About Medicines

Original Language Title: О лекарственных средствах

Read the untranslated law here: http://pravo.gov.ru/proxy/ips/?doc_itself=&infostr=x&backlink=1&fulltext=1&nd=102053738

Expired-the Federal law from 12.04.2010 N 61-FZ of the RUSSIAN FEDERATION FEDERAL LAW on medicinal products adopted by the State Duma on June 5, 1998 the year approved by the Federation Council of the year June 10, 1998 (as amended by the federal laws of 02.01.2000 N 5-FZ;
from out N 196-FZ; from 01/10/2003 N 15-FL;
30.06.2003 N 86-FZ; from 22/08/2004, no. 122-FZ;
from 16.10.2006 N 160-FZ; from 18.12.2006 y. N 231-FZ;
from 30.12.2008 N 309-FZ) this federal law creates a legal basis for the activity of subjects of circulation of medicines, establishes a system of State bodies involved in the publication of normative legal acts, the acts of the supervisory and monitoring the provision of public services, law enforcement practices in accordance with this federal law, allocates powers of executive power in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ) Chapter i. General provisions article 1. Subject of this federal law 1. This federal law regulates relations arising in connection with the development, production, manufacturing, preclinical and clinical studies of drugs, quality control, efficiency, security, drug trafficking and other actions in the sphere of circulation of medicines.
2. this federal law supersede State control the production, manufacture, quality, effectiveness, and safety of medicines.
Article 2. The scope of this federal law this federal law applies to relations arising in the sphere of circulation of medicines in the territory of the Russian Federation, if the legislation of the Russian Federation provides otherwise.
Article 3. The legislation of the Russian Federation on medicinal products 1. The legislation of the Russian Federation on medicinal products consists of this federal law and other federal laws and other regulatory legal acts of the Russian Federation, as well as the laws and other normative legal acts of the constituent entities of the Russian Federation.
2. features of treatment of narcotic drugs and psychotropic substances are governed by federal laws.
3. If an international treaty of the Russian Federation stipulates other rules than those stipulated by this federal law, the rules of the international treaty shall apply.
Article 4. The basic concepts used in the present Federal law for the purposes of this federal law uses the following concepts: medicines-substances used to prevent, diagnose, treat, cure disease, prevent pregnancy derived from blood, blood plasma, as well as organs, tissues, human or animal, plants, minerals, methods of synthesis and biological technologies. To medicines also include substances of vegetable, animal or synthetic origin which possess pharmacological activity and designed for the production and manufacture of drugs (pharmaceuticals); (As amended by federal law from 22/08/2004, no. 122-FZ) medications-metered-dose medicines, ready to use;
immunobiological medications-medications designed for immunologic prevention and immunologic therapy;
Narcotic medicines-medicines included in the list of narcotic drugs, compiled and updated in accordance with the single Convention on Narcotic Drugs of 1961 year and legislation of the Russian Federation;
psychotropic substances-substances included in a list drawn up and updated in accordance with the Convention on psychotropic substances of 1971 year and legislation of the Russian Federation;
patented medicines-medicines, the right to manufacture and sell which is protected by civil law; (As amended by federal law from 18.12.2006 y. N 231-FZ) illegal copies of medicines-medicines received treatment a violation of civil law; (As amended by federal law from 18.12.2006 y. N 231-FZ) of original medicines-medicines received treatment with registered own names;
reproduced medicines-medicines, received treatment after the expiry of the exclusive patent rights on the original medicines;
the quality of medicines-medicines compliance State standard for the quality of medicines;
the safety of medicines-drugs, feature based on a comparative analysis of their effectiveness and assessment of risk of injury to health;
the effectiveness of drugs characteristic degree of positive impact of drugs on the disease;

