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FEDERAL LAW OF THE RUSSIAN FEDERATION

of April 12, 2010 No. 61-FZ

About drug circulation

(as amended on 11-06-2021)

Accepted by the State Duma of the Russian Federation on March 24, 2010

Approved by Council of the Russian Federation on March 31, 2010

Chapter 1. General provisions

Article 1. Subject of regulation of this Federal Law

1. This Federal Law governs the relations arising in connection with the address - development, preclinical trials, clinical trials, examination, state registration, with standardization and with quality control, production, production, storage, transportation, import to the Russian Federation, export from the Russian Federation, advertizing, leave, realization, transfer, use, destruction of medicines.

2. This Federal Law establishes priority of state regulation of safety, quality and efficiency of medicines in case of their address.

Article 2. Scope of this Federal Law

This Federal Law is applied to the relations arising in case of drug circulation in the territory of the Russian Federation.

Article 3. Legislation on drug circulation

1. The legislation on drug circulation consists of this Federal Law, other Federal Laws and other regulatory legal acts of the Russian Federation.

1.1. The legislation on drug circulation is applied to the legal entities and individual entrepreneurs performing activities in the territory of the international medical cluster taking into account the features established by the Federal Law "About the International Medical Cluster and Modification of Separate Legal Acts of the Russian Federation".

2. Operation of this Federal Law extends to the address of narcotic medicines and psychotropic medicines taking into account the features established by the legislation of the Russian Federation on drugs, psychotropic substances and on their precursors.

3. Operation of this Federal Law extends to the address of radio pharmaceutical medicines taking into account the features established by the legislation of the Russian Federation in the field of ensuring radiation safety.

4. If the international treaty of the Russian Federation establishes other rules, than those which are provided by this Federal Law are applied rules of the international treaty.

4.1. The decisions of interstate bodies made based on provisions of international treaties of the Russian Federation in their interpretation contradicting the Constitution of the Russian Federation are not subject to execution in the Russian Federation. Such contradiction can be established according to the procedure, determined by the Federal constitutional Law.

5. Results of the clinical trials of medicines for medical application conducted outside the territory of the Russian Federation are recognized the Russian Federation according to international treaties of the Russian Federation and (or) on the basis of the principle of reciprocity.

Article 4. The basic concepts used in this Federal Law

For the purposes of this Federal Law the following basic concepts are used:

1) medicines - substances or their combinations coming into contact with human body or animal, getting into bodies, the body tissues of the person or animal applied to prevention, diagnosis (except for substances or their combinations which are not contacting to human body or animal), treatments of disease, rehabilitation, for preserving, prevention or abortion and received from blood, blood plasma, from bodies, body tissues of the person or animal, plants, minerals by methods of synthesis or using biological technologies. Pharmaceutical substances and medicines belong to medicines;

2) pharmaceutical substance - medicine in the form of one or several active ingredients having pharmacological activity regardless of the nature of origin which is intended for production of production of medicines and determines their efficiency;

3) excipients - the substances of inorganic or organic origin used in production process, production of medicines for giving of necessary physical and chemical properties to them;

4) medicines - the medicines in the form of dosage forms applied to prevention, diagnosis, treatment of disease, rehabilitation for preserving, prevention or abortion;

5) dosage form - the medicine condition corresponding to methods of its introduction and use and providing achievement of necessary medical effect;

5. 1) dosage - content of one or several active ingredients in quantitative expression per unit of dose, either unit of volume, or unit of mass according to dosage form or for some types of dosage forms amount of the active ingredient released from dosage form for unit of time;

6) the list of vital and essential drugs - the list of the medicines for medical application providing priority requirements of health care for the purpose of prevention and treatment of the diseases including prevailing in structure of incidence in the Russian Federation approved by the Government of the Russian Federation;

6. 1) orphan medicines - the medicines intended only for diagnosis or pathogenetic treatment (the treatment directed to the disease development mechanism) of rare (orphan) diseases;

6. 2) biological medicines - medicines which active ingredient is made or emitted from biological source and for determination of properties and which qualities the combination of biological and physical and chemical methods is necessary. The immunobiological medicines, medicines received from blood, blood plasma of the person and animals (except for whole blood), biotechnological medicines, gene therapeutical medicines belong to biological medicines;

