On Drug Circulation

 

Adopted by the State Duma                                                  March 24, 2010

 

 

Chapter 1. General Provisions

 

Article 1. Subject of Regulation of This Federal Law

 

1. This Federal Law governs the relations in connection with drug circulation, namely: development, pre-clinical and clinical trials, review, state registration, standardization and quality control, manufacturing, production, storage, transportation, import to/ export from the Russian Federation, advertising, dispensing, sales, transfer, administration and destruction.

2. This Federal Law prioritizes government control over drug safety, quality and efficacy in the field of their circulation.

Article 2. Scope of This Federal Law

 

This Federal Law is applicable to relations in the field of drug circulation in the Russian Federation.

Article 3. Legislation on Drug Circulation

 

1. The legislation on drug circulation comprises this Federal Law, other federal laws and other regulations of the Russian Federation.

2. This Federal Law covers circulation of narcotic and mood-altering drugs subject to specific features provided for by the law of the Russian Federation on narcotic, mood-altering drugs and their pre-cursors.

3. This Federal Law covers circulation of radioactive drugs subject to specific features provided for by the law of the Russian Federation on radiation safety.

4. If an international treaty of the Russian Federation establishes any other rules than those envisaged in this Federal Law, the provisions of the international treaty are applicable.

5. Findings of medicinal drug clinical trials held outside the Russian Federation are recognized in the Russian Federation in accordance with international treaties of the Russian Federation and/or on the basis of reciprocity principle.

Article 4. Main Definitions Used in This Federal Law

 

The following main definitions are used for the purposes of this Federal Law:-

1) Drugs mean substances or their combinations, which come into direct contact with and penetrate organs and tissues of a human or animal body, applied for disease prevention, diagnosis (except for those not coming into contact with a human or animal body) and treatment, recovery, pregnancy maintenance, prevention or interruption, which are obtained from blood, blood plasma and also human or animal organs, tissues, plants and minerals using the synthesis methods or with application of biological technologies. Drugs include pharmaceutical substances and pharmaceuticals;

2) Pharmaceutical Substances mean drugs in the form of active ingredients of biological, biotechnological, mineral or chemical origin, having pharmacological activity, intended for drug manufacturing and production and determining their efficacy;

3) Auxiliary Substances mean substances of organic and non-organic origin used in drug manufacturing and production to lend the necessary physical and chemical properties to them;

4) Pharmaceuticals mean drugs as dosage forms applied for disease prevention, diagnosis and treatment, recovery, pregnancy maintenance, prevention or interruption;

5) Dosage Form means the form of a pharmaceutical, which corresponds to the method of its administration and the way of its application and helps achieve the appropriate therapeutic effect;

6) List of Vital and Essential Drugs means the list of medicinal drugs as approved of by the Government of the Russian Federation on an annual basis, which help meet the top-priority healthcare needs in disease prevention and treatment, including those prevailing in the incidence pattern among the population of the Russian Federation;

7) Immunobiological Drugs mean pharmaceuticals of biological origin intended for immunological diagnosis, prevention and treatment;

8) Narcotic Drugs mean drugs and pharmaceutical substances that contain narcotic substances and are included into the List of narcotic drugs, mood-altering substances and their pre-cursors 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 Narcotic Drugs 1961;

9) Mood-Altering Drugs mean pharmaceuticals and pharmaceutical substances that contain mood-altering substances and are included into the list of narcotic drugs, mood-altering substances and their pre-cursors 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 Mood-altering Substances 1971;

10) Radioactive Drugs are drugs containing one or several radionuclides (radioactive isotopes) in the ready-for-use form;

11) Original Drug means a drug containing a new, newly obtained pharmaceutical substance or a new combination of pharmaceutical substances, the efficacy and safety of which are evidenced by the findings of drug pre-clinical and clinical trials;

12) Reproduced Drug means a drug that contains the same pharmaceutical substance or the combination of the same pharmaceutical substances in the same dosage form as the original drug and that entered the circulation after the original drug;

13) Medicinal Plant Raw Material means fresh or dried plants or their parts used for drug manufacturing by drug manufacturers or for drug production in pharmacies, veterinary pharmacies and by individual entrepreneurs holding a pharmaceutical license;

14) Medicinal Plant Drug means a drug manufactured or produced from one or several types of medicinal plant raw material and marketed in the prepackaged form in the secondary (consumer) package;

15) Homeopathic Drug means a drug manufactured or produced under a special technology;

16) International Non-Proprietary Name of a drug means the name of a pharmaceutical substance as recommended by the World Health Organization;

17) Trade Name of a drug means the name of a drug as assigned by the drug developer;

18) General Monograph means a document approved of by the competent federal executive authority and containing a list of quality parameters and/or quality control methods for any particular drug dosage, medicinal plant raw material, a description of biological, biochemical, microbiological, physical and chemical, physical, chemical and other medicinal drug analysis methods, requirements to used reagents, titrants, indicators;

19) Monograph means a document approved of by the competent federal executive authority and containing a list of quality parameters and medicinal drug quality control methods;

20) Regulatory Documents mean the document containing a list of medicinal drug quality parameters, drug quality control methods as determined based on the review results and established by its manufacturer;

21) Regulatory Document means the document containing a list of quality parameters and/or drug dosage quality control methods as determined based on the results of reviews and also a description of biological, biochemical, micro-biological, physical and chemical, physical, chemical and other veterinary drug analysis methods, requirements to used reagents, titrants, indicators and as established by its manufacturer;

22) Drug Quality means conformity of a drug to the Monograph requirements or, if they do not exist, to Regulatory Documents or the Regulatory Document;

23) Drug Safety means the drug feature based on comparative analysis of their efficacy and risk of harm to health;

24) Pharmaceutical Efficacy means the extent, to which a pharmaceutical produces a positive impact on the disease progress, duration or prevention, recovery, pregnancy maintenance, prevention or interruption;

25) Drug Series means quantity of a drug manufactured by the drug manufacturer as a result of one technological cycle;

26) Drug Registration Certificate means a document that evidences state registration of a drug;

27) Registration Number means a code designation assigned to a drug in state registration;

28) Drug Circulation means drug development, pre-clinical and clinical trials, review, state registration, standardization and quality control, manufacturing, production, storage, transportation, import to/ export from the Russian Federation, advertising, dispensing, sales, transfer, administration and destruction;

29) Drug Circulation Subjects mean individuals, including individual entrepreneurs, and legal entities that operate in the field of drug circulation;

30) Drug Developer means an organization holding rights to deliverables of drug pre-clinical and clinical trials and to drug manufacturing technology;

31) Drug Manufacturing means activities aimed at industrial manufacturing of drugs, including one, more or all stages of a technological process, including storage and sales of manufactured drugs;

32) Drug Manufacturer means an organization that manufactures drugs in accordance with requirements of this Federal Law;

33) Pharmaceutical Operations mean operations, including wholesale in drugs, storage, transportation and/or retail trade in drugs, dispensing, storage, transportation and production of drugs;

34) Drug Wholesaler means an organization that carries out wholesale trade in drugs, storage and transportation of drugs in accordance with requirements of this Federal Law;

35) Pharmacy means an organization, a business unit of a healthcare institution engaged in retail trade, storage, production and dispensing of medicinal drugs in accordance with requirements of this Federal Law;

36) Veterinary Pharmacy means an organization, a business unit of a veterinary organization engaged in retail trade, storage, production and dispensing of veterinary drugs in accordance with requirements of this Federal Law;

37) Fake Drug means a drug accompanied with untrue information on its composition and/or manufacturer;

38) Low-quality Drug means a drug that does not meet the Monograph requirements or Regulatory Documents or the Regulatory Document;

39) Counterfeited Drug means a drug circulated in violation of the civil law;

40) Drug Pre-Clinical Trial means biological, micro-biological, immunological, toxicological, pharmacological, physical, chemical and other trials aimed at obtaining, by application of scientific methods, of drug quality, efficacy and safety assessments and evidences;

41) Drug Clinical Trial means a study of diagnostic, therapeutic, preventive, pharmacological, properties of a drug when administered to a human being, an animal, including absorption, distribution, modification and clearance, aimed at obtaining, by application of scientific methods, of drug quality, efficacy and safety assessments and evidences, data on human or animal adverse responses to its administration and its interaction with other drugs and/or food (fodder);

42) Multicenter Medicinal Drug Trial means a medicinal drug clinical trial held by the drug developer in two and more healthcare institutions under the single drug clinical trial protocol;

43) International Multicenter Medicinal Drug Trial means a medicinal drug clinical trial held by the drug developer in various countries under the single drug clinical trial protocol;

44) Post-Registration Medicinal Drug Clinical Trial means a medicinal drug clinical trial held by the manufacturer of a drug brought in civil circulation after state registration for collection of additional data on its efficacy and safety, expansion of the drug indications and also identification of patients’ adverse responses to its effect;

45) Drug Bio-Equivalency Studies mean a type of clinical trials to determine the speed of absorption and clearance of the pharmaceutical substance and its quantity that reaches the systemic blood circulation, the findings of which enable to make a conclusion on bio-equivalence of any particular drug dosage and dose of a reproduced pharmaceutical to the respective original pharmaceutical;

46) Drug Therapeutic Equivalence Trial means a type of drug clinical trials, which is conducted for identification of the same drug parameters of a specific drug dosage, as well as of the same drug safety and efficacy parameters, if any, of the same clinical effects in their administration;

47) Drug Clinical Trial Protocol means a document that describes purposes of, arrangement for and methods of holding a clinical trial, statistical methods of processing of obtained results and measures to ensure safety of persons taking part in the drug clinical trial;

48) Investigator’s Booklet means consolidated statement of findings of held pre-clinical and clinical medicinal drug trial;

49) Patient’s Information Sheet means a document that contains, in intelligible form, information pertaining to the conducted drug clinical trial, with a documented patient’s voluntary informed consent to participation in a drug clinical trial which is given upon familiarization with all of the particular clinical trial features significant for decision-making;

50) Side Effect means an response of a body in connection with drug use in doses recommended in its leaflet for prevention, diagnosis, treatment of a disease or for recovery;

51) Severe Adverse Effect means an adverse response of a body in connection with drug use that resulted in death, congenital anomalies or developmental defects, or is life-threatening, requires admission to hospital or leads to permanent incapacity and/or disability;

52) Unexpected Adverse Effect means an adverse body response (including in connection with drug use in accordance with its leaftet), the essence and severity of which do not conform to the drug information contained in its leaflet;

53) Drug Prescription means a written drug prescription in the established format, which was issued by an authorized medical or veterinary worker for dispensing of the drug or for its production and dispensing;

54) Healthcare Institution, Veterinary Organization Requirement means a document in the established format, signed by a medical or veterinary worker with the respective right and containing a written instruction for a pharmacy to dispense a drug or to produce and dispense it for treatment purposes of the healthcare institution, veterinary organization.

 

Chapter 2. Powers of Federal Executive Authorities,

Executive Authorities of the Russian Federation Constituent Territories in the Field of Drug Circulation

 

Article 5. Powers of Federal Executive Authorities

in the Field of Drug Circulation

 

The powers of federal executive authorities in the field of drug circulation include:-

1) ensuring that the uniform governmental policy for provision of the population with drugs is implemented in the Russian Federation;

2) approval of General Monographs, Monographs and publication of the National Monograph;

3) exercise of governmental control and supervision;

4) licensing of drug manufacturing and pharmaceutical operations in accordance with the law of the Russian Federation;

5) arranging for drug review, ethical review in connection with medicinal drug clinical trials;

6) issue of authorizations for drug clinical trials and keeping of the Register of issued authorizations for drug clinical trials;

7) state registration of drugs and keeping of the State Register of drugs;

8) examination of drug manufacturing for conformity to the rules of drug manufacturing and quality control, issue of opinions on conformity of the drug manufacturer to the rules of drug manufacturing and quality control;

9) state registration of the maximum ex-works manufacturer prices for vital and essential drugs and keeping of the State Register of the maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

10) establishment of the procedure for drug import to/ export from the Russian Federation;

11) establishment of boards on drug circulation;

12) attestation and certification of specialists;

13) approval of educational programs for specialists’ training;

14) drug safety monitoring;

15) participation in international cooperation;

16) obtaining, at requests of a competent federal executive authority, of information on determination and application of drug prices and mark-ups thereon from executive authorities of the Russian Federation constituent territories and also from subjects of the medicinal drug circulation;

17) enforcement of measures for violation of the law of the Russian Federation.

Article 6. Powers of Executive Authorities

of the Russian Federation Constituent Territory

in the Field of Drug Circulation

 

The powers of executive authorities of the Russian Federation constituent territory in the field of drug circulation include:-

1) development and implementation of regional programs for provision of the population with drugs;

2) determination of the maximum wholesale and retail mark-ups on actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

3) exercise of control over application of prices for drugs included in the list of vital and essential drugs by wholesale operators, pharmacies and individual entrepreneurs holding a pharmaceutical license.

 

Chapter 3. National Monograph

 

Article 7. Development and Publication of

the National Monograph,

Placement of Data on It

 

1. The National Monograph is the code of General Monographs and Monographs.

2. Development of General Monographs and Monographs and inclusion thereof in the National Monograph are implemented in the manner established by the competent federal executive authority.

3. A Monograph for an original drug is developed and included in the National Monograph during the effective period of the original drug patent protection subject to consent of the drug developer.

4. The National Monograph is published by the competent federal executive authority using the federal budget funds and is subject to re-publication at least once in 5 years. In the period between publication dates of the National Monograph, appendices to the National Monograph, which contain General Monographs and/or Monographs approved of after publication/ re-publication of the National Monograph, are published.

