About Medicines

Original Language Title: О лекарственных средствах

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Overtaken by Federal Law N 61-FZ RUSSIAN FEDERATION FEDERAL LAW About medicines adopted by the State Duma on 5 June 1998 Approved by the Federation Council on 10 June 1998 year (In the version of federal laws dated 02.01.2000) N 5-FZ; , 30.12.2001 N 196-FZ; dated 10.01.2003 N 15-FZ; dated 30.06.2003 N 86-FZ; of 22.08.2004 N 122-FZ; , 16.10.2006 N 160-FZ; of 18.12.2006 N 231-FZ; , 30.12.2008 N 309-FZ) This federal law creates a legal basis for the operation of drug operators, establishes a system of state bodies that implement the regulatory framework legal acts, actions on control and supervision, provision of public services, law enforcement practice in accordance with this Federal Law, and assigns powers to executive authorities in the sphere of the circulation of medicinal drugs. funds. (In the wording of Federal Law of 22.08.2004) N 122-FZ Chapter I. General provisions Article 1. The subject of regulation of this Federal Law 1. This Federal Law regulates relations arising from the development, production, manufacture, pre-clinical and clinical studies of medicines, quality control, efficiency, security, trade Drugs and other actions in the field of medicines. 2. This Federal Law sets the priority of the state control of production, manufacture, quality, efficiency and safety of medicines. Article 2. Scope of application of this Federal Law This Federal Law applies to relations that arise in the sphere of the circulation of medicines in the territory of the Russian Federation, if the law The Russian Federation does not establish otherwise. Article 3. Russian Federation law on the medicines 1. The legislation of the Russian Federation on medicines consists of this Federal Act, other federal laws and other normative legal acts of the Russian Federation, as well as laws and other regulatory legal acts of the subjects of the Russian Federation. 2. The peculiarities of the circulation of narcotic drugs and psychotropic substances are regulated by federal laws. 3. If an international treaty to which the Russian Federation is a party establishes rules other than those established by this Federal Act, the rules of the international treaty shall apply. Article 4. The basic concepts used in this Federal Law For the purposes of this Federal Act, the following basic concepts are used: Drugs are substances used for prevention, diagnosis, treatment of the disease, prevention of pregnancy, blood plasma, blood plasma, organ, human or animal tissue, plants, minerals, synthesis methods or use of biological technologies. Drugs also include substances of vegetable, animal or synthetic origin with pharmacological activity for the production and manufacture of drugs class="ed"> (pharmaceutical substations); (In the wording of Federal Law of 22.08.2004) N 122-FZ Drug-prepared medicinal products ready for use; immunobiological medicines-medicines for immunological prevention; and Immunological treatment; drugs included in the list of narcotic drugs produced and updated in accordance with the Single Convention on Narcotic Drugs of 1961, and THE RUSSIAN FEDERATION psychotropic substances-substances on the list compiled and updated in accordance with the Convention on Psychotropic Substances of 1971 and the legislation of the Russian Federation; medicines, the right to production and sale of which are protected by civil law; (In the wording of Federal Law civil law; (In the wording of Federal Law organizations of wholesale trade and pharmacy establishments in the field of treatment wholesale and retail trade medicines, manufacture of medicines; (In the wording of Federal Law of 22.08.2004) N 122-FZ ) organization -producer of medicines-an organization carrying out drug production in accordance with the requirements of this Federal Law; class="ed"> (In the Federal Law of 22.08.2004) N 122-FZ ) a drug developer is an organization with patent rights and copyright on the results of his pre-clinical research; organization of wholesale trade in pharmaceuticals is an organization that trades wholesalers of medicines in accordance with the requirements of this Federal Law; (In the wording of the Federal Act) Law from 22.08.2004. N 122-FZ) Aptee agency-an organization that conducts retail trade in medicines, manufacture and leave of medicines in accordance with the requirements of this Federal Law; Agencies include pharmacies, pharmacies of health institutions, pharmacies, pharmacies, pharmacies, pharmacy kiosks; counterfeit medicines, accompanied by false information about the composition and/or manufacturer Drugs; (Paragraph added-Federal Law of 22.08.2004) N 122-FZ )malignant medicinal, wornout, and/or expired medicine. The paragraph is supplemented by the Federal Law of 22.08.2004. N 122-F) Chapter II. State regulation of the relations, of the medications medications Article 5. State regulation of relations arising in the field of medicine means 1. State regulation of relationships arising in the circulation of medicines is regulated by: 1) state registration of medicines; 2) licensing of individual species activities in the field of medicines; (In the wording of Federal Law of 10.01.2003) N 15-FZ) (3) certification and certification of professionals involved in the circulation of medicines; 4) State control of production, manufacture, quality, efficiency, safety of medicinal products ; 5) state regulation of prices for medicines. (...) (...) N 5-FZ) 2. State regulation of relations arising in the circulation of medicines is carried out by the federal executive authority, which is responsible for public policy and regulatory functions. Regulation on the circulation of medicines by the federal executive authority, which is responsible for the implementation of state control and supervision of medicines, the federal executive body and the executive branch. Authorities having