BRACE Law Firm has prepared its regular regulatory digest for the Russian pharmaceutical industry covering November 2019. November 2019 demonstrated significant legislative activity, marked by the adoption of legal acts that exert a substantial impact on the commercial circulation of medicines.

The most significant legal alerts include the following developments:

• The Collegium of the Eurasian Economic Commission approved the Guideline on Preclinical Safety Studies for Conducting Clinical Trials and Registration of Medicines to establish a unified framework for life sciences research across the EAEU.

• The Government of the Russian Federation enacted a new procedure for releasing medicinal products into commercial circulation. Market participants must now submit the manufacturer's quality certificate to the automated information system of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) prior to commercial release, confirming compliance with monograph requirements. The regulation also institutes additional prerequisites for the commercial distribution of medicines.

• Roszdravnadzor approved an official template for the permit required to release batches or lots of immunobiological medicinal products manufactured in or imported into the Russian Federation into commercial circulation.

• The Federal Antimonopoly Service (FAS Russia) obtained authorization to conduct test purchases to monitor compliance with pharmaceutical dispensing rules by retail entities.

• A legislative proposal envisions extending the deadline for the mandatory implementation of the track-and-trace serialization system for medicines until July 1, 2020.

• The Ministry of Health of the Russian Federation drafted a Regulation on the Conflict of Interest Resolution Commission for medical and pharmaceutical practice, establishing operational rules and decision-making mechanisms for potential conflict of interest cases.

• A new bill proposes assigning direct registration duties for specialized medicines used to treat diseases resulting from weapons exposure to the Ministry of Health.

This digest provides an in-depth regulatory analysis of these paramount statutory modifications and other critical shifts within the pharmaceutical law enforcement landscape.

1. Statutes, Administrative Regulations, and Legal News

1.1. Eurasian Economic Commission Approves Preclinical Safety Guidelines for Clinical Trials and Pharmaceutical Registration

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

The Guideline establishes that sponsors must expand clinical trials when preceding studies confirm the sufficient safety profile of a medicine, and when complementary preclinical safety data become available during successive stages of clinical development.

Prior to initiating clinical investigations, researchers must evaluate the in vitro metabolic profile and plasma protein binding capability in both animals and humans. They must also analyze systemic exposure data derived from repeated-dose toxicity studies in animal models, in alignment with toxicokinetics and systemic exposure evaluation guidelines adopted by the Eurasian Economic Commission.

The core battery of safety pharmacology studies mandates assessment of effects on the cardiovascular, central nervous, and respiratory systems. Sponsors must execute these evaluations before clinical development begins, adhering to the guidelines for safety pharmacology studies of medicinal products for human use.

Single-dose toxicity data must be standardly generated from toxicity studies involving two mammalian species, utilizing both the parenteral route of administration and the specific route detailed in the draft Summary of Product Characteristics (SmPC). New medicinal products for human use must undergo specific testing to determine their immunotoxic potential.

When determining the recommended initial human dose, investigators must consider all relevant preclinical data, including the pharmacological dose-response relationship, the toxicological profile, and pharmacokinetics.

The Guideline aims to institute a uniform framework for conducting preclinical safety studies to facilitate subsequent pharmaceutical registration within the Eurasian Economic Union.

This document takes effect on May 29, 2020.

1.2. Eurasian Economic Commission Establishes Standardized Classification for Pharmaceutical Sector Job Positions

Decision of the Collegium of the Eurasian Economic Commission No. 206 dated November 26, 2019, “On the Classifier of Employee Positions (with Respect to Positions Related to the Manufacture and Circulation of Medicines)”

The use of the Classifier’s code designations is mandatory when executing shared EAEU processes within the pharmaceutical sector. The Classifier covers professional designations including pharmacist, pharmacologist, and junior pharmacist. The act enters into force on February 2, 2020.

1.3. Enactment of the 2020 Russian Federation Federal Budget

Federal Law No. 380-FZ dated December 2, 2019, “On the Federal Budget for 2020 and for the Planning Period of 2021 and 2022”

The statutory budget provisions incorporate financial allocations dedicated to the implementation of the State Program of the Russian Federation “Development of the Pharmaceutical and Medical Industry” and the subprogram “Development of the Manufacture of Medicines.”

