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BRACE Law Firm presents its regulatory digest for the Russian pharmaceutical and life sciences sector covering March 2019.
During the past month, the College of the Eurasian Economic Commission approved key Recommendations aimed at updating definitions within the Eurasian Economic Union (EAEU) pharmaceutical regulatory framework. These updates modify the corresponding information directory for medicines circulation and establish new guidelines for pharmaceutical dosing selection.
At the federal legislative level, Russian authorities advanced regulatory clarity regarding the legal framework for palliative care delivery.
A critical regulatory development introduces a mandatory requirement to revoke the state registration of pharmaceutical products that have been absent from commercial circulation for three or more consecutive years.
Furthermore, March 2019 witnessed heightened legislative activity. Specifically, regulators introduced proposals to enhance liability for non-compliance with pharmaceutical manufacturing license requirements. Additionally, a newly proposed oversight framework seeks to approve the Procedure for monitoring the tracking and accounting of medicines designated for patients suffering from severe conditions, including hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, and malignant neoplasms.
Notable enforcement developments include recent Federal Antimonopoly Service (FAS) of Russia case law ruling that lookalike branding and shared characteristics between dietary supplements and identical-looking pharmaceutical products mislead consumers regarding the therapeutic properties of these goods.
1. Statutory Enactments, Subordinate Regulations, and Legal Updates
1.1. The College of the Eurasian Economic Commission Approved Recommendations Regarding the Updated Information Directory of Terms Utilized within the Eurasian Economic Union Framework for Medicines Circulation.
Recommendation of the College of the Eurasian Economic Commission dated March 19, 2019, No. 10 “On the Updated Information Directory of Terms Utilized within the Eurasian Economic Union Framework for Medicines Circulation”
As a matter of regulatory context, under the Agreement on Unified Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union (executed in Moscow on December 23, 2014), EAEU member states must adhere to standardized terminology established by the directory of terms and definitions for medicinal products when forming the common pharmaceutical market.
The updated information directory introduces several new regulatory concepts and definitions, including:
• **Biobatch** – a batch used in a clinical bioavailability (bioequivalence) study or a clinical efficacy study (confirming the functional characteristics of a dosage form). The biobatch size must correspond to at least an experimental-industrial batch scale; for solid oral dosage forms, this represents at least 10% of a full-scale production batch or 100,000 dosage units, whichever is greater.
• **Process Validation** – documented evidence providing a high degree of assurance that a specific manufacturing process, operating within established parameters, will consistently and effectively produce a medicinal product meeting its predetermined specifications and quality attributes.
• **Expiration Date (Shelf Life)** – the date indicated on the labeling of a pharmaceutical substance container or a finished medicinal product, marking the end of the period during which the product is expected to remain within its approved specifications if stored under defined conditions, after which it must not be used.
• **Dose Dumping** – the unintended, rapid premature release of an active substance from a modified-release dosage form.
We look upon the updates to this Information Directory as a well-founded advancement that aligns closely with the practical commercial need to harmonize the regulatory terminology employed across EAEU member states.
1.2. The College of the Eurasian Economic Commission Issued Guidance on Pharmaceutical Dosing Selection.
Recommendation of the College of the Eurasian Economic Commission dated March 12, 2019, No. 8 “On the Guideline for Pharmaceutical Dosing Selection”
This regulation, effective September 15, 2019, establishes that to mitigate instances of excessive dosing regimens during registration trials, clinical investigators must determine either the minimum effective dose showing clear therapeutic benefit or the maximum dose beyond which no incremental clinical benefit occurs. When selecting an initial dose, understanding the shape and location of the population mean dose-effect curve for both desired therapeutic effects and adverse reactions yields the highest clinical value. Determining this dose-effect relationship requires consideration of the diagnostic and therapeutic protocols influencing standard trial methods within each specific clinical area.
The clinical trial phase, the targeted indications for use, and the disease severity within the target patient cohort dictate the design selection for dose-effect relationship studies. For example, ethical considerations regarding the withholding of essential therapy in life-threatening or severe pathological conditions with irreversible outcomes may preclude clinical testing at doses below the maximum tolerated dose. Concurrently, the document outlines various clinical trial designs that have demonstrated efficacy in analyzing dose-effect dynamics, alongside general methodological directives for trial design execution.
1.3. Russian Legislature Enacts New Grounds for Non-Consensual Medical Intervention and Expands Palliative Care Framework.
