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Association of Clinical Trials Organizations (ACTO)
non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.

Home Page  >  Regulatory Documents: Russian  >  Federal Law on Medical Products No.86-FZ


June 22, 1998 

No. 86-FZ


RUSSIAN FEDERATION

FEDERAL LAW

ON MEDICINAL PRODUCTS

Adopted
by State Duma
June 5, 1998

Approved of
by the Federation Council
June 10, 1998

(as amended by Federal Laws
of January 02, 2000, No. 5-FZ; of December 30, 2001, No. 196-FZ;
of January 10, 2003, No. 15-FZ; of June 30, 2003, No. 86-FZ;
of August 22, 2004, No. 122-FZ (rev. 29.12.2004);
of October 16, 2006, No. 160-FZ; of December 18, 2006, No. 231-FZ;
of December 30, 2008, No. 309-FZ)

The present Federal Law puts in place a legal framework for the activities of subjects of medicinal products circulation, establishes a system of public authorities to issue statutory and regulatory acts, to provide control and supervision, public services, law enforcement hereunder, and allocates responsibilities to executive authorities in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Chapter I. GENERAL PROVISIONS

Article 1. Subject of Regulation of the present Federal Law
1. The present Federal Law regulates relations arising in connection with development, production, manufacture, non-clinical and clinical trials of medicinal products, control of their quality, efficacy, safety, trading in and other activities in the area of medicinal products circulation.
2. The present Federal Law establishes the priority of state control of production, manufacture, quality, efficacy, and safety of medicinal products.

Article 2. Scope of Application of the Present Federal Law
The present Federal Law applies to relations arising in the area of medicinal products circulation within the territory of the Russian Federation unless otherwise is provided for by the legislation of the Russian Federation.

Article 3. Legislation of the Russian Federation on Medicinal Products
1. The legislation of the Russian Federation on medicinal products comprises the present Federal Law, other federal laws and other statutory and regulatory acts of the Russian Federation, as well as laws and other statutory and regulatory acts of the Russian Federation constituent entities.
2. The specifics of commerce in narcotic medicinal products and psychotropic substances are regulated by the federal laws.
3. If an international treaty of the Russian Federation establishes other rules than those provided for herein, the rules of the international treaty shall be applied.

Article 4. Basic Concepts Used in the Present Federal Law
For the purposes hereof, the following basic concepts are used:
medicinal products are substances used for prophylaxis, diagnostics, treatment of illness, prevention of pregnancy as may be made of blood, blood plasma, as well as from human or animal organs or tissues, plants, minerals, by synthesis methods or using biological technologies. The medicinal products also include such substances of vegetative, animal or synthetic origin that have pharmacological action and are meant for the manufacture and manufacture of medicinal products (pharmaceutical substances);
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
medicinal preparations are dosed ready-to-use medicinal products;
immunobiological medicinal products are medicinal products meant for immunological prophylaxis and immunological therapy;
narcotic medicinal products are medicinal products included in the narcotic medicinal products list generated and updated in accordance with the 1961 Single Convention on Narcotic Medicinal Products and the legislation of the Russian Federation;
psychotropic substances are substances incorporated in the list generated and updated in accordance with the 1971 Convention on Psychotropic Substances and the legislation of the Russian Federation;
patented medicinal products are medicinal products the right to the production and distribution whereof is protected by civil legislation;
(as amended by Federal Law of December 18, 2006, No. 231-FZ)
illegal copies of medicinal products are medicinal products commercialized in violation of civil legislation;
(as amended by Federal Law of December 18, 2006, No. 231-FZ)
innovator medicinal products are medicinal products commercialized under proprietary names;
generic medicinal products are medicinal products commercialized after the end of the term of exclusive patent rights to innovator medicinal products;
medicinal products quality is the conformance of medicinal products to the national standard for the quality of medicinal products;
safety of medicinal products is the characteristic of medicinal products based on comparative analysis of their efficacy and assessment of health hazard;
efficacy of medicinal products–is the characteristic of the degree of positive action of the medicinal product as a treatment for an illness;
pharmacopoeial article is the national standard for a medicinal product with a list of specifications and procedures to control the quality of the medicinal product;
national pharmacopoeia is corpus of pharmacopoeial articles;
registration number is the designation assigned to a medicinal product in state registration;
quality certificate of the medicinal product is a document proving conformance of the quality of a medicinal product to the national standard for the quality of medicinal products;
medicinal products circulation is a blanket concept for activities involving development, trials, production, manufacture, storage, packaging, transportation, state registration, standardisation and quality control, sales, labelling, advertising, use of medicinal products, disposal of medicinal products no longer fit for use, or medicinal products with expired shelf life, and other activities in the area of medicinal products circulation;
subjects of medicinal products circulation are individuals and legal entities engaged in medicinal products circulation;
pharmaceutical activities are activities conducted by wholesalers and pharmacy institutions in the area of medicinal products circulation, which include wholesaling and retailing of medicinal products and manufacture of medicinal products;
(as amended by Federal Law of August 22, 2004, No. 122-FZ (rev. 29.12.2004))
manufacturer of a medicinal product is the organization engaged in the manufacture of medicinal products in compliance with the requirements hereof;
(as amended by Federal Law of August 22, 2004, No. 122-FZ (rev. 29.12.2004))
developer of a medicinal product is the organization with patent rights to a medicinal product and proprietary rights to the results of non-clinical trials;
wholesaler of a medicinal product is the organization engaged in wholesaling medicinal products in compliance with the requirements hereof;
(as amended by Federal Law of August 22, 2004, No. 122-FZ (rev. 29.12.2004))
pharmacy institution is the organization engaged in the retailing of medicinal products, manufacture and dispensation of medicinal products in compliance with the requirements hereof; pharmacy institutions include pharmacies, dispensaries of health care facilities, pharmacy outlets, pharmacy shops, and pharmacy booths;
counterfeit medicinal product is a medicinal product supplied with false information on the makeup and/or manufacturer of a medicinal product;
(Paragraph introduced by Federal Law of August 22, 2004, No. 122-FZ)
substandard medicinal product is a medicinal product no longer fit for use and/or medicinal product with expired shelf life.
(Paragraph introduced by Federal Law of August 22, 2004, No. 122-FZ)

