The Russian Federation is an increasingly important market for pharmaceuticals. This overview has been prepared by attorneys in Hogan & Hartson's Moscow office as a guide to how the Russian Federation regulates pharmaceuticals.

1. Introduction to the Russian Legal System and State Authorities Structure

The Russian Federation is a nation with a federal system of government consisting of republics, regions, federal cities, autonomous regions and autonomous districts that are equal “subjects” of the Russian Federation. Republics have their own constitutions and legislation. Regions, federal cities, autonomous regions and autonomous districts have their own charters and legislation. As part of the federal system of the Russian Federation, there is a split of authority and legal competence between the national government authorities of the Russian Federation and its subjects.

Health care issues fall within the joint competence of the Russian Federation and its subjects. On issues of joint competence, the Russian Federation enacts federal laws, and the subjects enact laws and legislative acts in compliance with the federal laws. The laws and legislative acts enacted by the subjects can not contradict federal laws. In case of conflict, federal laws shall apply.

The state power in the Russian Federation is exercised by the President, Federal Assembly (consisting of the Federation Council and Duma), government, and courts. The state power in the subjects is exercised by the state power bodies formed by the subjects. On issues of joint competence, state bodies of the Russian Federation and state bodies of the subjects represent a united system of state power in the Russian Federation.

The executive power is exercised by the Government of the Russian Federation, which consists of the Chairman, Deputies Chairman, and federal ministers. The government ensures a uniform policy in the sphere of health care. In furtherance of the Constitution, federal laws, and presidential decrees, the government issues decisions and orders that are mandatory for execution in the territory of the Russian Federation.

Health care issues fall within the competence of the Ministry of Healthcare and Social Development (the Ministry of Health) and, subordinate to it, (i) the Federal Service on Healthcare and Social Development Supervision (the Federal Health Service) and (ii) the Federal Agency on Healthcare and Social Development. In terms of the split of authority discussed earlier, the Ministry defines state policy and performs legislative regulation in the sphere of its competence, but can not perform control and supervision functions in the set sphere. The Federal Service performs control and supervision in the set sphere, but can not perform legislative regulation. The Federal Agency renders state services, performs management of state (public) property and law enforcement functions, except for control and supervision functions.

2. Overview of Pharmaceuticals Regulatory Environment

2.1 General Framework of Legal Requirements for Pharmaceuticals.

Federal legislation sets out the fundamentals of regulation in the sphere of health care. Federal Law on Pharmaceuticals No. 86-FZ of June 22, 1998 (as amended on December 18, 2006) (the Pharmaceutical Law) establishes the general framework of legal requirements applicable to circulation of pharmaceuticals (pharmaceuticals), including development, production, trials, quality control, efficacy, safety, importation and sale.

Given the importance to the public of the health care sector, and providing the population with safe and high quality pharmaceuticals, the Pharmaceutical Law makes it a priority for state to control the production, quality, efficacy, and safety of pharmaceuticals.

State regulation of pharmaceuticals is performed by way of:

  • State registration of pharmaceuticals;
  •  Licensing of certain activities in the sphere of circulation of pharmaceuticals;
  • Accreditation and certification of experts engaged in the sphere of circulation of pharmaceuticals;
  • State control over production, preparation, quality, effectiveness and safety of pharmaceuticals; and
  • State regulation of prices on pharmaceuticals.

2.2. State Registration of Pharmaceuticals

As a general rule, pharmaceuticals may be produced, imported, sold, and used in the Russian Federation only if they are registered with the state authority exercising control over the quality of pharmaceuticals. Presently, these functions are vested in the Federal Health Service.

Specifically, the following pharmaceuticals are subject to state registration: (i) new pharmaceuticals; (ii) new combinations of previously registered pharmaceuticals; (iii) previously registered pharmaceuticals but produced in other medical forms, with new doses or other combinations with supplementary substances; and (iv) generic versions of pharmaceuticals.

Registered pharmaceuticals shall be entered into the State Register of Pharmaceuticals.