1.4. Russian Government Prescribes New Framework for Releasing Medicines into Commercial Circulation

Decree of the Government of the Russian Federation No. 1510 dated November 26, 2019, “On the Procedure for Releasing Medicinal Products for Human Use into Commercial Circulation” (together with the Rules for Submitting Documents and Information on Medicinal Products for Human Use Released into Commercial Circulation; the Rules for Issuing a Test Protocol on the Compliance of 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 for by Regulatory Documentation; the Rules for Issuing a Permit for Releasing a Batch or Lot of an Immunobiological Medicinal Product into Commercial Circulation and Issuing a Certificate of Compliance of a Batch or Lot of an Immunobiological Medicinal Product with Requirements Established During Its State Registration; and the Rules for Deciding on the Termination of Commercial Circulation of a Batch or Lot of a Medicinal Product for Human Use)

As background, Federal Law No. 449-FZ dated November 28, 2018, integrated Article 52.1 into Federal Law No. 61-FZ dated April 12, 2010, “On the Circulation of Medicines.” Pursuant to this amendment, for all medicines released into commercial circulation after November 29, 2019, manufacturers must submit a quality certificate and a declaration of conformity signed by their Authorized Person verifying alignment with state registration parameters. This regulatory reform effectively abolishes the prior mandatory certification regime for pharmaceuticals.

The Decree enacted by the Russian Government specifies that domestic manufacturers must upload the quality certificate and the Authorized Person’s compliance confirmation into Roszdravnadzor's automated information system via their online portal prior to distributing each batch or lot.

Importers must similarly submit specialized data to the automated system before commercial distribution. Specifically, they must provide the manufacturer’s certificate confirming that the imported product meets pharmacopoeial monograph specifications (or regulatory dossier standards if no monograph exists). Additionally, they must upload a declaration from the importer’s representative, authorized by the foreign manufacturer, confirming compliance with state registration criteria.

Failure to transmit the required documentation triggers a formal enforcement mechanism: Roszdravnadzor will issue an administrative order to terminate the commercial circulation of the non-compliant pharmaceutical batches within five business days from discovering their presence in the market.

Crucially, the first three commercial batches of any newly introduced medicine require a full test protocol from an accredited federal laboratory operating under the Ministry of Health or Roszdravnadzor. To obtain this protocol, applicants must file a formal paper or electronic request detailing corporate data (name, Taxpayer Identification Number (INN), email, Main State Registration Number (OGRN)), product identifiers (trade name, International Nonproprietary Name (INN) or chemical designation), registration certificate details, and proof of payment. The application must include the manufacturer’s quality compliance documentation for the batch and a certified copy of the product's regulatory specifications.

Finally, the regulation dictates that permits for the commercial release of immunobiological batches require a certificate of compliance from Roszdravnadzor. The authority issues these specific permits free of charge.

1.5. Russian Government Establishes Subsidy Rules for Competitive Pharmaceutical Manufacturing

Decree of the Government of the Russian Federation No. 1464 dated November 16, 2019, “On Approval of the Rules for Granting Subsidies from the Federal Budget to Russian Organizations for Financial Support of Part of the Costs of Implementing Projects for the Development of Modern Technologies, Organizing the Production and Sale on Their Basis of Competitive Medicines, and on Recognizing Invalid Certain Acts of the Government of the Russian Federation”

The government offers these subsidies to support industrial manufacturers registered in the Russian Federation that specialize in R&D for advanced technologies and the scalable manufacture and commercialization of competitive medicines.

Only manufacturers that successfully pass a competitive state selection process are eligible to receive these financial disbursements.

The financial aid cannot exceed 70% of the total project implementation expenses incurred by the manufacturer, and remains subject to maximum caps established for each specific technology class.

To maintain equitable access for all market participants, the Ministry of Industry and Trade of the Russian Federation is establishing an interagency commission to review technology proposals and audit project implementation.

The Ministry of Industry and Trade will manage competitive bidding for approved technology categories no more than once per quarter, subject to available federal budget appropriations.

This statutory instrument takes effect on January 1 of the upcoming calendar year.

1.6. Roszdravnadzor Clarifies Electronic Reporting Rules for Commercial Distribution of Medicines

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

Starting November 29, 2019, entities manufacturing or importing medicines within the Russian Federation must upload product data to the external portal of Roszdravnadzor's automated information system.

Entities with pre-existing portal registrations do not require additional credentials to perform these compliance uploads.

To secure a commercial distribution permit for immunobiological products, applicants must complete the digital application form integrated with the Unified Identification and Authentication System (ESIA), accessible directly via the homepage of Roszdravnadzor's web interface.

Active Pharmaceutical Ingredients (APIs) remain governed by previous reporting scopes mandated under Roszdravnadzor Order No. 5539 dated August 7, 2015.

