patients to specialized inpatient centers for comprehensive diagnostic reviews, dosage titration, or clinical indications assessments regarding unregistered psychotropic imports.

We anticipate this guidance will streamline the procurement timeline for families navigating complex regulatory red tape, which frequently demands specialized legal analysis and strains personal resources.

18. Milestone Statutory Overhauls to the Medicine Circulation Framework Set for 2020 Implementation

Federal Law No. 475-FZ dated December 27, 2019 “On Amending the Federal Law 'On the Circulation of Medicines' and Amending the Federal Law 'On Amending the Federal Law 'On the Circulation of Medicines''”

Federal Law No. 462-FZ dated December 27, 2019 “On Amending the Federal Law 'On the Circulation of Medicines' and Amending the Federal Law 'On Amending the Federal Law 'On the Circulation of Medicines''”

The amendments clarify the definitions of “generic drug” (reproduced medicinal product) and “reference drug”, placing significant emphasis on bio- and therapeutic equivalence criteria.

Specifically, the statute defines “bioequivalence” as achieving comparable metrics for absorption rate, site delivery extent, and elimination rate of active pharmaceutical ingredients when administering human medicines sharing identical international nonproprietary (or chemical/grouping) names at equivalent dosages via identical routes of administration.

A reference drug serves as the control baseline for evaluating the bioequivalence, therapeutic equivalence, quality, efficacy, and safety of a generic or biosimilar product. For human applications, regulators designate the original (innovator) drug as the reference baseline. If the innovator product is unregistered or unavailable in the Russian Federation and international markets, the reference designation shifts to the first registered generic or biosimilar in commercial circulation, provided its safety and efficacy were validated against the original product and remain supported by pharmacovigilance data. For veterinary applications, the reference drug comprises a product registered in the Russian Federation supported by full preclinical and clinical trial data. A generic drug (reproduced medicinal product) defines a medicine featuring identical qualitative and quantitative active ingredient profiles in an equivalent dosage form whose bio- or therapeutic equivalence to the reference product has been established via appropriate scientific studies.

The statute permits the targeted importation of unregistered batches containing narcotic or psychotropic substances for life-saving indications. This mechanism requires a formal ruling from a hospital medical board confirming that registered alternatives are ineffective or contraindicated. The application must explicitly specify the international nonproprietary name (INN), dosage form, and required volume. The competent federal executive body maintains the approved list of conditions and matching controlled substances authorized for import under this framework.

These statutory amendments take effect on March 1, 2020.

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