In furtherance of the Pharmaceutical Law, the Ministry of Health enacted the Administrative Regulations approved by the Order No. 736 of October 30, 2006 that set out registration procedure for pharmaceuticals.

Either the developer of the pharmaceutical, or another legal entity authorized by the developer, shall apply for state registration of the pharmaceutical, in the name of the applicant specified in the application for registration.

Domestic and foreign pharmaceuticals enjoy the same treatment for the purposes of registration.

The following documents and information shall be filed with the Federal Health Service to register pharmaceuticals:

  • Application for state registration of a pharmaceutical;
  • Document evidencing payment of state registration fee;
  • Legal address of the manufacturer of the pharmaceutical;
  • Name of the pharmaceutical including International Non-proprietary Name (INN), any scientific name in Latin, and principal synonyms;
  • Original name of the pharmaceutical if it is registered as a trademark;
  • List of ingredients specifying their quantity,
  • Instructions for use of the pharmaceutical made in compliance with the Pharmaceutical Law requirements;
  • Quality certificate for the pharmaceutical;
  • Manufacturing data for the pharmaceutical and pharmacopoeia;
  • Methods for quality control;
  • Results of pre-clinical trials;
  • Results of pharmacological and toxicological testing of the pharmaceutical;
  • Results of clinical trials;
  • Samples of the pharmaceutical for its quality examination;
  • Proposals on price; and
  • Documents confirming the registration of the pharmaceutical if it has been registered outside Russia.

The above documents shall be filed in the Russian language or be supplied with a certified Russian translation.

The documents shall be reviewed and the decision on registration made within six months from the date of filing of a complete set of documents as specified above.

If the only differences between a pharmaceutical proposed to be registered and one that has already been registered are ancillary ingredients or production technology, and such differences cannot affect the quality, efficacy, and safety of the pharmaceutical, an expedited three months registration procedure shall apply.

As a result of state registration of a pharmaceutical, it is issued a registration certificate with an unlimited term of validity.

Amendments to the registration of a pharmaceutical shall be made either on the basis of an application and supporting documents filed by the registration certificate holder or by the Federal Health Service on the basis of data concerning quality, efficacy, or safety of the pharmaceutical. Amendments relating to quality or efficiency of a pharmaceutical shall be made within six months of filing a complete set of documents, and in all other cases, including those related to information on a new side effect or limitations in use, change of ownership of the pharmaceutical, or change of trade name or package, shall be made within one month from the date of filing.

2.3. Pre-clinical and Clinical Trials

The aim of pre-clinical trials of a pharmaceutical is to obtain by scientific methods evaluation and evidence of efficacy and safety of the pharmaceutical. In addition to the above, clinical trials are conducted in order to generate data on possible side effects that may occur as a result of use of the pharmaceutical or its interaction with other pharmaceuticals.

Pre-clinical trials are carried out by developers themselves according to the rules governing good laboratory practice (GLP). Upon receiving acceptable results from pre-clinical trials, the developer may develop a statement on the possibility of conducting clinical trials of the pharmaceutical.

Clinical trials shall be conducted by medical institutions approved by the Federal Health Service and on the basis of a decision permitting clinical trials issued by the Federal Health Service.

The following documents should be submitted to the Federal Heath Service in order to obtain a decision on conducting clinical trials of a pharmaceutical:

  • Application of the developer;
  • Consent of the Ethics Committee;
  • Report and statement on pre-clinical trials of the pharmaceutical; and
  • Instruction on use of the pharmaceutical.

Thus, the legal grounds for conducting clinical trials would be the decision of the Federal Heath Service and an agreement on clinical trials to be entered into between developers and medical institutions. The clinical trial agreement shall specify the following information:

  • Timeframe and scope of clinical trial of a pharmaceutical;
  • Total cost of the clinical trials program;
  • Form for presenting the results of the clinical trials to the Federal Health Service;
  • Terms of insurance covering patients enrolled in the clinical trials; and
  • Terms of insurance covering liability of persons conducting the clinical trials.