5. The competent federal executive authority posts data on the National Monograph and appendices thereto on the official website in the manner established by the authority.

 

Chapter 4. State Control over Drug Circulation

 

Article 8. Licensing of Drug Manufacturing

and Pharmaceutical Operations

 

1. Drug manufacturing and pharmaceutical operations is licensed in accordance with the legislation of the Russian Federation.

2. Indication in the applicant’s application of the dosage forms and/or types of pharmaceutical substances the drug manufacturer is willing to manufacture is the statutory condition for issuing a drug manufacturing license.

3. If drug manufacturing is expanded by new dosage forms and types of pharmaceutical substances, the drug manufacturer should obtain a new license.

Article 9. State Control over Drug Circulation

 

1. All drugs manufactured in and imported to the Russian Federation are subject to state control.

2. State control is exercised by competent federal executive bodies and executive authorities of the Russian Federation constituent territories in accordance with their respective powers.

3. State control over drug circulation includes control over drug pre-clinical and clinical trials, quality, manufacturing, production, storage, transportation, import to the Russian Federation, advertising, dispensing, sales, destruction, and administration.

4. State control is exercised through:-

1) auditing of compliance by drug circulation subjects with laboratory and clinical practice in medicinal drug pre-clinical and clinical trials, rules for veterinary drug pre-clinical and clinical trials, drug manufacturing and quality control rules, wholesale drug trade rules, drug dispensing rules, drug production and dispensing rules, drug storage rules, drug destruction rules;

2) licensing of drug manufacturing and pharmaceutical operations, auditing of compliance with license requirements and conditions;

3) quality control over drugs in civil circulation:-

a) by way of sampling;

b) when conditions of drug manufacturing and quality control, drug wholesale trade, drug retail trade, drug production and drug storage are found to be in conflict with license requirements and conditions;

4) by issuing of authorizations for drug import to the Russian Federation;

5) by drug safety monitoring;

6) by receiving, upon requests from the competent federal executive authority, information on determination and use of prices and mark-ups thereon from executive authorities of the Russian Federation constituent territories, from subjects of the medicinal drug circulation.

5. State control over drug circulation is an expenditure responsibility of the Russian Federation or the Russian Federation constituent territories by control types related to, respectively, powers of federal executive bodies or executive authorities of the Russian Federation constituent territories.

 

Chapter 5. Drug Development, Pre-Clinical Trials

and Veterinary Drug Clinical Trials

 

Article 10. Drug Development

 

1. Drug development includes search for new pharmacologically active ingredients, subsequent study of their therapeutic properties, pre-clinical trials, development of the production technologies for pharmaceutical substances, development of the drug manufacturing compositions and technologies.

2. The drug development is funded from:-

1) the federal budget funds;

2) drug developers’ funds;

3) drug manufacturers’ funds as part of research and development implemented under a contract between the drug developer and the drug manufacturer;

4) any other sources not prohibited by the law of the Russian Federation.

3. Drug developer’s rights are protected by the civil law.

Article 11. Medicinal Drug Pre-Clinical Trial

 

1. A medicinal drug pre-clinical trial is aimed at obtaining, by applying scientific methods, of the drug quality, efficacy and safety assessments and evidences.

2. Medicinal drug pre-clinical trials are held in accordance with the laboratory practice rules approved of by a competent federal executive authority.

3. To arrange for and to hold a medicinal drug pre-clinical trial, drug developers may engage research organizations, educational institutions of higher professional education, having the necessary materials and equipment and specialists qualified in the appropriate field.

4. A medicinal drug pre-clinical trial is held in accordance with a plan approved of by the drug developer, with a protocol kept and a report drafted and containing findings of the drug pre-clinical trial and an opinion on the possibility to hold a clinical trial for the medicinal drug.

5. Compliance with the laboratory practice of and regulations on the use of animals in medicinal drug pre-clinical trials is audited by the competent federal executive authority.

6. Findings of a medicinal drug pre-clinical trial may be submitted to the competent federal executive authority in the established manner, to have the drug registered by state authorities.

Article 12. Veterinary Drug Pre-Clinical and Clinical Trials

 

1. A veterinary drug pre-clinical trial is aimed at obtaining, by applying scientific methods, of the drug quality, efficacy and safety assessments and evidences, including at determining of the period of its clearance from an animal body, to ensure safety of animal products upon application of the drug.

2. Veterinary drug pre-clinical and clinical trials and also drug bio-equivalence trials are held in accordance with the rules approved of by the competent federal executive authority.

3. Veterinary drug pre-clinical and clinical trials are held in accordance with a plan approved of by the drug developer, with the protocol kept and the report drafted and containing findings of the pre-clinical and clinical trials.

4. To arrange for and hold pre-clinical and clinical trials, the drug developer may engage organizations having the necessary materials and equipment and specialists qualified in the appropriate field of studies.

5. Drug clinical trials are held in veterinary institutions and organizations engaged in animal keeping, breeding and raising to:-

1) determine healthy animals’ tolerance thereto;

2) select the most appropriate doses and treatment course using a limited group of animals suffering from any particular disease;

3) establish drug efficacy and safety for animals suffering from any particular disease or prevention efficacy for healthy animals;

4) study possibilities to extend the indications and to identify earlier unknown side effects of the registered drug.

6. A veterinary drug clinical trial is carried out using the drug developer’s funds.

7. Reports on findings of the veterinary drug pre-clinical and clinical trials are drafted by the drug developer, taking into account opinions of the organizations that took part in arranging for and holding of the these trials.

8. The competent federal executive authority performs control over drug pre-clinical and veterinary drug clinical trials.

 

Chapter 6. State Registration of Drugs

 

Article 13. State Registration of Drugs

 

1. Drugs enter into civil circulation in the Russian Federation, if they are registered by the competent federal executive authority.

2. Subject to state registration are:-

1) original drugs;

2) reproduced drugs;

3) new combinations of earlier registered drugs;

4) earlier registered drugs manufactured in other dosage forms, with new doses.

3. State registration of medicinal drugs is carried out based on findings of a drug review and an ethical review of the possibility of a medicinal drug clinical trial (hereinafter ‘the Ethical Review’). State registration of veterinary drugs is carried out based on findings of a veterinary drug review.

4. State registration of drugs is carried out by the competent federal executive authority within the period of time not exceeding two hundred and ten business days from the date the drug state registration application is accepted. This period of time includes the time required for a repeated drug review and/or ethical review in accordance with Article 25 of this Federal Law. The drug state registration period is calculated from the date the drug state registration application accompanied with all necessary documents is accepted by the competent federal executive authority to the date the drug registration certificate is issued. The drug clinical trial period is not accounted for in calculation of the drug state registration period.

5. Not subject to state registration are:-

1) drugs produced in pharmacies, veterinary pharmacies and by individual entrepreneurs holding a pharmaceutical license by drug prescriptions and at requests of medical, veterinary organizations;

2) medicinal plant raw materials;

3) drugs purchased by individuals outside the Russian Federation and intended for personal use;

4) drugs intended for export;

5) radioactive drugs produced in healthcare institutions in the manner established by the competent federal executive authority.

6. Prohibited is state registration:

1) of different drugs under the same trade name;

2) of one drug manufactured under different trade names and submitted for state registration as two and more drugs.

Article 14. Drug Review and Ethical Review Principles

 

1. Drug review and ethical review are based on principles of legality, observance of human and citizens’ rights and freedoms, legal entity rights and also of independence of an expert, neutrality, comprehensiveness and completeness of trials conducted using the most advanced scientific and technical achievements, of responsibility of a federal governmental budgetary drug review institution and experts for holding and quality of the review.

2. The medicinal drug review is conducted on a stage-by-stage basis:-

1) Stage One – review of documents for obtaining a clinical trial authorization for a drug, except for:

a) drugs authorized for medical use in the Russian Federation for over twenty years, with no possibility to hold a bio-equivalence trial in respect thereof;

b) medicinal drugs with global multicenter clinical trials held in respect thereof, including some held in the Russian Federation;

2) Stage Two – review of drug quality control methods proposed and of quality of provided drug samples using these methods (hereinafter ‘the Drug Quality Review’), as well as the review to assess the risk-benefit ratio for the drug, that are implemented after its clinical trial.

3. The veterinary drug review is carried out at one stage and includes the drug quality review and the review to assess the risk-benefit ratio for the drug.

Article 15. Federal Governmental Budgetary

Institution in Charge of Drug Review

 

Drug review is conducted by the federal governmental budgetary institution of the competent federal executive authority as established to ensure exercise of powers of this federal authority to issue authorizations for drug clinical trials and/or to register drugs by the state (hereinafter ‘the Expert Institution’).

Article 16. Drug Review Procedure for the Purpose of

Drug State Registration

 

1. Drug review is carried out by the Expert Institution’s Expert Commission appointed by the head of that institution, based on the drug review assignment issued by the competent federal executive authority. The head of the Expert Institution ensures the good quality of the drug review held in accordance with the assignment of the competent federal executive authority and arranges for drafting a consolidated opinion of the Commission. Persons not employed by the Expert Institution may be included into the Expert Commission as experts by resolution of the head of the Expert Institution, if their special knowledge is necessary for holding the review and there are no such experts in the Institution.

2. The expert in charge of drug review is a qualified employee of the Expert Institution with the higher medical, pharmaceutical, biological, veterinary or chemical education, holding the drug review in the course of his/her job duties (hereinafter ‘the Expert’).

3. In holding drug review, the Expert cannot be dependant in any way on the person who assigned the review, the drug developer or other persons interested in the review results.

4. During drug review it is not allowed to request from the applicant or any other sources any materials required for the review. In case of insufficient materials submitted to the expert for the expert opinion, the expert has the right to enquire submission of the necessary materials from the head of the Expert Institution, and the latter, in its turn, addresses the enquiry to the competent federal executive authority, that issued the drug review assignment.

5. The Expert is obliged, in conducting the drug review assigned to him/her by the head of the Expert Institution, to:-

1) carry out a comprehensive study of the objects and case materials provided to him/her, give a well-substantiated and unbiased opinion on questions posed to him/her or present a reasonable opinion on the impossibility for him/her to carry out the drug review, if the questions posed to him/her go beyond the scope of the expert’s special knowledge, if the study objects and case materials are unsuitable or insufficient for holding of the trials and giving the opinion or if the current scientific development level does not allow to answer the questions posed;

2) refrain from disclosing information, that became known to him/her in connection with the drug review and also information that constitutes public, business or other legally protected secret;

3) ensure preservation of the provided study objects and case materials.

6. The Expert is not entitled to:-

1) hold drug review upon approach by any organizations or individuals directly to him/her;

2) independently collect materials for drug review;

3) hold drug review as a non-governmental expert.

7. The Expert is free to petition the head of the Expert Institution for engagement of other experts in the drug review, if necessary.

8. Each Expert included into the Expert Commission in charge of drug review, independently and on its own, conducts trials, assesses the findings obtained by him/her personally and by other experts and formulates the conclusions on questions posed to them, to the extent of his/her special knowledge.

9. Drug review findings are formalized in the opinion of the Expert Commission. The opinion of the Expert Commission indicates what trials and to what extent were conducted by each expert, what facts were established by each expert and what conclusions were reached. The expert whose opinion differs from the resolution of the Expert Commission is free to draft his/her written opinion, that is attached to the opinion of the Expert Commission.

10. Experts included into the Commission are notified of their liability under the law of the Russian Federation for giving an opinion containing unsubstantiated or fabricated conclusions, and they swear in writing to that effect.

11. The expert qualification commissions determine the level of experts’ professional qualification and attest them as being qualified/not qualified to hold drug review in the manner established by the competent federal executive authority. The experts’ professional qualification level is subject to revision by these commissions at least once in five years.

12. The drug review procedure and the format of the Expert Commission’s opinion are established by the competent federal executive authority.

Article 17. Ethical Review

 

1. The ethical review is conducted to issue the opinion on the ethical feasibility of a medicinal drug clinical trial by the Ethics Board established in the manner established by the competent federal executive authority.

2. The Ethics Board experts may be representatives of medical, scientific, educational institutions of higher professional education, as well as representatives of public, religious associations and mass media. These experts shall not be dependant in any way on drug developers and other persons interested in the ethical review findings.

3. Remuneration is paid to the Board experts in accordance with the contract concluded between the competent federal executive authority that established the Ethics Board and the Ethics Board expert.

4. The Ethics Board experts are liable in accordance with the law of the Russian Federation.

5. Composition of the Ethics Board, the Regulations on the Board, its procedures, requirements to the Ethics Board experts’ qualification and experience in the field of expert assessment of scientific, medical and ethical dimensions of medicinal drug clinical trials, the ethical review arrangement and procedure, the format of the Ethics Board’s opinion are established by the competent federal executive authority. The number of representatives from healthcare institutions may not exceed half of the total number of the Ethics Board experts.

6. Information on the composition of the Ethics Board, its working plans and current activities is posted on the official website of the competent federal executive authority in the Internet in the manner established by the authority.

Article 18. Submission and Consideration of Applications

for State Registration оf Drugs and Presentation of

Necessary Documents

 

1. To ensure state registration of a drug, the drug developer or another legal entity authorized by the drug developer (hereinafter ‘the Applicant’) files an application for state registration of the drug with the competent federal executive authority in charge of state registration of drugs, as well as in the manner established by the latter, the necessary documents to form the drug registration file (hereinafter ‘the Registration File’).