7) immunobiological medicines - the medicines intended for forming of active or passive immunity or diagnosis of availability of immunity or diagnosis of the specific acquired change of the immunological answer to allergenic substances. Vaccines, anatoxins, toxins, serums, immunoglobulins and allergens belong to immunobiological medicines;

7. 1) biotechnological medicines - medicines which production is performed with use of bioengineering procedures and methods (including DNA-recombinant technology, technology of controlled expression of the genes coding biologically active proteins in prokariota and eukaryotes including the changed cells of mammals), gibridomny method and method of monoclonal antibodies;

7. 2) gene therapeutical medicines - medicines which pharmaceutical substance is recombinant nucleic acid or includes the recombinant nucleic acid allowing to perform regulation, reparation, replacement, addition or removal of the genetic sequence;

8) narcotic medicines - the medicines and pharmaceutical substances containing drugs and included in the List of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the Single convention on drugs of 1961;

9) psychotropic medicines - the medicines and pharmaceutical substances containing psychotropic substances and included in the List of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the Convention on psychotropic substances of 1971;

10) radio pharmaceutical medicines - medicines which contain one radionuclide or several radionuclides (radioactive isotopes) in form, ready for use;

10. 1) original medicine - medicine with new active ingredient which is registered by the first in the Russian Federation or in foreign states based on results of preclinical trials of medicines and clinical trials of the medicines confirming its quality, efficiency and safety;

11) reference medicine - medicine which is used for assessment of bioequivalence or therapeutic equivalence, quality, efficiency and safety of the reproduced medicine or bioanalog (biosimilar) medicine (bioanalogue). As reference medicine for medical application original medicine is used or if original medicine is not registered or is not in circulation in the Russian Federation and the reproduced medicine or bioanalog (biosimilar) medicine (bioanalogue) which is registered by the first from among being in circulation in the Russian Federation, bioequivalence or therapeutic equivalence which quality, efficiency and safety were estimated in relation to original medicine, and also quality which efficiency and safety are confirmed by results of pharmakonadzor and checks of compliance of the medicines which are in civil circulation, to the established requirements to their quality is not in circulation in foreign states. As reference medicine for veterinary use the medicine for veterinary use registered in the Russian Federation based on results of preclinical trials of medicines and clinical trials of the medicines confirming its quality, efficiency and safety is used;

12) the reproduced medicine - medicine for medical application which has high-quality structure equivalent to reference medicine and quantitative composition of active ingredients in equivalent dosage form, or medicine for veterinary use which has same, as reference medicine, high-quality structure and quantitative composition of active ingredients in the same dosage form bioequivalence or therapeutic equivalence of which to the corresponding reference medicine is confirmed with the corresponding researches;

12. 1) therapeutic equivalence of medicines - achievement of clinically comparable therapeutic effect and performance indicators and safety in case of use of the medicines for medical application having one international unlicensed (either chemical, or grouping) the name, in equivalent dosages according to the same indications to use and in case of identical method of introduction at the same group of patients;

12. 2) bioanalog (biosimilar) medicine (bioanalogue) - the biological medicine similar in parameters of quality, efficiency and safety to reference biological medicine in the same dosage form and the having identical method of introduction;

12. 3) interchangeable medicine - the medicine with the proved therapeutic equivalence or bioequivalence concerning reference medicine having high-quality compositions and quantitative composition of active ingredients, composition of excipients, dosage form and method of introduction equivalent to it;

12. 4) bioequivalence of medicines - achievement of comparable indicators of speed of absorption, extent of receipt to the scene of action and speed of removal of one or several active ingredients having pharmacological activity in case of use of the medicines for medical application having one international unlicensed (either chemical, or grouping) the name, in equivalent dosages and in case of identical method of introduction;

13) medicinal vegetable raw materials - the fresh or dried-up plants or their parts used for production of medicines by the organizations - producers of medicines or production of medicines by the pharmaceutical organizations, the veterinary pharmaceutical organizations, the individual entrepreneurs having the license for pharmaceutical activities;