The guidance notes that no formal statutory requirements currently dictate specific education or experience criteria for an importer’s authorized representative. However, given the liability landscape, this individual must demonstrate expert knowledge regarding product quality metrics and compliance documentation. If distribution agreements with foreign manufacturers place product liability and complaint-handling duties on the importer, management can issue an internal corporate resolution appointing a specific manager to oversee reception and quality confirmation. Foreign manufacturers may grant authorization directly to an individual employee or to the corporate import entity, after which the importer’s executive can execute a local power of attorney for the designated staff member.

1.7. Roszdravnadzor Constitutes Immunobiological Quality Commission and Finalizes Distribution Permit Forms

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 “Regulation 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 Approval of the Form of Permit for Releasing a Batch or Lot of an Immunobiological Medicinal Product Manufactured in the Russian Federation or Imported into the Russian Federation into Commercial Circulation in the Russian Federation and the Form of Conclusion on the Compliance of a Batch or Lot of an Immunobiological Medicinal Product with the Requirements Established During Its State Registration”

The head of Roszdravnadzor will formally approve the composition of the newly formed Quality Commission for Immunobiological Medicinal Products, which must comprise at least 10 expert members.

The Commission possesses the authority to retain independent life sciences experts specialized in immunobiological quality control and manufacturing. It can also demand operational information from executive authorities, domestic manufacturers, trade importers, and other market stakeholders.

The Commission will determine testing volumes for specific immunobiological product lines and manufacturers (accounting for dosage forms and strengths) in strict compliance with the approved quality testing evaluation framework.

The Commission resolves regulatory issues via open ballots decided by a simple majority vote.

1.8. Ministry of Health and FMBA Issue Joint Clinical Guidance on Managing Mycoplasma Outbreaks

Letter of the FMBA of Russia No. 32-024/758 dated November 5, 2019, “On Forwarding Recommendations” (together with the Information Letter “Treatment, Prevention”)

The guidance counsels clinicians selecting macrolide antibiotics to evaluate specific dosage forms (predetermined by pediatric age brackets) and potential drug-drug interactions. Medical practitioners should prioritize pediatric oral suspensions of azalides (azithromycin), or utilize josamycin, roxithromycin, and clarithromycin matching the target dosing matrices enclosed within the regulatory document.

1.9. Expanded Enforcement Powers Granted to Roszdravnadzor for Retail Market Surveillance

Decree of the Government of the Russian Federation No. 1459 dated November 15, 2019, “On Amending Certain Acts of the Government of the Russian Federation”

The Russian Government amended the core Charter of the Federal Service for Surveillance in Healthcare (originally enacted via Decree No. 323 dated June 30, 2004). This amendment expands Roszdravnadzor’s enforcement authority, granting investigators the right to conduct unannounced test purchases to verify retail compliance with prescription dispensing regulations and ensure strict adherence to statutory bans regarding the sale of falsified, adulterated, sub-standard, or counterfeit medicines.

2. Draft Legislative and Regulatory Proposals

2.1. Ministry of Health Proposes Revoking Legacy Wholesale Distribution Rules to Align with EAEU Standards

Draft Order of the Ministry of Health of Russia “On Recognizing as Invalid Order of the Ministry of Health and Social Development of the Russian Federation No. 1222n dated December 28, 2010, ‘On Approval of the Rules of Wholesale Trade in Medicines for Human Use’”

Under active provisions in Article 54 of Federal Law No. 61-FZ and clause 5.2.163 of the Ministry’s enabling Charter, the Ministry of Health retains sole authority to establish Good Distribution Practice (GDP) standards for human medicines.

Concurrently, member states executed the foundational Agreement on Unified Principles and Rules for the Circulation of Medicines within the EAEU on December 23, 2014. This treaty dictates that wholesale trade, transport logistics, and warehouse storage within the union must comply with the overarching EAEU Good Distribution Practice rules, enacted via Decision No. 80 of the Council of the Eurasian Economic Commission.

To eliminate conflicting requirements and eliminate regulatory red tape, the Ministry proposes to formally rescind historical Order No. 1222n, letting supranational EAEU GDP rules govern the market.

2.2. Ministry of Health Drafts Fee Methodology for Government Testing of Immunobiological Products

Draft Order of the Ministry of Health of the Russian Federation “On Approval of the Methodology for Determining the Amount of Fees for the Service of Testing a Batch or Lot of an Immunobiological Medicinal Product for Compliance with the Requirements Established During Its State Registration, and the Maximum Fee for Providing the Specified Service”

The draft Order puts forward a methodology to standardize price structures applied by accredited federal state laboratories operating under the Ministry of Health or Roszdravnadzor when performing mandatory quality evaluations on immunobiological batches.