2. The application for state registration of the drug indicates:-

1) name and address of the applicant and/or the drug manufacturer and the address of the drug manufacturing facilities;

2) the drug name (international non-proprietary or chemical and trade names);

3) a list of substances in the drug composition, with indication of quality for each of them;

4) the drug dosage, dose, administration and application method, shelf life;

5) description of pharmacological and pharmaco-dynamic or immunobiological properties of the drug;

6) the declared maximum ex-works manufacturer price in case of state registration of a drug included in the list of vital and essential drugs;

7) no need to hold a clinical trial, a bio-equivalence study for a drug authorized for medical use in the Russian Federation for over twenty years, with specification of normative legal acts evidencing the said period of use.

3. The following documents form the registration file:-

1) the mock-ups of primary and secondary (consumer) drug package;

2) a document translated in Russian, confirming that the manufacturer of the registered drug meets the drug production and quality control rules, issued by the competent authority of the registered drug manufacturer country and certified in the established manner;

3) draft regulatory documents or a draft regulatory document for the drug or indication of the appropriate Monograph;

4) the drug manufacturing process flow chart and its description and/or the pharmaceutical substance manufacturing process flow chart and its description;

5) a document translated in Russian, confirming that the manufacturer of the pharmaceutical substance meets the drug production and quality control rules, issued by the competent authority of the pharmaceutical substance manufacturer country, certified in the established manner, and containing:-

a) the pharmaceutical substance name (international non-proprietary or chemical and trade names);

b) name and address of the pharmaceutical substance manufacturer;

c) the pharmaceutical substance shelf life;

6) a document containing information on quality parameters of the pharmaceutical substance used in drug manufacturing;

7) regulatory documents or a regulatory document for the pharmaceutical substance or indication of the appropriate Monograph;

8) information on the drug storage and transportation conditions and other information;

9) a report on findings of the medicinal drug pre-clinical trial, that contains a description of the conducted drug pre-clinical trial, the findings of the pre-clinical trial and their statistical analysis;

10) a report on findings of the drug pre-clinical trial and the veterinary drug clinical trial;

11) the draft medicinal drug clinical trial protocol;

12) a booklet for an investigator;

13) the information sheet for a patient;

14) information on payments and compensations to patients/ healthy volunteers/ sick persons (hereinafter ‘the Patients’) involved in clinical trials of the medicinal drug, bio-equivalence and/or therapeutic equivalence studies;

15) a report on findings of the medicinal drug global multicenter clinical trials, including some held in the Russian Federation;

16) a draft drug leaflet that contains the following information:-

a) the drug name (international non-proprietary or chemical and trade names);

b) the drug dosage, with indication of names and quantities (activity) of the pharmaceutical substances and auxiliary substances;

c) the drug pharmaco-therapeutic group;

d) the indications;

e) the contraindications;

f) the dosage regimen, administration method; if necessary, the drug administration time, treatment duration (including in children younger and older than one);

g) the precautions at administration;

h) the overdosage sympthoms, assistance in case of overdosage;

i) the indication, if necessary, of the particular features of the drug effect at first administration or its cancellation;

j) the description, if necessary, of the physician’s/ his/her assistant’s/ veterinary specialist’s/ patient’s/ animal owner’s actions, if administration of one or more drug doses is omitted;

k) the possible side effects during drug administration;

l) the interaction with other drugs and/or food, fodder;

m) the indication of the possibility and particular features of medical use of the drug by pregnant women, breast-feeding women, minors and adults with chronic diseases;

n) the information on the possible medicinal drug effect on the ability to drive transportation vehicles, mechanisms;

o) the shelf life and the indication that the drug use is not allowed upon expiry of its shelf life;

p) the storage conditions;

q) the indication that the drug should be stored in locations inaccessible for children;

r) the indication, if necessary, of the special precautions at destruction of the unused drugs;

s) the time of possible use of animal products upon the veterinary drug administration to the animal;

t) the drug manufacturer name, address and the address of the drug manufacturing facilities;

17) a copy of the document, translated into Russian and certified in the established manner, which confirms the drug registration, if it is registered outside the Russian Federation;

18) the documents presented in accordance with Articles 19 to 23 of this Federal Law.

4. Reports on findings of the drug clinical trials, biological equivalence and/or therapeutic equivalence trials (including epidemiological or epizootological trials of immunobiological drugs intended for immunological prevention and treatment of infectious diseases, including in children) held in the applicant’s country and in other countries, which contain a description of the conducted drug trials, the findings and their statistical analysis, may be provided at the option of the applicant.

5. To be attached to an application for state registration of a drug are:-

1) a document evidencing payment of the state duty for the review of the documents with a view to obtain authorizations to hold medicinal drug clinical trials and the ethical review, in case of application for the drug state registration;

2) a document evidencing payment of the state duty for the drug quality review and the review to assess the risk-benefit ratio for a drug authorized for medical use in the Russian Federation for over twenty years, in case of state registration of the drug;

3) a document evidencing payment of the state duty for the drug quality review and the review to assess the risk-benefit ratio for a medicinal drug, with global multicenter clinical trials held in respect thereof, including some held in the Russian Federation, in case of state registration of the drug;

4) a document evidencing payment of the state duty for the drug quality review and the review to assess the risk-benefit ratio for a veterinary drug, in case of state registration of the drug.

Article 19. Making Decisions on Issuance of

Drug Review Assignments to

the Expert Institution and the Ethics Board

 

1. The competent federal executive authority, within five business days from the date the application for state registration of a drug is accepted, verifies completeness and reliability of information contained in the case materials submitted by the applicant and makes a decision to issue an assignment for:

1) the drug review, in particular the review of the documents to obtain a medicinal drug clinical trial authorization in accordance with the purposes specified in Article 38 of this Federal Law, and the ethical review for drugs with no clinical trials held in respect thereof in the Russian Federation, based on the documents specified in subpara. 1 to 9, 11 to 14, 17, par. 3, and subpar. 1, par. 5, Article 18 of this Federal Law;

2) the drug review, in particular the drug quality review and the review to assess the risk-benefit ratio for a medicinal drug authorized for medical use in the Russian Federation for over twenty years, based on the documents specified in subpara. 1 to 9, 16, par. 3, and subpar. 2, par. 5, Article 18 of this Federal Law, as well as for drugs with global multicenter clinical trials held in respect thereof, including some held in the Russian Federation, based on the documents specified in subpara. 1 to 9, 15 to 17, par. 3, and subpar. 3, par. 5, Article 18 of this Federal Law;

3) the drug review for a veterinary drug, based on the documents specified in subpara. 1 to 8, 10, lines ‘a’ to ‘e’, ‘g’ to ‘l’, ‘o’ to ‘t’ of subpar. 16, subpar. 17, par. 3, and subpar. 4, par. 5, Article 18 of this Federal Law.

2. The competent federal executive authority notifies the applicant in writing of the decision made, and in case of a denial, giving reasons for the denial.

3. Partial submission of documents listed in para. 3 and 5 of Article 18 hereof or submission of documents not containing comprehensive information serve as a reason for the denial to arrange for the reviews specified in par. 1 of this Article.

Article 20. Review of the Documents to Obtain

a Medicinal Drug Clinical Trial

Authorization and Ethical Review

 

1. Review of the documents to obtain a medicinal drug clinical trial authorization in accordance with the purposes specified in Article 38 of this Federal Law, ethical review, drafting by the Expert Commission and the Ethics Board of the opinions on the possibility or impossibility of conducting such clinical trial and their submission to the competent federal executive authority are carried out within the period of time not exceeding thirty business days from receipt by the Expert Institution of the assignment from the competent federal executive authority, with all necessary documents listed in subpara. 9, 11 and 12, par. 3, Article 18, and documents specified in par. 4, Article 18 hereof and presented at the applicant’s option, and by the Ethics Board – of the assignment from the competent federal executive authority, with all necessary documents listed in subpara. 11 to 14, par. 3, Article 18, of this Federal Law.

2. The documents contained in the Registration File and received at the Expert Institution, the Ethics Board for their review for the purpose of obtaining a medicinal drug clinical trial authorization are to be returned to the competent federal executive authority simultaneously with the review opinions.

Article 21. Obtaining a Medicinal Drug

Clinical Trial Authorization

 

1. The competent federal executive authority, within five business days from receipt of the opinions specified in Article 20 of this Federal Law, assesses the said opinions to determine whether or not they comply with the assignments for the respective reviews and notifies the applicant in writing of the results of the conducted reviews and the possibility or impossibility to issue a medicinal drug clinical trial authorization to the applicant.

2. If a decision is made on the possibility to issue a medicinal drug clinical trial authorization, the competent federal executive authority suspends state registration of the drug until the applicant submits an application for the medicinal drug clinical trial authorization to the competent federal executive authority.

3. If a decision is made on the impossibility to issue a medicinal drug clinical trial authorization, the competent federal executive authority terminates the drug state registration procedure.

Article 22. Decision on a Medicinal

Drug Clinical Trial

 

1. For obtaining a medicinal drug clinical trial authorization, the applicant submits to the competent federal executive authority the following documents:-

1) the application for the drug clinical trial authorization;

2) information on the investigators’ professional experience and background in the field of clinical trials;

3) copies of life and health obligatory insurance agreements with the patients participating in the medicinal drug clinical trial.

2. The competent federal executive authority, within five business days from the date the application specified in par. 1 of this Article, with all of the necessary documents, is accepted:-

1) verifies completeness and reliability of information contained in the case materials submitted by the applicant;

2) makes a decision to issue the medicinal drug clinical trial authorization or to deny the same;

3) notifies the applicant in writing of the decision made, and in case of a denial, giving reasons for the denial;

4) issues the medicinal drug clinical trial authorization in the manner established by the competent federal executive authority.

3. Failure to provide documents specified in par. 1 of this Article or non-conformity of the content of the submitted documents to the requirements of this Federal Law serve as reasons for a denial to issue the medicinal drug clinical trial authorization.

Article 23. Drug Quality Review and

Risk-Benefit Ratio Assessment

for a Medicinal Drug

 

1. The drug quality review and the risk-benefit ratio assessment for a medicinal drug, drafting by Expert Commissions of opinions on the drug quality review findings and on the drug risk-benefit assessment and their submission to the competent federal executive authority are carried out within the period of time not exceeding one hundred and ten business days from receipt by the Expert Institution of the assignment from the competent federal executive authority with documents specified in subpara. 1 to 8, 15 to 17, par. 3, Article 18 of this Federal Law, and a report on the conducted medicinal drug clinical trial.

2. For holding the review and the assessment specified in par. 1 of this Article, the applicant submits to the competent federal executive authority the following documents:-

1) an application for resumption of the drug state registration and holding of the review and the assessment specified in par. 1 of this Article;

2) a report on the conducted medicinal drug clinical trial;

3) a document evidencing payment of the state duty for the drug quality review and the review to assess the risk-benefit ratio for the medicinal drug, in case of state registration of the drug.

3. The competent federal executive authority, within five business days from the date the application with documents specified in par. 1 and subpara. 2 and 3, par. 2 of this Article, is accepted:-

1) verifies completeness of the information contained in the medicinal drug clinical trial report submitted by the applicant;

2) makes a decision to resume the drug state registration and to hold the review and the assessment specified in par. 1 of this Article or to deny resumption of the medicinal drug state registration and holding of the said review and assessment;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

4. Partial submission of documents specified in par. 1 and subpara. 2 and 3, par. 2 of this Article of this Article or submission of the medicinal drug clinical trial report not containing the comprehensive information serve as reasons for the denial to resume the drug state registration and to hold the said review and assessment.

5. The applicant, within fifteen business days from receipt of the competent federal executive authority’s decision on resumption of the drug state registration and holding of the review and the assessment specified in par. 1 of this Article, submits samples of the medicinal drug manufactured in accordance with the pilot industrial and/or industrial regulations approved of by the head of the drug manufacturer, as well as a sample of the pharmaceutical substance in quantities required to reproduce the quality control methods, to the Expert Institution for the drug quality review.

6. The Expert Institution, upon receipt of the samples of the drug and the pharmaceutical substance, provides the applicant with the document evidencing acceptance of the said samples and, within three business days, notifies the competent federal executive authority in writing of the above.

7. The period for the applicant’s submission of samples of the drug and the pharmaceutical substance and the period for notification by the Expert Institution of the competent federal executive authority in writing of the above, as set forth in para. 5 and 6 of this Article, are not included into the period for the review and the assessment specified in par. 1 of this Article.

8. Documents received by the Expert Institution for the review and the assessment specified in par. 1 of this Article are to be returned to the competent federal executive authority simultaneously with opinions on findings of the said review and assessment.

Article 24. Drug Quality Review and

Risk-Benefit Ratio Assessment

for a Veterinary Drug

 

1. The drug quality review and risk-benefit ratio assessment for a veterinary drug, drafting by Expert Commissions of opinions on findings of the said review and assessment and their submission to the competent federal executive authority are carried out within the period of time not exceeding one hundred and ten business days from receipt by the Expert Institution of the assignment from the competent federal executive authority, with documents specified in subpara. 1 to 8, 10, lines ‘a’ to ‘e’, ‘g’ to ‘l’, ‘o’ to ‘t’ of subpar. 16 and subpar. 17, par. 3, Article 18 of this Federal Law.

2. The applicant, within fifteen business days from obtaining the decision of the competent federal executive authority on holding the review and the assessment specified in par. 1 of this Article, submits samples of the veterinary drug manufactured in accordance with the technological regulations approved of by the head of the drug manufacturer, as well as a sample of the pharmaceutical substance in the quantities required for reproduction of the quality control methods, to the Expert Institution for the drug quality review.