14) medicinal vegetable drug - the medicine made or made of one type of medicinal vegetable raw materials or several types of such raw materials and realized in packaged type in secondary (consumer) package;

15) homeopathic medicine - the medicine made or made of pharmaceutical substance or pharmaceutical substances according to requirements of general pharmacopoeian clauses to homeopathic medicines or according to requirements of pharmacopeia of the country of the producer of such medicine;

16) the international non-proprietary name of medicine - the name of active ingredient of pharmaceutical substance recommended by the World Health Organization;

17) the trade name of medicine - the name of medicine appropriated by his developer, the holder or the owner of the registration certificate of medicine;

17. 1) the grouping name of medicine - the name of the medicine which does not have the international non-proprietary name, or combination of medicines, used for the purpose of their consolidation in group under the single name proceeding from identical composition of active ingredients;

18) general pharmacopoeian clause - the document approved by authorized federal executive body and containing list of indicators of quality and (or) methods of quality control of specific dosage form, medicinal vegetable raw materials, the description of biological, biochemical, microbiological, physical and chemical, physical, chemical and other methods of the analysis of medicine, and also the requirement to the reactants used for the purpose of carrying out this analysis, the titrated solutions, indicators;

19) pharmacopoeian Article - the document approved by authorized federal executive body and containing list of indicators of quality and methods of quality control of medicine;

19. 1) standard samples - substances by means of comparison with which quality control of the researched medicines by means of physical and chemical and biological methods for the purpose of confirmation of conformity of medicines to the requirements of the regulating documentation established when implementing state registration and which are applied to calibration of standard samples of the producer of the medicines used for quality control and other purposes in case of drug circulation is exercised;

19. 2) pharmacopoeian standard sample - the standard sample made according to pharmacopoeian Article;

20) the regulating documentation - the document containing list of the corresponding examinations of indicators of quality of medicine determined by results for medical application, control methods of its quality and established by his producer;

21) the regulating document - the document containing list of the corresponding examinations of indicators of quality and (or) methods of quality control of dosage form, the description of biological, biochemical, microbiological, physical and chemical, physical, chemical and other methods of the analysis of medicines determined by results for veterinary use, the requirement to the reactants used for the purpose of carrying out this analysis, the titrated solutions, indicators and established by his producer;

21. 1) the general technical document - the set of documents and materials consisting of several Sections - documentation of administrative nature, chemical, pharmaceutical and biological documentation, pharmacological, toxicological documentation, clinical documentation and represented along with the statement for state registration of medicine for medical application in the format established by authorized federal executive body;

22) quality of medicine - medicine compliance to requirements of pharmacopoeian Article or in case of its lack of the regulating documentation or the regulating document;

23) safety of medicine - the characteristic of medicine based on comparative analysis of its efficiency and risk of damnification to health;

24) efficiency of medicine - the characteristic of extent of positive influence of medicine on current, duration of disease or its prevention, rehabilitation, on preserving, prevention or abortion;

25) medicine series - the amount of medicine made as a result of one production cycle by his producer;

26) the registration certificate of medicine - the document confirming the fact of state registration of medicine;

26. 1) the holder or the owner of the registration certificate of medicine - developer of medicine, producer of medicines or other legal entity having right of possession the registration certificate which bear responsibility for quality, efficiency and safety of medicine;

27) registration number - the specification symbol appropriated to medicine in case of its state registration;

28) drug circulation - development, preclinical trials, clinical trials, examination, state registration, standardization and quality control, production, production, storage, transportation, import to the Russian Federation, export from the Russian Federation, advertizing, leave, realization, transfer, use, destruction of medicines;

29) subjects of drug circulation - physical persons, including individual entrepreneurs, and the legal entities performing activities in case of drug circulation;

30) developer of medicine - the organization having rights to results of preclinical trials of medicine, clinical trials of medicine and (or) to the production technology of medicine;

31) production of medicines - activities for production of medicines by the organizations - producers of medicines at one stage, several or all stages of engineering procedure, and also on storage and realization of the made medicines;

31. 1) the production site - territorially isolated complex of the producer of medicines intended for accomplishment of all production process of medicines or its certain stage;