Pharmacopoeial article-State standard the medicinal product, containing the list of indicators and methods of quality control of medicinal products;
State Pharmacopoeia-collection of Officinal articles;
registration number-code to be assigned to medicinal means when State registration;
medicinal product quality certificate-a document certifying the conformity of the quality of medicinal products the State standard for the quality of medicines;
treatment of drugs-a generalized notion of activities, including development, research, production, manufacture, storage, packaging, transportation, State registration, standardization and quality control, sale, labelling, advertising, use of drugs, destruction of drugs, degraded, or medicines expired and other actions in the sphere of circulation of medicines;
actors handling medicinal products-natural and legal persons carrying out treatment medicines;
pharmaceutical activities-activities undertaken by organizations of wholesale and pharmacy institutions in the sphere of circulation of medicines, including wholesale and retail trade in drugs, the manufacture of medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) Organization-manufacturer of medicines-the governing production of medicines in accordance with the requirements of this federal law; (As amended by federal law from 22/08/2004, no. 122-FZ), developer of the drug organization, which has patent rights on medicines and copyrights on the results of its pre-clinical research;
the Organization of wholesale trade in medicinal products-organization conducting wholesale trade in medicinal products in accordance with the requirements of this federal law; (As amended by federal law from 22/08/2004, no. 122-FZ) laboratory establishment-organization conducting drug retailing, manufacturing and leave medicines in accordance with the requirements of this federal law; the pharmacy institutions include pharmacies, drugstores, health institutions, pharmaceutical items, pharmaceutical stores, chemist's kiosks;
falsifyed medicine-medicine, accompanied by false information about the composition and (or) the manufacturer of the medicinal product; (The paragraph is supplemented by federal law from 22/08/2004, no. 122-FZ) defective remedy-remedy, unserviceable, and (or) drug expired. (The paragraph is supplemented by federal law from 22/08/2004, no. 122-FZ), chap. II. State regulation of relations in the sphere of circulation of medicines, Article 5. State regulation of relations in the sphere of circulation of medicines 1. State regulation of relations in the sphere of circulation of medicines carried out through: 1) State registration of medicines;
2) licensing of separate types of activity in the sphere of circulation of medicines; (As amended by the Federal law dated 01/10/2003 N 15-FZ) 3) appraisal and certification of specialists working in the sphere of circulation of medicines;
4) State control the production, manufacture, quality, effectiveness, safety of medicines;
5) State regulation of prices for medicines. (Supplemented by federal law from 02.01.2000 N 5-FZ)
2. State regulation of relations in the sphere of circulation of medicines, is carried out by the federal body of executive power, which includes the functions of State policy and normative-legal regulation in the sphere of circulation of medicines, the Federal Executive authority which is competent to exercise supervision and control in the sphere of circulation of medicines, the federal body of executive power responsible for provision of public services, management of State property and enforcement functions except for the functions of control and supervision in the sphere of circulation of medicines, and the executive authorities of the constituent entities of the Russian Federation. (As amended by federal law from 22/08/2004, no. 122-FZ), Article 6. The authority of the Government of the Russian Federation in the sphere of circulation of medicines, the Government of the Russian Federation: 1) in the Russian Federation provides for a unified State policy in the field of population of the Russian Federation drugs;
2) approves the amount and procedure of implementation of fees for State registration of medicines;
3) determines the order of import and export of medicines registered in the Russian Federation.
(Article in the Editorial Office of the Federal law dated 22/08/2004, no. 122-FZ)

Article 7. The powers of the executive authorities of the constituent entities of the Russian Federation in the sphere of circulation of medicines, the executive bodies of the subjects of the Russian Federation in the sphere of circulation of medicines, developing and implementing regional programmes for the subjects of the Russian Federation providing the population with medicines. (As amended by federal law from 22/08/2004, no. 122-FZ) 1) (repealed-Federal Act of 22/08/2004, no. 122-FZ) 2) (repealed-Federal Act of 22/08/2004, no. 122-FZ) 3) (repealed-Federal Act of 22/08/2004, no. 122-FZ), chap. III. State monitoring system of quality, efficiency, safety of medicines Article 8. State monitoring system of quality, efficiency, safety of medicines 1. State control all drugs produced on the territory of the Russian Federation and imported into the territory of the Russian Federation.
2. the procedure for State control of quality, efficacy, safety of medicines is established by this federal law, regulatory legal acts of the Russian Federation, including the regulations of a federal body of executive power, which is competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
3. The State system of quality control, efficiency, safety of medicines includes: 1), the federal body of executive power, which is competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 2), the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines, and its territorial bodies; (As amended by federal law from 22/08/2004, no. 122-FZ) 3), the federal body of executive power performing functions for the provision of public services, management of State property and enforcement functions, except for the functions of control and supervision in the sphere of circulation of medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 4) (repealed-Federal Act of 22/08/2004, no. 122-FZ) 5) information system, providing actors handling medicinal products.
Article 9. (Repealed-Federal Act of 22/08/2004, no. 122-FZ), Article 10. (Repealed-Federal Act of 22/08/2004, no. 122-FZ), Article 11. (Repealed-Federal Act of 22/08/2004, no. 122-FZ) Article 12. (Repealed-Federal Act of 22/08/2004, no. 122-FZ), chap. IV. Production and manufacture of medicinal products Article 13. Production of drugs 1. Production of medicines-serial receive medicines in accordance with the rules of organization of production and quality control of drugs approved by the federal executive body competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. Production of medicines carried out organizations-manufacturers of medicines that have licenses for the production of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
3. production of medicines is prohibited: 1) have not been registered in the Russian Federation, except in the case of drugs intended for clinical research;
2) without a licence to manufacture pharmaceutical products;
3) with violation of the rules of organization of production and quality control of drugs approved by the federal executive body competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
4. production of patented drugs and their sale is carried out in accordance with the civil legislation. (As amended by federal law from 18.12.2006 y. N 231-FZ) Article 14. State control of production of medicinal products 1. State control of drug production on the territory of the Russian Federation is the Federal Executive authority competent to exercise supervision and control in the sphere of circulation of medicines, and its territorial bodies. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. (repealed-Federal Act of 22/08/2004, no. 122-FZ)

3. federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines, inspects the organizations-manufacturers of medicinal products and is the conclusion about accordance of organization of production and quality control of medicines regulation, organization of production and quality control of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
4. On behalf of the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines, its territorial bodies periodically checking organizations-manufacturers of medicines, situated on the territory of the relevant constituent entities of the Russian Federation. (As amended by federal law from 22/08/2004, no. 122-FZ)

5. federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines, and its territorial bodies shall have the right: (as amended by federal law from 22/08/2004, no. 122-FZ) 1) to receive access to any organization-manufacturer of medicines, to seize samples of manufactured medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 2) copies of documents required for production and quality control of medicines;
3) prohibit the manufacture and sale of medicines already produced medicines in cases, an exhaustive list of which is contained in the rules of organization of production and quality control of medicines.
Article 15. Licensing of production of medicinal products 1. The license for the production of medicines issued organization-manufacturer of medicines by the federal executive body competent to exercise supervision and control in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)

2. license to manufacture medicines are issued based on the application of the Organization-manufacturer of medicines containing a list of medicines that the Organization-manufacturer of medicines is ready to produce. (As amended by federal law from 22/08/2004, no. 122-FZ)
3. In order to obtain a licence, the applicant is licensed with the federal executive body competent to exercise supervision and control in the sphere of circulation of medicines, the following documents: (as amended by federal law from 22/08/2004, no. 122-FZ) describes the basic technological processes to ensure the quality of medicines;
the consent of the local self-government bodies on placement of drug production in the territory;
certified in the prescribed manner copies of patents of the Russian Federation or authorizing the production and sale of patented medicines licensing agreements.

4. License for the production of medicines shall be issued for a period not less than five years. (Para supplemented by federal law from 22/08/2004, no. 122-FZ) (Article in the Editorial Office of the Federal law dated 01/10/2003 N 15-FZ) Article 16. Marking and registration of medicinal products 1. Marking and registration of medicines must meet the requirements of this federal law.
2. drugs come into circulation, if the inner and outer packages good readable typeface in Russian are indicated: 1) name of the medicinal product and the international non-proprietary name;
2) name of the Organization-manufacturer of medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 3) serial number and date of manufacture;
4) method of application;
5) dose number of doses per pack;
6) expiry date;
7) conditions.
8) conditions of storage;
9) precautions when applying medicines.
3. All medicines obtained from blood, blood plasma, as well as organs, tissues, have the inscription: "antibodies to the human immunodeficiency virus is missing".
Whey comes into circulation with the indication of blood plasma, blood, organs, tissues of any animal they received; vaccines-indicating nutrient Wednesday, used for the reproduction of viruses and bacteria.
4. Medicinal products registered as homeopathic, have an inscription: "Homeopathic".
5. drugs intended for the treatment of animals, have an inscription: "For animals."
6. drugs derived from plant material, have the inscription: "the products have passed the radiation control.
7. drugs intended for clinical research, are the words: "for clinical research".
8. Medicinal products intended solely for export, are the words: "for export Only".
9. Medicines must be issued only with the instructions for use of the medicinal product, containing the following information:

1) the name and legal address of the Organization-manufacturer of the medicinal product; (As amended by federal law from 22/08/2004, no. 122-FZ) 2) name of the medicinal product and the international non-proprietary name;
3) information about what is included in the composition of the medicinal product;
4) scope;
5) contraindications;
6) side effects;
7) interaction with other drugs;
8) dosage and method of administration;
9) expiry date;
10) specifies that the medicinal product after the expiry date shall not apply;
11) specifies that the medicinal product must be stored in locations not accessible to children;
12) terms.
10. Introduction of data not included in paragraphs 2-8 of this article, as well as the allowable reduction for medicines are set by the federal executive body competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ) Article 17. Manufacturing of medicinal products 1. Manufacture of medicines in the pharmacy facility is carried out according to the prescriptions on the basis of the medicinal products registered in the Russian Federation.
2. the manufacture of medicinal products is carried out in the establishment of a pharmacy that has a license for pharmaceutical activities with the manufacture of medicines approved by the federal executive body competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
3. marking and registration of medicinal products, manufactured in pharmaceutical facility must comply with those rules.
4. (deleted in accordance with Federal Act from 01/10/2003 N 15-FZ), Article 18. Responsibility for failure to comply with the rules of organization of production and quality control of drugs and medicines manufacturing rules 1. Organization-manufacturer of medicines is responsible for non-compliance with the rules of organization of production and quality control of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. Laboratory establishment is responsible for failure to observe the manufacture of medicines, as well as for processing, packaging and quality of medicines manufactured in pharmaceutical facility.
3. natural persons responsible for the manufacture and quality of medicines, shall bear disciplinary, administrative and criminal liability for violation of the provisions hereof. (As amended by the Federal law dated 01/10/2003 N 15-FZ), chap. V. State registration of medicinal products Article 19. State registration of medicinal products 1. Medicines can be manufactured, sold and used in the territory of the Russian Federation, if they are registered by the federal executive body competent to exercise supervision and control in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ) State registration of narcotic drugs and psychotropic substances used in medicine as medicines and subject to State control in accordance with the Federal law on Narcotic Drugs and psychotropic substances ", accompanied by the introduction of these tools and substances in the relevant lists in the manner prescribed by the Federal law on Narcotic Drugs and psychotropic substances".
Medicines intended for the treatment of animals, also are subject to state registration by the federal executive body competent to exercise supervision and control in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. State registration shall be: 1) new drugs;
2) new combinations of previously registered drugs;
3) medicines registered earlier, but made in the other dosage forms, dosage or other composition of excipients;
4) reproduced medicines.
3. The public register shall not be subject to medicinal products produced in pharmacies for prescriptions.
4. It is allowed to use unregistered drugs in clinical trials of drugs or testing medicines intended for the treatment of animals.
5. it is not allowed to state registration of various medicines under the same name, as well as multiple State registration of the same medicinal product under the same or different names.