Patients enrolled in clinical trials enjoy special protection. The patients shall be given information on the pharmaceutical and the aim of the clinical trials, on the expected efficicacy and safety of the pharmaceutical and the level of risk, on actions to be taken in case of any unexpected effect of the pharmaceutical on the patient health, and on the terms of insurance of patients. Patients shall give written informed consent prior to participation in clinical trials and may terminate their participation at any time.

Requirements for conducting clinical trials are further specified in the Rules for Clinical Practice (the Rules) in the Russian Federation approved by the Order of the Ministry of Health No. 266 of June 19, 2003. These rules apply to all participants of clinical trials conducted in the Russian Federation.

The rules prohibit direct payments to specialists of the medical institution conducting clinical trials by the developers or sponsors, and allow only payments to the medical institution itself against invoices issued in accordance with the clinical trials agreement. Although this limitation is no longer stated in the Pharmaceutical Law, the Rules continue to have this limitation.

Violation of the rules of good clinical practice (GCP) and falsification of the results of clinical trials would result in liability according to the legislation of the Russian Federation.

2.4. Importation of Pharmaceuticals

As a general rule, pharmaceuticals shall be registered in the Russian Federation in order to be imported. An exception is made for pharmaceuticals that are imported for clinical trials, on the basis of a relevant permission issued by the Federal Health Service.

The quality of imported pharmaceuticals shall be confirmed by the quality certificate issued by the manufacturer. It is illegal to import pharmaceuticals that are counterfeit or illegal copies of those registered in the Russian Federation.

The Russian Pharmaceutical Law establishes certain limitations in regard to importers of pharmaceuticals into Russia. Specifically, only the following legal entities are entitled to import pharmaceuticals: (i) pharmaceutical manufacturers; (ii) pharmaceutical wholesalers; (iii) scientific and research organizations, institutes, and laboratories for development, research and control of pharmaceutical quality, efficacy, and safety; (iv) foreign pharmaceutical manufacturers and pharmaceutical wholesale companies, if they have representative offices in the Russian Federation.

Importation of certain pharmaceuticals is approved by the Decision of the Government on the Import and Export of Pharmaceuticals Intended for Medical Use No. 438 of July 16, 2005 shall be carried out on the basis of an import license issued by the Ministry of Economic Development and Trade.

The import license is issued on the basis of a statement of the Federal Health Service on expediency of issuance of a license to import pharmaceuticals. According to the Administrative Regulations on the Issuance of Statements on Expediency of Granting a License to Import Pharmaceuticals, approved by the Order of the Ministry of health No. 903 of December 31, 2006, the Federal Health Service shall issue such statements within 15 days from the date of filing of the following documents:

  • An application, coordinated with the Permanent Committee for Supervision over Narcotic Drugs, that specifies the name and address of the applicant, number and date of contract, term of license (for pharmaceutical activity or for production of Pharmaceuticals), name and address of seller, name and address of purchaser; name and address of the manufacturer furnishing a quality certificate (certificate of analysis) for each imported pharmaceutical, information on imported pharmaceuticals (full names, weight of consignment, quantity, price, name of the manufacturer and country of origin, and information on state registration in Russia);
  • A copy of the relevant license for pharmaceutical activity or for production of pharmaceuticals;
  • Copies of contracts including information on imported pharmaceuticals and terms of purchase;
  • A copy of contract between exporter (importer) and manufacturer (consumer) if the applicant is an agent;
  • Copies of foundation and registration documents of the applicant; and
  • Copies of state registration documents of each of imported pharmaceuticals.

In order to protect the domestic market and local manufacturers, the law permits the Russian Government to apply special customs duties to imported pharmaceuticals in accordance with the customs legislation.

