BRACE Law Firm presents its latest Regulatory Digest of the Russian Pharmaceutical Industry, detailing key legal developments.

Characteristically for the beginning of the calendar period, legislative activity remained relatively low. Nevertheless, regulatory authorities enacted several key pieces of legislation establishing new compliance benchmarks.

The Collegium of the Eurasian Economic Commission approved significant regulatory updates, specifically the Guideline on the Choice of Trade Names for Medicinal Products and the Guideline on the Manufacture of Finished Dosage Forms of Medicinal Products. These documents build upon the Rules for Registration and Examination of Medicinal Products for Human Use (approved by Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016) and the Good Manufacturing Practice (GMP) Rules of the Eurasian Economic Union (approved by Decision of the Council of the Eurasian Economic Commission No. 77 dated November 3, 2016).

Under the Guideline on the Choice of Trade Names for Medicinal Products, a drug's trade name must not carry misleading connotations based on therapeutic or pharmaceutical properties. The guidelines strictly prohibit promotional trade names and discourage designations that could be perceived as offensive or carry negative connotations in any of the official languages of the EAEU member states.

Pursuant to the Guideline on the Manufacture of Finished Dosage Forms of Medicinal Products, the manufacturing process description must capture comprehensive data on critical stages and intermediate products. It must also trace the link between pharmaceutical development, the proposed control strategy, and process validation. For each stage of the manufacturing process, applicants must submit detailed information on all participating manufacturing sites and testing facilities, including quality control and analytical laboratories. The manufacturer must thoroughly justify the technical description of the production process.

A significant, long-awaited statutory change permitted the issuance of electronic prescriptions for medicinal products containing narcotics and psychotropic substances. However, practical implementation may introduce potential compliance risks and operational pitfalls due to the unreadiness of physicians, healthcare organizations, or pharmacies to issue and process digital prescriptions.

The Ministry of Health of the Russian Federation has proposed abolishing the annual approval process for the List of Vital and Essential Drugs (VED).

1. Statutory Acts, Regulations, and Legal Developments

1.1. The Collegium of the Eurasian Economic Commission has approved the Guideline on the Choice of Trade Names for Medicinal Products.

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

This Guideline establishes the rules for selecting and evaluating trade names for medicinal products for human use registered under the Rules for Registration and Examination of Medicinal Products for Human Use, approved by Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016.

Notably, competent authorities do not consider intellectual property rights when evaluating a trade name. The trade name of a medicinal product must not carry misleading connotations based on therapeutic or pharmaceutical data. The guidelines strictly prohibit promotional trade names and discourage designations that could be perceived as offensive or carry negative connotations in any of the official languages of the EAEU member states.

The Recommendation establishes that the evaluation approach for trade names of orphan drugs aligns with that for non-orphan medicinal products. To evaluate trade names of orphan drugs, applicants must provide comprehensive details regarding the specific conditions under which the drug will be dispensed and administered, alongside its target patient population.

If a trade name consists of a newly invented word, it must not be confusingly similar to or replicate any existing International Nonproprietary Name (INN).

Stakeholders should also note that exceptionally short trade names, such as random letter combinations, may be deemed unacceptable for designating a medicinal product in certain EAEU member states.

1.2. The Collegium of the Eurasian Economic Commission has approved the Guideline on the Manufacture of Finished Pharmaceutical Products.

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

The Commission developed this Guideline in accordance with the stringent requirements of the Good Manufacturing Practice (GMP) Rules of the Eurasian Economic Union, approved by Decision of the Council of the Eurasian Economic Commission No. 77 dated November 3, 2016.

The document mandates that the manufacturing process description must capture data on critical processing steps and intermediates, while establishing traceability between pharmaceutical development, the proposed control strategy, and process validation.

Applicants must submit data for each manufacturing stage regarding all participating production sites and testing facilities, including contract analytical and quality control laboratories. The manufacturer must soundly justify the description of the manufacturing process.

The description of the manufacturing process must be exhaustive and include an appended flowchart detailing every process step along with relevant in-process controls (IPCs), where applicable, and identifying each stage where raw materials enter production.

Essential criteria for describing manufacturing processes include completeness, precise technical detail, and a sequential characterization of processing steps, including batch size and equipment type or capacity, where necessary. Manufacturers must pay close attention to the frequency of in-process controls and explicitly define the timelines for finished product release testing.

The appendix to the Guideline provides a sample framework for such a manufacturing process description.

1.3. Rosstat Clarifies Reporting Procedures for Small and Medium-Sized Enterprises Under the Federal Statistical Monitoring Framework.

Order of Rosstat No. 22 dated January 23, 2019, “On Approval of Guidelines for Completing Federal Statistical Monitoring Form No. PM 'Data on Key Performance Indicators of a Small Enterprise'”

As a general rule, legal entities qualifying as small enterprises (excluding micro-enterprises) must submit Federal Statistical Monitoring Form No. PM “Data on Key Performance Indicators of a Small Enterprise.”