Chapter II. PUBLIC REGULATION OF RELATIONSHIPS
CREATED IN THE AREA OF MEDICINAL PRODUCTS CIRCULATION

Article 5. State Regulation of Relations Arising in the Area of Medicinal Products Circulation
1. State regulation of relationships created in the area of medicinal products circulation is effected through:
1) state registration of medicinal products;
2) licensing of certain types of activities in the area of medicinal products circulation;
(as amended by Federal Law of January 10, 2003, No. 15-FZ)
3) rating and certification of personnel employed in the area of medicinal products circulation;
4) state control of production, manufacture, quality, efficacy, and safety of medicinal products;
5) state regulation of prices for medicinal products.
(par. 5 introduced by Federal Law of January 02, 2000, No. 5-FZ)
2. State regulation of relations arising in the area of medicinal products circulation is effected by the federal authority whose responsibilities include the functions of developing state policy and providing statutory regulation in the area of medicinal products circulation, the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation, the federal authority performing the functions of providing state services, managing state property, and law enforcement functions other than the functions of control and supervision, in the area of medicinal products circulation, and executive authorities of the Russian Federation constituent entities.
(par. 2 as amended by Federal Law of August 22, 2004, No. 122-FZ)

Article 6. Powers of the Government of the Russian Federation in the Area of Medicinal Products Circulation
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
The Government of the Russian Federation:
1) arranges for a uniform state policy to be implemented in the Russian Federation applicable to the supply of the Russian Federation population with medicinal products;
2) approves the rate and procedure of payment for state registration of medicinal products;
3) establishes the procedure for import and export of medicinal products registered in the Russian Federation.

Article 7. Powers of Executive Authorities of the Russian Federation constituent entities in the Area of Medicinal Products Circulation
The executive authorities of the Russian Federation constituent entities in the area of medicinal products circulation develop and implement regional programmes of supply the population of the Russian Federation constituent entities with medicinal products.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
1) - 3) are no longer in force. - Federal Law of August 22, 2004, No. 122-FZ.

Chapter III. STATE SYSTEM FOR QUALITY, EFFICACY AND SAFETY CONTROL OF MEDICINAL PRODUCTS

Article 8. State System for Quality, Efficacy and Safety Control of Medicinal Products
1. All medicinal products manufactured in, or brought into, the Russian Federation are subject to state control.
2. The procedure for the implementation of state control of medicinal products quality, efficacy and safety is established by the present Federal Law and regulatory legal acts of the Russian Federation, including regulatory legal acts of the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3. The system for quality, efficacy and safety control of medicinal products control comprises:
1) federal executive authorities whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2) federal executive authorities whose responsibilities include providing state control and supervision in the area of medicinal products circulation, and its regional bodies;
(par. 2 as amended by Federal Law of August 22, 2004, No. 122-FZ)
3) federal executive authorities performing the functions of providing public services, managing public property, and law enforcement functions other than the functions of control and supervision in the area of medicinal products circulation;
(par. 3 as amended by Federal Law of August 22, 2004, No. 122-FZ)
4) is no longer in force. - Federal Law of August 22, 2004, No. 122-FZ;
5) the information system to supply subjects of medicinal products circulation with information required.

Articles 9 - 12. No longer in force. - Federal Law of August 22, 2004, No. 122-FZ.