For the purposes of importing pharmaceuticals, the following documents are required to be submitted to the customs office:

  • Contracts or other documents on imported pharmaceuticals;
  • Certificates of quality of pharmaceuticals;
  • Information on state registration of each imported pharmaceutical;
  • Information on the consignor of pharmaceuticals;
  • Information on the consignee of pharmaceuticals;
  • Information on the person forwarding the goods (if other than consignor or consignee); and
  • Permission of the Federal Health Service to a import a consignment of pharmaceuticals intended for clinical trials.

The importation of pharmaceuticals falls within the customs regime for “release of goods for internal consumption,” which implies that the imported goods are to remain in Russia without the obligation of their re-exportation. This customs regime requires the payment of a full amount of the (i) import customs duty, (ii) VAT and (iii) customs fees.

2.5. Certification of Pharmaceuticals

In addition to state registration, domestic and imported pharmaceuticals are subject to certification of compliance with state quality standards for pharmaceuticals. The procedure for mandatory certification of pharmaceuticals is set out in the Rules for the Certification of Pharmaceuticals in the GOSTR Certification System approved by the Resolution of the Russian State Committee on Standardization, Metrology and Certification No. 36 of 24 May 2002 (as amended, September 3, 2003).

Certification is carried out by certification centers accredited under the GOSTR Certification System of the Pharmaceuticals on the basis of protocols for testing issued by accredited testing laboratories. A certificate of conformity is issued for a particular consignment or line of the pharmaceuticals and without any specific period of validity. This certificate is valid until the expiration date of the pharmaceuticals that are subject to the certificate.

The type of certification required is determined on a case-by-case basis by the certification authorities, depending on the type of Pharmaceuticals.

2.6. Licensing of Certain Activities on Circulation of Pharmaceuticals

According to Federal Pharmaceutical Law No. 128-FZ “On Licensing of Certain Types of Activities” of 8 August 2001 (as amended December 6, 2007), “pharmaceutical activity” and production of pharmaceuticals are subject to licensing.

“Pharmaceutical activity” includes wholesale and retail sale of pharmaceuticals and preparation of pharmaceuticals and may be carried out by legal entities and natural persons, including individual entrepreneurs. Licensing of such activity is performed out by the Federal Health Service.

The Regulations on Licensing of Pharmaceutical Activity approved by the Decision of the Government No. 416 of 6 July 2006 (as amended July 19, 2007) set out the following licensing requirements for applicants wishing to engage in a pharmaceutical activity:

  • Available premises and equipment in compliance with sanitary and other applicable requirements for conducting pharmaceutical activity owned or used by the applicant;
  • Compliance by any applicant engaged in wholesale of Pharmaceuticals with the relevant requirements set out in the Pharmaceutical Law and the rules for pharmaceutical wholesalers;
  • Compliance by any applicant engaged in retail sale of pharmaceuticals with the relevant requirements set out in the Pharmaceutical Law and retail sale rules for pharmaceuticals in accordance with the provisions for protection of consumers rights in the Pharmaceutical Law;
  • Compliance by any applicant engaged in the preparation of Pharmaceuticals with the relevant requirements set out in Pharmaceutical Law and the rules for quality control of pharmaceuticals prepared in pharmacies;
  • Compliance with the requirements prohibiting sale of pharmaceuticals unfit for use, pharmaceuticals past their expiration dates, and counterfeit and illegal copies of pharmaceuticals registered in the Russian Federation; and destruction of such pharmaceuticals pursuant to the Pharmaceutical Law; and
  • Compliance with the following qualification requirements:
    • Heads (CEOs) of the applicant involved in the acceptance, storage, release, preparation and destruction of the Pharmaceuticals shall have the higher educational decree in pharmaceuticals and at least 3 years of professional experience and a certificate of an expert;
    • Individual entrepreneur-applicants shall have the higher or intermediary educational decree in pharmaceuticals and a certificate as an expert;
    • Employees of the applicant involved in the preparation, storage, release and sale of pharmaceuticals shall have the higher or intermediary educational degree in pharmaceuticals and a certificate as an expert; and
    • Professional upgrade of experts involved in pharmaceutical activity at least once every five years.