responsibility for public services, The administration of State property and law enforcement functions, with the exception of the functions of control and supervision, in the circulation of medicines, and the executive authorities of the constituent entities of the Russian Federation. (...) (...) N 122-FZ) Article 6. The power of the Government of the Russian Federation in Government of the Russian Federation: 1) ensures the holding in the Russian Federation of a single State policy on the provision of medicines to the population of the Russian Federation; (2) approves the size and order of the payment for state registration of medicines; 3) defines procedures for the import and export of drugs registered in Russian Federation. (Article in the wording of Federal Law of 22 August 2004). N 122-FZ) Article 7. Authorities of the executive branch of the constituent entities of the Russian Federation in the sphere of handling the medicines executive authorities of the constituent entities of the Russian Federation The Russian Federation develops and implements regional programmes to provide medicines to the population of the constituent entities of the Russian Federation. (...) (...) N 122-FZ) 1) (Federal Act of 22.08.2004) N 122-FZ 2) (Federal Act of 22.08.2004) N 122-FZ 3) (Federal Act of 22.08.2004) N 122-FZ Chapter III. State system of quality control, effectiveness, safety of medicinal means Article 8. State quality control system, effectiveness, drug safety 1. All medicines produced in the territory of the Russian Federation and imported into the territory of the Russian Federation are subject to State control. 2. The procedure for the exercise of state control of the quality, efficiency and safety of medicines is established by this Federal Law, the normative legal acts of the Russian Federation, including normative legal acts The federal executive body, which is responsible for the implementation of the public policy and regulatory framework for the circulation of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 3. The State system of quality control, effectiveness, safety of medicines includes: 1) the federal executive branch of power, which is responsible for carrying out the development functions State policy and regulations in the circulation of medicines; (Federal Act of 22.08.2004 N 122-FZ ) 2) the federal executive authority, which is responsible for state control and supervision of the circulation of medicines, and its territorial bodies; (B Federal Law of 22.08.2004 N 122-FZ )3) the federal executive body performing public services, State property management and law enforcement functions, excluding functions Control and supervision in the circulation of medicines; (as amended by the wording of the Federal Law of 22 August 2004). N 122-FZ 4) (Federal Act of 22.08.2004) N 122-FZ) 5) an information system that provides essential information for drug operators. Article 9. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ) Article 10. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ) Article 11. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ) Article 12. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ) Chapter IV Manufacture and manufacture of drugs Article 13. Production of drugs 1. Production of medicines-serial production of medicines in accordance with the rules of organization of production and quality control of medicines approved by the Federal Executive The competence of which is to carry out the functions of formulating public policy and regulatory and legal regulation in the field of appeal of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 2. The production of medicines is carried out by organizations -producers of medicines licensed to produce medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 3. The production of medicines is prohibited: 1) Unregistered State registration in the Russian Federation, except for medicines for clinical trials; 2) without a licence (b) The production of medicines; 3), in violation of the rules for the production and control of the quality of medicines approved by the Federal Executive the implementation of public policy functions and Legal and regulatory framework for the circulation of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 4. The production of patented drugs and their sale are carried out in accordance with the Civil Law. (In the wording of Federal Law 1. The State control of the production of medicines in the territory of the Russian Federation is carried out by the federal executive authority responsible for the exercise of State control and supervision in the sphere of treatment. and its territorial bodies. (...) (...) N 122-F) 2. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ) 3. The federal executive authority, which is responsible for the implementation of state control and supervision of the circulation of medicines, carries out inspections of pharmaceutical producers ' organizations. on the conformity of production and control of quality of medicines with the rules of organization of production and quality control of medicines. (...) (...) N 122-FZ)4. On behalf of the federal executive authority, which is responsible for the exercise of State control and supervision of the circulation of medicines, its territorial bodies periodically check the organizations. OF THE PRESIDENT OF THE RUSSIAN FEDERATION (...) (...) N 122-FZ 5. The federal organ of the executive branch, which is responsible for carrying out state control and supervision of the circulation of medicines, and its territorial bodies have the right: Federal Law of 22.08.2004 N 122-FZ ) 1) to freely access the in any organization -the manufacturer of medicines, to seize samples of produced medicines; (In the wording of the Federal Law of 22.08.2004 N 122-FZ) (2) to remove copies of documents necessary for the control of production and quality of medicinal products; 3) prohibit the production of medicines and the