3. The Expert Institution, upon receipt of the samples of the drug and the pharmaceutical substance, provides the applicant with the document evidencing receipt of the said samples and, within three business days, notifies the competent federal executive authority in writing of the above.

4. The period for submission by the applicant of samples of the drug and the pharmaceutical substance and the period for notification by the Expert Institution of the competent federal executive authority in writing of the above, as specified in subpara. 2 and 3 of this Article, are not included into the period for the review and the assessment specified in par. 1 of this Article.

5. Documents received by the Expert Institution for holding the review and the assessment specified in par. 1 of this Article are to be returned to the competent federal executive authority simultaneously with the opinions on findings of the said review and assessment.

Article 25. Repeated Drug Review

and Ethical Review

 

1. If an opinion issued by the Expert Commission or the Ethics Board lacks substantiation or is incomplete, contains contradicting data, falsified conclusions on the drug review and/or the ethical review, if reasons for challenging an expert as being interested in the review findings are hidden from the competent federal executive authority, if there are data on direct or indirect intervention into the review by persons not involved in the review, which influenced the progress and findings thereof, then the competent federal executive authority assigns a repeated drug review and/or ethical review.

2. A repeated drug review is implemented within the period of time established by the competent federal executive authority and not exceeding forty business days from the date the repeated drug review assignment is received by the Expert Institution, and a repeated ethical review, within the period of time not exceeding fifteen business days from the date the repeated ethical review assignment is received by the Ethics Board.

3. The repeated drug review is not funded, and the funds transferred earlier for the review are to be returned to the federal budget.

Article 26. Accelerated Drug Review Procedure

 

1. The accelerated drug review procedure for the purposes of the drug state registration is applied with respect to reproduced drugs. In the course of the procedure, to be submitted is information obtained in drug clinical trials and published in specialized publications, as well as documents containing findings of the medicinal drug bio-equivalence and/or therapeutic equivalence studies or of the veterinary drug bio-equivalence study.

2. The accelerated drug review procedure is not applied with respect to immunobiological drugs, insulin drugs and drugs first registered in the Russian Federation.

3. The accelerated drug review procedure is implemented by decision of the competent federal executive authority within the period of time not exceeding sixty business days. In this case, the review of the Registration File documents for obtaining the medicinal drug clinical trial authorization and the ethical review are conducted within the period of time not exceeding fifteen business days, and the drug quality review and the risk-benefit ratio assessment, within the period of time not exceeding forty five business days.

4. The accelerated drug review procedure is implemented in the manner established in Articles 17 to 20, 23 and 24 of this Federal Law and does not mean relaxation of the drug safety, quality and efficacy requirements.

Article 27. Decision on Drug State Registration

 

1. The competent federal executive authority, within five business days from the date opinions on findings of the drug quality review and the risk-benefit ratio assessment are received from the Expert Commission:-

1) assesses the opinions to determine whether or not they conform to the assignment for the said review and assessment;

2) makes a decision on the drug state registration or on a denial to hold the drug state registration;

3) if a decision is made to conduct the drug state registration, enters data on the registered drug, including on the pharmaceutical substance in its composition, into the State Register of drugs and issues the drug registration certificate, the format of which is approved of by the competent federal executive authority, as well as the approved regulatory documents, regulatory document, drug leaflet and mock-ups of primary and secondary (consumer) package with indication of the drug registration certificate number and its state registration date, to the applicant, or, if a decision is made to deny the drug state registration, notifies the applicant in writing of the above giving reasons for the denial.

2. The decision taken by the competent federal executive authority to the effect that the registered drug efficacy is not confirmed by the obtained data or to the effect that the risk of harm to human or animal health as a result of the drug administration exceeds its efficacy serves as the reason to deny state registration of the drug.

3. In case of state registration of a drug included in the list of vital and essential drugs, the necessary data is entered into the State Register of the maximum ex-works manufacturer prices for drugs included in the said list.

Article 28. Drug Registration Certificate

 

1. A drug registration certificate, with indication of the drug dosage forms and doses, is issued for an indefinite period of time, except for the registration certificates issued for five years for drugs first registered in the Russian Federation.

2. Upon expiry of the period of time specified in par. 1 of this Article, the perpetual registration certificate for a drug is issued, provided that the drug state registration is confirmed.

Article 29. Drug State Registration

Confirmation Procedure

 

1. State registration of a drug is confirmed when the perpetual registration certificate for the drug is issued in the case indicated in par. 2, Article 28 of this Federal Law, within the period of time not exceeding ninety business days from the date the competent federal executive authority receives an application for confirmation of the drug state registration, executed in accordance with in par. 2, Article 18 of this Federal Law.

2. The drug state registration is confirmed based on findings of the drug risk- benefit ratio assessment.

3. An application for confirmation of the drug state registration is accompanied with a document evidencing payment of the state duty for confirmation of the medicinal drug state registration or the veterinary drug state registration and a document containing findings of the drug safety monitoring held by the applicant, in the format established by the competent federal executive authority.

4. The competent federal executive authority, within ten business days from the date the application for the drug state registration confirmation with all of the necessary documents is accepted:-

1) verifies completeness and reliability of information contained in the case materials submitted by the applicant;

2) makes a decision to hold or to deny the risk-benefit ratio assessment;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

5. Partial submission of documents specified in para. 1 and 3 of this Article or lack of comprehensive information that should be included in the submitted documents serve as reasons to deny the risk-benefit ratio assessment.

6. The risk-benefit ratio assessment to confirm the drug state registration is held in the manner established in Articles 23 and 24 of this Federal Law.

7. During the state registration confirmation procedure the drug is in the civil circulation in the Russian Federation.

Article 30. Amendments to Documents

in the Registration File for

the Registered Medicinal Drug

 

1. For the purpose of amendments to documents contained in the Registration File for the registered medicinal drug, the applicant submits to the competent federal executive authority the application for such amendments, in the format established by the competent federal executive authority, with amendments to the said documents, as well as documents evidencing the need in such amendments. The decision to make such amendments or to deny the same is taken within the period of time not exceeding ninety business days from the date the competent federal executive authority accepts the application for such amendments.

2. If there is a need to amend the drug leaflet in respect of information specified in lines ‘e’ to ‘o’ of subpar. 16, par. 3, Article 18 of this Federal Law, the medicinal drug composition, then the drug review, in particular the drug quality review and/or the risk-benefit ratio assessment for the medicinal drug, is carried out. If there is a need to make other amendments to the said leaflet, the drug review for the purpose of amendments to information on the registered drug is not carried out.

3. In addition to documents specified in par. 1 of this Article, the application for amendments to the Registration File documents on the registered medicinal drug is accompanied with documents evidencing payment of the state duty for amendments to the medicinal drug leaflet, the state duty for amendments to the medicinal drug composition.

4. The competent federal executive authority, within ten business days from the date the application specified in par. 1 of this Article with all of the necessary documents is received:-

1) verifies completeness and reliability of information contained in the case materials submitted by the applicant;

2) makes a decision to hold the drug review and the assessment specified in par. 2 of this Article or to deny the same;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

5. Partial submission of documents specified in para. 1 and 3 of this Article or lack in the submitted documents of information confirming the need in amendments serve as reasons for the denial to hold the review and the assessment specified in par. 2 of this Article.

6. The review and the assessment specified in par. 2 of this Article are held in the manner established in Article 23 of this Federal Law.

7. The competent federal executive authority, within five business days from the date the Expert Commissions’ opinions on findings of the review and the assessment specified in par. 2 of this Article are received:-

1) makes a decision to amend the Registration File documents on the registered medicinal drug or to deny the same;

2) enters, by the decision on amendments to the Registration File documents on the registered medicinal drug, the required amendments into the State Register of drugs and returns the documents to the applicant.

8. The opinion of the competent federal executive authority on the possible drug quality deterioration, efficacy and safety reduction in case of amendments to the Registration File documents on the registered medicinal drug serves as a reason for the denial to make such amendments.

9. Medicinal drugs manufactured before the competent federal executive authority makes a decision to amend the Registration File documents on the said drugs or to deny the same are allowed in civil circulation.

Article 31. Amendments to Documents

in the Registration File

for the Registered Veterinary Drug

 

1. For the purpose of amendments to documents contained in the Registration File for the registered veterinary drug, the applicant submits to the competent federal executive authority the application for such amendments, in the format established by the competent federal executive authority, with amendments to the said documents, as well as documents evidencing the need in such amendments. The decision to make such amendments or to deny the same is taken within the period of time not exceeding ninety business days from the date the competent federal executive authority accepts the application for such amendments.

2. If there is a need to amend the veterinary drug leaflet in respect of changes to the doses, the deadlines for possible use of the animal products upon application of the veterinary drug, the veterinary drug review is carried out. If there is a need to make other amendments to the said leaflet, the veterinary drug review is not carried out.

3. In addition to documents specified in par. 1 of this Article, the application for amendments to the Registration File documents on the registered veterinary drug is accompanied with documents evidencing payment of the state duty for amendments to the veterinary drug leaflet.

4. The competent federal executive authority, within ten business days from the date the application specified in par. 1 of this Article, with all of the necessary documents, is received:-

1) verifies completeness and reliability of information contained in the documents submitted by the applicant;

2) makes a decision to hold the veterinary drug review or to deny the same;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

5. Partial submission of documents specified in para. 1 and 3 of this Article or lack in the submitted documents of information evidencing the need in amendments serve as reasons for the denial to hold the veterinary drug review.

6. The veterinary drug review for the purposes of amendments to the Registration File documents on the registered veterinary drug is held in the manner established in Article 24 of this Federal Law.

7. The opinion of the competent federal executive authority on the possible veterinary drug quality deterioration, efficacy and safety reduction in case of amendments to the Registration File documents on the registered veterinary drug serves as a reason for the denial to make amendments to the said documents.

8. Veterinary drugs manufactured before the competent federal executive authority makes a decision to amend the Registration File documents on the registered veterinary drug or to deny the same are allowed in civil circulation.

Article 32. Drug State Registration Cancellation

 

A decision to cancel the drug state registration and to exclude the drug from the State Register of drugs is made by the competent federal executive authority, if:-

1) the opinion on the risk or threat to life and health of a human being or an animal as a result of the drug administration, which exceeds the drug efficacy based on results of the drug safety monitoring carried out by the competent federal executive authority, is submitted;

2) the drug developer or its authorized legal entity submits the application for cancellation of the drug state registration;

3) the drug state registration is not confirmed upon expiry of the effective period of the registration certificate issued for five years;

4) the applicant fails to submit information that might entail the need in amendments to the Registration File documents on the registered drug within thirty business days from occurrence of these changes;

5) the drug is registered by the state under the trade name of a drug earlier registered under this trade name;

6) one and the same drug is registered by the state under different trade names;

7) a court makes a decision on violation of rights of the intellectual property rights holder in the field of drug circulation.

Article 33. State Register of Drugs

 

1. The State Register of drugs contains a list of drugs passed state registration, a list of pharmaceutical substances in the composition thereof and the following information:-

1) with respect to drugs:-

а) the drug name (international non-proprietary or chemical and trade names);

b) the drug dosage, with indication of the drug dose and its quantity per consumer package;

c) the drug developer name;

d) the drug manufacturer name and address;

e) the drug pharmaco-therapeutic group;

f) the drug indications and contraindications;

g) the drug side effects;

h) the drug shelf life;

i) the drug storage conditions;

j) the drug dispensing conditions;

k) the number of the Monograph or, if it does not exist, the number of regulatory documents or a regulatory document;

l) the drug state registration date and number;

2) with respect to pharmaceutical substances:-

а) the pharmaceutical substance name (international non-proprietary or chemical and trade names);

b) the pharmaceutical substance manufacturer name and address;

c) the pharmaceutical substance shelf life;

d) the pharmaceutical substance storage conditions;

e) the number of the Monograph or, if it does not exist, the number of the regulatory documents or a regulatory document.

2. The pharmaceutical substance not used in manufacturing of drugs may be entered into the State Register of drugs on the basis of the drug developer’s/ manufacturer’s or its authorized legal entity’s application, provided that the pharmaceutical substance quality review is held with respect to such pharmaceutical substance in the manner established in Article 34 of this Federal Law.

3. The procedures for keeping the State Register of medicinal drugs and the State Register of veterinary drugs are approved of by the competent federal executive authority.

Article 34. Review of Quality of

a Pharmaceutical Substance

Not Used in Drug Manufacturing

 

1. For a pharmaceutical substance not used in drug manufacturing be included into the State Register of drugs the review of its quality is conducted.

2. The review of quality of a pharmaceutical substance specified in par. 1 of this Article, drafting by the Expert Commission of opinions on the review findings and their submission to the competent federal executive authority are carried out within the period of time not exceeding sixty business days from receipt by the Expert Institution of the assignment from the competent federal executive authority with documents specified in subpara. 4 to 7, par. 3, Article 18 of this Federal Law.

3. For holding the review of quality of a pharmaceutical substance specified in par. 1 of this Article, the applicant submits to the competent federal executive authority the following documents:-

1) an application for inclusion of the pharmaceutical substance into the State Register of drugs;

2) a document evidencing payment of the state duty for inclusion of the pharmaceutical substance not used in drug manufacturing into the State Register of drugs;

3) documents specified in subpara. 4 to 7, par. 3, Article 18 of this Federal Law.