Chapter IV. PRODUCTION AND MANUFACTURE OF MEDICINAL PRODUCTS

Article 13. Production of Medicinal Products

1. Production of medicinal products is a mass production of medicinal products in compliance with the rules for the organization of production and quality control of medicinal products, as approved by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. Production of medicinal products is performed by manufacturers of medicinal products with licences to produce medicinal products.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3. It is forbidden to produce medicinal products:
1) without state registration in the Russian Federation, except for medicinal products to be used in clinical trials;
2) without a licence to produce medicinal products;
3) in violation of the rules for the organization of production and quality control of medicinal products, as approved by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
4. Production and sale of patented medicinal products are performed in accordance with civil legislation.
(as amended by Federal Law of December 18, 2006, No. 231-FZ)

Article 14. State Control of Production of Medicinal Products

1. State control of production of medicinal products within the Russian Federation is performed by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation, and its regional bodies.
(par. 1 as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. No longer in force. - Federal Law of August 22, 2004, No. 122-FZ.
3. The federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation conducts audits of manufacturers of medicinal products and produces reports on the conformance of medicinal product manufacturing process management and quality control to the rules for medicinal product manufacturing process management and quality control.
(par. 3 as amended by Federal Law of August 22, 2004, No. 122-FZ)
4. On behalf of the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation, its regional bodies conduct on a regular basis audits of manufacturer of a medicinal products based in the Russian Federation constituent entities involved.
(par. 4 as amended by Federal Law of August 22, 2004, No. 122-FZ)
5. The federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation, and its regional bodies are entitled to:
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
1) have unrestricted access to any manufacturer of a medicinal product and remove samples of medicinal products manufactured;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2) make copies of such documents as may be necessary for auditing the manufacturing and quality of medicinal products;
3) forbid produce of medicinal products and sale of medicinal products already produced in the circumstances an exhaustive list of which is provided in the rules for medicinal product manufacturing process management and quality control.

Article 15. Licensing of Production of Medicinal Products

(as amended by Federal Law of January 10, 2003, No. 15-FZ)

1. A licence to produce medicinal products is issued to a manufacturer of a medicinal product by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation.
(par. 1 as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. A licence to produce medicinal products is issued upon an application of the manufacturer of a medicinal product containing a list of the medicinal products that the manufacturer of a medicinal product can manufacture.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3. To procure a licence, the licence applicant files with the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation the following documents:
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
description of key manufacturing processes that ensure medicinal product quality;
consent of local authorities to the sitting of facilities to produce medicinal products within the territory involved;
duly certified copies of the Russian Federation patents or licensing contracts authorizing production and sale of patented medicinal products.
4. A licence to produce medicinal products is issued for a term of not less than five years.
(par. 4 introduced by Federal Law of August 22, 2004, No. 122-FZ)

Article 16. Marking and Labelling of Medicinal Products

1. Marking and labelling of medicinal products must be consistent with the requirements hereof.
2. Medicinal products may be commercialized if the inner and outer packaging specify in the Russian language, using easily readable font:
1) [trade] name of medicinal product and international non-proprietary name;
2) name of the manufacturer of a medicinal product;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3) lot number and date of production;
4) route of administration;
5) dose per unit and number of units in package;
6) expiry date;
7) dispensation terms;
8) storage conditions;
9) precautions against misuse of medicinal product.
3. All medicinal products made of blood, blood plasma, as well as human organs or tissues should bear inscription: "No HIV antibodies".
Sera are commercialized specifying what animal's blood, blood plasma, organs or tissues are used to produce them; vaccines are commercialized specifying the culture medium used for reproduction of viruses and bacteria.
4. Medicinal products registered as homoeopathic medicinal products should bear inscription: "Homoeopathic".
5. Medicinal products meant for treatment of animals should bear inscription: "For animals".
6. Medicinal products made from vegetable stock should bear inscription: "Product passed radiation safety test".
7. Medicinal products for clinical trials should bear inscription: "For clinical trials".
8. Medicinal products meant solely for export should bear inscription: "For export only ".
9. Circulation of medicinal products may only be effectuated with administration instructions featuring the following information in the Russian language:
1) name and registered address of manufacturer of a medicinal product;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2) [trade] name of medicinal product and international non-proprietary name;
3) information on ingredients;
4) scope of application;
5) contraindications;
6) side effects;
7) interaction with other medicinal products;
8) dosage and route of administration;
9) expiry date;
10) caution against using the medicinal product past the expiry date;
11) caution against keeping the medicinal product within reach of children;
12) dispensation terms.
10. Introduction of details not covered by Paragraphs 2 - 8 of this Article, as well as authorized abbreviations in the marking of medicinal products are established by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Article 17. Manufacture of Medicinal Products

1. Manufacture of medicinal products by a pharmacy institution is performed based on the prescriptions of physicians using medicinal products registered in the Russian Federation.
2. Manufacture of medicinal products is performed by a pharmacy institution with a pharmaceutical licence, according to the rules for the manufacture of medicinal products, as approved by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3. The marking and labelling of medicinal products prepared by a pharmacy institution must be consistent with the said rules.
4. Deleted. - Federal Law of January 10, 2003, No. 15-FZ.