sale of medicines already produced of the Convention on the Rights of the Article 15. Licensing production of medicines 1. The license for the production of medicines is issued to the pharmaceutical producer organization by the federal executive authority, which is responsible for the exercise of state control and supervision in the sphere of treatment. Medicinal products. (...) (...) N 122-FZ 2. A license for the production of medicines is issued on the basis of a statement by the pharmaceutical producer organization containing a list of medicines that the pharmaceutical producer organization is ready to produce. (...) (...) N 122-FZ) 3. In order to obtain a license, the applicant shall submit the following documents to the federal executive body, which is responsible for the exercise of state control and supervision in the field of medicine, and the following documents: Federal Law of 22.08.2004 N 122-FZ )description of essential medicines quality processes; consent of local government authorities for the production of medicinal products of the territory; certified copies of the patents of the Russian Federation or authorizing the production and sale of patented pharmaceuticals. 4. A licence to produce medicines is issued for a period of not less than five years. The paragraph is supplemented by the Federal Law of 22.08.2004. N 122-FZ) (Article as amended by Federal Law of 10 January 2003). N 15-FZ) Article 16. Marking and processing of drugs 1. The marking and processing of medicines must comply with the requirements of this Federal Act. 2. Medicines are available if the Russian language is clearly legible in the interior and exterior packages: 1) the name of the drug and the international generic name; 2) the name Organizations -the manufacturer of medicines; (In the wording of Federal Law of 22.08.2004). N 122-FZ ) 3) the series number and date of manufacture; 4) the method of application; 5) the dose and quantity in the package; 6) shelf life; 7) conditions of leave; 8) storage; 9) Precautions in the use of medicines. 3. All the drugs that came from the blood, blood plasma, and organs, human tissue, have the inscription: "No antibody to human immunodeficiency virus." The serum comes into circulation with instructions, blood plasma, blood plasma, organs, tissues of which animal they have received; vaccines-indicating the breeding ground used for the breeding of viruses and bacteria. 4. Drugs registered as homeopathic are marked "Homeopathic". 5. Drugs for animal treatment bear the inscription "For the animals". 6. Drugs received from plant raw materials bear the inscription: "The products have undergone radiation control". 7. Clinical research has the following text: "For clinical trials." 8. The only means of export are: "Only for export". 9. Medicines must be issued only with the instruction for the use of the drug containing the following Russian data: 1) the name and legal address of the organization of the pharmaceutical producer; (In the wording of Federal Law of 22.08.2004, 2004). N 122-FZ ) 2) the name of the drug and the international generic name; 3) information about the components of the drug; 4) scope of application; 5) 6) side effects; 7) interaction with other drugs; 8) dosage and usage; 9) the expiry date; 10) indicating that The expiry date shall not be used; 11) indicates that the medication should be kept in places not accessible to children; 12) the terms of the leave. 10. The introduction of data not included in paragraphs 2 to 8 of this article, as well as permissible reductions in the marking of medicines, shall be established by the federal authority of the executive power whose competence is to be implemented. The role of the State in the formulation of public policies and regulations in the field of medicines. (In the wording of Federal Law of 22.08.2004) N 122-FZ) Article 17. Manufacture of medicines 1. The manufacture of medicines in the pharmacy is carried out according to prescriptions of doctors on the basis of medicines registered in the Russian Federation. 2. The manufacture of drugs is carried out in an pharmacical institution licensed for pharmaceutical activities, according to the rules of manufacture of medicines approved by the federal executive authority The competence of which is to carry out the functions of formulating public policy and regulatory and legal regulation in the field of appeal of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 3. The marking and presentation of medicines manufactured in the pharmacy institution shall comply with the regulations. 4. (Deleted-Federal Law of 10.01.2003) N 15-FZ) Article 18. Accountability for failure to comply with the rules of the organization production and quality control of medicines drugs and rules of manufacture 1. Organization -producer of medicines is responsible for failure to observe the rules of organization of production and quality control of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 2. The institution is responsible for the failure to comply with the rules of manufacture of medicines, as well as for the presentation, packaging and quality of medicines manufactured in the pharmacy facility. 3. The individuals responsible for the manufacture and quality of medicines shall be liable to disciplinary, administrative and criminal liability for violation of the provisions of this Federal Law. (In the wording of Federal Law of 10.01.2003) N 15-FZ) Chapter V. State registration of drugs Article 19. State registration of medicines 1. The funds may be manufactured, sold and applied in the territory of the Russian Federation, if they are registered by a federal body of the executive power, of which the State is responsible. monitoring and oversight of the treatment of drugs. (In the wording of Federal Law of 22.08.2004) N 122-FZ ) State registration of narcotic drugs and psychotropic substances used in medicine as medicines and subject to state control under the Federal Law " About narcotic drugs and psychotropic substances ", is accompanied by the specified tools and substances in the appropriate lists in the order defined Federal law "About narcotic drugs and psychotropic substances". The federal body of the executive branch, which is responsible for the exercise of state control and supervision of the circulation of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 2. State registration is subject to: 1) new medicines; 2) new combinations of previously registered medicines; 3) medicines registered previously but produced in other medicinal forms, with new dosage or other formulations of auxiliary substances; 4) produced medicinal products. 