6. State registration of medicinal product is conducting a federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines in a period not exceeding six months from the date of filing the application for the State registration of the medicinal product. (As amended by federal law from 22/08/2004, no. 122-FZ), the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines, determines the degree of change the dosage, composition of excipients registered drug, which entails its registration as a drug with a different name. (As amended by federal law from 22/08/2004, no. 122-FZ)
7. Application for State registration of medicinal products is served in the Federal Executive authority competent to exercise supervision and control in the sphere of circulation of medicines by the applicant, which may make the drug developer organization or other legal entity on behalf of the Organization-the developer of the drug. (As amended by federal law from 22/08/2004, no. 122-FZ)
8. Registered medicinal products shall be entered in the State Register of medicinal products.
9. For State registration of medicinal products, the applicant submits to the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines the following documents and information: (as amended by federal law from 22/08/2004, no. 122-FZ) 1) application for State registration of the medicinal product;
2) receipt of implementation of payment for State registration of the medicinal product; (As amended by federal law from 22/08/2004, no. 122-FZ) 3) legal address of the Organization-manufacturer of the medicinal product; (As amended by federal law from 22/08/2004, no. 122-FZ) 4) name of the medicinal product, including the International Nonproprietary name, scientific name in Latin, the main synonyms;
5) the original name of the medicinal product, if it is registered as a trademark in accordance with the legislation of the Russian Federation on trademarks, service marks and appellations of origin of goods;
6) list of components included in the drug product, and their amount;
7) instructions for use of the drug, designed in accordance with the requirements of this federal law;
8) certificate of quality of the medicinal product;
9) data on the manufacture of the medicinal product, the original text of the Pharmacopeia articles;
10) methods to control the quality of the medicinal product;
11) results of preclinical studies of the medicinal product;
12) results of pharmacological and toxicological studies of the medicinal product;
13) results of clinical trials of the medicinal product;
14 veterinary research) results if you register a medicinal product intended for the treatment of animals;
15) drug samples for the examination of its quality;
16) listings for the price of the medicinal product; (New subparagraph 16 supplemented; subparagraph 16 is considered subparagraph 17-Federal Law 02.01.2000 N 5-FZ) 17) documents that confirm the registration of the medicinal product, if it is registered outside the Russian Federation.
10. federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines can apply the accelerated procedure for the State registration of medicines. Provision on the expedited procedure for the State registration of medicines being developed and published by the federal body of executive power, which is competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. Expedited procedure for the State registration of medicines does not mean lowering the quality requirements, efficiency, safety of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ) 11. Expedited procedure for the State registration of medicines may apply if registered reproduced remedy equivalent to the already registered in the Russian Federation the original medicinal means, possibly produced by another technology or other composition of excipients.
Chapter VI. The importation of drugs into the territory of the Russian Federation. Export of medicines from the territory of the Russian Federation, article 20. The order of entry of drugs into the territory of the Russian Federation