Article 18. Liability for Failure to Comply with the Rules for Medicinal Product Manufacturing Process Management and Quality Control and the Rules for Manufacture of Medicinal Products

1. The manufacturer of a medicinal product shall be liable for failure to comply with the rules for medicinal products manufacturing process management and quality control.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. The pharmacy institution shall be liable for failure to comply with rules for the manufacturing of medicinal products, as well as for the processing, packaging and quality of medicinal products manufactured by the pharmacy institution
3. Individuals responsible for medicinal products manufacture and quality are subject to disciplinary, administrative and criminal sanctions for breach of the provisions hereof.
(as amended by Federal Law of January 10, 2003, No. 15-FZ)

Chapter V. STATE REGISTRATION OF MEDICINAL PRODUCTS

Article 19. State Registration of Medicinal Products

1. Medicinal products may be produced, sold and used within the Russian Federation if they are registered by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
State registration of such narcotic medicinal products and psychotropic substances as are used in medicine as medicinal products and are subject to state control under the Federal Law On Narcotic Medicinal Products and Psychotropic Substances involves the inclusion of the said medicinal products and substances in relevant lists in the manner stipulated by the Federal Law On Narcotic Medicinal Products and Psychotropic Substances.
Medicinal products meant for the treatment of animals are also subject to state registration by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. State registration is required for:
1) new medicinal products;
2) new combinations of medicinal products registered earlier;
3) medicinal products registered earlier, but produced in other pharmaceutical forms, with new dosage or a different mix of excipients;
4) generic medicinal products.
3. No state registration is required for medicinal products prepared at pharmacies based on physicians' prescriptions.
4. It is allowed to use unregistered medicinal products in clinical trials of medicinal products or testing of medicinal products meant for the treatment of animals.
5. It is forbidden to perform state registration of different medicinal products under an identical name, or multiple state registration of one and the same medicinal product under a single or different names.
6. State registration of medicinal product is performed by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation within six months after the filing of application for state registration of medicinal product.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
The federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation establishes such degree of change in the dosage and excipient mix of the medicinal product registered as necessitates state registration thereof as a medicinal product under a different name.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
7. Application for state registration of medicinal product is to be filed with the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation by an applicant such as the developer of a medicinal product or another legal entity on behalf of the developer of a medicinal product.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
8. The medicinal product registered is entered into the state register of medicinal products.
9. State registration of medicinal product requires the applicant to file with the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation the following documents:
(as amended by Federal Law of August 22, 2004, No. 122-FZ (rev. 29.12.2004))
1) application for state registration of medicinal product;
2) receipt for payment made for state registration of medicinal product;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3) registered address of the manufacturer of a medicinal product;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
4) names of medicinal product, including international non-proprietary name, generic name in Latin, and main synonyms;
5) trade name of medicinal product if registered as a trademark pursuant to the Russian Federation legislation on trademarks, service marks and names of products' places of origin;
6) list of medicinal product ingredients and their quantity;
7) medicinal product administration instructions produced in compliance with the requirements hereof;
8) medicinal product quality certificate;
9) details of medicinal product production and original text of pharmacopoeial article;
10) medicinal product quality control methods;
11) results of non-clinical trials of medicinal product;
12) results of pharmacological and toxicological trials of medicinal product;
13) results of clinical trials of medicinal product;
14) results of veterinary trials for registration of a medicinal product meant for the treatment of animals;
15) samples of medicinal product to enable expert assessment of its quality;
16) suggested price of medicinal product;
(par. 16 introduced by Federal Law of January 02, 2000, No. 5-FZ)
17) documents to prove registration of medicinal product if registered outside the Russian Federation.
(as amended by the Federal Law of 02.01.2000, No. 5-FZ)
10. The federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation may use a fast-track procedure for the state registration of medicinal products. Regulation on a fast-track procedure for the state registration of medicinal products is developed and published by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation. Fast-track procedure for the state registration of medicinal products does not mean downgrading of requirements for the quality, efficacy and safety of medicinal products.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
11. Fast-track procedure for the state registration of medicinal products may be used for the registration of a generic medicinal product equivalent to a branded medicinal product already registered in the Russian Federation and possibly produced using another process or another mix of excipients.