3. State registration is not subject to medicines manufactured in pharmacies according to prescription dispensaries. 4. Unregistered medicines may be used in clinical studies of medicines or testing of medicinal products intended for the treatment of animals. 5. State registration of different drugs under the same name is not permitted, as is the multiple State registration of the same medicine under one or different names. 6. State registration of a drug is carried out by the federal body of the executive power, which is responsible for the exercise of state control and supervision of the circulation of medicines on time, not exceeding six months from the date of the application for state registration of the drug. (In the wording of Federal Law of 22.08.2004) N 122-FZ The Federal Executive, which is responsible for exercising State control and supervision of the circulation of medicines, determines the degree of change The dosage, the composition of the subsidiary substance of the registered drug, which entails the necessity of its state registration as a medicine with another name. (In the wording of Federal Law of 22.08.2004) N 122-F) 7. The application for state registration of medicine is submitted to the federal body of the executive power, which is responsible for the exercise of state control and supervision of the circulation of medicines. The applicant has the capacity to act as a drug developer or other legal entity on behalf of the drug developer. (In the wording of Federal Law of 22.08.2004) N 122-F) 8. A registered drug is entered in the state register of medicines. 9. For the State registration of a drug, the applicant is represented in the federal body of the executive power, which is responsible for exercising state control and supervision in the sphere of treatment . The following documents and data: (In the wording of Federal Law of 22.08.2004, 2004). N 122-FZ ) 1) a statement about the state registration of a drug; 2) a receipt for the state registration of a drug for the state registration of a medicine; (B Federal Law of 22.08.2004 N 122-FZ ) 3) the legal address of the pharmaceutical manufacturer; (In the wording of Federal Law from 22.08.2004. N 122-FZ ) 4) the name of the medicine, including the international generic name, the scientific name in Latin, the main synonyms; 5) the original name of the drug if it is is registered as a trademark in accordance with the laws of the Russian Federation on trade marks, signs of service and names of places of origin; 6) a list of components of the drug, number; 7) instructions for using Drugs in accordance with the requirements of this Federal Law; 8) certificate of quality of medicine; 9) drug production data, original text Pharmacopoeia; 10) methods of drug quality control; 11) results of pharmaceutical research; 12) results of pharmacological and toxicological studies medicines; 13) clinical results Medical research; 14) results of veterinary studies, if a drug for the treatment of animals is registered; 15) samples of the drug for the examination quality; 16) drug price proposals; (New sub-paragraph 16; sub-paragraph 16 is considered sub-paragraph 17-Federal law 02.01.2000 g. N 5-FZ 17) documents confirming the registration of a drug if it is registered outside the Russian Federation. 10. The [ [ Federal Executive Office]], which is responsible for the exercise of state control and supervision of the circulation of medicines, can use the accelerated procedure of state registration Medicinal products. The fast-track procedure for the State registration of medicines is developed and published by the federal executive authority, which is responsible for the exercise of public administration. Policies and regulations in the field of medicines. The accelerated procedure of state registration of medicines does not mean reduction of requirements for quality, efficiency, safety of medicines. (In the wording of Federal Law of 22.08.2004) N 122-FZ 11. The accelerated procedure of state registration of medicines may be applied if the reproduced drug is registered, equivalent to the original drug already registered in the Russian Federation, possibly made by another technology or with a different composition of subsidiary substances. Chapter VI: The importation of medicines into the territory of the Russian Federation. The delivery of drugs from the territory of the Russian Federation Article 20. Procedure for the importation of drugs into the territory Russian Federation 1. The importation of medicines registered in the Russian Federation into the territory of the Russian Federation is carried out in accordance with the procedure defined by the Government of the Russian Federation. (B) Federal Law of 22.08.2004 N 122-F) 2. (Spconsumed by Federal Law of 22.08.2004) N 122-F) 3. (Spconsumed by Federal Law of 22.08.2004) N 122-F) 4. (Spconsumed by Federal Law of 22.08.2004) N 122-F) 5. The imported medicines must be registered in the Russian Federation. 