Federal Law dated March 6, 2019, No. 18-FZ “On Amending the Federal Law ‘On the Basics of Health Protection of Citizens in the Russian Federation’ Regarding Palliative Care Delivery”
Under the amended law, healthcare providers may authorize medical intervention without the consent of a citizen, parent, or legal representative during the provision of palliative care if the patient's medical condition prevents them from expressing their intent and no legal representative is present. A medical commission must issue this decision; if assembling a commission is unfeasible, a medical consultation or the attending (duty) physician may authorize treatment directly. The authorizing party must document the decision in the patient's medical records and subsequently notify the healthcare organization's executives, the patient, or their legal representatives.
The statute explicitly guarantees a patient's right to pain management, including through the administration of narcotic and psychotropic drugs.
The law refines the definition of “palliative care,” characterizing it as a comprehensive suite of measures—including medical interventions, psychological support, and specialized nursing care—designed to enhance the quality of life for terminally ill citizens by relieving pain and mitigating other debilitating symptoms of the underlying disease.
Healthcare institutions deliver palliative medical care across outpatient settings (including home care), day hospitals, and inpatient facilities. To administer this care, medical professionals must undergo specialized regulatory training.
1.4. Marketing Authorization Holders Must Apply to Revoke Registrations for Pharmaceutical Products Absent from Commercial Circulation for Three or More Years.
Letter of the Ministry of Health of the Russian Federation dated March 4, 2019, No. 20-3/328 “On Submission to the Ministry of Health of Russia of an Application for the Revocation of State Registration of Medicinal Products Absent from Commercial Circulation in the Russian Federation for Three or More Years”
The directive mandates that the marketing authorization holder, owner of the drug registration certificate, or their authorized legal representative must submit an application to revoke the state registration of any medicinal product that has not been actively circulated within the Russian Federation for three or more consecutive years.
1.5. Russian Government Amends the State Program for the Development of the Pharmaceutical and Medical Industries.
Government Decree of the Russian Federation dated March 29, 2019, No. 359 “On Amending Government Decree of the Russian Federation dated April 15, 2016, No. 305”
The amended program targets several primary strategic pathways for the development of the pharmaceutical and medical industries, including:
• transitioning toward an innovation-driven developmental path;
• restructuring and expanding the scale of pharmaceutical and medical device manufacturing;
• cultivating a competitive market landscape;
• integrating into the global manufacturing and supply chains for medicinal products and medical devices.
The decree adjusts key target benchmarks, establishing that locally manufactured medicines must comprise 53% and local medical devices 43% of total domestic consumption value.
Furthermore, the core objectives of the Program now encompass building out the scientific, technological, and manufacturing infrastructure of the domestic pharmaceutical sector.
1.6. Regulatory Alerts Identify Counterfeit Signs in Batches of Vidaza.
Letter of Roszdravnadzor dated March 26, 2019, No. 01I-798/19 “On Signs of Falsification of the Medicinal Product Vidaza”
This official communication enumerates the physical signs of product falsification detected in batch 7B965A of Vidaza (lyophilizate for subcutaneous injection suspension, 100 mg, single-vial carton packs). The regulator directs medical organizations purchasing this pharmaceutical product to perform immediate compliance checks to verify the presence or absence of counterfeit indicators.
2. Draft Statutory Acts and Proposed Regulations
2.1. Ministry of Health Initiates Public Consultation on Draft Amendments for Calculating Controlled Substances Requirements.
Draft Order of the Ministry of Health of the Russian Federation “On Amending Order of the Ministry of Health of the Russian Federation dated December 1, 2016, No. 917n ‘On Approving Standards for Calculating Requirements for Narcotic and Psychotropic Drugs Intended for Medical Use’”
Explanatory notes indicate that regulators plan to finalize this draft to optimize supply chain calculations for medicinal narcotic and psychotropic stockpiles based on the exact size of target patient populations, alongside addressing the legal necessities of delivering controlled substances for home-based palliative care.
Currently, authorities calculate requirement metrics per 1,000 individuals annually without specifying separate quotas for home-administered medical care. We view this legislative drafting initiative as highly relevant to modern clinical workflows, as it will enable more precise calculations for strategic pharmaceutical supplies.
2.2. Ministry of Health Proposes Repealing Historic Annual Quota Metrics for Narcotic Drugs.
Draft Order of the Ministry of Health of the Russian Federation “On Repealing Appendix 3 to Order of the Ministry of Health of the Russian Federation dated November 12, 1997, No. 330 ‘On Measures to Improve the Accounting, Storage, Prescription, and Use of Narcotic Drugs and Psychotropic Substances’ and Order of the Ministry of Health of the Russian Federation dated January 9, 2001, No. 2 ‘On Amending and Supplementing Order of the Ministry of Health of the Russian Federation dated November 12, 1997, No. 330’”
This draft regulation explicitly repeals the legacy calculation metrics that governed annual narcotic and psychotropic substance requirements per 1,000 citizens (measured in grams). It also invalidates the provisions of the prior Ministry of Health order that amended the specific appendix containing those historic metrics.