Chapter VI. IMPORT OF MEDICINAL PRODUCTS INTO THE RUSSIAN FEDERATION. EXPORT OF MEDICINAL PRODUCTS FROM THE RUSSIAN FEDERATION

Article 20. Procedure for Import of Medicinal Products into the Russian Federation

1. Import of medicinal products registered in the Russian Federation into the Russian Federation is performed in the manner established by the Government of the Russian Federation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2 - 4. No longer in force. - Federal Law of August 22, 2004, No. 122-FZ.
5. The medicinal products exported must be registered in the Russian Federation.
6. It is allowed to import into the Russian Federation a specific consignment of unregistered medicinal products to be used in clinical trials of medicinal products if authorized by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
7. The quality of medicinal products imported into the Russian Federation must be proved with the certificate of the manufacturer of a medicinal product representing that the exported medicinal products are produced in compliance with the national medicinal product-quality standard established by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
8. For the purposes of protecting the market and manufacturers of medicinal products within the Russian Federation, the Government of the Russian Federation may introduce special types of customs duties on the finished medicinal products imported pursuant to the customs legislation of the Russian Federation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
9. It is forbidden to import into the Russian Federation medicinal products that are imitations or illegal copies of medicinal products registered in the Russian Federation, or counterfeit medicinal products. Upon discovery of such medicinal products, the customs authorities of the Russian Federation confiscate them, with subsequent destruction thereof in the manner established by the federal authoring whose responsibilities include the functions of developing state policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Article 21. Legal Entities Authorized to Import Medicinal Products into the Russian Federation

Medicinal products may be imported into the Russian Federation by:
1) manufacturers of medicinal products for the purposes of own manufacture of medicinal products;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2) wholesalers of medicinal products;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3) research centres, institutes and laboratories for the development, trialling and control of quality, efficacy and safety of medicinal products subject to a permit from the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation to import a specific consignment of medicinal products;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
4) foreign manufacturers of medicinal products and wholesalers of medicinal products provided they have their representations within the Russian Federation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Article 22. Import of Medicinal Products into the Russian Federation for Personal use and Other Non-Commercial Purposes

1. Medicinal products may be brought into the Russian Federation without proper paperwork if intended for:
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
1) personal use by individuals arriving in the Russian Federation;
2) members of diplomatic corps or representatives of international organisations accredited in the Russian Federation;
3) treatment of passengers of transport facility arriving in the Russian Federation.
2. Medicinal products meant for the treatment of individual animals in zoos may be brought into the Russian Federation without proper paperwork.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3. In the circumstances provided for in Paragraphs 1 and 2 of this Article, it is allowed to import into the Russian Federation medicinal products that are not registered in the Russian Federation.
4. Medicinal products meant for humanitarian purposes are imported into the Russian Federation in the manner established by the Government of the Russian Federation.
It is forbidden to import into the Russian Federation unregistered medicinal products for humanitarian purposes.

Article 23. No longer in force. - Federal Law of August 22, 2004, No. 122-FZ.

Article 24. Documents to be Filed with Customs Authorities of the Russian Federation When Importing Medicinal Products into the Russian Federation

When medicinal products are being imported into the Russian Federation, the customs authorities of the Russian Federation must be given the following documents and details:
1) contracts or other documents containing information on the medicinal products being imported and the terms of their acquisition;
2) quality certificates for medicinal products;
3) details of state registration for each of the medicinal products being imported, with relevant registration numbers specified;
4) details of the shipper of medicinal products;
5) details of the consignee of medicinal products in the Russian Federation;
6) details of the individual carrying the medicinal products;
7) permit from the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation to import a specific consignment of medicinal products in the circumstances provided for in Article 20 hereof.
(par. 7 as amended by Federal Law of August 22, 2004, No. 122-FZ)

Article 25. Individuals and Legal Entities Authorized to Export Medicinal Products from the Russian Federation

1. Medicinal products may be exported from the Russian Federation by manufacturer of a medicinal products and medicinal product wholesalers.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. Individuals may take medicinal products out in quantities necessary for personal use in the manner established by the customs legislation of the Russian Federation.

Article 26. No longer in force. - Federal Law of August 22, 2004, No. 122-FZ.

Article 27. Coordination between customs authorities of the Russian Federation and the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

1. The federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation makes available to the customs authorities of the Russian Federation a list of medicinal products registered in the Russian Federation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. Customs authorities of the Russian Federation notify the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation of import of medicinal products into the Russian Federation and export of medicinal products from the Russian Federation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Chapter VII. WHOLESALING OF MEDICINAL PRODUCTS

Article 28. Sale of Medicinal Products by Manufacturers of Medicinal Products
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Manufacturer of medicinal products may sell or make medicinal products available for disposal to:
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
1) other manufacturer of medicinal products for the purposes of manufacture;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2) wholesalers of medicinal products;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3) pharmacy institutions;
4) research centres for research.