1. import of medicines registered in the Russian Federation on the territory of the Russian Federation in accordance with the procedure determined by the Government of the Russian Federation. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. (repealed-Federal Act of 22/08/2004, no. 122-FZ) 3. (Repealed-Federal Act of 22/08/2004, no. 122-FZ)
4. (repealed-Federal Act of 22/08/2004, no. 122-FZ) 5. Imported medicines must be registered in the Russian Federation.
6. it is allowed to import into the territory of the Russian Federation to a particular party of unregistered drugs intended for clinical trials of drugs, to resolve a federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
7. the territory of the Russian Federation could import drugs, the quality of which is confirmed by the certificate of organization-manufacturer of medicines, certifying that the imported medicinal products produced in accordance with the State standard for the quality of medicines, established by the federal body of executive power, which is competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
8. in order to protect the market and organisations-manufacturers of medicinal products on the territory of the Russian Federation, the Government of the Russian Federation may enter special kinds of customs duties on imported medicines in accordance with the customs legislation of the Russian Federation. (As amended by federal law from 22/08/2004, no. 122-FZ)
9. it is prohibited to import into the territory of the Russian Federation of medicines are fakes or illegal copies in the Russian Federation registered medicines, counterfeit medicines. If you detect such medicines the Russian Customs authorities confiscate them with subsequent destruction in the manner determined by the federal executive body competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ), Article 21. Legal persons who are allowed to import drugs into the territory of the Russian Federation On the territory of the Russian Federation may bring medicines: 1)-manufacturers of drugs for the purposes of own manufacture of medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 2) wholesale trade in medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 3) research facilities, institutes, laboratories for the development, research and development, quality control, efficiency, safety of medicines with the permission of a federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines, on imports of a particular batch of drugs; (As amended by federal law from 22/08/2004, no. 122-FZ) 4) foreign organizations-manufacturers of medicines and the Organization of wholesale trade in medicinal products provided that they have their own representation in the territory of the Russian Federation. (As amended by federal law from 22/08/2004, no. 122-FZ), Article 22. The importation of drugs into the territory of the Russian Federation for personal use and other non-commercial purposes 1. Medicines can be imported into the territory of the Russian Federation without proper registration, if they are intended for: (as amended by federal law from 22/08/2004, no. 122-FZ) 1) personal use by individuals coming into the territory of the Russian Federation;
2) employees of the diplomatic corps and representatives of international organizations accredited in the Russian Federation;
3) treat the passengers of a vehicle arriving into the territory of the Russian Federation.
2. Medicinal products intended for the treatment of specific animals in zoos may be imported into the territory of the Russian Federation without proper clearance. (As amended by federal law from 22/08/2004, no. 122-FZ)
3. In cases stipulated in points 1 and 2 of this article, it is permitted to import into the territory of the Russian Federation of medicines that are not registered in the Russian Federation.
4. Medicinal products intended for humanitarian purposes, are imported into the territory of the Russian Federation in accordance with the procedure determined by the Government of the Russian Federation.
It is prohibited to import into the territory of the Russian Federation unregistered medicines intended for humanitarian purposes.
Article 23. (Repealed-Federal Act of 22/08/2004, no. 122-FZ)

Article 24. Documents submitted to the Customs authorities of the Russian Federation to the importation of drugs into the territory of the Russian Federation to the importation of drugs into the territory of the Russian Federation to the Customs authorities of the Russian Federation, the following documents must be submitted: 1) contracts or other documents that contain information about imported drugs and the conditions for their purchase;
2) certificates for the quality of medicines;
3) for information about State registration of each imported medicines with corresponding registration numbers;
4) originator information medicines;
5) data about the recipient of pharmaceuticals in the Russian Federation;
6) the identity of the person, peremeshhajushhem medicines;
7) resolution of a federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines, on imports of a particular batch of medicines in cases stipulated by article 20 hereof. (As amended by federal law from 22/08/2004, no. 122-FZ), Article 25. Natural and legal persons authorized to export medicines from the territory of the Russian Federation 1. To export medicines from the territory of the Russian Federation can organizations-manufacturers of medicines and the Organization of wholesale trade in medicinal products. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. individuals may bring back drugs in quantities needed for your personal use, in the manner determined by the customs legislation of the Russian Federation.
Article 26. (Repealed-Federal Act of 22/08/2004, no. 122-FZ), Article 27. Cooperation of the Customs authorities of the Russian Federation and of the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medical means (text as amended by the Federal Act of 22/08/2004, no. 122-FZ dated December 30, 2008) 1. The Federal Executive authority competent to exercise supervision and control in the sphere of circulation of medicines, places at the disposal of the Customs authorities of the Russian Federation, a list of medicines that are registered in the Russian Federation. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. The Customs authorities of the Russian Federation shall inform the Federal Executive authority competent to exercise supervision and control in the sphere of circulation of medicines, on the importation of drugs into the territory of the Russian Federation and the export of medicines from the territory of the Russian Federation. (As amended by federal law from 22/08/2004, no. 122-FZ), chap. VII. Wholesale drugs Article 28. Sale of medicines-medicines producers organizations (as amended by federal law from 22/08/2004, no. 122-FZ) Organization-pharmaceuticals producers can sell medicines or send them to: (as amended by federal law from 22/08/2004, no. 122-FZ) 1) other organizations-manufacturers of medicinal products for the purposes of production; (As amended by federal law from 22/08/2004, no. 122-FZ) 2) organizations of wholesale trade in medicinal products; (As amended by federal law from 22/08/2004, no. 122-FZ) 3) pharmacies;
4) research institutions for research work.
Article 29. Selling medicines wholesale drug trafficking organizations (as amended by federal law from 22/08/2004, no. 122-FZ) of wholesale trade in medicinal products can sell medicines or send them to: (as amended by federal law from 22/08/2004, no. 122-FZ) 1) other organizations of wholesale trade in medicinal products; (As amended by federal law from 22/08/2004, no. 122-FZ) 2) organizations-manufacturers of medicinal products for the purposes of production; (As amended by federal law from 22/08/2004, no. 122-FZ) 3) pharmacies;
4) research institutions for scientific research;
5) individual entrepreneurs having a licence for carrying out medical activities. (As amended by the Federal law dated 01/10/2003 N 15-FZ) Article 30. (Deleted-the Federal law dated 01/10/2003 N 15-FZ) Article 31. Prohibition of the sale of medicines of non-standard quality or are illegal copies of registered pharmaceuticals in the Russian Federation 1. Prohibits the sale of drugs, dilapidated, medicines with expired, counterfeit medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. drugs, dilapidated, medicines expired and counterfeit medicines must be destroyed. (As amended by federal law from 22/08/2004, no. 122-FZ)

