BRACE Law Firm is pleased to present its routine regulatory digest covering key updates in the Russian pharmaceutical industry for December 2019.

During the specified period, regulatory authorities enacted a substantial number of major legal acts governing the circulation of medicines. The most significant developments include the following:

• The Eurasian Economic Commission approved the Guideline on the Selection of Non-Investigational Medicinal Products for Clinical Trials of Medicinal Products. The document establishes that a medicinal product is deemed non-investigational if its administration within a clinical trial does not constitute the direct objective of such trial, and delineates the criteria for selecting non-investigational products during clinical trials.

• The Federal Service for Surveillance in Healthcare (Roszdravnadzor) approved the Procedure for Assessing the Scope of Quality Testing for Immunobiological Medicinal Products.

• Major amendments were introduced to Federal Law No. 61-FZ "On the Circulation of Medicines" and the Federal Law "On Amending the Federal Law 'On the Circulation of Medicines'". These updates affect the determination of the bioequivalence of medicinal products and permit the importation into the Russian Federation of specific batches of unregistered medicinal products containing narcotic drugs or psychotropic substances to provide emergency medical care based on life-saving indications.

• Regarding the price revision of maximum manufacturer selling prices for medicinal products included in the list of Vital and Essential Drugs (VED), the Government of the Russian Federation empowered the Ministry of Health (Minzdrav) and the Federal Antimonopoly Service (FAS) to issue independent decisions on the mandatory revision of maximum manufacturer selling prices for medicinal products.

This legal digest provides a comprehensive and detailed overview of the aforementioned changes and other equally significant regulatory updates in the current legislation.

1. Enacted Laws, Subordinate Regulations, and Legal News

1.1. The Eurasian Economic Commission approved the Guideline on the Selection of Non-Investigational Medicinal Products for Clinical Trials.

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 Clinical Trials of Medicinal Products"

The Guideline defines the term "non-investigational medicinal product." It establishes that a medicinal product is classified as non-investigational if its administration during a clinical trial does not constitute the direct objective of the clinical trial.

The document sets forth selection criteria for non-investigational medicinal products when conducting clinical trials of medicinal products, as well as the scope of information on non-investigational products to be submitted as part of the application dossier to obtain clinical trial approvals.

Medicinal products registered in accordance with the EAEU Rules for Registration and Examination of Medicines, or registered in any of the member states where the clinical trial is to be conducted pursuant to the legal acts comprising the law of the Eurasian Economic Union, are most frequently used as non-investigational medicinal products.

If a sponsor intends to use a medicinal product that is not registered in the Eurasian Economic Union or its member states as a non-investigational medicinal product, the sponsor must ensure that such product was manufactured in compliance with the specified EAEU Rules.

The regulation establishes specific categories of non-investigational medicinal products, including rescue medication (emergency therapy), non-investigational medicinal products used to assess clinical trial endpoints, and concomitant non-investigational medicinal products systematically prescribed to trial subjects.

The Guideline enters into force on June 19, 2020.

1.2. The Eurasian Economic Commission amended the Rules for Registration and Examination of Medicinal Products for Human Use.

Disposition of the Collegium of the EEC No. 202 dated December 17, 2019 "On the Draft Decision of the Council of the Eurasian Economic Commission 'On Amending the Rules for Registration and Examination of Medicinal Products for Human Use'"

The document introduces a supplementary clause establishing that following the alignment of a marketing authorization application dossier with EAEU requirements, manufacturers and importers may continue to manufacture and import the medicinal product under a marketing authorization certificate issued in accordance with the national legislation of an EAEU member state for a period of 180 calendar days from the date the dossier was aligned with EAEU requirements.

Distributors may simultaneously market the medicinal product until its expiration date in packaging and with patient information leaflets corresponding either to the application dossier approved under the national legislation of the EAEU member states or to the application dossier aligned with EAEU requirements.