Article 29. Sale of Medicinal Products by Wholesalers of Medicinal Products
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Wholesalers of Medicinal Products may sell or make medicinal products available for disposal to:
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
1) other wholesalers of Medicinal Products;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2) manufacturer of a medicinal products for the purposes of manufacture;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3) pharmacy institutions;
4) research centres for research;
5) sole traders licensed to engage in medical activities.
(par. 5 as amended by Federal Law of January 10, 2003, No. 15-FZ)

Article 30. Deleted. - Federal Law of January 10, 2003, No. 15-FZ.

Article 31. Ban on Sale of Medicinal Products of Substandard Quality or Illegal Copies of Medicinal Products Registered in the Russian Federation

1. It is forbidden to sell medicinal products that are no longer fit for use, medicinal products with expired shelf life, or counterfeit medicinal products.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. Medicinal products that are no longer fit for use, medicinal products with expired shelf life and counterfeit medicinal products must be destroyed.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3. Procedure for the destruction of medicinal products no longer fit for use, medicinal products with expired shelf life, and counterfeit medicinal products is developed, subject to the requirements of human, animal and environmental safety, and approved by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Laws of August 22, 2004, No. 122-FZ, and of December 30, 2008, No. 309-FZ)
4. It is forbidden to sell counterfeit medicinal products or medicinal products that are illegal copies of medicinal products registered in the Russian Federation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Chapter VIII. RETAILING OF MEDICINAL PRODUCTS

Article 32. Arrangements for Retailing of Medicinal Products

1. Retailing of medicinal products is performed by pharmacy institutions. It is permitted to retail only medicinal products registered in the Russian Federation.
2. Prescription medicinal products may only be sold through pharmacies and pharmacy outlets. Over-the-counter medicinal products may also be sold at pharmacy shops and pharmacy booths.
3. The list of over-the-counter medicinal products is reviewed and approved every five years by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation. Addendum to the list is published annually.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
4. The types of pharmacy institutions, the rules and procedure for the dispensation of medicinal products are established and approved by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
5. Resolution to set up a new pharmacy institution is passed by the local authority.
6. Retailing of medicinal products meant for the treatment of animals is performed by a pharmacy, veterinary pharmacy or veterinary surgeon.
7. Pharmacy institutions are obligated to sell medicinal products only as ready-to-use items and in quantities required for the compliance with the physician's prescriptions.
8. Pharmacy institutions are obligated to carry a minimum range of medicinal products necessary for administering medical aid, as established by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
9. Pharmacy institutions are entitled to stock and sell, along with medicinal products, medical accessories, disinfectants, hygiene items, optical goods, natural and man-made mineral water, health food, baby food and invalid food, cosmetics and perfume products.
10. The activities of pharmacy institutions in the Armed Forces of the Russian Federation, other corps and military units, and bodies with statutory military service are regulated by the present Federal Law and by regulations enacted by the competent federal authorities.
(as amended by Federal Law of June 30, 2003, No. 86-FZ)
Enforcement of compliance with the provisions hereof by the said pharmacy institutions is provided by the appropriate ministries and other federal authorities.

Article 33. Pharmaceutical Activities of Individuals as Pharmacy Institutions

Individuals may engage in certain types of pharmaceutical activities provided they have a higher-education degree in pharmaceutics or a mid-level degree in pharmaceutics and a professional certificate.

Article 34. Licensing of Pharmaceutical Activities

(as amended by Federal Law of January 10, 2003, No. 15-FZ)

1. Pharmaceutical activities are subject to licensing pursuant to the legislation of the Russian Federation.
2. The licence issue is contingent upon the licence applicant's filing documents to prove the licence applicant's right to use premises facilities for the purposes of conducting pharmaceutical activities, the personnel engaged in pharmaceutical activities having certificates, and the availability of a sanitary and epidemiological inspection report saying that the premises meet the requirements of sanitary rules.

Chapter IX. DEVELOPMENT, NON-CLINICAL AND CLINICAL TRIALS OF MEDICINAL PRODUCTS

Article 35. Development of New Medicinal Products

1. Development of new medicinal products involves the search for new medicinal product substances, subsequent investigation of their medicinal properties, as well as non-clinical trials.
2. Financing of the development of new medicinal products is provided using:
1) federal funds;
2) funds of developers of medicinal products;
3) funds of manufacturer of a medicinal products within the framework of R&D projects implemented under a contract between the developer of medicinal products and the manufacturer of a medicinal product;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
4) other funding sources, including the funds of charities and dedicated contributions of individuals and legal entities.
3. The rights of the developer of new medicinal are protected by civil legislation.
(as amended by Federal Law of December 18, 2006, No. 231-FZ)