3. Order of destruction of drugs, dilapidated, medicines with expired, counterfeit medicines being developed with security in mind people, animals and the environment Wednesday and approved by the federal executive body competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by the federal laws from 22/08/2004, no. 122-FZ; from 30.12.2008 N 309-FZ)
4. it is prohibited to sell counterfeit medicines, as well as drugs that are illegal copies of drugs that are registered in the Russian Federation. (As amended by federal law from 22/08/2004, no. 122-FZ), chap. VIII. Retail sale of drugs Article 32. Retail order drugs 1. Retail sale of drugs is carried out by the chemist's establishments. Authorized retail only medicines registered in the Russian Federation.
2. Medicines, prescription of a physician, be sold only through pharmacies, drugstore items. Medicines, over-the-counter drugs without a doctor's prescription can also be sold in chemist's shops and chemist's kiosks.
3. list of drugs, sold without the doctor's prescription, is reviewed and approved every five years the Federal Executive authority competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. Addition to the list is published annually. (As amended by federal law from 22/08/2004, no. 122-FZ)
4. Types of pharmaceutical institutions, rules and procedures of the medicinal products are defined and approved by the federal executive body competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
5. Decision on opening a new pharmacy institutions accepted body of local self-government.
6. Retail sale of drugs intended for the treatment of animals is carried out in the pharmacy, veterinary pharmacy or vet.
7. Pharmacies are obliged to sell medicines only in ready to use form and quantities needed to perform medical appointments.
8. Pharmacies are obliged to ensure that established the Federal Executive authority competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines, the minimum range of drugs needed for medical care. (As amended by federal law from 22/08/2004, no. 122-FZ)
9. Pharmaceutical institutions, along with the drugs have the right to acquire and sell medical products, disinfectants, hygiene, optics, natural and artificial mineral waters, therapeutic, children's and dietary food, cosmetic and Perfumery products.
10. the work of the chemist's establishments of the armed forces of the Russian Federation, other troops, military formations and organs in which the law provides for military service is regulated by this federal law and regulations, approved by the relevant federal bodies of executive power. (As amended by the Federal law 30.06.2003 N 86-FZ) monitor compliance with the provisions of this federal law specified chemist's establishments is carried out by the relevant ministries and other federal bodies of executive power.
Article 33. Pharmaceutical activities of individuals in chemist's establishments, individuals can engage in certain types of pharmaceutical activity in the presence of higher pharmaceutical education or secondary pharmaceutical education specialist certificate.
Article 34. Licensing of pharmaceutical activity 1. Pharmaceutical activities subject to licensing in accordance with the legislation of the Russian Federation.
2. Prerequisites for a decision on the licence are a representation of the license applicant documents confirming the right of the applicant to license premises for the implementation of pharmaceutical activity, availability of certificates from the experts carrying out pharmaceutical activities, as well as the sanitary-epidemiological conclusion on the compliance of the premises requirements sanitary rules.
(Article in the Editorial Office of the Federal law dated 01/10/2003 N 15-FZ), chap. IX. Development, pre-clinical and clinical trials of medicinal products Article 35. The development of new drugs