6. The importation into the territory of the Russian Federation of a specific consignment of unregistered drugs for clinical studies of medicines is permitted, as authorized by the Federal Authority The executive authority, which is responsible for the exercise of state control and supervision of the circulation of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 7. In the territory of the Russian Federation medicines can be imported, the quality of which is confirmed by the certificate of the manufacturer of medicines certifying that imported medicines are produced in accordance with the State standard for the quality of medicines prescribed by the federal authority of the executive power, which is responsible for the implementation of public policy functions and legal regulation in the field of treatment Medicinal products. (In the wording of Federal Law of 22.08.2004) N 122-F) 8. In order to protect the market and organizations -producers of medicines in the territory of the Russian Federation, the Government of the Russian Federation may impose special types of customs duties on imported ready-to-use medicines. OF THE PRESIDENT OF THE RUSSIAN FEDERATION N 122-F) 9. It is prohibited to import into the territory of the Russian Federation medicines that are forged or illegal copies of medicines registered in the Russian Federation. In the detection of such drugs, the customs authorities of the Russian Federation shall confiscate them, with subsequent destruction, in the manner determined by the federal executive The role of the State in the formulation of public policies and regulations in the field of medicines. (In the wording of Federal Law of 22.08.2004) N 122-FZ) Article 21. Legal persons who are allowed to import drugs into the territory of the Russian Federation Russian Federation may import medicines: 1) organizations are manufacturers of medicines for their own production of medicines; (In the wording of Federal Law of 22.08.2004 N 122-FZ ) 2) the wholesale trade in medicines; (In the wording of Federal Law of 22.08.2004 N 122-FZ) 3) research institutions, institutes, laboratories for the development, research and control of quality, efficiency, safety of medicines, subject to the permission of the Federal The executive authority, which is responsible for the exercise of State control and supervision of the circulation of medicines, on the importation of a specific consignment of medicines; (In the wording of the Federal Law from 22.08.2004. N 122-FZ ) 4) foreign organizations -producers of medicines and organization wholesale drug trade, provided that they have their own of the Russian Federation. N 122-FZ) Article 22. Importation into the territory of the Russian Federation for personal use and other non-commercial purposes 1. The funds can be imported into the territory of the Russian Federation without a corresponding decorationif they are intended for: (In the wording of Federal Law from 22.08.2004. N 122-FZ ) 1) personal use by natural persons arriving in the territory of the Russian Federation; (2) employees of the diplomatic corps or representatives of international organizations accredited to the OF THE PRESIDENT OF THE RUSSIAN FEDERATION 2. Drugs intended for the treatment of specific animals in zoos may be imported into the territory of the Russian Federation without the corresponding design. (In the wording of Federal Law from 22.08.2004. N 122-F) 3. In the cases referred to in paragraphs 1 and 2 of this article, the importation into the territory of the Russian Federation of medicines not registered in the Russian Federation shall be permitted. 4. Drugs for humanitarian purposes are imported into the territory of the Russian Federation in the manner determined by the Government of the Russian Federation. The entry into the territory of the Russian Federation of unregistered medicines for humanitarian purposes is prohibited. Article 23. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ) Article 24. OF THE PRESIDENT OF THE RUSSIAN FEDERATION The customs authorities of the Russian Federation should be provided with the following documents and information: 1) contracts or other documents containing information about imported medicines and their conditions of purchase; 2) medicines quality certificates; 3) State registration of each imported drug with the appropriate registration numbers; 4) data on the originator of medicines; 5) data on the recipient of drugs in of the Russian Federation; 6) data on the person moving the medicines; 7) the authorization of the federal executive authority responsible for the exercise of State control; and in the field of drug treatment, the importation of a particular shipment of medicines in the cases prescribed by article 20 of this Federal Act. (...) (...) N 122-FZ) Article 25. Natural and legal persons who are permitted export of medicines from the territory Russian Federation 1. The supply of medicines from the territory of the Russian Federation can be carried out by the organization -the producers of medicinal products and the wholesale trade in medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 2. Natural persons may export medicines in quantities necessary for personal use in a manner determined by the customs laws of the Russian Federation. Article 26. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ) Article 27. Cooperation between the customs authorities of the Russian Federation of the Federation and the federal body of the executive of power implementation of state control and drug management oversight (In the wording of Federal Law from 22.08.2004 N 122-FZ) 1. The Federal Executive Office, which is responsible for the exercise of State control and supervision of the circulation of medicines, is made available to the customs authorities of the Russian Federation. list of medicines registered in the Russian Federation. (In the wording of the Federal Law of 22.08.2004) N 122-F) 2. OF THE PRESIDENT OF THE RUSSIAN FEDERATION of the Russian Federation and the export of medicines from the territory of the Russian Federation. (In the wording of Federal Law of 22.08.2004 N 122-FZ Chapter VII. Wholesale drug trade Article 28. Sales of medicines organizations - drug producers (Federal Law of 22.08.2004 N 122-FZ ) Organizations -manufacturers of medicines can sell medicines or transfer them to the order: (In the wording of Federal Law from 22.08.2004. N 122-FZ ) (1) other organizations -producers of medicines for production purposes; (In the wording of Federal Law from 22.08.2004. N 122-F) 2) organizations of wholesale trade in medicines; (Federal Law of 22.08.2004 N 122-FZ ) 3) pharmacists; 4) research institutions for research. Article 29. Sale of medicines organizations wholesale drug trade (Federal Law of 22.08.2004 N 122-FZ Organizations wholesale trade can sell medicines or transfer them to the order: (In the wording of Federal Law from 22.08.2004. N 122-FZ ) (1) other wholesale drug trade; (Federal Law of 22.08.2004 N 122-FZ ) 2) organizations -manufacturers of medicines for production purposes; (In the wording of Federal Law from 22.08.2004. N122-FZ ) 3) pharmacists; 4) research institutions for research work; 5) individual entrepreneurs licensed for implementation Medical activities. (In the wording of the Federal Law of 10 January 2003, N 15-FZ) Article 30. (Deleted-Federal Law of 10.01.2003) N 15-FZ) Article 31. Prohibition of sales of drugs non-standard quality or illegal copies of medicines registered in Russian Federation of medicines 1. It is prohibited to sell medicines that have come into disrepair, or the shelf life of, counterfeit drugs. (In the wording of the Federal Act, Law of 22.08.2004 N 122-F) 2. Medicines that have become obsolete, medicinal expired and counterfeit medicines are to be destroyed. (In the wording of Federal Law of 22.08.2004) N 122-FZ) 3. Procedures for the destruction of obsolete, medicalized and adulderated medicines are developed in accordance with the requirements of human, animal and environmental safety and is approved by the federal executive authority, which is responsible for the administration of public policies and regulations governing the circulation of medicines. (In the wording of the federal laws of 22 August 2004, N 122-FZ; dated 30.12.2008. N 309 F) 4. The sale of counterfeit medicines, as well as drugs, which are illegal copies of medicines registered in the Russian Federation is prohibited. Federal Law of 22.08.2004 N 122-FZ) Chapter VIII. Retail sales of drugs Article 32. The Order of Retail Trade Tools 1. The retail sale of medicines is carried out by pharmacies. Retail trade is permitted only with medicines registered in the Russian Federation. 2. Medical prescription drugs are to be sold only through pharmacies or pharmacies. The medicinal products that are left without a doctor's prescription can also be sold in pharmacy stores and pharmacy kiosks. 3. A list of drugs issued without a doctor's prescription is reviewed and approved every five years by the federal executive branch of power, which is responsible for carrying out the functions of a doctor State policy and regulatory frameworks in the area of drug abuse. The supplement to the list is published annually. (In the wording of Federal Law of 22.08.2004) N 122-F) 4. The types of pharmacists, rules and procedures for the release of medicines are defined and approved by the federal executive authority of the, which is responsible for the exercise of public policy in the area of medicines. (In the wording of Federal Law of 22.08.2004 N 122-F) 5. The decision to open a new pharmacy will be made by the local government. 6. Retail medicine for the treatment of animals is carried out at the pharmacy, veterinary pharmacy or veterinarian. 7. Pharmacists are obliged to sell medicines only in the ready use of the form and quantities necessary for the performance of medical appointments. 8. Aphers are obliged to ensure that the federal executive branch,, is responsible for public policy and regulatory functions The minimum range of medicines needed for medical care is the minimum range of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 9. Pharmacists have the right to purchase and sell medical products, disinfectants, articles of personal hygiene, optics, natural and artificial mineral water, therapeutic, children's and other medicines. diet, cosmetic and perfumery products. 10. OF THE PRESIDENT OF THE RUSSIAN FEDERATION by the relevant federal executive authorities. (In the wording of Federal Law No. N 86-FZ) The relevant ministries and other federal executive authorities are responsible for monitoring compliance with the provisions of this Federal Act. Article 33. Pharmaceutical activities of natural persons in pharmacies Natural persons may engage in certain pharmaceutical activities with the presence of higher pharmaceutical education or on average Pharmaceutical Education and Certificate. Article 34. Licensing of pharmaceutical activities 1. Pharmaceutical activities are subject to licensing under the laws of the Russian Federation. 2. The requirement for a licence to be issued is the submission by the applicant of a licence of documents confirming the right of the applicant to be licensed to use premises for the purpose of pharmaceutical activities, Certificates in pharmaceutical, sanitary and epidemiological reports on the compliance of premises with sanitary rules. (Article in the wording of the Federal Law dated 10.01.2003 N 15-FZ Chapter IX. Development, pre-clinical and clinical drug research Article 35. Development of new drugs 1. The development of new drugs includes the search for new pharmacologically active substances, the subsequent study of their medicinal properties, as well as pre-clinical studies. 2. Funding for the development of new drugs is provided by: 1) Federal budget; 2) funds for drug development organizations; 3) class="ed"> organizations of pharmaceutical companies in the framework of research work performed under a contract between a drug developer and an organization medicines; (In the wording of Federal Law from 22.08.2004. N 122-FZ ) 4) other sources of funding, including charitable funds and earmarked contributions from natural and legal persons. 