32) producer of medicines - the organization performing production of medicines according to requirements of this Federal Law;

33) pharmaceutical activities - the activities including wholesale trade by medicines, their storage, transportation and (or) retail trade by medicines, including remote method, their leave, storage, transportation, production of medicines;

34) the organization of wholesale trade by medicines - the organization performing wholesale trade by medicines, their storage, transportation according to requirements of this Federal Law;

35) the pharmaceutical organization - the organization, structural division of the medical organization performing retail trade medicines, including by remote method, storage, transportation, production and leave of medicines for medical application according to requirements of this Federal Law;

36) the veterinary pharmaceutical organization - the organization, structural division of the veterinary organization performing retail trade medicines, including by remote method, storage, production and leave of medicines for veterinary use according to requirements of this Federal Law;

37) counterfeited medicine - the medicine accompanied with false information about its structure and (or) the producer;

38) substandard medicine - the medicine which is not conforming to requirements of pharmacopoeian Article or in case of its absence to requirements of the regulating documentation or the regulating document;

39) counterfeit medicine - the medicine which is in circulation with violation of the civil legislation;

40) preclinical trial of medicine - biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other researches of medicine by use of scientific methods of estimates for the purpose of receipt of proofs of safety, quality and efficiency of medicine;

41) clinical trial of medicine - studying of diagnostic, medicinal, preventive, pharmacological properties of medicine in the course of its use for the person, animal, including processes of absorption, distribution, change and removal, by use of scientific methods of estimates for the purpose of the receipt of proofs of safety, quality and efficiency of medicine this about undesirable reactions of human body, animal on use of medicine and about effect of its interaction with other medicines and (or) foodstuff, sterns;

42) multicenter clinical trial of medicine for medical application - the clinical trial of medicine for medical application conducted by developer of medicine in two and more medical organizations for the single protocol of clinical trial of medicine;

43) the international multicenter clinical trial of medicine for medical application - the clinical trial of medicine for medical application conducted by developer of medicine in the different countries under the single protocol of clinical trial of medicine;

44) post-registration clinical trial of medicine for medical application - the clinical trial of medicine for medical application conducted by producer of medicine which civil circulation is performed after state registration, for the purpose of the additional charge of data on its safety and efficiency, extension of indications to use of this medicine, and also identification of undesirable reactions of patients to its action;

45) research of bioequivalence of medicine - type of clinical trial of medicine which carrying out is performed for determination of speed of absorption and removal of one or several active ingredients having pharmacological activity, amount of the medicine reaching system blood-groove and which results allow to draw conclusion on bioequivalence of the reproduced medicine in the determined dosage form and dosage, the corresponding form and dosage of reference medicine;

46) research of therapeutic equivalence of medicines - type of clinical trial of medicines which carrying out is performed for detection of identical properties of medicines of certain dosage form, and also availability of identical indicators of safety and efficiency of medicines, identical clinical effects in case of their use;

47) the protocol of clinical trial of medicine - the document in which the purposes, forms of the organization and methodology of conduct of clinical trial, statistical techniques of processing of results of such research and measure for safety of the physical persons participating in clinical trial of medicine are determined;

48) the brochure of the researcher - summary statement of results of preclinical trial of medicine and clinical trial of medicine for medical application;

49) the information leaflet of the patient - the document in which contain in available form of the data, concerning the conducted clinical trial of medicine, and in writing the voluntary consent of the patient to participation in clinical trial of medicine after acquaintance with the features of clinical trial important for expression of such consent;

50) side effect - the reaction of organism which arose in connection with use of medicine in the doses recommended in the instruction for its use for prevention, diagnosis, treatment of disease or for rehabilitation;

50. 1) undesirable reaction - inadvertent adverse reaction of organism which can be connected using medicine;

51) serious undesirable reaction - the undesirable reaction of organism connected using medicine, which led to death, congenital anomalies or malformations or representing threat of life, requiring hospitalization or led to permanent disability and (or) disability;