2.3. Ministry of Health Outlines Rules for the Mandatory Re-registration of Maximum Manufacturer Prices for VEDMP.
Draft Decree of the Government of the Russian Federation “On Approving the Rules for the Mandatory Re-registration in 2019–2020 of Registered Maximum Manufacturer Prices for Medicinal Products Included in the List of Vital and Essential Medicinal Products, and Amending Specific Acts of the Government of the Russian Federation Regarding the State Registration and Re-registration of Maximum Manufacturer Prices for Medicinal Products Included in the List of Vital and Essential Medicinal Products”
The draft decree establishes a comprehensive framework for the mandatory re-registration during 2019–2020 of all maximum manufacturer wholesale prices for products on the VEDMP list that were previously registered under varying methodologies prior to the enactment of this bill.
Beginning January 1, 2021, the law prohibits manufacturers from commercializing any pharmaceutical product if they have failed to re-register its maximum manufacturer price under the new regulatory methodology.
2.4. Ministry of Health Proposes Amending Timelines for Reference Pricing Applications in State Drug Procurement.
Draft Order of the Ministry of Health of the Russian Federation “On Amending the Procedure for Determining the Initial (Maximum) Contract Price, and the Price of a Contract Concluded with a Single Supplier (Contractor, Performer), when Procuring Medicinal Products for Medical Use, Approved by Order of the Ministry of Health of the Russian Federation dated October 26, 2017, No. 871n”
The proposed amendments stipulate that state procurement authorities shall apply reference pricing metrics only when the corresponding pricing data is officially published within the Unified Information System (UIS).
This structural shift aligns with the implementation roadmap for determining pharmaceutical interchangeability. Under this roadmap, regulatory bodies assess interchangeability across distinct drug clusters grouped by matching International Nonproprietary Names (INN), dosage forms, and strengths. Concurrently, the Ministry plans a phased transition toward calculating reference prices for medicinal products throughout 2019.
2.5. Proposed Tracking and Allocation Protocols for Specialized High-Cost Orphan and Oncological Medicines.
Draft Order of the Ministry of Health of Russia “On Approving the Procedure for Monitoring the Movement and Accounting of Medicinal Products within the Constituents of the Russian Federation Designed to Provide for Persons Suffering from Hemophilia, Cystic Fibrosis, Pituitary Dwarfism, Gaucher Disease, Malignant Neoplasms of Lymphoid, Hematopoietic, and Related Tissues, Multiple Sclerosis, Hemolytic Uremic Syndrome, Juvenile Arthritis with Systemic Onset, Mucopolysaccharidosis Types I, II, and VI, and Persons Following Organ and/or Tissue Transplantation, Bringing to the Notice of the Authorized Executive Bodies of the Constituents of the Russian Federation the Data Obtained from Monitoring Results, and Reconciling Requests of the Authorized Executive Bodies of the Constituents of the Russian Federation on the Reallocation of Medicinal Products Between the Constituents of the Russian Federation”
The draft assigns organizational oversight and monitoring administration for these specialized medicinal products to the Department of Pharmaceutical Supply and Medical Device Regulation of the Russian Ministry of Health.
Under the proposed guidelines, regional health authorities must submit drug tracking data to the Department for comprehensive analysis. Following review, the Department distributes the aggregated monitoring metrics back to authorized bodies. In turn, regional regulatory entities review this consolidated data and submit redistribution requests to the Department for final review and approval to shift supply allocations between different constituents of the Russian Federation.
The regulation introduces an exhaustive list of grounds upon which the Department may reject a submitted reallocation request, specifically:
• determining, through monitoring data, an objective lack of consumer requirement for the requested pharmaceutical supplies;
• identifying that the application contains product names, dosage forms, or strengths that are statutorily excluded from the reallocation framework.
2.6. Ministry of Industry and Trade Seeks Heightened Administrative Fines for Manufacturing License Violations.
Draft Federal Law “On Amending the Code of the Russian Federation on Administrative Offenses”
This legislative draft introduces substantial amendments to the Code of Administrative Offenses (CoAOR), significantly enhancing statutory liability for violating pharmaceutical manufacturing license compliance mandates. The bill similarly penalizes non-compliance with the lawful directives or timely enforcement orders issued by officials executing industrial licensing control, as well as any direct obstruction of an inspector's official duties.