3. The rights of the new drug developer are protected by Civil Law. (In the wording of Federal Law executive authority, which is responsible for The exercise of public policy and regulatory functions in the field of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 3. Doctrine studies of medicines are carried out according to the approved plan of the protocol and the production of a report, which are recorded in the results of pre-clinical studies of medicines. The organization-the developer of medicines-gives an opinion on the possibility of carrying out further clinical studies of medicinal products. 4. Doctrine studies on animal medicines are conducted in accordance with international regulations. The control over the observance of the legal and ethical norms of the use of animals in the conduct of pre-clinical investigations of medicines is carried out by the Federal Executive It includes the exercise of public policy and regulatory functions in the field of medicines and its own by the territorial bodies. (In the wording of Federal Law of 22.08.2004) N 122-FZ) Article 37. Decision on Clinical Research Drug 1. The objective of clinical studies of medicines is to obtain scientific methods of assessments and evidence of the effectiveness and safety of medicines, data on expected side effects from the use of drugs and effects Interactions with other drugs. 2. The decision to conduct clinical studies of a particular drug is taken by the federal body of the executive power, which is responsible for the exercise of state control and supervision in the sphere of treatment of medicines, on the basis of the following documents: (In the wording of Federal Law No. N 122-FZ (1) a statement by the drug developer organization; 2) the positive conclusion of the Ethics Committee of the federal executive State control and supervision of the circulation of medicines; (In the wording of the Federal Law 22.08.2004 N122-FZ ) 3) on the report and conclusions on dose-patient research; 4) instructions for the use of the drug. 3. Clinical studies of medicines are carried out in the health care institutions ofaccredited by the federal executive authority, which is responsible for exercising state control and supervision in the sphere medicines. (In the version of federal laws of 10.01.2003) N 15-FZ; of 22.08.2004 N 122-FZ ) (Paragraph 4 is deleted, para. 5 is considered to be para. 4-Federal Law of 10.01.2003) N 15-FZ 4. The list of health institutions authorized to carry out clinical studies of medicines is compiled and published by the federal executive authority of the, whose competence is to implement State control and supervision in the circulation of medicines. (In the wording of Federal Law of 22.08.2004 N 122-FZ) Article 38. The legal basis for clinical drug research and funding for clinical research drugs 1. The legal basis for the conduct of clinical research on medicines is: 1) the decision of the federal body of the executive, which is responsible for the implementation of the State the control and supervision of medicines, the conduct of clinical trials of the drug; (In the wording of the Federal Law from 22.08.2004. N 122-FZ) (2) a contract for clinical studies of the drug. (In the wording of Federal Law of 22.08.2004) N 122-F) 2. The contract for the clinical research of the drug should contain: 1) the duration and volume of clinical research of the drug; 2) on the total cost of the clinical program of drug research; 3) on the form of the presentation of clinical research findings to the federal executive State control and supervision of the circulation of medicines; (In the wording of Federal Law of 22.08.2004) N 122-FZ ) 4) on the conditions of health insurance for patients participating in clinical trials of the drug; 5) on the conditions of insurance for civil society The responsibility of the persons carrying out the clinical research of the drug. (...) (...) N 122-F) 3. The funding of clinical research is from: (1) of the federal budget; (2) funds of the drug development organization in accordance with the terms of the treaty -Clinical research of a drug; 3) other sources. 4. (Spconsumed by Federal Law of 22.08.2004) N 122-F) 5. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ) Article 39. Clinical study of drugs 1. The head of the health facility who is conducting clinical studies of the drug, approves the program of clinical research of the drug and appoints its head. The programme manager of these studies may be appointed as a physician with the experience of clinical studies of drugs for at least two years. The drug clinical research programme is being developed with the participation of an ethical committee in the establishment of a health clinic that conducts clinical studies of the drug. 2. The head of the clinical research program of the drug should be informed about the results of the pre-clinical studies of the drug and is entitled to receive any additional information relevant to the drug pre-clinical studies of the drug. 3. The head of the clinical research program of the drug is responsible for the selection of patients who may be involved in clinical studies of the drug. 4. A report on the results of clinical research of the drug is compiled by the head of the clinical research program of the drug. 5. Clinical studies of the drug may be interrupted if the patient's health is at risk. The decision to discontinue the clinical research of the drug may be taken by the head of the research program. 6. Violation of the rules of clinical practice, as well as the falsification of the results of clinical studies of medicines, is punishable under the legislation of the Russian Federation. Article 40. The rights of patients participating in clinical drug research 1. The participation of patients in clinical trials of drugs is voluntary. 