52) unexpected undesirable reaction - undesirable reaction of organism which is connected using medicine in the doses recommended in the protocol of its clinical trial, the brochure of the researcher or using medicine in the doses recommended in the instruction for its use for prevention, diagnosis, treatment of disease or medical rehabilitation of the patient, and essence weight or outcome of which does not correspond to information on medicine containing in the protocol of its clinical trial, the brochure of the researcher or in the application instruction of medicine;

52. 1) pharmakonadzor - the type of activity on monitoring of efficiency and safety of medicines directed to identification, assessment and prevention of undesirable effects of use of medicines;

52. 2) the risk management plan - the detailed description of the actions for pharmakonadzor directed to identification, assessment and prevention or risk minimization, connected with medicines including efficiency evaluation of these actions;

53) the recipe on medicine - the medical document of the established form containing purpose of medicine for medical application, issued by the health worker for the purpose of leave of medicine or its production and leave on paper or with the consent of the patient or his legal representative in electronic form signed with use of the strengthened qualified digital signature of the health worker or the document of the established form containing purpose of medicine for veterinary use, issued by the specialist in the field of veterinary science for the purpose of leave of medicine or its production and leave on paper;

54) the requirement of the medical organization, veterinary organization - the document of the established form which is written out by the health worker or the specialist in the field of veterinary science having the right to it and contains in writing specifying of the pharmaceutical organization or veterinary pharmaceutical organization about leave of medicine or about its production and about leave for ensuring medical process in the medical organization, the veterinary organization;

55) complex assessment of medicine - assessment of the registered medicine including information analysis about comparative clinical performance and safety of medicine, assessment of economic effects of its use, studying of additional effects of use of medicine for the purpose of decision making about possibilities of inclusion of medicine in the list of vital and essential drugs, the regulatory legal acts and other documents determining procedure for delivery of health care, or its exception of the specified lists, acts and documents;

56) monitoring system of movement of medicines for medical application - federal state information system of monitoring of movement of medicines for medical application from the producer to the final consumer with use in respect of medicines for medical application of means of identification.

Chapter 2. Powers of federal executive bodies, executive bodies of subjects of the Russian Federation in case of drug circulation

Article 5. Powers of federal executive bodies in case of drug circulation

In case of drug circulation treat powers of federal executive bodies:

1) carrying out in the Russian Federation single state policy in the field of providing citizens with medicines in the Russian Federation;

2) approval of general pharmacopoeian clauses, pharmacopoeian Articles, edition of the state pharmacopeia, creation and maintaining register of pharmacopoeian standard samples;

3) implementation of federal state control (supervision) in the field of drug circulation;

4) licensing of production of medicines, including federal state licensed control of activities for production of medicines, periodic confirmation of conformity of the licensee having the license for production of medicines and pharmaceutical activities in accordance with the legislation of the Russian Federation;

5) the organization of examination of medicines, ethical examination of possibility of conduct of clinical trial of medicine for medical application, examination of the documents submitted for determination of opportunity to consider medicine for medical application in case of state registration as orphan medicine;

5. 1) the organization of carrying out complex assessment of medicine for the purpose of decision making about possibilities of inclusion of medicine in the list of vital and essential drugs, the regulatory legal acts and other documents determining procedure for delivery of health care or its exception of the specified lists, acts and documents;

6) issue of permissions to conduct of clinical trials of medicines, maintaining the register of the issued permissions to conduct of clinical trials of medicines;

7) state registration of medicines, maintaining the state register of medicines;

8) the organization and (or) conducting inspection of subjects of drug circulation on compliance to rules of proper laboratory practice, to rules of proper clinical practice, rules of proper practice of storage and transportation of medicines, rules of proper distributor practice, rules of proper pharmaceutical practice;

8. 1) the organization and (or) conducting inspection of subjects of drug circulation on compliance to requirements of rules of proper production practice, issue of the conclusions about compliance of the producer of medicines to requirements of rules of proper production practice;

8. 2) establishment of procedure for maintaining and maintaining the state register of the conclusions about compliance of the producer of medicines to requirements of rules of proper production practice;

9) marginal state registration of selling prices of producers on the medicines included in the list of vital and essential drugs, and maintaining the marginal state register of selling prices of producers on the medicines included in the list of vital and essential drugs;