4. The competent federal executive authority, within five business days from the date the application for inclusion of the pharmaceutical substance specified in par. 1 of this Article into the State Register of drugs with documents specified in par. 1 and subpar. 2, par. 3 of this Article is accepted:-

1) verifies completeness of the information contained in the documents submitted by the applicant;

2) makes a decision to send to the Expert Institution of the assignment for the review of quality of the pharmaceutical substance specified in par. 1 of this Article or to deny the same;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

5. Failure to submit documents specified in par. 2 and subpar. 2, par. 3 of this Article, serves as a reason for the denial send to the Expert Institution of the assignment for the review of quality of the pharmaceutical substance specified in par. 1 of this Article.

6. The applicant, within fifteen business days from receipt of the competent federal executive authority’s decision on sending to the Expert Institution of the assignment for the review of quality of the pharmaceutical substance specified in par. 1 of this Article, submits samples of the pharmaceutical substance in quantities required to reproduce the quality control methods to the Expert Institution for the review. The Expert Institution, upon receipt of the samples of the pharmaceutical substance specified in par. 1 of this Article, provides the applicant with the document evidencing acceptance of the said samples and, within three business days, notifies the competent federal executive authority in writing of the above. These periods are not included into the review period.

7. Documents received by the Expert Institution for the review of quality of the pharmaceutical substance specified in par. 1 of this Article are to be returned to the competent federal executive authority simultaneously with opinions on findings of the said review.

8. The competent federal executive authority, within five business days from the date the opinion on findings of the review of quality of the pharmaceutical substance specified in par. 1 of this Article is received from the Expert Commission:-

1) assesses the opinion to determine whether or not it conforms to the assignment for the said review;

2) makes a decision on inclusion of the pharmaceutical substance specified in par. 1 of this Article into the State Register of drugs or to deny the same;

3) if a decision is made to include the pharmaceutical substance specified in par. 1 of this Article into the State Register of drugs, enters the information specified in subpar. 2, par. 1, Article 33 of this Federal Law and notifies the applicant in writing of the above.

Article 35. Repeated Submission of a Drug

Failed to Pass State Registration of Drugs

for State Registration of Drugs

 

Repeated submission to the competent federal executive authority of a drug, which did not pass state registration of drugs or the state registration of which was denied, and the composition of which was subsequently modified, is regarded as submission for state registration of a new drug, irrespective of keeping its original name.

Article 36. Appeal of a Decision to Deny Issuance of

a Drug Clinical Trial Authorization or

to Deny State Registration of a Drug

 

A decision of the competent federal executive authority to deny issuance of a drug clinical trial authorization or to deny state registration of a drug may be appealed in the manner established by the law of the Russian Federation.

Article 37. Information on State Registration of Drugs;

Information on Registered Drugs and Drugs

Excluded from the State Register of Drugs

 

1. The competent federal executive authority posts information pertaining to state registration of drugs, including information on drug reviews, registered drugs and drugs excluded from the State Register of drugs, on the official website in the Internet within five business days from the date of acceptance by the competent federal executive authority of an application for state registration of a drug.

2. The timing of and the procedure for posting information specified in par. 1 of this Article are established by the competent federal executive authority.

 

Chapter 7. Medicinal Drug Clinical Trials,

Agreements for their Conduct;

Rights of Patients Involved in these Trials

 

Article 38. Medicinal Drug Clinical Trials

 

1. Medicinal drug clinical trials, including global multicenter, multicenter and post-registration, are held for state registration of drugs and other purposes in one or more healthcare institutions in accordance with the clinical practice rules approved of by the competent federal executive authority in order to:-

1) determine drug safety for healthy volunteers and/or healthy volunteers’ tolerance thereto, except for such trials in respect of drugs manufactured outside the Russian Federation;

2) select the most appropriate doses and treatment course for patients suffering from any particular disease, the most appropriate doses and schemes for immunobiological drug administration in healthy volunteers;

3) establish drug safety and efficacy in patients suffering from any particular disease, preventive efficacy of immunobiological drugs in healthy patients;

4) study possibilities to extend the medical indications and to identify earlier unknown side effects of registered drugs.

2. As for reproduced medicinal drugs, bioequivalence and/or therapeutic equivalence are studied in the manner established by the competent federal executive authority.

3. Entitled to conduct medicinal drug clinical trials are:-

1) the drug developer or its authorized person;

2) the higher and/or additional professional education institutions;

3) R&D institutions.

4. Medicinal drug clinical trials are conducted in the manner established in Articles 20 to 22 of this Federal Law by virtue of the drug clinical trial authorization issued by the competent federal executive authority in accordance with purposes specified in par. 1 of this Article. The competent federal executive authority keeps the Register of issued drug clinical trial authorizations, with indication of their purpose or purposes, in the manner established by the authority.

5. In case of drug state registration, the state duty for the review of the documents with a view to obtain authorizations to hold medicinal drug clinical trials and for the ethical review, in case of drug state registration in accordance with the purpose or purposes specified in par. 1 of this Article, is paid once.

6. Legal entities of any legal form of incorporation may be engaged by the drug developer in holding of medicinal drug clinical trials, provided that these trials comply with this Federal Law.

7. Medicinal drug clinical trials are held in healthcare institutions accredited by the competent federal executive authority in the manner established by the Government of the Russian Federation.

8. The list of healthcare institutions entitled to hold medicinal drug clinical trials and the Register of issued drug clinical trial authorizations are published and posted by the competent federal executive authority on its official website in the Internet in the manner established by the authority.

Article 39. Medicinal Drug Global Multicenter

Clinical Trial or Medicinal Drug

Post-Registration Clinical Trial

 

1. A medicinal drug global multicenter clinical trial in the Russian Federation or a medicinal drug post-registration clinical trial are carried out on the basis of the drug clinical trial authorization issued by the competent federal executive authority based on findings of the review of documents required for obtaining an authorization to hold a drug global multicenter clinical trial or a drug post-registration clinical trial and the ethical review.

2. To obtain a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization, the applicant submits to the competent federal executive authority the following documents:-

1) the application for a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization;

2) a document evidencing payment of the state duty for a medicinal drug global multicenter clinical trial authorization or for a medicinal drug post-registration clinical trial authorization;

3) a report on drug pre-clinical trials and a report on earlier conducted medicinal drug clinical trials (if any);

4) the draft protocol of the medicinal drug clinical trial;

5) the draft investigator’s booklet;

6) the information sheet for the patient involved in medicinal drug clinical trials;

7) information on investigators’ professional experience and background in the field of clinical trials;

8) copies of life and health obligatory insurance agreements with the patients participating in medicinal drug clinical trials;

9) information on the drug composition with a view to obtain a medicinal drug global multicenter clinical trial authorization.

3. The competent federal executive authority, within five business days from the date the application specified in subpar. 1, par. 2 of this Article with all of the necessary documents is accepted:-

1) verifies completeness and reliability of information contained in the documents submitted by the applicant;

2) makes a decision to conduct the review of documents for obtaining a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization and the ethical review or to deny the same;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

4. Partial submission of documents specified in par. 2 of this Article or lack in the submitted documents of comprehensive information or data that should be included therein serve as reasons to deny the review of the documents for obtaining a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization and the ethical review.

5. The review of documents for obtaining a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization and the ethical review and issue of a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization are conducted in the manner established in Articles 20 to 22 of this Federal Law.

6. Decisions to deny the review of documents for obtaining a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization and the ethical review and the issue of a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization may be appealed in the manner established by the law of the Russian Federation.

Article 40. Holding of a Medicinal Drug Clinical Trial

 

1. The head of a healthcare institution that conducts a medicinal drug clinical trial appoints an investigator responsible for holding the trial and having a medical specialization that corresponds to the conducted drug clinical trial, with at least five-year experience in drug clinical trials, and, at his/her proposal, appoints co-investigators out of the physicians of the healthcare institution.

2. The investigator selects patients who, by their medical indications, may be involved in the medicinal drug clinical trial.

3. The investigator and the co-investigators should be familiar with findings of the drug pre-clinical trial, which are contained in the investigator’s booklet, as well as with the draft medicinal drug clinical trial protocol developed by the drug developer or any other legal entity engaged in the medicinal drug clinical trial and with other materials of the trial.

4. If there is a need to amend the medicinal drug clinical trial protocol, institutions in charge of the medicinal drug clinical trial as specified in par. 3, Article 38 of this Federal Law, notify the competent federal executive authority, that issued the trial authorization, of the above.

5. The competent federal executive authority, within thirty business days from the date the notice specified in par. 4 of this Article is received, considers the notice in the manner established by the authority and makes a decision to amend the medicinal drug clinical trial protocol or to deny the same.

6. A medicinal drug clinical trial may be suspended or terminated, if a threat to life and health of patients is identified in holding thereof. If there is a threat to life and health of a patient who takes part in a medicinal drug clinical trial, the investigators are obliged to notify the head of the healthcare institution and the organization, that received the drug clinical trial authorization from the competent federal executive authority, of the above. The decision on suspension of the medicinal drug clinical trial is made by the head of the healthcare institution and/or the organization, that received the medicinal drug clinical trial authorization from the competent federal executive authority, and on termination of such trial, by the competent federal executive authority on the basis of a written notice from the head of the healthcare institution and/or the organization, that received the medicinal drug clinical trial authorization from the competent federal executive authority.

7. The institutions specified in par. 3, Article 38 of this Federal Law, within five business days from the date the medicinal drug clinical trial is completed, suspended or terminated, sends a notice of the above to the competent federal executive authority, in the format established by the authority.

8. The form of the notice on completion, suspension or termination of the medicinal drug clinical trial contains:-

1) information on the healthcare institution(s) that held the trial;

2) description of the trial;

3) investigator’s personal data (full name, place of employment, position, specialization, drug clinical trials he/she was involved in (periods of involvement) as investigator or co-investigator);

4) the trial result (completion, suspension or termination of the trial, with indication of reasons and their impact on assessment of the trial findings and the overall assessment of risk-benefit ratio for the studied drug, as well as further actions proposed).

9. The competent federal executive authority publishes and posts the notice of the medicinal drug clinical trial completion, suspension or termination on its official website in the Internet within the period of time not exceeding five business days from the date the notice is received.

10. The competent federal executive authority keeps the Register of investigators holding or having held medicinal drug clinical trials in accordance with rules approved of by the authority and posts the Register on its official website in the Internet in the manner established by the authority. The said Register contains information specified in subpar. 3, par. 8 of this Article.

11. A report on findings of the medicinal drug clinical trial is drafted by an institution specified in par. 3, Article 38 of this Federal Law, on the basis of opinions by medical institutions that held the trial and is submitted to the competent federal executive authority that issued the trial authorization, within three months from the date of completion, suspension or termination of the trial, in the manner established by the competent federal executive authority.

12. Violation of the clinical practice rules and falsification of findings of the medicinal drug clinical trial entail liability in accordance with the law of the Russian Federation.

13. In conducting a medicinal drug clinical trial, it is allowed to take patients’ biological materials (samples of biological liquids, tissues, secretions and waste products, physiological and pathological excretions, swabs, scrapes, lavages, microorganisms, biopsy material) for their study in and/or outside the Russian Federation.

14. The procedure for import to/ export from the Russian Federation of the biological materials obtained in a medicinal drug clinical trial is established by the Government of the Russian Federation.

Article 41. Agreement for a Medicinal Drug Clinical Trial

 

1. A medicinal drug clinical trial is held in accordance with an agreement for a medicinal drug clinical trial concluded between the organization that obtained the trial authorization from the competent federal executive authority and the healthcare institution that holds the trial.

2. The agreement for a medicinal drug clinical trial contains:-

1) the conditions and terms of the trial;

2) the overall cost of the trial program with indication of the amount intended for payments to investigators, co-investigators;

3) the form for submission of the trial findings to the competent federal executive authority.

Article 42. Funding of a Medicinal Drug Clinical Trial

 

A medicinal drug clinical trial is funded from:-

1) the federal budget;

2) funds of the organizations that obtained the trial authorizations, in accordance with terms and conditions of the agreement for the trial;

3) other sources not prohibited by the law of the Russian Federation.

Article 43. Rights of Patients Involved in

a Medicinal Drug Clinical Trial

 

1. Involvement of patients in a medicinal drug clinical trial is voluntary.

2. A patient or his/her legal representative is to be notified in writing of:-

1) the medicinal drug and the essence of the clinical trial for this drug;

2) the safety of the medicinal drug, its anticipated efficacy and the degree of risk to the patient;

3) the conditions of the patient’s participation in the medicinal drug clinical trial;

4) the purpose or purposes and duration of the medicinal drug clinical trial;

5) the actions to be taken by the patient in case of any unforeseeable effects of the medicinal drug on his/her health status;

6) the conditions of life and health obligatory insurance for the patient;

7) the guarantees of confidentiality of the patient’s involvement in the medicinal drug clinical trial.

3. A patient’s voluntary consent to participation in a medicinal drug clinical trial is confirmed by his/her signature or the signature of his/her legal representative on the information sheet for the patient.

4. A patient or his/her legal representative is free to withdraw from a medicinal drug clinical trial at any stage of such trial.

5. It is allowed to conduct a medicinal drug clinical trial in children as patients, always provided that their parents, adoptive parents give a written consent to the above. Children may be regarded as potential patients of the trial only when the trial is needed to promote children’s health or to prevent infectious diseases in minors or when the purpose of the trial is to obtain information on the most appropriate drug dose for treatment of minors. In these cases, the trial in minors should be preceded by the medicinal drug clinical trial in adults.