1.3. The Government of the Russian Federation approved the rules for granting subsidies to stimulate demand and enhance the competitiveness of Russian industrial products.

Decree of the Government of the RF No. 1908 dated December 27, 2019 "On Approving the Rules for Granting Subsidies from the Federal Budget to Stimulate Demand and Enhance the Competitiveness of Russian Industrial Products and Declaring Certain Acts of the Government of the Russian Federation Invalid"

Pursuant to the specified Rules, the authorities grant subsidies to organizations included in the register of subsidy recipients, provided that such organizations comply with the following conditions:

• The leasing agreement was concluded no earlier than January 1 of the current financial year for a term of at least 12 months from the date of executing the acceptance certificate for the industrial products, and the leased industrial products were manufactured no earlier than January 1 of the year preceding the year of receiving the subsidy;

• State support for the manufacture and sale of a single unit of industrial product is provided only once during the service life of such unit;

• The organization has no outstanding obligations for taxes, fees, insurance contributions, penalties, fines, or interest payable in accordance with the tax legislation of the Russian Federation, as of a date no earlier than 30 calendar days prior to the submission date of the application for the qualification selection;

• The organization has no overdue indebtedness regarding the repayment of subsidies or budget investments to the federal budget, including those provided under other legal acts, or any other overdue obligations to the federal budget, as of a date no earlier than 30 calendar days prior to the submission date of the application for the qualification selection;

• The organization is neither a foreign legal entity nor a Russian legal entity whose charter (share) capital contains an aggregate share of participation exceeding 50 percent by foreign legal entities registered in states or territories included in the list approved by the Ministry of Finance of the Russian Federation that offer a preferential tax regime and/or do not require the disclosure or provision of information during financial transactions (offshore zones);

• The organization is not undergoing reorganization or liquidation, is not subject to bankruptcy proceedings, and its business operations have not been suspended in the manner prescribed by the legislation of the Russian Federation;

• The organization has no overdue monetary obligations to the Russian Federation.

The Decree establishes that subsidy agreements concluded pursuant to Decree of the Government of the Russian Federation No. 1047 dated October 1, 2015 "On Approving the Rules for Granting Subsidies from the Federal Budget to Russian Organizations to Compensate for Part of the Costs Incurred in the Implementation of Projects for Organizing the Manufacture of Medicinal Products and/or Pharmaceutical Substances within the Subprogram 'Development of the Manufacture of Medicinal Products' of the State Program of the Russian Federation 'Development of the Pharmaceutical and Medical Industry' for 2013–2020" shall remain effective until the recipients fulfill their respective obligations. Concurrently, the specified older Rules are declared repealed as of January 12, 2020 (the effective date of the new Rules adopted by the Russian Government).

1.4. The Procedure for Assessing the Scope of Quality Testing for Immunobiological Medicinal Products by the Roszdravnadzor Commission was approved.

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

Effective January 12, 2020, the Commission evaluates the scope of quality testing for immunobiological medicinal products whose data are entered into the State Register of Medicines and which have been released into commercial circulation within the Russian Federation, provided that the automated information system of Roszdravnadzor contains information on such products.

The Commission determines the scope of quality testing for an immunobiological medicinal product of a specific brand name and manufacturer (taking into account its dosage form and strength) based on an annual quality data analysis submitted to the Commission by March 1 of each year.

Based on the available information, the Commission holds a session annually no later than April 1 of the year following the reporting year. During this session, it resolves on the scope of quality testing for the immunobiological medicinal product of a specific brand name and manufacturer (including dosage form and strength) and establishes the frequency of conducting testing across all parameters of the approved standard documentation.

All Commission members present at the session must sign the decision determining the scope of quality testing for immunobiological medicinal products.