Article 36. Non-Clinical Trials of Medicinal Products

1. The objective of non-clinical trials of medicinal products is to obtain, using scientific methods, estimates and conclusive evidence of the efficacy and safety of medicinal products.
2. Non-clinical trials of medicinal products are conducted by medicinal product developers in adherence to the good laboratory practices approved by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3. Non-clinical trials of medicinal products are conducted as per approved plan, with record-keeping and generation of a report to present the results of non-clinical trials of medicinal products. The medicinal product developer issues an opinion as to whether it may be possible to proceed to clinical trials of medicinal products.
4. Non-clinical trials of medicinal products on animals are conducted in accordance with international rules. Enforcement of compliance with legal and ethical standards for the use of animals in non-clinical trials of medicinal products is provided by the federal authority whose responsibilities include the functions of developing public policy and providing statutory regulation in the area of medicinal products circulation and its regional bodies, respectively.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Article 37. Resolution to Conduct Clinical Trials of Medicinal Products

1. The objective of clinical trials of medicinal products is to obtain, using scientific methods, estimates and conclusive evidence of the efficacy and safety of medicinal products, information on anticipated side effects of medicinal products and interaction with other medicinal products.
2. Resolution to conduct clinical trials of a given medicinal product is passed by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation based on the following documents:
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
1) application from the medicinal product developer;
2) positive finding by the ethics committee of the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3) report and opinion on the non-clinical trials of medicinal product;
4) instructions on the administration of medicinal product.
3. Clinical trials of medicinal products are conducted by medical facilities accredited by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation.
(as amended by Federal Laws of January 10, 2003, No. 15-FZ, and of August 22, 2004, No. 122-FZ)
4. Deleted. - Federal Law of January 10, 2003, No. 15-FZ.
4. List of medical facilities certified to conduct clinical trials of medicinal products is generated and published by the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Article 38. Legal Framework for Clinical Trials of Medicinal Products and Financing of Clinical Trials of Medicinal Products

1. The legal framework for clinical trials of medicinal product is provided by following documents:
1) resolution of the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation to conduct clinical trials of medicinal product;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2) contract to conduct clinical trials of medicinal product.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. The contract to conduct clinical trials of medicinal product shall specify:
1) timescale and scope of clinical trials of medicinal product;
2) total cost of the programme of clinical trials of medicinal product;
3) format of the results of clinical trials of medicinal product to be filed with the federal authority whose responsibilities include providing state control and supervision in the area of medicinal products circulation;
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
4) terms of health insurance for the patients involved in clinical trials of medicinal product;
5) terms of public liability insurance for individuals conducting clinical trials of medicinal product.
(par. 5 introduced by Federal Law of August 22, 2004, No. 122-FZ)
3. Financing of clinical trials of medicinal product is provided using:
1) federal funds;
2) funds of the developer of medicinal products in accordance with the terms of the contract to conduct clinical trials of medicinal product;
3) other sources.
4 - 5. No longer in force. - Federal Law of August 22, 2004, No. 122-FZ.

Article 39. Clinical Trials of Medicinal Products

1. The head of the medical facility conducting clinical trials of medicinal product approves a programme of clinical trials of medicinal product and appoints its manager. The manager appointed for the programme of such trials must be a physician with at least two years of experience on programmes of clinical trials of medicinal products. The programme of clinical trials of medicinal product is developed with the involvement of the ethics committee of the medical facility conducting clinical trials of medicinal product.
2. The manager of the programme of clinical trials of medicinal product must be briefed on the results of the non-clinical trials of the medicinal product and is entitled to receive any additional information bearing upon the non-clinical trials of the said medicinal product.
3. The manager of the programme of clinical trials of medicinal product selects the patients who may be involved in the clinical trials of the medicinal product based on medical indications.
4. A report on the clinical trials of medicinal product is produced by the manager of the programme of clinical trials of medicinal product.
5. Clinical trials of medicinal product may be suspended if proving a danger to the patients' health while in progress. The decision to terminate clinical trials of medicinal product may be taken by the manager of the programme of the said trials.
6. Failure to comply with good clinical practices, as well as falsification of the results of clinical trials of medicinal products are subject to responsibility under the laws of the Russian Federation.

