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BRACE Law Firm proudly presents its latest regulatory digest of the Russian pharmaceutical industry for December 2018, detailing key statutory shifts and compliance updates.
Key regulatory adjustments include a newly established legal status for clinical guidelines, which legislative authorities intend to fully revise by December 31, 2021.
Furthermore, the legislature enacted sweeping amendments governing the introduction of medicinal products for medical use into commercial circulation, with most provisions scheduled to take effect in November 2019.
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) has obtained expanded enforcement authority to conduct unannounced test purchases. This mechanism aims to verify strict regulatory compliance among retail pharmaceutical market participants and pharmacies.
The Government of the Russian Federation approved the 2019 List of Vital and Essential Drugs (VED), expanding the scope of covered therapies compared to the 2018 framework.
Executive authorities ratified a new state program of healthcare guarantees for the free provision of medical care to citizens, covering 2019 and the 2020–2021 planning cycles.
Regulators also established the formal Rules for Online Publication of Public Information Stored in the Medicinal Product Track and Trace System.
Additionally, the Prime Minister signed several Government Decrees approving the underlying Regulations on the National Track and Trace System and setting forth specific implementation timelines for serialized product tracking.
Following the ratification of the Agreement on Unified Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union (EAEU), the Ministry of Health of the Russian Federation introduced a draft bill amending the Federal Law "On the Circulation of Medicines" to refine the Life Sciences regulatory landscape. To ensure alignment with Government Decree No. 871 dated August 28, 2014 "On Approving the Rules for Forming Lists of Medicinal Products...", the Ministry also drafted revisions to the internal Regulations governing its specialized List Formation Commission.
1. Legislation, Regulatory Enactments, and Legal News
1.1. Regulators execute a novel approach to clinical guidelines, positioning them as the mandatory operational foundation for medical care delivery.
Federal Law No. 489-FZ dated December 25, 2018 "On Amending Article 40 of the Federal Law 'On Mandatory Medical Insurance in the Russian Federation' and the Federal Law 'On the Basics of Health Protection of Citizens in the Russian Federation' Regarding Clinical Guidelines"
These amendments supplement Federal Law No. 323-FZ dated November 21, 2011 "On the Basics of Health Protection of Citizens in the Russian Federation," codifying a formal statutory definition of "clinical guidelines." Under the updated text, clinical guidelines constitute scientifically validated, structured documents covering disease prevention, diagnostics, treatment, and patient rehabilitation. They encompass specific clinical protocols (patient management pathways), medical intervention variations, and sequential operational workflows for healthcare professionals based on disease progression, potential complications, comorbidities, and other outcomes-defining clinical variables.
Prior statutes broadly required healthcare providers to organize and deliver medical care under general medical procedures and standards across the Russian Federation (excluding clinical trials). The updated framework explicitly mandates that medical care be organized and delivered:
• Pursuant to the underlying organizational regulations issued by the competent federal executive body for each type of medical care;
• Pursuant to mandatory medical care delivery procedures prescribed by the competent federal executive body, binding on all healthcare organizations nationwide;
• On the basis of formal clinical guidelines;
• In consideration of medical care standards approved by the competent federal executive body.
Medical professional non-profit associations shall approve clinical guidelines endorsed by the Scientific and Practical Council, subject to mandatory review at least once every three years.
Relevant entities must complete the development and approval of new clinical guidelines no later than December 31, 2021.
Clinical guidelines approved prior to these amendments remain valid until their formal revision, but no later than December 31, 2021.
1.2. Legislative amendments expand enforcement mechanisms for the circulation of medicines, authorizing unannounced test purchases.
Federal Law No. 511-FZ dated December 27, 2018 "On Amending Certain Legislative Acts of the Russian Federation"
These statutory modifications empower the Federal Service for Surveillance in Healthcare (Roszdravnadzor) to execute unannounced test purchases. This enforcement tool serves to verify that retail pharmaceutical operators adhere to dispensing rules and comply with the absolute statutory ban on marketing falsified, substandard, or counterfeit medicinal products.
1.3. Significant statutory revisions transform the commercial launch protocols for medicinal products, with major compliance provisions taking effect in November 2019.
Federal Law No. 449-FZ dated November 28, 2018 "On Amending Certain Legislative Acts of the Russian Federation Regarding the Introduction of Medicinal Products for Medical Use into Commercial Circulation"
On December 3, 2018, the Official Gazette of the Russian Federation (Sobranie Zakonodatelstva RF) published a federal law that heavily restructures the compliance workflows for launching medicinal products into commercial circulation.