1. development of new drugs involves finding new pharmacologically active substances, further study of their medicinal properties, and preclinical studies.
2. financing the development of new medicines is available from: 1) of the federal budget;
2) of organisations-developers of drugs;
3) means organizations-manufacturers of medicinal products within the framework of scientific-research works carried out under the contract between the developer of drugs and the Organization-manufacturer of medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 4) other sources of funding, including charitable trusts and trust deposits of individuals and legal entities.
3. Rights of the developer of a new medicinal product protected by civil law. (As amended by federal law from 18.12.2006 y. N 231-FZ) Article 36. Preclinical studies of medicinal products 1. Objective preclinical studies of medicinal products is to obtain scientific methods of evaluation and evidence of the effectiveness and safety of medicines.
2. Preclinical studies of drugs are conducted by organizations-developers of medicines according to the rules of laboratory practices, approved by the federal executive body competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ)
3. Preclinical studies of drugs are conducted by approved plan with the conduct of the Protocol and report that record the results of preclinical studies of drugs. Organization-developer of medicines issues an opinion on the possibility of conducting further clinical trials of drugs.
4. Preclinical studies of medicines on animals are conducted in accordance with international rules. Monitoring compliance with the legal and ethical use of animals in conducting preclinical studies of medicinal products is carried out according to the federal body of executive power, which is competent to exercise the functions of State policy and normative-legal regulation in the sphere of circulation of medicines and its territorial bodies. (As amended by federal law from 22/08/2004, no. 122-FZ) Article 37. The decision to conduct clinical trials of medicinal products 1. The purpose of clinical trials of medicinal products is to obtain scientific methods of evaluation and evidence of efficacy and safety of medicinal products, data on the expected side effects from the use of drugs and the effects of interactions with other drugs.
2. the decision on conducting clinical trials for a particular medicinal product is accepted by the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medical means, based on the following documents: (as amended by federal law from 22/08/2004, no. 122-FZ) 1) declarations of the Organization of the development of the medicinal product;
2) positive opinion of the Ethics Committee at the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 3) report and opinion on the preclinical studies of the medicinal product;
4) instructions for use of the drug.
3. Clinical trials of medicines carried out in health facilities accredited by the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines. (As amended by the federal laws from 01/10/2003 N 15-FL; from 22/08/2004, no. 122-FZ) (paragraph 4 deleted item 5 is considered paragraph 4-the Federal law dated 01/10/2003 N 15-FZ) 4. List of healthcare institutions eligible to conduct clinical trials of medicines, compiled and published by the federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines. (As amended by federal law from 22/08/2004, no. 122-FZ) Article 38. The legal basis for clinical trials of drugs and funding of clinical trials of medicinal products 1. The legal basis for clinical trials of the medicinal product consists of the following documents: 1) the decision of a federal body of executive power, which is competent to exercise supervision and control in the sphere of circulation of medicines, clinical trials of the medicinal product; (As amended by federal law from 22/08/2004, no. 122-FZ)

2) agreement on carrying out clinical trials of the medicinal product. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. Agreement on carrying out clinical trials of the medicinal product must contain: 1) on the timing and amounts of clinical trials of the medicinal product;
2) on the total cost of the program of clinical trials of the medicinal product;
3) on presentation of the results of clinical trials of the medicinal product with the federal executive body competent to exercise supervision and control in the sphere of circulation of medicines; (As amended by federal law from 22/08/2004, no. 122-FZ) 4) on conditions of health insurance for patients participating in clinical trials of the medicinal product;
5) on the conditions of civil liability insurance of persons engaged in the conduct of clinical trials of the medicinal product. (Supplemented by federal law from 22/08/2004, no. 122-FZ)
3. Financing of clinical trials of the medicinal product is made of: 1) of the federal budget;
2) Organization-developer of the medicinal product in accordance with the terms of the contract on conducting clinical trials of the medicinal product;
3) from other sources.
4. (repealed-Federal Act of 22/08/2004, no. 122-FZ) 5. (Repealed-Federal Act of 22/08/2004, no. 122-FZ) Article 39. Clinical trials of medicinal products 1. The head of the health care institutions conducting clinical trials of the drug, approved the programme of clinical trials of medicinal products and shall appoint its head. Program Manager of these studies can be assigned to a doctor with experience of clinical research programme drugs for at least two years. Program of clinical trials of the medicinal product is developed with participation of the Ethics Committee in establishing health, long-term clinical trials of the medicinal product.
2. Program Manager, clinical trials of the medicinal product shall be familiarized with the results of the preclinical studies of the drug and is entitled to receive any additional information relevant to the research dokliniceski the specified drug.
3. Program Manager, clinical trials of the medicinal product to select patients who for medical reasons may be involved in clinical trials of the drug.
4. report on the results of clinical trials of the medicinal product shall be drawn up by the programme manager of clinical trials of the medicinal product.
5. Clinical trials of a drug may be interrupted if the process found health risks to patients. Decision on termination of the clinical trials of a drug may take these studies program manager.
6. Violation of the regulations for clinical practice, as well as falsification of the results of clinical trials of medicinal products shall be punishable in accordance with the legislation of the Russian Federation.
Article 40. The rights of patients participating in clinical trials of medicinal products 1. Participation of patients in clinical trials of drugs is voluntary.
2. the patient consents to participate in clinical trials of the medicinal product.
3. the patient must be informed: 1) on medication tool and the entity specified clinical trials of the medicinal product;
2) about the expected efficiencies, on the safety of the medicinal product, the degree of risk to the patient;
3) about the actions of the patient in case of unforeseen effects of the influence of the drug on his State of health;
4) on the conditions of the patient's health insurance.
4. the patient has the right to refuse to participate in clinical trials of the medicinal product at any stage of conducting these studies.
5. Not allowed clinical studies of drugs to minors, except in cases where the target drug is intended exclusively for the treatment of childhood diseases, or when the purpose of clinical trials is to obtain data on the best dosage of the medicinal product for the treatment of minors. In the latter case, clinical studies of the drug to minors must be preceded by a clinical study it for adults.
6. When conducting clinical trials of drugs to minors written consent of their parents.
7. it is prohibited to conduct clinical trials of medicines: 1) minors who have no parents;