The Commission may approve a reduction in the scope of quality testing for immunobiological medicinal products only in the simultaneous absence of:

• Information regarding detected non-compliance with established quality requirements;

• Information concerning serious adverse reactions posing a potential threat to life, instances of harm to the life and health of citizens, or cluster cases of insufficient therapeutic efficacy;

• Results of statistical analysis indicating that quantitative data trends derived from immunobiological quality testing fall outside acceptable confidence intervals;

• Gross violations of license requirements identified during regulatory monitoring of drug manufacturing activities, as well as critical non-compliances identified during Good Manufacturing Practice (GMP) inspections.

1.5. Extensive amendments were introduced to the Federal Law "On the Circulation of Medicines," entering into force in 2020.

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

The legislator amended statutory definitions concerning "generic medicinal product" (interchangeable drug) and "reference medicinal product."

The statutory terminology focuses significantly on equivalence. Specifically, the law introduces the term "bioequivalence," which denotes the attainment of comparable parameters regarding the rate of absorption, the extent of delivery to the site of action, and the rate of elimination of one or more pharmacologically active substances following the administration of medicinal products for human use that possess the same International Nonproprietary Name (INN) (or chemical name, or grouping name), in equivalent dosages and via identical routes of administration. A reference medicinal product is defined as a medicinal product used to assess the bioequivalence or therapeutic equivalence, quality, safety, and efficacy of a generic or biosimilar (biologically similar) medicinal product (biosimilar). The original medicinal product serves as the reference medicinal product for human use. However, if the original product is not registered or circulating in the Russian Federation and is not circulating in foreign states, a generic or biosimilar product may serve as the reference, provided it was the first to be registered among those circulating in the Russian Federation, its bioequivalence or therapeutic equivalence, quality, efficacy, and safety were evaluated relative to the original product, and its quality, efficacy, and safety are substantiated by pharmacovigilance data and compliance audits of medicines in commercial circulation. For veterinary use, a reference medicinal product is defined as a veterinary drug registered in the Russian Federation on the basis of preclinical and clinical trials confirming its quality, safety, and efficacy. A generic medicinal product is a drug for human use that has a qualitative and quantitative active substance composition equivalent to the reference medicinal product in an equivalent dosage form, or a veterinary drug that has the identical qualitative and quantitative active substance composition in the identical dosage form, whose bioequivalence or therapeutic equivalence to the corresponding reference medicinal product has been confirmed by appropriate studies.

The amendments permit the importation into the Russian Federation of specific batches of unregistered medicinal products containing narcotic drugs or psychotropic substances to provide medical assistance for life-saving indications of a specific patient or group of patients. This requires a formal decision by the medical commission of a healthcare institution certifying the inefficacy or impossibility of administering other registered medicinal products to the specific patient (including those containing different active substances) and verifying the necessity of importing a specific unregistered drug, indicating its International Nonproprietary Name (or chemical, or grouping name), dosage form, and quantity. The authorized federal executive body approves the list of diseases and conditions, along with the corresponding narcotic or psychotropic medicines eligible for importation under this section.

The aforementioned changes enter into force on March 1, 2020.

Effective January 1, 2023, the competent authority shall cancel the marketing authorization of a medicinal product and remove it from the State Register of Medicines if the marketing authorization holder (MAH) or owner of a drug for human use fails, within six months from the suspension date of its clinical use, to submit to the authorized body the documents or data required to perform an expert evaluation of the application dossier to determine interchangeability. The same penalty applies if the MAH fails to submit an application to amend the documentation contained in the application dossier within forty business days from the date the authorized body publishes data indicating the necessity of modifying the patient information leaflet regarding indications, contraindications, identified side effects, or adverse reactions.

The enforcement of track-and-trace serialization requirements (identification marking) for drugs used in several orphan and high-cost nosologies has been deferred. Medicinal products for human use intended for patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, and persons post-organ and/or tissue transplantation, manufactured prior to December 31, 2019, as well as other medicinal products for human use manufactured prior to July 1, 2020, may be stored, transported, dispensed, sold, transferred, and administered without identification markings until their expiration date.