Effective from the enactment date, the law imposes a strict mandatory requirement on pharmaceutical manufacturers and importers to notify Roszdravnadzor and the Ministry of Industry and Trade of the Russian Federation at least one year prior to any planned discontinuation or suspension of medicinal product manufacturing or import operations. Exemptions apply solely to immunobiological medicinal products intended for clinical trials, regulatory expertise for state registration, or unregistered drugs required on critical life-saving grounds for specific patients.
The remaining amendments introduced by this regulatory act take effect on November 29, 2019, and encompass the following obligations:
• Market participants must execute the commercial launch of imported medicinal products into the Russian Federation strictly pursuant to the procedures established by the pharmaceutical circulation legislation;
• To launch a domestic medicinal product into commercial circulation (excluding immunobiological products), the manufacturer must submit a quality compliance certificate to Roszdravnadzor, alongside a formal confirmation from the manufacturer's Authorized Person verifying that the batch complies with its state registration parameters;
• Importers must submit the manufacturer's batch certificate to Roszdravnadzor prior to commercial launch, certifying that the imported medicine complies with the relevant pharmacopoeia monograph (or corporate specifications in the absence of a monograph), alongside a statement from the importer's authorized representative verifying compliance with state registration requirements;
• Pharmaceutical manufacturers and importers must annually, no later than February 1, submit an independent testing protocol to Roszdravnadzor for at least one batch of each medicinal product launched into commercial circulation during the preceding year.
1.4. The Government of the Russian Federation updates the List of Vital and Essential Drugs for 2019.
Government Decree No. 2738-r dated December 10, 2018 "On Approving the List of Vital and Essential Drugs for 2019, as well as Lists of Medicinal Products for Medical Use and the Minimum Assortment of Medicinal Products Required for the Provision of Medical Care"
Compared to the 2018 frameworks, the Russian Government expanded the Vital and Essential Drugs (VED) list with new international nonproprietary names (INNs) and introduced new dosage forms, including deferasirox (film-coated tablets) and omalizumab.
1.5. Executive authorities ratify the new State Healthcare Guarantees Program, requiring an annual implementation assessment from the Ministry of Health.
Government Decree No. 1506 dated December 10, 2018 "On the Program of State Guarantees for the Free Provision of Medical Care to Citizens for 2019 and the 2020–2021 Planning Period"
This program establishes that regional budget allocations of the constituent entities of the Russian Federation shall fund:
• The provision of prescription medicines and medical devices free of charge for specific population groups and disease categories during outpatient treatment, pursuant to federal law;
• The provision of prescription medicines at a 50% discount for designated outpatient groups.
1.6. Regulatory authorities enact the formal Regulations on the Pharmaceutical Track and Trace System.
Government Decree No. 1556 dated December 14, 2018 "On Approving the Regulations on the System for Monitoring the Movement of Medicinal Products for Medical Use"
The newly approved Regulations codify the operating standards for the Track and Trace System, defining:
• The procedure for applying identification marks to medicinal products, including structural and data format criteria;
• The operational lifecycle governing the architecture, deployment, commissioning, and decommissioning of the monitoring system;
• Interoperability protocols linking the trace system with external state and corporate IT infrastructure;
• Reporting requirements, data composition, and transmission protocols binding on legal entities and individual entrepreneurs;
• Data accessibility rules and disclosure governance for information stored within the system.
When applied to the secondary (outer) packaging—or primary packaging if no secondary container exists—the unique identifier must meet the following technical specifications:
• A two-dimensional matrix barcode rendered via dot symbols pursuant to National Standard GOST R ISO/IEC 16022-2008 ("Automatic Identification. Bar Coding. Data Matrix Bar Code Symbology Specification");
• A print quality grade of Class C or higher in compliance with National Standard GOST R ISO/IEC 15415-2012 ("Information Technology. Automatic Identification and Data Capture Techniques. Bar Code Symbol Print Quality Test Specification. Two-dimensional Symbols");
• Error correction capabilities utilizing the ECC-200 algorithm in accordance with National Standard GOST R ISO/IEC 16022-2008;
• Standardized ASCII character encoding based on National Standard GOST R ISO/IEC 16022-2008.
1.7. Regulators outline specialized phased implementation rules for high-cost orphan drugs within the monitoring framework.