6. It is prohibited to hold a medicinal drug clinical trial with participation of the following persons as patients:-

1) orphans;

2) pregnant and breast-feeding women, except for cases when the studied drug is intended for the said women, when the necessary information may only be obtained in the appropriate clinical trials and when all the necessary efforts are taken to eliminate the risk of harm to a pregnant woman, a breastfeeding woman, a fetus or a baby;

3) military men, except for clinical trials of a drug specially intended for administration in hostilities, emergencies and also for prevention and treatment of diseases and conditions resulting from adverse factors of chemical, biological and radioactive nature. A clinical trial of such drug may be conducted with participation of military men as patients, except for draftees, in accordance with the requirements established by this Federal Law with respect to civilians;

4) employees of law enforcement authorities;

5) persons in prison and persons under arrest in pretrial detention centers.

8. It is allowed to conduct a clinical trial of a medicinal drug intended for treatment of mental diseases with participation of such patients as persons suffering from mental diseases, recognized as disabled in the manner established by the law of the Russian Federation. In this case, the drug clinical trial is conducted subject to a written consent of legal representatives of the said persons.

Article 44. Obligatory Insurance for Life

and Health of Patients Involved in

Medicinal Drug Clinical Trials

 

1. The organization that obtained a medicinal drug clinical trial authorization is obliged to insure, at its own expense as an insurer, life and health of the patient involved in the drug clinical trials by entering into an agreement for obligatory life and health insurance for the patient in case of any harm to life or health of the patient occurring as a result of the medicinal drug clinical trials (hereinafter in this Article ‘the Obligatory Insurance Agreement’).

2. The subject of the obligatory insurance is the property interest of the patient in connection with any harm to the patient’s life or health as a result of the medicinal drug clinical trials.

3. The event insured under the Obligatory Insurance Agreement is the patient’s death or impairment of health, including the invalidity established and entailed, as a result of involvement in the drug clinical trials, if there is any cause-effect relation between the events occurred and the drug administration.

4. Claims to compensate for harm to the patient’s life or health are satisfied within limitation periods established by the civil law.

5. The insurance compensation amount under the Obligatory Insurance Agreement is as follows:-

1) in case of the patient’s death, two million rubles per each patient involved in the drug clinical trials;

2) in case of impairment of the patient’s health:-

a) entailing the established Group I invalidity, one million five hundred thousand rubles per each patient involved in the drug clinical trials;

b) entailing the established Group II invalidity, one million rubles per each patient involved in the drug clinical trials;

c) entailing the established Group III invalidity, five hundred thousand rubles per each patient involved in the drug clinical trials;

d) not entailing the established invalidity, less than three hundred thousand rubles per each patient involved in the drug clinical trials.

6. The insurance compensation amount may be increased by a court decision.

7. The Obligatory Insurance Agreement term may not be less than the drug clinical trial period.

8. Insurance tariffs under the obligatory insurance for life and health of the patient involved in the drug clinical trials, the list of documents required for insurance compensation, the procedure for payment of insurance premium, the procedure for exercise of the parties’ rights and obligations under the Obligatory Insurance Agreement as established by this Federal Law and other federal laws are defined in standard rules of obligatory insurance for life and health of the patient involved in the drug clinical trials as approved of by the Government of the Russian Federation.

9. In case of any harm to life of the patient involved in the drug clinical trials, beneficiaries under the Obligatory Insurance Agreement are citizens having the right for compensation of harm in case of the supporter’s death in accordance with the civil law, and if such citizens do not exist, parents, spouse, children of the dead patient that was involved in the drug clinical trials; in case of death of the patient that was involved in the drug clinical trials and had no independent income, the citizens that supported him/her; in respect of compensation for expenses on a burial for the patient that was involved in the drug clinical trials, the person that incurred such expenses.

10. The insurance compensation amount to compensate for any harm to life of the patient that was involved in the drug clinical trials is distributed equally among beneficiaries in proportion to their number.

11. In case of an insured event, the patient that was involved in the drug clinical trials and the beneficiary are entitled to claim, directly from the assurer, the compensation for any harm incurred. The assurer pays the insurance compensation within thirty days from the date the required documents are submitted. The patient that was involved in the drug clinical trials or the beneficiary in accordance with the law of the Russian Federation on personal data is obliged to provide the assurer with his/her personal data defined in standard life and health insurance rules specified in par. 8 of this Article and required for payment of the insurance compensation.

12. Upon application of the patient that was involved in the drug clinical trials or the beneficiary, the assurer, before the compensation amount due for any harm is fully defined, is entitled to pay such amount of the insurance compensation that corresponds to the harm incurred and actually defined.

13. The insurance compensation under the Obligatory Insurance Agreement is paid regardless of payments due under insurance policies of other types.

14. The competent federal executive authority that issues drug clinical trial authorizations carries out control over implementation by the organization that obtained the drug clinical trial authorization of the obligation established by this Article in respect of obligatory insurance for life and health of the patient that was involved in drug clinical trials.

 

Chapter 8. Drug Manufacturing and Labeling

 

Article 45. Drug Manufacturing

 

1. Drug manufacturing should conform to the drug manufacturing and quality control rules approved of by the Government of the Russian Federation.

2. Drug manufacturing in the Russian Federation is carried out by drug manufacturers holding drug manufacturing licenses.

3. Drug manufacturing is carried out in compliance with requirements of industrial regulations, which are approved of by the head of the drug manufacturer and include the list of used pharmaceutical and auxiliary substances, with indication of quantity for each of them, data on equipment employed, description of the technological process and control methods at all drug manufacturing stages.

4. In drug manufacturing the pharmaceutical substances included in the State Register of drugs are used.

5. It is prohibited to manufacture:-

1) drugs not included in the State Register of drugs, except for drugs manufactured for clinical trials and export;

2) fake drugs;

3) drugs not covered by the drug manufacturing license;

4) drugs manufactured in violation of the drug manufacturing and quality control rules.

6. When drugs are brought into civil circulation the drug manufacturer’s authorized person confirms conformity of the drugs to the requirements set forth in their state registration and guarantees that the drugs are manufactured in accordance with the drug manufacturing and quality control rules.

7. The drug manufacturer’s authorized person is its employee with higher pharmaceutical, chemical or biological education or, in case of the veterinary drug manufacturing, veterinary education, with at least five-year experience in drug manufacturing and quality control, and qualified in the manner established by the competent federal executive authority.

8. Drug manufacturers may sell drugs or transfer them in the manner established by the law of the Russian Federation:-

1) to other drug manufacturers for drug manufacturing;

2) to drug wholesale operators;

3) to pharmacies, veterinary pharmacies and individual entrepreneurs holding pharmaceutical or medical licenses;

4) to research and development organizations for research and development;

5) to medical and veterinary organizations;

6) to animal breeding, raising and keeping organizations.

Article 46. Drug Labeling

 

1. Drugs, except for those produced in pharmacies, veterinary pharmacies or by individual entrepreneurs holding pharmaceutical licenses, should enter into circulation, if:-

1) the drug name (international non-proprietary or chemical and trade names), series number, date of manufacture (for immunobiological drugs), shelf life, dose and dosage form, quantity and the number of doses (for immunobiological drugs) are legibly indicated on the primary package in Russian;

2) the drug name (international non-proprietary or chemical and trade names), the drug manufacturer name, series number, date of manufacture (for immunobiological drugs), registration certificate number, shelf life, application method, dose and number of doses per package, dosage form, dispensing conditions, storage conditions, precautions in drug administration and warnings are legibly indicated on the secondary (consumer) package.

2. Pharmaceutical substances should enter into circulation, if the pharmaceutical substance name (international non-proprietary or chemical and trade names), the pharmaceutical substance manufacturer name, series number and date of manufacture, quantity per package and units of quantity, shelf life and storage conditions are legibly indicated on the primary package in Russian.

3. Serums should enter into circulation with indication of which animal blood, blood plasma, organs and tissues they are derived from. Vaccines should enter into circulation with indication of the culture medium used for re-production of viruses and bacteria.

4. Drugs derived from human blood, blood plasma, organs and tissues should bear on their secondary (consumer) package the inscription: ‘There are no HIV-1, HIV-2, hepatitis C virus antibodies and the hepatitis B virus surface antigen.’

5. Radioactive drugs should bear on their primary and secondary (consumer) packages the radiation danger sign.

6. Homeopathic drugs should bear on their secondary (consumer) package the inscription: ‘Homeopathic.’

7. Drugs from the plant raw materials should bear on their secondary (consumer) package the inscription: ‘The products passed radiation control.’

8. Drugs intended for clinical trials should bear on their primary and secondary (consumer) packages the inscription: ‘For clinical trials.’

9. Drugs intended for export only are labeled in accordance with requirements of the importer country.

10. The transport containers not intended for consumers, with drugs packed therein, should bear information on the drug name, series, date of manufacture, the number of drug secondary (consumer) packages, the drug manufacturer with indication of its name and location (address, including the country and/or place of drug manufacturing), the drug shelf life, storage and transportation conditions, as well as the necessary warning signs and handling marks.

11. Veterinary drugs should bear on their primary and secondary (consumer) packages the inscription: ‘For veterinary use.’

12. A drug secondary (consumer) package should bear a bar code.

Chapter 9. Drug Import to/ Export from

the Russian Federation

 

Article 47. Procedure for Drug Import to/

Export from the Russian Federation

 

1. Drugs are imported to the Russian Federation in the manner established by the Government of the Russian Federation in accordance with the law of the Russian Federation.

2. Drugs imported to the Russian Federation should be included in the State Register of drugs.

3. It is allowed to import to the Russian Federation any particular consignment of non-registered drugs intended for clinical trials, for drug review for the purposes of the drug state registration or for provision of healthcare according to individual indications with respect to a patient’s life by virtue of the authorization issued by the competent federal executive authority at the application of persons specified in Article 48 of this Federal Law. Consideration of the application and making of the decision to issue the authorization for import of any particular consignment of non-registered drugs intended for drug clinical trials, for drug review for the purposes of the drug state registration or for provision of healthcare according to individual indications with respect to a patient’s life, or to deny the issue of the said authorization, are carried out within the period of time not exceeding five business days. No payment is collected for issue of the said authorization.

4. The drugs, the quality of which is certified by the drug manufacturer’s certificate confirming that the imported drugs meet the requirements of Monographs or, in their absence, of regulatory documents or the regulatory document may be imported to the Russian Federation.

5. It is prohibited to import fake, low-quality and counterfeited drugs to the Russian Federation.

6. Fake and low-quality drugs are subject to withdrawal and subsequent destruction or removal from the Russian Federation, and counterfeited drugs, to withdrawal and subsequent destruction. Destruction or removal from the Russian Federation of fake, low-quality and counterfeited drugs is carried out at the expense of the importing person. The procedure for destruction of withdrawn fake, low-quality and counterfeited drugs is established by the Government of the Russian Federation.

7. Persons importing fake, low-quality and counterfeited drugs to the Russian Federation are liable in accordance with the law of the Russian Federation.

8. Drugs are exported from the Russian Federation without any limitations established by the law of the Russian Federation on state regulation of foreign trade. Drugs intended for humanitarian (support) purposes or emergency purposes are exported from the Russian Federation by virtue of the resolution of the Government of the Russian Federation or of governmental authorities of the Russian Federation constituent territories on provision of assistance to a foreign country.

Article 48. Legal Entities Entitled to Import

Drugs to the Russian Federation

 

The following persons may import drugs to the Russian Federation:-

1) drug manufacturers, for their own manufacturing purposes;

2) foreign drug developers and manufacturers or other legal entities at the assignment of the drug developer, for drug clinical trials, state registration, entering a pharmaceutical substance into the State Register of drugs, drug quality control, provided that there is an authorization issued by the competent federal executive authority for import of any particular drug consignment;

3) drug wholesale operators;

4) R&D organizations, educational institutions of higher professional education, drug manufacturers, for drug development, trials, safety/quality/efficacy control, provided that there is an authorization issued by the competent federal executive authority;

5) healthcare institutions, as well as other institutions specified in para. 1 to 4 of this Article, for provision of healthcare according to individual indications with respect to a patient’s life, provided that there is an authorization issued by the competent federal executive authority for import of any particular drug consignment, in the established manner, in the format of an electronic document with a digital signature.

Article 49. Documents Submitted to Customs Authorities

of the Russian Federation at Drug Import

to the Russian Federation

 

1. At drug import to the Russian Federation, in addition to documents, submission of which is envisaged by the law of the Russian Federation, the following documents are submitted to the customs authorities of the Russian Federation:-

1) the drug manufacturer’s certificate confirming that the imported drug conforms to the requirements of the Monograph or, in case of its absence, regulatory documents or the regulatory document;

2) the authorization issued by the competent federal executive authority for import of any particular drug consignment, in cases set forth in par. 3, Article 47 of this Federal Law.

2. Documents specified in subpara. 1 and 2, par. 1 of this Article, are submitted to the customs authorities of the Russian Federation upon delivery of drugs to the Russian Federation.

Article 50. Import of Drugs to the Russian Federation

for Personal Use and Other

Non-Commercial Purposes

 

1. Drugs may be imported to the Russian Federation without taking into account the requirements envisaged in para. 1 to 4 of Article 47, Articles 48 and 49 of this Federal Law, if they are intended for:-

1) personal use by individuals arrived to the Russian Federation;

2) use by employees of diplomatic corps or representatives of international organizations accredited in the Russian Federation;

3) treatment of passengers and crews of vehicles, train crews and vehicle drivers arrived to the Russian Federation;

4) treatment of participants in international cultural and sports events and expeditions;

5) treatment of any particular animals in zoos and also animals imported to the Russian Federation for participation in sports and entertainment.