2) pregnant women, except when conducted clinical trials of medicines intended for pregnant women, where the necessary information can be obtained only when the clinical trials of drugs on pregnant women and when completely removed the risk of harm to the pregnant woman and the fetus;
3);
4) persons serving sentences in places of deprivation of liberty, as well as on persons in custody at pre-trial detention facilities.
8. Permitted clinical trials of medicines intended for the treatment of mental illness, persons with mental illness and declared in the manner prescribed by the law of the Russian Federation on psychiatric care and guarantees of citizens ' rights in its provision ". Clinical trials of medicines in this case are subject to the written consent of the legal representatives of the above-mentioned persons.
9. the patient's health insurance contract, participating in clinical trials of the drug, is between the developer of the drug and health insurance organization.
Article 41. Responsibility of subjects of circulation of medicines to report cases of side effects and about the interactions of drugs with other drugs 1. Actors handling medicinal products are obliged to report to the Federal Agency, which is responsible for the implementation of supervision and control in the sphere of public health, and its territorial bodies on all cases of side-effects of drugs and on peculiarities of interaction of medicines with other drugs that do not correspond to information on medicinal products contained instructions on how to use them. (As amended by federal law from 22/08/2004, no. 122-FZ)
2. For failure to disclose or concealment of information under paragraph 1 of this article, the persons to whom they have become known in the course of their professional activities shall bear disciplinary, administrative or criminal liability in accordance with the legislation of the Russian Federation.
Chapter x. (repealed Federal Act from 22/08/2004, no. 122-FZ) Article 42. (Repealed-Federal Act of 22/08/2004, no. 122-FZ), chap. XI. Information on medicinal products (as amended by federal law from 16.10.2006 N 160-FZ) Article 43. Information on medicinal products 1. Information on medicinal products is carried out in accordance with the requirements of the public information standard.
2. information on the drugs, sold without the doctor's prescription can appear in publications and media announcements, specialized and General publications, instructions for use of the drugs, other editions actors handling medicinal products.
3. information about medicines, prescription of a physician is permitted only in specialized publications intended for medical and pharmaceutical workers. Information about medicines for treatment professionals of medicines can be presented in the form of monographs, manuals, scientific articles, reports on congresses, conferences, symposia, research councils, as well as instructions on the use of medicines intended for physicians.
4. Permitted use of any media material on medicinal products that enable you to store, share and use this information without distortion.
Article 44. (Repealed-the Federal law from 16.10.2006 N 160-FZ), chap. XII. Responsibility for harm to human health, the use of drugs Article 45. Damages associated with damage to human health due to the application of medicinal products 1. Damages associated with damage to human health due to the application of medicines and illegal actions of the subjects of circulation of medicines shall be carried out in accordance with the fundamentals of the legislation of the Russian Federation on health care.
2. If, as a result of the use of the drug caused harm to human health, the Organization-manufacturer, produced this drug has an obligation to compensate the victim, when it is proven that: (as amended by federal law from 22/08/2004, no. 122-FZ) 1) medicinal product used according to in accordance with the instructions for use of the drug and cause harmful effects of the drug were errors of manufacture of the medicinal product;
2) harm caused to the use of the drug because of erroneous instructions for use of the drug, published by the manufacturer of the drugs. (As amended by federal law from 22/08/2004, no. 122-FZ)

3. If the damage caused by the use of the drug, unserviceable as a result of violations of rules of wholesale drugs or pharmaceutical activity rules drugstores, wholesale organization reimburses the damage drugs or laboratory facility, the fault of which went on sale were released or a specified remedy. (As amended by federal law from 22/08/2004, no. 122-FZ) chap. XIII. Final provisions Article 46. Bringing of normative legal acts in accordance with this federal law to propose to the President of the Russian Federation and to entrust the Government of the Russian Federation to bring its normative acts in compliance with this federal law.
Article 47. The entry into force of this federal law this federal law shall enter into force three months after the date of its official publication.
The President of the Russian Federation, b. Yeltsin, Kremlin, Moscow June 22, 1998, N 86-FZ