Government Decree No. 1557 dated December 14, 2018 "On the Specifics of Implementing the System for Monitoring the Movement of Medicinal Products for Medical Use"
For commercial enterprises engaged in the supply chain of high-cost orphan drugs (covering therapies for hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, lymphoid/hematopoietic malignancies, multiple sclerosis, and post-transplant immunosuppression), the government mandates the following compliance roadmap:
• Complete formal registration within the tracking platform between July 1, 2019, and July 8, 2019 (or within 7 calendar days from triggering a commercial reporting obligation);
• Submit an interface integration testing request to the system operator within 21 calendar days of registration, and successfully complete system interoperability testing within two months of internal IT system readiness;
• Populate the centralized platform with exhaustive transaction and product movement logs starting October 1, 2019.
1.8. Executive decrees establish disclosure transparency frameworks for the tracking platform's public data.
Government Decree No. 1558 dated December 14, 2018 "On Approving the Rules for Publishing Public Information Stored in the Medicinal Product Track and Trace System on the Internet (Including Open Data Formats)"
This decree defines the scope of open-access data available to the public. The system operator must maintain these disclosures on the monitoring platform's web portal, ensuring users can utilize structured categorization, search indexes, and specialized navigation functionalities for data analysis.
2. Draft Legislative and Regulatory Instruments
2.1. The Ministry of Health proposes statutory revisions to the Law on the Circulation of Medicines to align national legislation with supranational EAEU frameworks.
Draft Federal Law "On Amending Articles 30 and 65 of the Federal Law 'On the Circulation of Medicines'"
On December 29, 2018, regulators initiated public consultations on a draft bill amending Article 30 of the Federal Law "On the Circulation of Medicines." The draft introduces a strict 30-day window for marketing authorization holders or their authorized legal representatives to file an application to amend a product's patient information leaflet following Roszdravnadzor's publication of new, verified safety data concerning adverse drug reactions or side effects. Should a registration holder fail to submit this application within 30 calendar days, the competent authority may initiate proceedings to suspend the commercial circulation of the affected medicinal product.
2.2. Draft ministerial orders reshape the structural composition and compliance requirements for marketing authorization application dossiers.
Draft Order of the Ministry of Health of the Russian Federation "On Amending the Procedure for Organizing a Marketing Authorization Application Dossier and Document Requirements, Approved by Order of the Ministry of Health of the Russian Federation No. 409n Dated July 12, 2017"
The updated marketing authorization application requires applicants to disclose corporate and tax data beyond standard names and addresses. Filings must state the Taxpayer Identification Number (INN) for domestic entities, or the country of incorporation, registration authority, registration number, and corporate tax code for foreign legal entities. Furthermore, applicants must detail the precise address of the manufacturing facility, identifying every single participant across each individual stage of the manufacturing process.
2.3. The Ministry of Health moves to restructure its List Formation Commission, revising quorums and voting thresholds to ensure procedural alignment with Decree No. 871.
Draft Order of the Ministry of Health of the Russian Federation "On Amending the Regulations on the Ministry of Health Commission on Forming Lists of Medicinal Products for Medical Use and the Minimum Assortment of Medicinal Products Required for the Provision of Medical Care, Approved by Order of the Ministry of Health of the Russian Federation No. 498n Dated September 9, 2014"
The draft order introduces a new mandate requiring public disclosure of the Commission's decisions on the official ministry website within 5 business days post-session.
The draft stipulates that sessions must convene by the 10th day of the second month of the quarter following the submission period. The Commission capped individual sessions at 15 medicinal product reviews. To accelerate governance, the draft lowers the operational quorum to a simple majority (at least half of the Commission members), down from the previous two-thirds requirement.
The Commission will now adopt resolutions based on a simple majority vote of attending members, derived from scorecards detailing a comprehensive evaluation and reflecting the evidence-based recommendation of the chief expert. The previous rules required a two-thirds supermajority.
Each Commission member holds a single vote during ballots.
In exceptional circumstances, a member absent for a verified justifiable reason may delegate their voting power to a designated representative via a formal power of attorney.
2.4. Regulators launch public consultations on standardized procurement supply forms for the federal high-cost orphan disease program.
Draft Order of the Ministry of Health of the Russian Federation "On Approving the Supply Application Form for Medicinal Products Intended for Patients Diagnosed with Hemophilia, Cystic Fibrosis, Pituitary Dwarfism, Gaucher Disease, Lymphoid, Hematopoietic and Related Tissue Malignancies, Multiple Sclerosis, Hemolytic Uremic Syndrome, Juvenile Arthritis with Systemic Onset, Mucopolysaccharidosis Types I, II, and VI, and Post-Transplant Individuals"
The Ministry drafted this standardized form to execute the procurement workflows mandated by Government Decree No. 1416 dated November 26, 2018. The template requires applicants to explicitly specify the target pathology and the exact logistics delivery window.