1.6. Procedures for submitting documents to list a pharmaceutical substance in the State Register of Medicines will be simplified starting in 2021.

Federal Law No. 478-FZ dated December 27, 2019 "On Amending Certain Legislative Acts of the Russian Federation in Part of Introducing a Registry Model for Providing State Services for Licensing Certain Types of Activities"

Effective January 1, 2021, several documents submitted for the purpose of including a pharmaceutical substance in the State Register of Medicines shall be requested via interagency electronic information systems. Specifically, the competent authority must initiate such an electronic inquiry if the applicant fails to submit proof of state duty payment along with the application. Similarly, interagency requests will be utilized if the applicant fails to attach a copy of the drug manufacturing license or a copy of the GMP compliance certificate issued by the authorized federal executive body (for domestic manufacturing). For manufacturing outside the Russian Federation, this mechanism applies if the applicant fails to submit copies of the manufacturing authorization issued by the competent authority of the manufacturing country (with a certified Russian translation), and a copy of the GMP compliance certificate issued by the Russian authorized body or a copy of the decision to conduct a site inspection.

1.7. The Ministry of Health issued clarifications regarding public procurement of medicinal products required for specific patients based on medical indications.

Letter of the Ministry of Health of Russia No. 3175/25-2 dated December 17, 2019 "On Specific Aspects of Conducting Procurement of Medicinal Products"

In the presence of medical indications (such as individual intolerance or life-saving emergencies), a medical commission may authorize the prescription of medicinal products by their trade name (brand name) rather than their International Nonproprietary Name. The medical commission must record its decision in a formal protocol and enter it into the patient's medical documentation.

Physicians may prescribe not only reference (original) medicinal products but also generic or biosimilar (biologically similar) medicinal products selected for the patient based on life-saving indications.

When describing a procurement object, state contract procurement officers may likewise specify trade names for medicinal products required for patients under life-saving indications.

Pursuant to Federal Law No. 44-FZ "On the Contract System in the Procurement of Goods, Works, and Services for State and Municipal Needs," when procuring medicinal products by trade names for patients under life-saving indications, procurement officers may utilize the following sourcing methods:

• Requests for proposals, including electronic requests for proposals;

• Single-source procurement (sole supplier).

The procurement must satisfy the following restrictive conditions:

• A single state contract cannot cover medicinal products required for the prescription of two or more patients;

• The medical commission's decision must be entered into the state contract register simultaneously with the contract itself.

If a supplier is selected via a request for proposals, the procurement notice must be published on the Unified Information System (UIS) website no later than five days prior to the date of the request, or no later than five business days prior if conducted electronically. No statutory cap is imposed on the initial (maximum) contract price in this instance.

In the case of a single-source procurement, a formal justification of the contract price is not required; however, the contract value under this sourcing method must not exceed 1 million rubles. Furthermore, the volume of procured medicines must not exceed the quantity necessary for the patient during the period required to execute the procurement process. Publication of a procurement notice is not required.

1.8. Rules for the mandatory price revision in 2019–2020 of registered maximum manufacturer selling prices for Vital and Essential Drugs were approved.

Decree of the Government of the Russian Federation No. 1683 dated December 16, 2019 "On Amending Certain Acts of the Government of the Russian Federation in Part of State Registration and Revision of Maximum Manufacturer Selling Prices for Medicinal Products Included in the List of Vital and Essential Drugs"

The mandatory price revision of maximum manufacturer selling prices allows for the preservation of the latest registered (revised) maximum prices for immunobiological medicinal products, drugs containing narcotic or psychotropic substances manufactured in EAEU member states, as well as medicinal products in the low-price segment under 100 rubles.

The regulation stipulates that applications for the mandatory price revision in 2019–2020 of registered maximum manufacturer prices for a reference VED drug must be submitted by the MAH or owner of the reference medicinal product within 40 business days from the effective date of Decree of the Government of the Russian Federation No. 1683.