The financial formulas incorporate direct costs derived from document review, analytical quality expertise, specialized laboratory consumables, and institutional overhead. Labor expenses are quantified via empirical time-motion studies monitoring specialized lab staff during testing procedures.

The maximum fee caps are calculated based on longest-case analytical timelines and largest-volume documentation dossiers submitted to verify quality.

2.3. Fee Framework Formulated for Mandatory Quality Testing of Novel Market Entrants

Draft Order of the Ministry of Health of the Russian Federation “On Approval of the Methodology and Determination of the Amount of Fees for Providing the Service of Testing the Compliance of 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 for by Regulatory Documentation”

This draft regulatory proposal sets forth the calculation framework for fees levied on testing the first three production batches of newly manufactured or newly imported non-immunobiological medicines. Regulators constructed these financial rules on an economically justified cost-recovery model to secure a predictable and uniform pricing process for mandatory pre-market quality screening.

The analytical pricing matrix reflects essential operational outlays, including laboratory analysis costs, reagent acquisition, and administrative overhead, alongside labor timesheets derived from structured workplace time-tracking.

2.4. Ministry of Industry and Trade Seeks Amendments for Importing Foreign Inspection Samples

Draft Federal Law “On Amending the Federal Law ‘On the Circulation of Medicines’ No. 61-FZ dated April 12, 2010”

The legislative initiative proposes revising Part 3 of Article 47 of Federal Law No. 61-FZ to explicitly permit the import of target batches of registered or unregistered medicines intended for laboratory testing, when selected as reference samples during official GMP inspections of manufacturing sites located outside the Russian Federation.

In its formal statement of rationale, the ministry notes that this bill harmonizes domestic customs and pharmaceutical statutes with the EAEU Rules for Conducting Pharmaceutical Inspections, approved under Decision No. 83 of the Council of the Eurasian Economic Commission.

2.5. New Operational Charter Proposed for Medical and Pharmaceutical Conflict of Interest Boards

Draft Order of the Ministry of Health of Russia “On Approval of the Regulation ‘On the Commission for the Resolution of Conflicts of Interest in the Performance of Medical and Pharmaceutical Activities’”

Pursuant to the draft framework, the administrative commission will hold authority to issue formal rulings establishing the following legal conclusions:

• No conflict of interest exists regarding the employee’s active professional duties;

• Personal interest creates or may induce a conflict during clinical or pharmacy practice, prompting the Commission to formally recommend that the employee or the executive management of the medical/pharmaceutical facility execute specific mitigation and avoidance protocols;

• The employee fully adhered to prescribed compliance rules regarding conflict mitigation;

• The employee breached conflict of interest policies, leading the Commission to advise executive management or the sole proprietor to issue formal compliance warnings or apply specific disciplinary sanctions under employment law.

2.6. Proposed Civil Code Amendments to Enact Compulsory Licensing Pathways for State Emergencies

Draft Federal Law “On Amending Article 1360 of the Civil Code of the Russian Federation”

The draft statute establishes that under extreme necessity involving national defense, state security, or urgent public health and life protection, the Government of the Russian Federation may authorize the use of a patent, utility model, or industrial design without the patent holder's consent, provided the state transmits prompt notice and remits fair market compensation.

The amendment further stipulates that the federal government will explicitly define the underlying financial methodology and payment rules for these compulsory licensing compensation awards.

2.7. Bill Links Manufacturing Licenses Directly to Supranational EAEU GMP Compliance Certificates

Draft Federal Law “On Amending the Federal Law ‘On Licensing of Certain Types of Activities’ and the Federal Law ‘On the Circulation of Medicines’”

The proposed legislation sets forth that facilities passing official inspections will obtain a formal certificate of conformity verifying compliance with EAEU Good Manufacturing Practice (GMP) rules.

Crucially, the regulatory mechanism links the status of the manufacturing certificate directly to corporate operating rights: if the licensing authority suspends the EAEU GMP certificate, it must immediately suspend the firm’s core industrial manufacturing license for an identical duration.

Furthermore, if a manufacturer denies access or fails to facilitate an official EAEU GMP field audit, regulators will automatically deem the facility non-compliant. In such scenarios, the competent authority will issue an administrative ruling to revoke any previously issued compliance certifications.

2.8. Legislative Initiative Proposes Graduated Transition for Serialization Requirements

Draft Federal Law “On Amending Article 67 of the Federal Law ‘On the Circulation of Medicines’”

According to the explanatory memorandum accompanying the bill, ensuring the continuous stability of the national drug supply and preventing supply chain disruptions warrants a phased implementation of the serialization track-and-trace system, extending the final grace period to July 1, 2020.