Article 40. Rights of Patients Involved in Clinical Trials of Medicinal Products

1. Participation of patients in clinical trials of medicinal products is voluntarily.
2. The patient gives his consent in writing to participate in clinical trials of medicinal product.
3. The patient must be informed of:
1) medicinal product and the nature of clinical trials of the medicinal product;
2) anticipated efficacy and safety of medicinal product, and the degree of risk for the patient;
3) patient's action in the event of unforeseen effects of the medicinal product on his health;
4) terms of health insurance for the patient.
4. The patient may withdraw from the clinical trials of medicinal product at any stage thereof.
5. It is forbidden to conduct clinical trials of medicinal products on minors, except where the medicinal product under trial is meant exclusively for the treatment of childhood diseases or where the objective of clinical trials is to obtain data on the best dosage of medicinal product for the treatment of minors. In the latter case, clinical trials of medicinal product on minors must be preceded by clinical trials thereof on adults.
6. When clinical trials of medicinal products are to be conducted on minors, consent in writing must be secured from their parents.
7. It is forbidden to conduct clinical trials of medicinal products on:
1) minors without parents;
2) pregnant women, except for clinical trials conducted on medicinal products for pregnant women where the information sought may only be obtained in clinical trials of medicinal products on pregnant women provided that there is absolutely no risk of harm being caused to the pregnant woman and the foetus;
3) military personnel;
4) individuals serving sentences at places of confinement, or on individuals in custody at detention facilities.
8. It is allowed to conduct clinical trials of medicinal products designed for the treatment of mental disorders on individuals with mental disorders certified in the manner provided for in the Law of the Russian Federation On Psychiatric Care and Guarantees of the Rights of the Citizens Provided Therewith. Clinical trials of medicinal products in this case are conducted subject to consent in writing having been given by legal representatives of the said individuals.
9. A health insurance contract for the patient involved in clinical trials of medicinal product is made between the medicinal product developer and a medical insurer.

Article 41. Obligation of Subjects of Medicinal Products Circulation to Report Side Effects and Specifics of Interaction between the Medicinal Products and other Medicinal Products

1. Subjects of medicinal products circulation must report to the federal authority whose responsibilities include providing state control and supervision in the area of national health service, and its regional bodies all instances of side effects of medicinal products and patterns of medicinal product interaction with other medicinal products at variance with the information on the medicinal products in the instructions on the administration thereof.
(par. 1 as amended by Federal Law of August 22, 2004, No. 122-FZ)
2. For failure to disclose or concealment of details specified in Section 1 of this Article, the individuals to have become aware thereof in the line of their professional activities are subject to disciplinary, administrative or criminal sanctions under the laws of the Russian Federation.

Chapter X. STATE GUARANTEES OF AFFORDABILITY OF MEDICINAL PRODUCTS

No longer in force. - Federal Law of August 22, 2004, No. 122-FZ.

Chapter XI. INFORMATION ON MEDICINAL PRODUCTS
(as amended by Federal Law of October 16, 2006, No. 160-FZ)

Article 43. Information on Medicinal Products

1. Information on medicinal products is provided in compliance with the requirements of national information standard.
2. Information on over-the-counter drugs may be featured in publications and announcements of mass media, specialist and general printed matter, instructions on the administration of medicinal products and other publications of subjects of medicinal products circulation.
3. Information on prescription medicinal products may only be featured in specialist publications targeting medical and pharmaceutical professionals. Information on medicinal products for medicinal products circulation professionals may be presented in the form of treatises, reference books, research papers, reports at congresses, conferences, symposia, academic board meetings, as well as instructions on the administration of medicinal products meant for physicians.
4. It is allowed to use any such physical storage media for information on medicinal products as enable storage, transfer and use of information without corruption.

Article 44. No longer in force. - Federal Law of October 16, 2006, No. 160-FZ.

Chapter XII. LIABILITY FOR HARM TO HUMAN HEALTH CAUSED BY ADMINISTRATION OF MEDICINAL PRODUCTS

Article 45. Indemnification for Harm Caused to Human Health as a Result of Administration of Medicinal Products

1. Indemnification for harm caused to human health as a result of administration of medicinal products and illegal action by subjects of medicinal products circulation is provided in accordance with the Framework Legislation of the Russian Federation on Health Care for the Citizens.
2. If administration of medicinal product results in damage to human health, then the manufacturer of the medicinal product shall indemnify the injured party provided it is proved that:
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
1) the medicinal product was used for its intended purpose in accordance with the instructions on the administration of medicinal product and the adverse effect of the medicinal product is due to medicinal product manufacturing errors;
2) the damage to health is caused by the administration of medicinal product through misleading instructions on the administration of medicinal product issued by the manufacturer of a medicinal product.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)
3. If the damage to health is caused by the administration of a medicinal product no longer fit for use a result of breach of the rules for wholesaling of medicinal products or the rules for pharmaceutical activities of pharmacy institutions, then the indemnification is provided by the medicinal product wholesaler or the pharmacy institution responsible for releasing the medicinal product for distribution, or for the dispensation thereof.
(as amended by Federal Law of August 22, 2004, No. 122-FZ)

Chapter XIII. FINAL PROVISIONS

Article 46. Harmonization of Regulatory Legal Acts with the present Federal Law

Suggest to the President of the Russian Federation and instruct the Government of the Russian Federation that they bring their regulatory legal acts in line herewith.

Article 47. Coming into Force of the Present Federal Law

The present Federal Law comes into force three months after the date of its official publication.

President
of the Russian Federation
B. YELTSIN
Moscow, Kremlin
June 22, 1998
N 86-FZ



 
   
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