The production of pharmaceuticals may be carried out by legal entities in accordance with relevant requirements The Regulations on Licensing of Production of Pharmaceuticals, approved by the Decision of the Government No. 415 of 6 July 2006 (as amended July 19, 2007), sets out the following licensing requirements for applicants wishing to engage in pharmaceutical production:

  • Available premises and equipment (owned or leased) in compliance with sanitary and other applicable requirements as necessary for production activity;
  • Compliance by the applicant engaged in production of pharmaceuticals with the relevant requirements set out in the Pharmaceutical Law with respect to production and quality control of pharmaceuticals in dosage forms approved for production;
  • Legal grounds for production and sale of patented and/or original pharmaceuticals in accordance with requirements in patent and trademarks legislation;
  • Compliance with the requirements prohibiting sale of pharmaceuticals unfit for use, pharmaceuticals past their expiration date, or counterfeit and illegal copies of pharmaceuticals registered in the Russian Federation; and destruction of such pharmaceuticals pursuant to the Pharmaceutical Law;
  • Available staff members specialists responsible for production, quality, and labeling of pharmaceuticals who have higher or intermediary educational degrees (in chemistry, technology, biotechnology, pharmaceutical science, or medicine) and who have at least three years of professional experience; and
  • Professional upgrade of the experts involved in pharmaceutical activity at least once every five years.

The license for pharmaceutical activity or for production is issued for five years and may be extended

2.7. Production and Preparation of Pharmaceuticals

Production of pharmaceuticals may be carried out by manufacturers that have a license for production of pharmaceuticals.

It is prohibited to produce pharmaceuticals (i) not registered in the Russian Federation except those intended for clinical trials; (ii) without a license for production; and (iii) in violation of rules for production and quality control approved by the Ministry of Health.

Production of patented pharmaceuticals and their sale is performed in compliance with patent and trademark legislation. State control over production of pharmaceuticals is carried out by the Federal Health Service, which is entitled (i) to have free access to the manufacturer’s facilities and to take samples of produced pharmaceuticals; (ii) to make copies of documents necessary for pharmaceuticals quality control; and (iii) prohibit production of pharmaceuticals and sale of finished pharmaceuticals where forbidden in the rules for production and quality control.

Preparation of pharmaceuticals is carried out in pharmacies that have a license for pharmaceutical activity to dispense pharmaceuticals, in accordance with physicians’ prescriptions, that have been registered in the Russian Federation, and in accordance with the relevant rules approved by the Ministry of Health.

2.8. Wholesale and Retail Sale of Pharmaceuticals

The Pharmaceutical Law restricts the range of organizations to which the manufacturers may sell pharmaceuticals. Sales may be made to:

  • Other manufacturers for production purposes;
  • Wholesale trade organizations;
  • Pharmaceutical institutions;
  • Scientific and research institutions for scientific and research work; or
  • Individual entrepreneurs who have licenses to conduct pharmaceutical activity.

Retail sale of pharmaceuticals may be conducted only through pharmaceutical institutions.

Pharmaceuticals may be put into circulation if the internal or external package bears the following information in Russian:

  • Name of the pharmaceutical and its International Non-proprietary Name;
  • Name of the manufacturer of the pharmaceutical;
  • Series and date of production;
  • Method of application;
  • A dose and quantity in the package;
  • Term of fitness (expiration date); 
  • Conditions for sale;
  • Conditions for storage; and
  • Precautionary measures in taking the pharmaceutical.

The pharmaceuticals shall be put into circulation only with the instructions for use, which must contain the following information in Russian:

  • Name and legal address of the manufacturer of the pharmaceutical;
  • Name of a pharmaceutical and its International Non-proprietary Name;
  • Information on the ingredients of a pharmaceutical;
  • Indications;
  • Contraindications;
  • Side effects;
  • Interactions with other pharmaceuticals;
  • Doses and method of use;
  • Fitness term (expiration date);
  • Indication that a pharmaceutical shall not be used after its expiration date;
  • Indication that a Pharmaceutical shall be kept in places not accessible to children; and
  • Conditions for sale.