For medicines used in pediatric practice (for which no maximum manufacturer price has been registered), the price calculation must comply with the requirements established for reference medicinal products. In this regard, the maximum variance between the lowest registered maximum selling price for the drug and the price submitted for state registration, calculated based on the cost per active substance unit, cannot exceed 90 percent.

Furthermore, the Ministry of Health and the Federal Antimonopoly Service are now vested with powers to independently initiate and execute mandatory revisions of the maximum manufacturer selling price of a medicinal product.

1.9. The Ministry of Health approved the procedure for determining the initial (maximum) contract price and single-source contract prices for pharmaceutical procurements.

Order of the Ministry of Health of Russia No. 1064n dated December 19, 2019 "On Approving the Procedure for Determining the Initial (Maximum) Contract Price, the Price of a Contract Concluded with a Single Supplier (Contractor, Performer), and the Initial Unit Price of Goods, Works, or Services when Procuring Medicinal Products for Human Use"

When applying the comparable market price method (market analysis), the procurement officer must compile and evaluate publicly available pricing data and issue formal requests for pricing information to suppliers.

To determine the weighted average price when procuring multi-component (fixed-dose combination) medicinal products consisting of two or more active substances, or kits of registered drugs, the procurement officer may disregard unit prices from fulfilled supply contracts for the corresponding single-component medicines. An exception applies if the fulfilled single-component contract was executed as a result of a competitive bidding process for multi-component drugs or kits. Additionally, procurement officers may now exclude the pricing of delivered medicines whose residual shelf life deviates by 20 percent or more from the residual shelf life specified by the customer in the description of the procurement object, as well as contracts where the customer recovered liquidated damages (penalties, fines) due to non-performance or improper performance of contractual obligations.

When establishing the unit price of a medicinal product, reference price values are excluded if the price is determined for single-source procurement under Clause 28, Part 1, Article 93 of Federal Law No. 44-FZ via requests for proposals or electronic requests for proposals. Prices for medicinal products that are not in commercial circulation are likewise excluded.

1.10. Roszdravnadzor published an Official Guidance Memo on drug acceptance following the implementation of the new commercial market entry rules.

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

Roszdravnadzor clarifies that entities can verify the lawful circulation of a specific batch or lot of a medicinal product on the official website of Roszdravnadzor.

To perform this verification, users must navigate to the "Medicinal Products" section on the Roszdravnadzor portal and locate the registry service titled "Information on Medicinal Products Released into Commercial Circulation in the Russian Federation" under the "Electronic Services" column.

The database supports multi-parameter searches, including brand name, batch/lot number, manufacturer, and country of manufacture.

Information regarding Roszdravnadzor clearances for the commercial release of a batch or lot of an immunobiological medicinal product is likewise published under the "Electronic Services" / "Information on Medicinal Products Released into Commercial Circulation in the Russian Federation" registry.

If the Roszdravnadzor database lacks information regarding the commercial entry of a specific batch or lot of a medicine, the verifying entity should report the matter to the territorial body of Roszdravnadzor to initiate regulatory enforcement and inspection measures.

1.11. Legislative amendments were enacted concerning the circulation of medicines and medical devices commissioned by the Ministry of Defense.

Federal Law No. 518-FZ dated December 27, 2019 "On Amending the Federal Law 'On Defense' and Article 38 of the Federal Law 'On the Basics of Health Protection of Citizens in the Russian Federation'"

The Ministry of Defense of the Russian Federation establishes the cases and procedures for the provision of medical care by the medical personnel of military-medical organizations, units, and detachments of the Armed Forces of the Russian Federation, other troops, military formations, and bodies when such organizations and units are deployed outside the territory of the Russian Federation (including the procedure for administering medicinal products and medical devices unregistered in the Russian Federation).