The clarifications specifically address reporting requirements for small and medium-sized enterprises (SMEs) engaged in the sale of medicinal products. Specifically, the document notes that line 18 of the form must reflect the value of pharmacy-compounded medicines dispensed to the public, legal entities, and individual entrepreneurs, as well as commission fees earned for dispensing finished pharmaceuticals under free or subsidized prescriptions (provided the pharmacy does not purchase these drugs directly).

1.4. Production of Medicinal Products Authorized Within the “Galich” Territory of Advanced Socio-Economic Development.

Decree of the Government of the Russian Federation No. 37 dated January 25, 2019, “On the Establishment of the 'Galich' Territory of Advanced Socio-Economic Development”

This Decree of the Russian Government designates the manufacture of medicinal products and medical materials as an authorized economic activity within the “Galich” Territory of Advanced Socio-Economic Development (TASED).

Within the first year following a legal entity's registration in the TASED resident register, the resident must make a minimum capital investment of RUB 2.5 million under the investment project for the relevant economic activities. Furthermore, the investment project must generate a minimum of 10 new permanent jobs.

1.5. Russian Government Approves “Business Climate Transformation” Action Plan, Targeting Veterinary Medicinal Products.

Order of the Government of the Russian Federation No. 20-r dated January 17, 2019, “On Approval of the 'Business Climate Transformation' Action Plan and Revocation of Certain Acts of the Government of the Russian Federation”

This document schedules the preparation and submission of proposals for February 2019 to update the List of Veterinary Drugs Prohibited for Use in Productive Animals within the Customs Territory of the Eurasian Economic Union. The proposals seek to ban veterinary medicines containing nitrofurans (including furazolidone). The Ministry of Agriculture, the Ministry of Industry and Trade, and the Ministry of Economic Development of the Russian Federation serve as the lead executing agencies for this initiative.

1.6. Interagency Information-Sharing Framework Expanded to Include Data on Import and Export Permits for Clinical Trial Biological Materials.

Order of the Government of the Russian Federation No. 35-r dated January 19, 2019, “On Amending the List Approved by Order of the Government of the Russian Federation No. 724-r Dated April 19, 2016”

The Government has expanded the list of documents and data requested and obtained via interagency information-sharing channels by state control (supervisory) and municipal control bodies during audits. Under this updated framework, the Ministry of Health of the Russian Federation will share data from the register of issued permits (and decisions denying permit issuance) for the import into or export from the Russian Federation of biological materials (including samples of human biological fluids, tissues, secretions, waste products, physiological and pathological discharges, swabs, scrapings, washings, microorganisms, and biopsy materials) obtained during clinical trials of medicinal products for human use.

1.7. Electronic Prescriptions Permitted for Controlled Substances and Psychotropic Medications Effective January 1, 2019.

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

This statute dictates that healthcare providers must organize and deliver medical care utilizing telemedicine technologies in accordance with procedures established by the competent federal executive body, medical care protocols, and healthcare standards. Physicians must issue prescriptions for narcotics or psychotropic substances using specialized paper forms or, upon obtaining consent from the patient or their legal representative, generate them as electronic documents. Such digital prescriptions require an advanced qualified electronic signature from the attending physician (or an authorized paramedic or midwife performing the duties of an attending physician) and the issuing healthcare organization.

2. Draft Legislative and Regulatory Acts

2.1. Following the ratification of the Agreement on Common Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union, the Ministry of Health of the Russian Federation has proposed amendments to the Federal Law “On the Circulation of Medicines” to enhance the regulatory framework governing medicinal products for human use.

Draft Federal Law “On Amending Certain Legislative Acts of the Russian Federation Regarding Drug Provision for Citizens”

The draft bill proposes amendments to Article 6.2 of Federal Law No. 178-FZ dated July 17, 1999 “On State Social Assistance,” Federal Law No. 61-FZ dated April 12, 2010 “On the Circulation of Medicines,” and Federal Law No. 323-FZ dated November 21, 2011 “On the Basics of Health Protection of Citizens in the Russian Federation.” The proposed legislation eliminates the requirement for annual approval of the VED List. It further mandates that, under territorial programs of state guarantees for free medical care, state authorities of the Russian Federation subjects must establish lists of outpatient medicinal products that are at least as comprehensive as the VED List, excluding drugs restricted by their instructions to inpatient use only.

2.2. Public Consultations Conclude for Proposed Amendments Requiring Market Analysis in Sole-Source Pharmaceutical Procurement Decrees.

Draft Federal Law “On Amending Article 93 of the Federal Law 'On the Contract System in the Field of Procurement of Goods, Works, and Services for State and Municipal Needs'”

The draft bill proposes an amendment to Article 93 of the Law on the Contract System, requiring that the drafting of legal acts by the President or the Government of the Russian Federation designating a sole-source supplier must factor in specific pharmaceutical market criteria. Government-established criteria will evaluate both the market dynamics of the medicines up for sole-source procurement and the qualifications that sole-source pharmaceutical suppliers must satisfy.

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