2.9. State Control Over Quality, Efficacy, and Safety of Pharmaceuticals

According to Administrative Regulations on Performing Examination of Quality, Efficacy and Safety of Pharmaceuticals, approved by the Order of the Ministry of Health No. 734 of October 30, 2006, state control over the quality, efficacy, and safety of pharmaceuticals is performed by the Federal Health Service by way of:

  • Examination of pharmaceutical quality, efficacy, and safety during the state registration process;
  • Obtaining and analyzing information on side effects related to use of pharmaceuticals;
  • Examination of quality while performing preliminary state control that applies to pharmaceuticals produced in or imported into the Russian Federation for the first time, or produced under a changed technology, or produced after termination in production for a three-year period;
  • Examination of quality during random checks by state control officials, carried out pursuant to random sampling plans by the Federal Health Service developed on the basis of information on quality of pharmaceuticals;
  • Examination of quality while performing a repeated random sampling by state control officials, conducted in case of uncertainty concerning the quality of pharmaceuticals; and
  • Obtaining and analyzing information on quality of pharmaceuticals

2.10. State Regulation of Prices on Pharmaceuticals

The Russian Government performs state regulation of prices of pharmaceuticals that are included into the list of vital pharmaceuticals approved by the government as well as pharmaceuticals provided to persons entitled to receive social aid pursuant to the Program of Additional Supply of Pharmaceuticals (the so-called DLO program).

Pursuant to the Regulation on State Regulation of Prices of Vital Pharmaceuticals, approved by the Decision of the Government No. 782 of November 9, 2001 (as amended October 17, 2005), state regulation of prices of pharmaceuticals is carried out by way of state registration of maximum selling prices of pharmaceuticals (from both Russian and foreign manufacturers) and establishment of maximum wholesale and retail price markups for these pharmaceuticals.

State registration of prices is performed by the Federal Health Service, free of charge, on the basis of the following documents and information:

  • Application for registration of maximum selling price;
  • Copy of license for production of pharmaceuticals;
  • Copy of registration certificates for pharmaceuticals;
  • Information on International Non-proprietary Name for a pharmaceutical as specified by the manufacturer for state registration purposes, a code in compliance with the product’s classification, form, dose, quantity in the consumer’s package and barcode, according to the form approved by the Federal Health Service;
  • Substantiation to be furnished by a Russian manufacturer of maximum selling price to a pharmaceutical in expressed in RUR (Russian rubles) per unit (for each consumer’s package) on conditions of ex factory warehouse and specifying data on volume of sales for half a year preceding the date of submitting the selling price for state registration and a forecast for the subsequent year data on volume of sales (in kind and in cash), face value and profit, according to the form approved by the Federal Health Service and Federal Tariff Service; and
  • Substantiation to be furnished by a foreign manufacturer of maximum selling price to a pharmaceutical in foreign currency and in RUR, according to the Central Bank of Russia (CBR) exchange rate on the date of registration of price per unit (for each consumer’s package), on conditions of delivered duty unpaid (DDU) with the account of expenses related to customs clearance of goods (payment of customs duty and fee) specifying the volume of sales of the pharmaceutical in the Russian Federation for the half year preceding the date of submitting the selling price for state registration and a forecast for the subsequent year data on volume of sales (in kind and in cash in foreign currency), volume of sales in the country of the manufacturer and other countries in which it was registered, import customs duty and customs fee rate according to the form approved by the Federal Health Service and Federal Tariff Service.

In the case of state registration, the maximum selling price of a Russian manufacturer is specified in RUR and the maximum selling price of a foreign manufacturer is expressed in foreign currency and in RUR, according to the CBR exchange rate on the date of registration of the price. The registered price shall be re-registered, subject to changes in raw material costs, salaries, demand, and expenses.