2.5. The Ministry of Health initiates a Regulatory Impact Assessment (RIA) to eliminate statutory redundancies between Russian domestic law and supranational EAEU decisions.
Notice of Intent to Develop Amendments to the Federal Law "On the Circulation of Medicines"
According to the official notice on the federal regulatory portal, the Ministry has opened consultations regarding prospective updates to the Federal Law "On the Circulation of Medicines". The initiative addresses redundancies: bioequivalence studies for generic drugs and marketing dossier modifications (specifically regarding excipient justification and testing) already fall under the formal regulatory review process. Furthermore, EAEU Council Decisions No. 78 and No. 85 already establish comprehensive protocols for applicants to demonstrate that variations in excipients or delivery devices do not compromise safety or efficacy when proprietary data is inaccessible. Consequently, the proposed draft seeks to repeal overlapping and conflicting domestic provisions to streamline market access.
2.6. The Ministry of Agriculture finalizes mandatory template terms for veterinary pharmaceutical public procurement contracts.
Draft Order of the Ministry of Agriculture of the Russian Federation "On Approving Template Contract Terms for the Supply of Medicines or Preparations for Veterinary Use"
The Ministry of Agriculture finalized the definitive text for mandatory template contract terms in veterinary medicine procurement. The order approves standard terms set forth in Appendix No. 1, cross-referenced with performance metrics defined in the information card in Appendix No. 2. The finalized draft incorporates purely technical corrections following legal review.
2.7. Draft ministerial protocols define specialized clinical workflows for pediatric parasitic disease management.
Draft Order of the Ministry of Health "On Approving the Procedure for Providing Medical Care to Children Diagnosed with Parasitic Diseases"
The draft specifies that where clinical indications warrant, healthcare facilities must manage pediatric parasitic conditions by integrating certified specialists matching the official national nomenclature of postgraduate medical and pharmaceutical specialties.
3. Judicial Precedents and Enforcement Practice
3.1. The Supreme Court of the Russian Federation upholds a public collector's determination to disqualify an electronic auction bidder for failing to provide adequate pricing justification under anti-dumping rules.
Supreme Court Ruling No. 303-KG18-20816 Dated December 20, 2018, in Case No. A73-686/2018
The antitrust authority argued that procurement statutes do not prescribe an exhaustive checklist or a rigid template for documents justifying a heavily discounted contract price.
The Supreme Court, however, ruled that under Part 9 of Article 37 of the Contract System Act (Federal Law No. 44-FZ), if a public auction covers goods essential for vital operations—such as medicines—any bidder offering a price 25% or more below the initial maximum contract price must submit objective pricing justification. Valid justification includes an official manufacturer's guarantee letter stating pricing and volume, proof of inventory possession, or detailed cost accounting. Accordingly, the Supreme Court sustained the lower courts' rulings, holding that submitting a self-issued guarantee letter from the bidder fails to satisfy the clear statutory mandates of the Contract System Act.
3.2. The Supreme Court reverses a lower court ruling on single-source procurement monopolies, validating regional consolidation of pharmaceutical distribution services.
Supreme Court Ruling Dated December 12, 2018, in Case No. 1-APG18-17
The challenged provincial statutory provision established a mandatory framework coordination model linking the Arkhangelsk Regional Ministry of Health, the state-owned unitary enterprise "Farmatsiya", and local public hospitals. Under this framework, "Farmatsiya" acted as the exclusive single-source supplier—across all financing streams—for comprehensive logistics services, including the procurement, verification, storage, tracking, and delivery of medicines, specialized clinical nutrition, medical devices, and disinfectants for participating public hospitals, alongside the centralized compounding and distribution of extemporaneous formulations.
The Supreme Court of the Russian Federation rejected the lower court's literal interpretation of Clause 6, Part 1, Article 93 of the Contract System Act, which had erroneously concluded that while a constituent entity may statutorily define the operational scope of a subordinate enterprise, it cannot explicitly appoint it as a single-source contractor.
As the Supreme Court has currently released only the operative part of its ruling, BRACE Law Firm will provide a deeper analysis of this landmark public procurement precedent once the court publishes the full text of its reasoned opinion.
PDF Version of the Regulatory Digest