9. 1) approval of drafts of decisions of executive bodies of subjects of the Russian Federation on establishment and (or) limiting change of the sizes of wholesale allowances and the extreme sizes of retail allowances to the actual selling prices established by producers of medicines on the medicines included in the list of vital and essential drugs;

10) issue, establishment of approval procedure on import of specific batch of medicine to the Russian Federation;

10. 1) issue, establishment of procedure for issue and the document form which confirms that production of medicine for medical application is performed according to requirements of rules of proper production practice or that medicine for veterinary use is allowed to the address in the Russian Federation, and is subject to representation upon the demand of authorized body of the country into which medicine is imported;

10. 2) issue, establishment of the procedure for issue and the document form containing data on the stages of engineering procedure of production of medicine for medical application performed in the territory of the Eurasian Economic Union;

11) creation of councils on the questions connected with drug circulation;

12) certification and certification of specialists;

13) ceased to be valid according to the Federal Law of the Russian Federation of 02.07.2013 No. 185-FZ

14) implementation of pharmakonadzor;

15) participation in international cooperation;

16) obtaining on requests of authorized federal executive body from executive bodies of subjects of the Russian Federation, and also from subjects of drug circulation for medical application of information on questions of establishment and use of the prices of medicines and allowances to them;

17) use of measures of responsibility for violation of the legislation of the Russian Federation;

18) approval of rules of proper laboratory practice, rules of proper clinical practice, rules of proper production practice, rules of proper practice of storage and transportation of medicines, rules of proper distributor practice, rules of proper pharmaceutical practice, rules of proper practice of pharmakonadzor of medicines for medical application;

19) establishment of procedure for forming of the registration file on medicine and requirements to documents in its structure;

20) approval of rules of the rational choice of names of medicines for medical application;

21) approval of the list of names of dosage forms;

22) ceased to be valid according to the Federal Law of the Russian Federation of 27.12.2019 No. 475-FZ

23) approval of requirements to the instruction on medical application of medicines and to the instruction for veterinary use of medicines;

24) decision making, the domain names and (or) indexes of pages of the websites which are the bases for inclusion on the Internet, and also network addresses in the single automated information system "The Unified Register of Domain Names, Indexes of Pages of the Websites on the Internet and the Network Addresses Allowing to Identify the Websites on the Internet Containing Information Which Distribution in the Russian Federation Is Forbidden", concerning information containing the offer on retail trade medicines, including by remote method, retail trade by which it is limited or prohibited according to this Federal Law, and (or) information containing the offer on retail trade by medicines, including by remote method, persons not having the license and permission to implementation of such activities if receipt of the license and permission is stipulated by the legislation about drug circulation;

25) issue of permissions to input in civil circulation of immunobiological medicines.

Article 5.1. Transfer of implementation of powers of federal executive bodies in case of drug circulation to executive bodies of subjects of the Russian Federation

The powers of federal executive bodies in case of drug circulation provided by this Federal Law can be transferred for implementation to executive bodies of subjects of the Russian Federation by orders of the Government of the Russian Federation according to the procedure, No. 184-FZ established by the Federal Law of October 6, 1999 "About the general principles of the organization of legislative (representative) and executive bodies of the government of subjects of the Russian Federation".

Article 6. Powers of executive bodies of the subject of the Russian Federation in case of drug circulation

In case of drug circulation treat powers of executive bodies of the subject of the Russian Federation:

1) development and implementation of regional programs of providing population with medicines;

2) limiting establishment of the sizes of wholesale allowances and the extreme sizes of retail allowances to the actual selling prices established by producers of medicines on the medicines included in the list of vital and essential drugs;

3) implementation of regional state control of use of the prices of the medicines included in the list of vital and essential drugs, the organizations of wholesale trade by medicines, the pharmaceutical organizations, the individual entrepreneurs having the license for pharmaceutical activities, the medical organizations having the license for pharmaceutical activities and their separate divisions (out-patient clinics, medical assistant's and medical and obstetrical centers, the centers (departments) of general medical (family) practice) located in rural settlements in which there are no pharmaceutical organizations;

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