2. In cases envisaged in par. 1 of this Article, it is allowed to import drugs not registered in the Russian Federation to the Russian Federation.

3. Drugs intended for humanitarian (support) purposes or emergency purposes are imported to the Russian Federation in the manner established by the Government of the Russian Federation. It is prohibited to import non-registered drugs intended for humanitarian (support) purposes or emergency purposes to the Russian Federation.

Article 51. Cooperation between the Federal

Executive Customs Authority

and Other Competent Federal

Executive Authorities

 

1. The competent federal executive authorities make available to the federal executive customs authority the State Register of drugs and also information on the issued authorizations for import of any particular drug consignment, in cases set forth in par. 3, Article 47 of this Federal Law.

2. The federal executive customs authority notifies the competent federal executive authorities specified in par. 1 of this Article of drug import/ export to/ from the Russian Federation in the format and the manner established by the Government of the Russian Federation.

 

Chapter 10. Pharmaceutical Operations

 

Article 52. Pharmaceutical Operations

 

1. Pharmaceutical operations are carried out by drug wholesale operators, pharmacies, veterinary pharmacies, individual entrepreneurs holding pharmaceutical licenses, healthcare institutions holding pharmaceutical licenses and by their separate business units (outpatient departments, feldsher’s and feldsher’s/maternity stations, centers/divisions of general healthcare / family practice) located in rural settlements where there are no pharmacies, and also by veterinary organizations holding pharmaceutical licenses.

2. Individuals may carry out any particular pharmaceutical operations, provided that they have higher or secondary pharmaceutical education, or higher or secondary veterinary education, and a professional certificate.

Article 53. Drug Sales and Transfer

by Drug Wholesale Operators

 

Drug wholesale operators may sell drugs or transfer them in the manner established by the law of the Russian Federation to:-

1) other drug wholesale operators;

2) drug manufacturers for manufacturing purposes;

3) pharmacies and veterinary pharmacies;

4) research and development organizations for research and development;

5) individual entrepreneurs holding pharmaceutical or medical licenses;

6) healthcare and veterinary organizations;

7) animal breeding, raising and keeping organizations.

Article 54. Drug Wholesale Rules

 

Drug wholesale trade is carried out by drug manufacturers and drug wholesale operators in accordance with rules approved of by the competent federal executive authorities.

Article 55. Drug Retail Rules

 

1. Drug retail trade in the quantities required for fulfillment of physician’s/ feldsher’s prescriptions or prescriptions by veterinary professionals is carried out by pharmacies, veterinary pharmacies, individual entrepreneurs holding pharmaceutical licenses, healthcare institutions holding pharmaceutical licenses and by their separate business units (outpatient departments, feldsher’s and feldsher’s/maternity stations, centers/divisions of general healthcare / family practice) located in rural settlements where there are no pharmacies, and also by veterinary organizations holding pharmaceutical licenses. Retail trade in drugs registered in the Russian Federation or produced in pharmacies, veterinary pharmacies or by individual entrepreneurs holding pharmaceutical licenses only is allowed.

2. The types of pharmacies and the medicinal drug dispensing rules for pharmacies and individual entrepreneurs holding pharmaceutical licenses and also the medicinal drug dispensing rules for healthcare institutions holding pharmaceutical licenses and their separate business units (outpatient departments, feldsher’s and feldsher’s/maternity stations, centers/divisions of general healthcare / family practice) located in rural settlements where there are no pharmacies is approved of by the competent federal executive authority.

3. The dispensing rules for narcotic drugs and mood-altering drugs registered as drugs and also drugs containing narcotic substances and mood-altering substances is approved of by the competent federal executive authority upon agreement with the federal executive authority in charge of the governmental policy, normative and legal regulation, control over and supervision of circulation of narcotic drugs, mood-altering drugs and their precursors and also of combating their illegal circulation.

4. Veterinary drugs are to be dispensed through veterinary pharmacies, veterinary organizations and by individual entrepreneurs holding pharmaceutical licenses. The veterinary drug dispensing rules are approved of by the competent federal executive authority.

5. The list of healthcare institutions holding pharmaceutical licenses and their separate business units (outpatient departments, feldsher’s and feldsher’s/maternity stations, centers/divisions of general healthcare / family practice) located in rural settlements where there are no pharmacies and also the list of drugs (except for narcotic drugs and mood-altering drugs) that are allowed for sales by the said organizations and their separate business units veterinary organizations are established by executive authorities of the Russian Federation constituent territories.

6. Pharmacies and individual entrepreneurs holding pharmaceutical licenses are obliged to procure the minimum drug range required for health care and established by the competent federal executive authority.

7. Pharmacies and individual entrepreneurs holding pharmaceutical licenses have rights to purchase and sell, in addition to drugs, medicinal products, disinfectants, personal hygiene items and means, medicinal dishes, items and means for nursing, taking care of newborns and children younger than three, spectacles and spectacles care items, mineral waters, therapeutic, child and dietetic products, biologically active food supplements, therapeutic perfumery and cosmetic products, medical and sanitary education publications for healthy lifestyle promotion.

8. Operations of pharmacies in the Armed Forces of the Russian Federation, other troops, military units and authorities where the law of the Russian Federation envisages military or law enforcement services are governed by this Federal Law and the provisions approved of by the competent federal executive authorities. Control over compliance with the provisions of this Federal Law by the said pharmacies is implemented by the competent federal executive authorities.

Article 56. Drug Production and Dispensing

 

1. Drug production and dispensing in pharmacies, veterinary pharmacies and by individual entrepreneurs holding pharmaceutical licenses is carried out at physician’s prescriptions and at requests of healthcare and veterinary organizations in accordance with the drug production and dispensing rules approved of by the competent federal executive authority.

2. In production of drugs by pharmacies, veterinary pharmacies and individual entrepreneurs holding pharmaceutical licenses, the pharmaceutical substances included in the State Register of medicinal drugs and the State Register of veterinary drugs, respectively, in the established manner are used. It is not allowed to produce drugs registered in the Russian Federation in pharmacies, veterinary pharmacies and by individual entrepreneurs holding pharmaceutical licenses.

3. Labeling and packaging of drugs produced by pharmacies, veterinary pharmacies and individual entrepreneurs holding pharmaceutical licenses should meet the requirements specified in par. 1 of this Article.

4. Pharmacies, veterinary pharmacies and individual entrepreneurs holding pharmaceutical licenses are liable for non-compliance with the drug production and dispensing rules in accordance with the law of the Russian Federation.

Article 57. Prohibition on Sales of Fake,

Low-Quality and Counterfeited Drugs

 

It is prohibited to sell fake drugs, low-quality drugs and counterfeited drugs.

Article 58. Drug Storage

 

1. Drugs are stored by drug manufacturers, drug wholesaler operators, pharmacies, veterinary pharmacies, individual entrepreneurs holding pharmaceutical or medical licenses, healthcare, veterinary and other organizations involved in drug circulation.

2. The drug storage rules are approved of by the competent federal executive authority.

3. Narcotic drugs, mood-altering drugs and radioactive drugs are stored in accordance with the law of the Russian Federation.

 

Chapter 11. Drug Destruction

 

Article 59. Grounds and Procedure

for Drug Destruction

 

1. Low-quality and fake drugs are subject to withdrawal from civil circulation and destruction in the manner established by the Government of the Russian Federation. The decision by the drug owner or by the competent federal executive authority or by a court serves as grounds for drug destruction.

2. Counterfeited drugs are subject to withdrawal from civil circulation and destruction by a court judgment. The counterfeited drug destruction procedure is established by the Government of the Russian Federation.

3. Counterfeited, low-quality and fake drug destruction costs are indemnified for by the owner thereof.

4. The drug owner provides the competent federal executive authority with a document evidencing drug destruction or its copy certified in the established manner.

5. The competent federal executive authority that resolved to destroy drugs performs control over their destruction.

6. Drugs are destroyed by organizations holding appropriate licenses, on/in specially equipped grounds, sites and premises, in compliance with environment protection requirements and in accordance with the law of the Russian Federation.

7. Narcotic drugs, mood-altering drugs and radioactive drugs are destroyed in accordance with the law of the Russian Federation.

 

Chapter 12. State Regulation of Prices for

Medicinal Drugs

 

Article 60. State Regulation of Prices for

Medicinal Drugs

 

State regulation of prices for medicinal drugs is carried out through:-

1) approval of the list of vital and essential drugs (included in the list under international non-proprietary or chemical names) meeting the following criteria:-

a) use of any particular drug for diagnosis, prevention or treatment of diseases, including those prevailing in the incidence pattern among the population of the Russian Federation;

b) an advantage of any particular drug in comparison to other drugs used to treat any particular disease, symptom or clinical condition;

c) the therapeutic equivalence of any particular drug to drugs with a similar mechanism of the pharmacological action;

2) approval of the procedure for determination of maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

3) the state registration of maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

4) keeping of the State Register of maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

5) approval of the procedure for determination by executive authorities of the Russian Federation constituent territories of the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

6) setting out of the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

7) approval of the rules for giving to executive authorities of the Russian Federation constituent territories of instructions on bringing to conformity with the law of the Russian Federation of decisions on determination of the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs, if they are adopted in contravention of the law of the Russian Federation, in the manner established by the Government of the Russian Federation;

8) sending by the competent federal executive authority to executive authorities of the Russian Federation constituent territories of instructions on bringing to conformity with the law of the Russian Federation of decisions on determination of the maximum wholesale and retail mark-ups on prices for drugs included in the list of vital and essential drugs, if they are adopted in contravention of the law of the Russian Federation;

9) performance of state control over application of prices for drugs;

10) enforcement of measures provided for by the law of the Russian Federation for violation of the pricing procedure for vital and essential drugs.

Article 61. State Registration of the Maximum Ex-works

Manufacturer Prices for Vital and

Essential Drugs and Sales Thereof

 

1. The maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs are subject to state registration.

2. The maximum ex-works manufacturer price for a vital and essential drug included in the list of vital and essential drugs is subject to state registration, if it does not exceed the price rate for this drug as calculated in accordance with the Procedure for determination of maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs as approved of in the manner established by the Government of the Russian Federation.

3. Sales of drugs included in the list of vital and essential drugs with no maximum ex-works manufacturer prices registered for the same is not allowed.

Article 62. State Register of the Maximum Ex-Works

Manufacturer Prices for Drugs

Included in the List of Vital

and Essential Drugs

 

1. The registered maximum ex-works prices for drugs included in the list of vital and essential drugs are subject to entering into the State Register of the maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs.

2. The State Register of the maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs contains the following information:-

1) the drug manufacturer name;

2) the drug name (international non-proprietary or chemical and trade names);

3) the drug registration certificate number;

4) the dosage form with an indication of the drug dose and its quantity per secondary (consumer) package;

5) the registered maximum ex-works price in rubles;

6) the date of state registration of the maximum ex-works price for drugs included in the list of vital and essential drugs.

3. State registration of the maximum ex-works prices for drugs included in the list of vital and essential drugs and keeping of the State Register of the maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs are carried out in the manner established by the Government of the Russian Federation.

Article 63. Determination by Executive Authorities

of the Russian Federation Constituent Territories

of the Maximum Wholesale and Retail Mark-ups

on the Actual Ex-works Manufacturer Prices

for Medicinal Drugs

 

1. Executive authorities of the Russian Federation constituent territories determine the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs in accordance with the Procedure for determination by executive authorities of the Russian Federation constituent territories of the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs as approved of in the manner established by the Government of the Russian Federation.

2. Sales by wholesale operators and/or pharmacies, individual entrepreneurs holding pharmaceutical licenses of drugs included in the list of vital and essential drugs is carried out at prices not exceeding the sum of the actual ex-works manufacturer price that does not exceed the registered maximum ex-works price and of the wholesale and/or retail mark-ups that do not exceed the maximum wholesale and/or retail mark-ups, respectively, set out in the Russian Federation constituent territory.

3. Executive authorities of the Russian Federation constituent territories place in the Internet or publish information on the registered maximum ex-works price for drugs included in the list of vital and essential drugs, on the maximum wholesale and/or retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs as established in the Russian Federation constituent territory and on the sum specified in par. 2 of this Article. The information envisaged in this paragraph is to be placed in pharmacies in the format available for all the persons concerned and is to be updated as it is published.

4. Decisions on determination of the maximum wholesale and retail mark-ups on the registered maximum ex-works prices for drugs included in the list of vital and essential drugs as made by executive authorities of the Russian Federation constituent territory in contravention of the law of the Russian Federation are subject to cancellation at court.

 

Chapter 13. Safety Monitoring for Drugs

in Circulation in the Russian Federation

 

Article 64. Drug Safety Monitoring

 

1. Drugs circulating in the Russian Federation are subject to safety monitoring in order to identify any possible adverse effects of drug administration, to warn and protect patients from use of such drugs.

2. Drug safety is monitored at all stages of their circulation in the Russian Federation by the competent federal executive authority.

3. The drug circulation subjects are obliged to notify, in the manner established by the competent federal executive authority, of all cases of side effects not included in the drug leaflets, of severe adverse effects, of unexpected adverse effects in drug administration and of the particular features of the drug interaction with other drugs as identified in clinical trials and in drug administration.

4. For failure to provide or for hiding of information envisaged in par. 3 of this Article the persons to whom such information became available in the course of their professional activities are liable in accordance with the law of the Russian Federation.