According to Administrative Regulations on Registration of Maximum Selling Prices of Pharmaceuticals, approved by the Order of the Ministry of Health No. 907 of December 31, 2006, the state registration of prices shall be effected within 35 business days from the date of filing a complete set of documents with the Federal Health Service.

2.11. Liability in the sphere of Circulation of Pharmaceuticals

Injury caused to human health as a result of use of pharmaceuticals and by the illegal actions of persons/entities involved in circulation of pharmaceuticals shall be compensated according to the requirements set out by the Fundamentals of the Legislation of the Russian Federation on Protection of Health of Citizens No. 5487-1 of 22 July 1993 (as amended October 18, 2007).

Pursuant to the Pharmaceutical Law, if injury to human health resulted from the use of a pharmaceutical, the manufacturer shall compensate for damages caused to the injured person, if it was proved that (i) a pharmaceutical was used according to its prescription and in compliance with the instructions for use, and its harmful effect was caused by errors in the production of the pharmaceutical; (ii) injury to human health was the result of erroneous instructions for the use of the pharmaceutical issued by the manufacturer.

If an injury to human health resulted from use of a pharmaceutical that became unfit for use, due to violation of pharmaceuticals wholesale rules or the rules for pharmaceutical activity by pharmaceutical institutions, the injury shall be compensated by such wholesale organization or pharmaceutical institution

3. Other Issues Related to Circulation of Pharmaceuticals

3.1. Protection of Intellectual Property Rights in Respect of Pharmaceuticals

The issues of intellectual property and means of their protection in Russia are currently regulated by the fourth part of the Russian Civil Code that came into force as of January 1, 2008.

The exclusive rights to inventions certified by patents issued by the relevant intellectual property authorities, and valid in the Russian Federation pursuant to international treaties, are recognized in Russia. However, according to the current practice, such rights shall be confirmed by a Russian patent to be issued by the Russian Federal Service on Intellectual Property, Patents and Trademarks (FSIPPT).

The use by third parties of inventions by way of importation, production, application, sale, or other use in a civil turnover is possible only with the permission of the patent owner.

Therefore, a pharmaceutical developer that is considering commercializing a pharmaceutical in the Russian Federation should first, before disclosing any information on the pharmaceutical while undergoing state registration procedures to ensure protection of the invention in the Russian Federation by patenting it with FSIPPT. A patent is valid for 20 years and may be extended.

It is furthermore recommended that pharmaceutical developers ensure protection of the names of pharmaceuticals by way of their registration as trademarks with FSIPPT. The registration of trademark is valid for 10 years and may be extended.

Foreign companies shall liaise with FSIPPT through accredited patent agents acting on the basis of a power of attorney issued by developers.

3.2. Advertising

Federal Pharmaceutical Law on Advertising No. 38-FZ of March 13, 2006 (as amended December 1, 2007) sets forth specific requirements for advertising of pharmaceuticals.

Particularly, advertising of a pharmaceutical shall not:

  • Be addressed to minors;
  • Contain a reference to specific cases of recovery from disease or state that improvement of health has occurred as the result of use of a Pharmaceutical;
  • Contain an expression of gratitude by individual in connection with use of a pharmaceutical;
  • Imply that a pharmaceutical offers advantages by reference to its assessment in the course of mandatory state registration of pharmaceuticals;
  • Assert or assume that prospective consumers of that pharmaceutical have certain diseases or health disorders;
  • Create an impression that healthy persons should use the pharmaceutical;
  • Create the impression that there is no need to visit a medical doctor;
  • Guarantee a positive effect of a pharmaceutical, its safety, efficacy, and lack of side effects;
  • Present a pharmaceutical as a biologically-active supplement and food supplement or other product as not being a pharmaceutical; and
  • Assert that the safety and/or efficacy of a pharmaceutical are guaranteed by its natural origin.

Advertising of a pharmaceutical shall be accompanied by a warning on contra-indications for its use and on the necessity to become familiar with instructions on use or to seek the advice of specialists.