Specifically, for failing to execute the mandates of an authorized regulatory oversight body, the bill proposes administrative fines ranging from 5,000 to 10,000 rubles for corporate executives, and from 50,000 to 500,000 rubles for corporate entities, or an administrative suspension of operations. Committing an identical administrative violation within a three-year period triggers escalated penalties, exposing corporate officers to fines of 30,000 to 40,000 rubles, and legal entities to fines ranging from 100,000 to 1,000,000 rubles, alongside potential licensing suspension.
For manufacturing human medicines in gross violation of statutory licensing terms and conditions, the draft law levies aggressive financial penalties, including administrative fines from 100,000 to 200,000 rubles for responsible corporate officers, and from 1,000,000 to 5,000,000 rubles for corporate entities, or a mandatory administrative suspension of the manufacturing license.
2.7. Enhanced Statutory Protocols Proposed for the Suspension, Reinstatement, and Revocation of Pharmaceutical Manufacturing Licenses.
Draft Federal Law “On Amending Article 1 of the Federal Law ‘On the Licensing of Specific Types of Activities’ and the Federal Law ‘On the Circulation of Medicines’”
The bill harmonizes current domestic legislation with the treaty obligations under the EAEU Agreement on Unified Principles and Rules for the Circulation of Medicines (dated December 23, 2014) to maintain a coordinated regional policy and uniform regulatory baselines for drug manufacturing.
The proposal grants licensing authorities the power to suspend a manufacturing license until the operator remedies the non-compliance, capped at a maximum of three years, under the following circumstances:
1) failure to execute a licensing authority's enforcement order within the prescribed timeframe;
2) recurrence of an identical violation within a rolling three-year window;
3) detection of unauthorized manufacturing of medicinal products not listed in the State Register of Medicines;
4) direct obstruction of a licensing officer's lawful inspection activities;
5) absence of the licensee from the registered place of business where the licensed activity is legally authorized;
6) inspection findings revealing a total lack of specialized facilities or equipment at the registered manufacturing site;
7) identification of a severe, gross violation of statutory licensing requirements by the regulatory body;
8) formal notifications from external state oversight bodies detailing evidence that the operator's practices pose an imminent risk of harm or have caused active harm to human life and health.
Under the draft legislation, a competent court may permanently revoke a license upon formal application by the regulatory authority in the following instances:
1) recurrence of a gross violation of licensing conditions by the licensee within a single calendar year from the prior infraction;
2) failure by the licensee to remedy a compliance violation that previously triggered an active license suspension within the time limit prescribed by the regulatory body.
3. Judicial and Enforcement Practice
3.1. FAS Russia Attributes High Market Pricing of Medicines to Cost-Plus Regulatory Inefficiencies.
Presentation by Daria Starykh, Head of the Pharmaceutical Price Regulation Department of the Social Sphere and Trade Control Administration of FAS Russia, on the Impact of Indicative Benchmarks in Mitigating Pharmaceutical Market Prices
The speaker emphasized that excessive drug pricing directly stemmed from structural inefficiencies inherent in the legacy "cost-plus" pricing methodology. To curb unsustainable price escalation, the regulator advocates shifting from cost-based state registration models to an "indicative pricing" methodology. Proposed interventions include linking markdown coefficients to generic drugs, indexing prices based on specific drug price tiers while establishing definitive ceilings, and introducing mandatory international price benchmarking across all pharmaceutical products, irrespective of their local manufacturing depth.
3.2. FAS Russia Rules Lookalike Branding of Dietary Supplements and Registered Pharmaceuticals as Unfair Competition.
Administrative Offense Resolution of FAS Russia dated March 15, 2019, in Case No. 4-14.33-2243/00-08-18
FAS Russia determined that because pharmacies retail both the registered drug and the lookalike supplement over-the-counter (OTC) using identical branding, and because the supplement packaging mirrors the core labeling of the pharmaceutical product, average consumers lack the specialized skills to distinguish between the two categories. Furthermore, buyers cannot accurately evaluate the quantitative active ingredients relative to expected therapeutic outcomes. Consequently, this overlapping presentation creates a severe probability that consumers will experience an absolute absence of therapeutic efficacy, potentially exacerbating the progression of their underlying illness.
Noting that antitrust statutes strictly prohibit unfair competition via deceptive marketing—specifically regarding the quality, consumer attributes, intended purpose, manufacturing conditions, usage guidelines, or expected clinical results of commercial goods—the regulator imposed an administrative fine of 12,000 rubles on Biopharmus LLC.
We analyze this landmark FAS ruling as a critical reminder highlighting the commercial importance of pre-market risk assessments for product naming and labeling. Life sciences operators must verify that supplement branding does not mislead potential consumers regarding therapeutic or medicinal properties.