The Government of the Russian Federation shall regulate the specific aspects of the circulation of medicinal products and medical devices developed under commissions from the Ministry of Defense and other federal executive bodies authorized in the management of military formations. This applies to products intended for use in wartime, during military operations, or for the execution of combat, training, and operational missions, and utilized for the diagnosis, prevention, and treatment of diseases and injuries resulting from exposure to weaponry, military equipment, or adverse chemical, biological, and radiation factors.

1.12. The Government amended the Decree governing medical services, high-cost treatments, and medicines eligible for social tax deductions.

Decree of the Government of the RF No. 1740 dated December 20, 2019 "On Amending Decree of the Government of the Russian Federation No. 201 dated March 19, 2001"

The executive branch repealed the previous List of medical services and high-cost types of treatment in medical institutions of the Russian Federation, the payment amounts for which out of the taxpayer's own funds are taken into account when determining the social tax deduction.

1.13. The Government incorporated amendments to the drug circulation and healthcare laws into its 2020 legislative planning agenda.

Disposition of the Government of the RF No. 3205-r dated December 26, 2019 "On Approving the Legislative Drafting Activity Plan of the Government of the RF for 2020"

The Government plans to introduce draft laws to the State Duma in July 2020 to amend Federal Law No. 323-FZ "On the Basics of Health Protection of Citizens in the Russian Federation" (in part of systematizing mandatory requirements in healthcare operations) and to amend Federal Law No. 61-FZ "On the Circulation of Medicines" (in part of systematizing mandatory requirements within the lifecycle and circulation of medicines).

1.14. Government Decree No. 667 expanding the list of controlled potent substances entered into force on December 1, 2019.

Decree of the Government of the RF No. 667 dated May 17, 2019 "On Amending Decree of the Government of the Russian Federation No. 964 dated December 29, 2007"

For the purpose of enforcing Article 234 of the Criminal Code of the Russian Federation (illegal trafficking of potent or poisonous substances for the purpose of sale), the executive branch included Pregabalin, Tapentadol, and Tropicamide in the schedule of potent and poisonous substances whose unauthorized sale triggers criminal liability.

2. Draft Regulatory and Legal Acts

2.1. The Ministry of Health proposes amendments to the Regulations on the Track-and-Trace Monitoring System for Medicinal Products for Human Use.

Draft Decree of the Government of the Russian Federation "On Amending Decree of the Government of the Russian Federation No. 1556 dated December 14, 2018 'On Approving the Regulations on the System for Monitoring the Movement of Medicinal Products for Human Use'"

Currently, Decree of the Government of the Russian Federation No. 1557 dated December 14, 2018 "On Establishing Specific Aspects of Implementing the Monitoring System for the Movement of Medicinal Products for Human Use" defines implementation schedules and guidelines specifically for high-cost nosology drugs (medicinal products intended for patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, and persons post-organ and/or tissue transplantation).

The law does not currently establish specific serialization implementation rules or distinct deadlines for other categories of medicinal products for human use.

The draft proposes that fees charged by the track-and-trace system operator for generating and providing serialization barcodes shall apply starting July 1, 2020.

Retail sale, free or discounted dispensing via prescriptions, or administration during medical care of medicinal products manufactured from July 1, 2020, shall be permitted exclusively if identification marking is present on the primary packaging (if no secondary packaging is utilized) and on the secondary (consumer) packaging, and provided that the entity transmits serialization data regarding sale, dispensing, or medical utilization to the monitoring system. These restrictions do not apply to medicinal products exempted from mandatory identification marking under the Regulations approved by this Decree and international treaties of the Russian Federation.

2.2. The Ministry of Health proposes revising qualification criteria for individuals with pharmaceutical degrees seeking to practice.

Draft Order of the Ministry of Health of the Russian Federation "On Amending the Regulations on the Accreditation of Specialists Approved by Order of the Ministry of Health of the Russian Federation No. 334n dated June 2, 2016"

The draft proposes that information systems automatically assemble a combination of practical assignments to evaluate clinical/practical skills under simulated conditions, alongside situational case tasks within professional examinations, drawing items from the Unified Database of Assessment Tools.