The draft text specifies that orphan and high-cost nosology drugs commercialized prior to October 1, 2019, as well as general pharmaceuticals commercialized before July 1, 2020, remain fully eligible for warehouse storage, distribution logistics, retail dispensing, and clinical use without digital identification marks until their designated expiration dates.

Additionally, the draft federal law establishes a strict statutory obligation for all legal entities and sole proprietors engaged in the pharmaceutical supply chain to register within the centralized national medicine tracking database.

2.9. State Duma Defers Deliberations on Proposed Broadcast Advertising Restrictions for Pharmaceuticals

Draft Federal Law “On Amending Article 24 of the Federal Law ‘On Advertising’”

During the Council session of the State Duma of the Russian Federation on November 3, 2019, lawmakers once again postponed committee review of the bill that seeks to implement a complete ban on television and radio advertising for medicines. Leadership rescheduled the next round of legislative debates for December of the current year.

2.10. State Duma Passes First Reading of Bill Empowering Ministry of Defense with Targeted Drug Registration Rights

Draft Federal Law “On Amending the Federal Law ‘On Defense’ and Article 38 of the Federal Law ‘On the Basics of Health Protection of Citizens’”

The bill aims to facilitate the rapid deployment of specialized pharmaceuticals and medical devices tailored for tactical deployment by units, divisions, and organizations of the Armed Forces of the Russian Federation. The legislative framework authorizes the Ministry of Defense to independently register therapeutics and medical devices engineered for preventing and treating trauma or injuries caused by weapons exposure.

2.11. Legislative Proposal Aims to Centralize Orphan Drug Procurement for Rare Conditions at the Federal Level

Draft Federal Law “On Amending the Federal Law ‘On the Basics of Health Protection of Citizens in the Russian Federation’”

The bill introduces structural amendments to Articles 14, 44, and 83 of the foundational healthcare statute. These revisions shift procurement and supply duties for patients diagnosed with unspecified aplastic anemia or hereditary deficiencies of factors II (fibrinogen), VII (labile), and X (Stuart-Prower) directly to the federal budget under the Ministry of Health.

3. Judicial Review and Regulatory Enforcement Practice

3.1. Russian Ministry of Health Issues Pioneer Marketing Authorization Under Supranational EAEU Framework

According to official statements released by the Ministry of Health, the regulator finalized its first regional marketing authorization under Decision No. 78 of the Council of the Eurasian Economic Commission. The milestone approval governs Granisetron (concentrate for solution for infusion, 1 mg/mL, manufactured by Ozon LLC, Russia). The regulatory agency processed the certificate via the mandatory transition procedure, which requires updating existing legacy product dossiers to meet supranational EAEU standards before the December 31, 2020 deadline.

3.2. Appellate Court Affirms Antitrust Sanctions on Regional Pharmaceutical Cartel

Ruling of the First Arbitrage Appellate Court dated December 2, 2019, in Case No. A43-18292/2019

As detailed in the judicial record, digital forensic auditing of the public procurement bids submitted by General Medical Systems LLC and Medicine and Diagnostics LLC since January 1, 2016, revealed identical typographic layouts. Furthermore, metadata logs extracted from the bid documents proved that a single individual created and edited the files for both independent tender participants. The antitrust authority concluded that these facts demonstrate coordinated bid rigging orchestrated by a single actor, establishing clear collusive preparation violating competition law.

3.3. R-Pharm Successfully Defends Against Procurement Collusion Allegations in Arbitrage Court

Judgment of the Arbitrage Court of the City of Moscow dated October 29, 2019, in Case No. A40-252379/18-94-2716

The court found that the other co-defendants named in the underlying antitrust administrative action did not actually submit bids for the specific public auction under investigation. The competitive process involved only the plaintiff and a third-party distributor that FAS Russia never accused of cartel behavior or named as a party to the proceedings. Additionally, market analysis performed by the antimonopoly regulator failed to identify any suppliers that unlawfully abstained from bidding. Consequently, the auction took place under authentic competitive conditions involving an independent operator and culminated in a legitimate win for JSC R-Pharm. Given these circumstances, R-Pharm lacked any economic rationale to enter into an anti-competitive agreement. The complete absence of a second collusive partner precludes the legal qualification of the firm's bidding actions as an illegal cartel under antitrust law.

The court further ruled that a correlation between corporate addresses, legal registrations, or overlapping electronic IP logs on a digital bidding portal does not, in and of itself, suffice to substantiate an illegal anti-competitive conspiracy. The court thus held that the initial FAS Russia investigation was incomplete, and its administrative findings regarding the company’s participation in a cartel contract conflicted with the evidentiary record.

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