2. The patient gives written consent to participate in clinical trials of the drug. 3. The patient must be informed: 1) about the drug and clinical research nature of the drug; 2) on the expected effectiveness, safety of the drug, the degree of risk to the drug a patient; 3) about the patient's actions in case of unforeseen effects of medicinal effects on his health; 4) on the conditions of the patient's health insurance. 4. The patient has the right to refuse to participate in clinical studies of the drug at any stage of the studies. 5. Clinical research on drugs for minors is not permitted, except where the drug is intended solely for the treatment of childhood illnesses or clinical studies is the receipt of data on the best dosage of the drug for the treatment of minors. In the latter case, clinical trials of minors should be preceded by clinical studies on adults. 6. There is a need for the written consent of their parents in carrying out clinical studies of medicines on minors. 7. It is prohibited to conduct clinical research on medicines on: 1) minors without parents; (2) pregnant women, except in cases where clinical studies of medicinal drugs are conducted Tools intended for pregnant women, where the necessary information can only be obtained from clinical studies of medicines on pregnant women and when the risk of harm to the pregnant woman and the foetus is completely eliminated; 3) soldiers; 4) persons serving Punishment in places of deprivation of liberty, as well as on persons held in remand centres. 8. Clinical research on drugs for the treatment of mental illness, on persons with mental disabilities and recognized incapacitated in the manner prescribed by the Act of the Russian Federation " About psychiatric care and the guarantee of citizens ' rights when it is provided. Clinical studies of medicines in this case are conducted with the written consent of the legal representatives of the persons concerned. 9. The contract of health insurance of the patient participating in the clinical research of the drug is concluded between the organization-the developer of the drug and the medical insurance organization. Article 41. Duty of drug operators to report cases of side effects and on the peculiarities of drug interaction class="ed"> 1. Drug users are required to report to the federal executive authority responsible for the exercise of State control and supervision in the sphere of health and its territorial authorities in all cases by-actions of medicines and about the peculiarities of the interaction of medicines with other medicines, which do not correspond to the information on medicines contained in the instructions for their use. (...) (...) N 122-F) 2. For failure to communicate or concealment of the particulars referred to in paragraph 1 of this article, persons who have become known by the nature of their professional activity shall be liable to disciplinary, administrative or criminal liability in accordance with OF THE PRESIDENT OF THE RUSSIAN FEDERATION Chapter X. (Spconsumed out-Federal Law of 22.08.2004) N 122-FZ) Article 42. (Spconsumed by Federal Law of 22.08.2004) N 122-FZ Chapter XI. Information about medicines (In the wording of Federal Law of 16.10.2006) N 160-FZ) Article 43. Information about medicines 1. Information on medicines is provided in accordance with the requirements of the State information standard. 2. Information on medico-prescription drugs can be found in publications and announcements of mass media, specialized and general printed publications, instructions on the use of medicines, other publications of the drug appeal. 3. Information on prescription drugs is permitted only in specialized print publications for medical and pharmaceutical workers. Information on medicines for specialists in the circulation of medicines can be presented in monographs, gazetteers, scientific papers, reports at congresses, conferences, symposiums, scientific councils, as well as instructions on The use of medicines for doctors. 4. Any material media may be used to store, transmit and use this information without distortion. Article 44. (Spconsumed by Federal Law of 16.10.2006) N 160-FZ) Chapter XII. { \field { \cs6\f1\cf6\lang1024 } { \cs6\f1\cf6\lang1024 } { \cs6\f1\cf6\lang1024 } { \cs6\f1\cf6\lang1024 } { \cs6\f1\cf6\lang1024 Reparation for harm caused by the injury to human health caused by the use of Drugs 1. Compensation for harm caused to human health caused by the use of medicines and illegal actions of drug users is carried out in accordance with the FundamFundamence of Laws of the Russian Federation. Federation for the Protection of Citizens ' Health. 2. If, as a consequence of the use of a drug, the health of a person is harmed, the organization, which issued the drug, has the duty to compensate the victim when it is proved that: class="ed"> (In the Federal Law of 22.08.2004) N 122-FZ) (1) the medication was used for the purpose, in accordance with the instructions on the use of the medication and the cause of the medicinal activity means; (2) the health damage caused by the use of a medicine because of the wrong instructions on the use of a drug issued by the organization -the manufacturer of medicines. (In the wording of Federal Law of 22.08.2004) N 122-F) 3. If damage to the health is caused by the use of medicinal products that have been damaged as a result of violations of the wholesale trade rules or the pharmaceutical activity of the pharmacy establishments, the damage shall be compensated The wholesale trade in medicines or pharmaces that have been sold or released. (In the wording of Federal Law of 22.08.2004) N 122-FZ) Chapter XIII. Final provisions Article 46. Enact normative legal acts in conformity with this Federal Law Propose to the President of the Russian Federation and instruct the Government of the Russian Federation to bring its normative legal acts into 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. President of the Russian Federation B. Yeltsin Moscow, Kremlin 22 June 1998 N 86-FZ