The number of practical assignments and situational tasks within a professional examination is established independently for each pharmaceutical specialty, with a mandatory minimum of five items.

An examinee is allocated 10 minutes to complete a single practical assignment.

An examinee is allocated 30 minutes to resolve a single situational task containing 12 distinct questions.

Information systems generate professional examination results automatically based on the percentage of correctly executed practical actions relative to total mandatory actions, combined with the percentage of correct answers given to the questions in the situational tasks.

Based on the automated system output, the accreditation subcommission evaluates the candidate's performance during this stage using the following grading criteria:

• "Passed" if the examinee achieves a score of 70% or more correctly executed practical actions out of the total actions and a score of 70% or more correct answers when solving situational tasks (provided they are included in the professional examination);

• "Failed" if the examinee scores 69% or less correctly executed practical actions out of the total actions and/or scores 69% or less correct answers when solving situational tasks.

2.3. The legislative review schedule for the bill on online mail-order drug sales was extended.

Draft Law No. 285949-7 "On Amending Certain Legislative Acts of the Russian Federation in Part of E-Commerce and Distance Retail Trade of Medicinal Products"

The State Duma extended the previously defined deadline for submitting amendments intended to establish accounting procedures for prescription forms, alongside mechanisms to verify the authenticity of prescriptions transmitted remotely by buyers. Lawmakers must also delineate the procedures for identifying individuals presenting prescription forms during remote fulfillment.

2.4. Roszdravnadzor drafted model templates for official inspection reports on regulatory mystery shopping operations.

Draft Order of Roszdravnadzor "On Approving Model Templates for Reports on Conducting Test Purchases of Goods (Works, Services)"

The specified draft underwent mandatory anti-corruption expert review in December 2019. The draft order proposes to approve a model template for the Official Report on Conducting a Test Purchase of Goods (Works, Services) alongside a model template for the Official Report on Conducting a Remote Test Purchase of Goods (Works, Services).

2.5. The Ministry of Health announced plans to establish a unified federal registry of eligible beneficiaries for subsidized medicines.

The project aims to eliminate duplicative drug provisioning of subsidized categories of citizens funded simultaneously from the federal budget and the regional budgets of the constituent entities of the Russian Federation. The authorities plan to complete the full rollout of the registry project within two to three years.

2.6. The Ministry of Education proposes shortening the duration of vocational training programs for secondary pharmaceutical education.

Draft Order of the Ministry of Education of the Russian Federation "On Approving the Federal State Educational Standard for Vocational Education in Specialty 33.02.01 Pharmacy"

The Ministry of Education proposes reducing the enrollment period for students completing vocational programs in "Pharmacy." The draft outlines that the training period for students enrolling on the basis of basic general education (grades 5–9) will be 2 years and 10 months, whereas enrollment based on completed secondary general education (grades 10–11) will be 1 year and 10 months.

3. Judicial and Regulatory Enforcement Practice

3.1. FSUE Russian Post launched a pilot project to retail over-the-counter and prescription medicines within post office branches.

According to data published on the organization's official website, pharmaceutical kiosk spaces have opened across three post office branches in the Samara Oblast. The management plans to evaluate the commercial viability of expanding this retail practice to other regions following a four-month evaluation window.

3.2. Alcon Pharmaceuticals LLC successfully avoided administrative liability after complying with an enforcement warning from the Russian FAS.

The company complied with an administrative warning issued by the competition regulator, which mandated the cessation of actions violating antimonopoly legislation. Specifically, the entity voluntarily corrected the indicia of antitrust violations by agreeing to perform technical maintenance on Allegretto excimer lasers utilizing laser gas mixtures chosen freely by the customer, whereas past enforcement evidence pointed to instances where Alcon tied servicing to the compulsory purchase of a specific manufacturer's gas mixture.

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