5. The procedure for monitoring of drug safety, for registration of side effects, severe adverse effects and unexpected adverse effects in drug administration, including for provision of information on the same, is established by the competent federal executive authority.

Article 65. Drug Use Suspension

 

If information on side effects not specified in the drug leaflet, on severe adverse effects, unexpected adverse effects in drug administration and on the particular features of its interaction with other drugs that may pose threat to patient’s life and health and also information not corresponding to the drug information contained in its leaflet is obtained, the competent federal executive authority considers suspension of the drug use in the manner established by the competent federal executive authority.

Article 66. Information on Findings of

Drug Safety Monitoring

 

Following findings of the monitoring, the competent federal executive authority that monitors drug safety posts on its official website in the Internet information on the decisions made to amend the drug leaflets, to suspend the drug use, to withdraw the drug from circulation or to resume the drug use.

 

Chapter 14. Drug Information

 

Article 67. Drug Information

 

1. Information on drugs dispensed at the physician’s prescription (prescription drugs) should only be available in specialized publications intended for medical, pharmaceutical and veterinary workers. Information on drugs for specialists in the field of drug circulation may be available as monographs, reference books, scientific articles, reports at congresses, conferences, symposiums, scientific boards and also as drug leaflets.

2. Information on drugs dispensed without the physician's prescription (over-the-counter drugs) may be available in mass media publications and announcements, specialized and general publications, drug leaflets, other publications of the drug circulation subjects. The advertising materials on an over-the-counter drug should correspond to its leaflet.

3. It is allowed to use any tangible media enabling storage, transmission and use of drug information without distortion.

 

Chapter 15. Liability for Violation of the Russian Federation Law on Drug Circulation and Indemnification for Harm to Health of Citizens as a Result of Drug Administration

 

Article 68. Liability for Violation

of the Russian Federation Law

On Drug Circulation

 

Violation of the Russian Federation law on drug circulation entails liability in accordance with the law of the Russian Federation.

Article 69. Indemnification for Harm to

Health of Citizens as a Result of

Drug Administration

 

1. The drug manufacturer is obliged to indemnify for harm to health of citizens as a result of the drug administration, if it is proven that:-

1) the drug was administered in accordance with its indications and the drug leaflet and the harm was caused by bringing a low-quality drug in civil circulation;

2) harm to health was due to the untrustworthy information contained in the drug leaflet published by the drug manufacturer.

2. If harm to health of citizens is caused by administration of a drug that became unfit because of violation of the drug storage rules, the drug wholesale trade rules, the drug dispensing rules, and the drug production and dispensing rules, the harm is indemnified for by the drug wholesale operator, the pharmacy, the individual entrepreneur holding a pharmaceutical or a medical license, the healthcare institution holding a pharmaceutical license (its separate business unit – an outpatient department, feldsher’s and feldsher’s/maternity stations, a center/division of general healthcare / family practice) located in a rural settlement where there are no pharmacies), respectively, that is at fault for selling or dispensing of the drug.

3. Indemnification for harm to health of citizens as a result of the drug administration or illegal actions of the drug circulation subjects is performed in accordance with the law of the Russian Federation.

 

 

Chapter 16. Final Provisions

 

Article 70. On Invalidation of Separate Laws

(Provisions of Laws)

of the Russian Federation

 

To invalidate:-

1) Federal Law of June 22, 1998, No. 86-FZ, On Drugs (Collection of Laws of the Russian Federation, 1998, No. 26, Art. 3006);

2) Federal Law of January 2, 2000, No. 5-FZ, On Amendments and Supplements to the Federal Law On Drugs (Collection of Laws of the Russian Federation, 2000, No. 2, Art. 126);

3) Article 40, Federal Law of January 10, 2003, No. 15-FZ, On Amendments and Supplements to Certain Laws of the Russian Federation in Connection with Adoption of the Federal Law On Licensing Individual Business Activities (Collection of Laws of the Russian Federation, 2003, No. 2, Art. 167);

4) Article 31, Federal Law of June 30, 2003, No. 86-FZ, On Amendments and Supplements to Certain Laws of the Russian Federation, Invalidation of Separate Laws of the Russian Federation, Provision of Certain Guarantees to Employees of Interior Departments, Narcotic and Mood-Altering Drug Circulation Supervision Departments and the Abolished Federal Tax Police in Connection with State Administration Improvement Efforts (Collection of Laws of the Russian Federation, 2003, No. 27, Art. 2700);

5) Article 101, Federal Law of August 22, 2004, No. 122-FZ, On Amendments to Laws of the Russian Federation and on Invalidation of Certain Laws of the Russian Federation in Connection with Adoption of Federal Laws On Amendments and Supplements to the Federal Law ‘On General Principles of Establishment of Legislative/Representative and Executive Authorities of the Russian Federation Constituent Territories’ and ‘On General Principles of Establishment of Local Self-Governments in the Russian Federation’ (Collection of Laws of the Russian Federation, 2004, No. 35, Art. 3607);

6) Article 28, Federal Law of December 18, 2006, No. 231-FZ, On Enforcement of Part IV, Civil Code of the Russian Federation (Collection of Laws of the Russian Federation, 2006, No. 52, Art. 5497).

Article 71. Enactment of this Federal Law

 

1. This Federal Law inures from September 1, 2010.

2. Drugs registered before this Federal Law takes effect are subject to entering into the state registers of drugs, with inclusion of information on these drugs as specified in par. 1, Article 33 of this Federal Law, without the need to pass the drug state registration procedure once again.

3. State registration of drugs submitted for the said registration before this Federal Law takes effect is carried out in accordance with this Federal Law on the basis of the documents and information submitted before this Federal Law takes effect.

4. It is allowed to conduct drug review by experts of the Expert Institution before they pass attestation in the manner established by the federal executive authority during the period from enactment of this Federal Law to April 30, 2011, inclusively.

5. The complete transfer to drug manufacturing in accordance with drug manufacturing and quality control rules specified in par. 1, Article 45 of this Federal Law, is carried out during the period from enactment of this Federal Law to December 31, 2013, inclusively. The periods for transfer to drug manufacturing in accordance with specific requirements of these rules, including the periods for attestation of authorized persons specified in para. 6 and 7, Article 45 of this Federal Law, are established by the Government of the Russian Federation.

6. Drugs manufacturing licenses issued prior to January 1, 2014, are effective after January 1, 2014, until their expiration, provided that the licensee complies with drug manufacturing and quality control rules specified in par. 1, Article 45 of this Federal Law.

 

          President of

the Russian Federation                                                                     D. Medvedev

 

 

 

 

 

 

 

 

 

 

On Drug Circulation

 

Adopted by the State Duma                                                  March 24, 2010

 

 

Chapter 1. General Provisions

 

Article 1. Subject of Regulation of This Federal Law

 

1. This Federal Law governs the relations in connection with drug circulation, namely: development, pre-clinical and clinical trials, review, state registration, standardization and quality control, manufacturing, production, storage, transportation, import to/ export from the Russian Federation, advertising, dispensing, sales, transfer, administration and destruction.

2. This Federal Law prioritizes government control over drug safety, quality and efficacy in the field of their circulation.

Article 2. Scope of This Federal Law

 

This Federal Law is applicable to relations in the field of drug circulation in the Russian Federation.

Article 3. Legislation on Drug Circulation

 

1. The legislation on drug circulation comprises this Federal Law, other federal laws and other regulations of the Russian Federation.

2. This Federal Law covers circulation of narcotic and mood-altering drugs subject to specific features provided for by the law of the Russian Federation on narcotic, mood-altering drugs and their pre-cursors.

3. This Federal Law covers circulation of radioactive drugs subject to specific features provided for by the law of the Russian Federation on radiation safety.

4. If an international treaty of the Russian Federation establishes any other rules than those envisaged in this Federal Law, the provisions of the international treaty are applicable.

5. Findings of medicinal drug clinical trials held outside the Russian Federation are recognized in the Russian Federation in accordance with international treaties of the Russian Federation and/or on the basis of reciprocity principle.

Article 4. Main Definitions Used in This Federal Law

 

The following main definitions are used for the purposes of this Federal Law:-

1) Drugs mean substances or their combinations, which come into direct contact with and penetrate organs and tissues of a human or animal body, applied for disease prevention, diagnosis (except for those not coming into contact with a human or animal body) and treatment, recovery, pregnancy maintenance, prevention or interruption, which are obtained from blood, blood plasma and also human or animal organs, tissues, plants and minerals using the synthesis methods or with application of biological technologies. Drugs include pharmaceutical substances and pharmaceuticals;

2) Pharmaceutical Substances mean drugs in the form of active ingredients of biological, biotechnological, mineral or chemical origin, having pharmacological activity, intended for drug manufacturing and production and determining their efficacy;

3) Auxiliary Substances mean substances of organic and non-organic origin used in drug manufacturing and production to lend the necessary physical and chemical properties to them;

4) Pharmaceuticals mean drugs as dosage forms applied for disease prevention, diagnosis and treatment, recovery, pregnancy maintenance, prevention or interruption;

5) Dosage Form means the form of a pharmaceutical, which corresponds to the method of its administration and the way of its application and helps achieve the appropriate therapeutic effect;

6) List of Vital and Essential Drugs means the list of medicinal drugs as approved of by the Government of the Russian Federation on an annual basis, which help meet the top-priority healthcare needs in disease prevention and treatment, including those prevailing in the incidence pattern among the population of the Russian Federation;

7) Immunobiological Drugs mean pharmaceuticals of biological origin intended for immunological diagnosis, prevention and treatment;

8) Narcotic Drugs mean drugs and pharmaceutical substances that contain narcotic substances and are included into the List of narcotic drugs, mood-altering substances and their pre-cursors 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 Narcotic Drugs 1961;

9) Mood-Altering Drugs mean pharmaceuticals and pharmaceutical substances that contain mood-altering substances and are included into the list of narcotic drugs, mood-altering substances and their pre-cursors 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 Mood-altering Substances 1971;

10) Radioactive Drugs are drugs containing one or several radionuclides (radioactive isotopes) in the ready-for-use form;

11) Original Drug means a drug containing a new, newly obtained pharmaceutical substance or a new combination of pharmaceutical substances, the efficacy and safety of which are evidenced by the findings of drug pre-clinical and clinical trials;

12) Reproduced Drug means a drug that contains the same pharmaceutical substance or the combination of the same pharmaceutical substances in the same dosage form as the original drug and that entered the circulation after the original drug;

13) Medicinal Plant Raw Material means fresh or dried plants or their parts used for drug manufacturing by drug manufacturers or for drug production in pharmacies, veterinary pharmacies and by individual entrepreneurs holding a pharmaceutical license;

14) Medicinal Plant Drug means a drug manufactured or produced from one or several types of medicinal plant raw material and marketed in the prepackaged form in the secondary (consumer) package;

15) Homeopathic Drug means a drug manufactured or produced under a special technology;

16) International Non-Proprietary Name of a drug means the name of a pharmaceutical substance as recommended by the World Health Organization;

17) Trade Name of a drug means the name of a drug as assigned by the drug developer;

18) General Monograph means a document approved of by the competent federal executive authority and containing a list of quality parameters and/or quality control methods for any particular drug dosage, medicinal plant raw material, a description of biological, biochemical, microbiological, physical and chemical, physical, chemical and other medicinal drug analysis methods, requirements to used reagents, titrants, indicators;

19) Monograph means a document approved of by the competent federal executive authority and containing a list of quality parameters and medicinal drug quality control methods;

20) Regulatory Documents mean the document containing a list of medicinal drug quality parameters, drug quality control methods as determined based on the review results and established by its manufacturer;

21) Regulatory Document means the document containing a list of quality parameters and/or drug dosage quality control methods as determined based on the results of reviews and also a description of biological, biochemical, micro-biological, physical and chemical, physical, chemical and other veterinary drug analysis methods, requirements to used reagents, titrants, indicators and as established by its manufacturer;

22) Drug Quality means conformity of a drug to the Monograph requirements or, if they do not exist, to Regulatory Documents or the Regulatory Document;

23) Drug Safety means the drug feature based on comparative analysis of their efficacy and risk of harm to health;

24) Pharmaceutical Efficacy means the extent, to which a pharmaceutical produces a positive impact on the disease progress, duration or prevention, recovery, pregnancy maintenance, prevention or interruption;

25) Drug Series means quantity of a drug manufactured by the drug manufacturer as a result of one technological cycle;

26) Drug Registration Certificate means a document that evidences state registration of a drug;

27) Registration Number means a code designation assigned to a drug in state registration;

28) Drug Circulation means drug development, pre-clinical and clinical trials, review, state registration, standardization and quality control, manufacturing, production, storage, transportation, import to/ export from the Russian Federation, advertising, dispensing, sales, transfer, administration and destruction;

29) Drug Circulation Subjects mean individuals, including individual entrepreneurs, and legal entities that operate in the field of drug circulation;

30) Drug Developer means an organization holding rights to deliverables of drug pre-clinical and clinical trials and to drug manufacturing technology;

31) Drug Manufacturing means activities aimed at industrial manufacturing of drugs, including one, more or all stages of a technological process, including storage and sales of manufactured drugs;

32) Drug Manufacturer means an organization that manufactures drugs in accordance with requirements of this Federal Law;

33) Pharmaceutical Operations mean operations, including wholesale in drugs, storage, transportation and/or retail trade in drugs, dispensing, storage, transportation and production of drugs;

34) Drug Wholesaler means an organization that carries out wholesale trade in drugs, storage and transportation of drugs in accordance with requirements of this Federal Law;

35) Pharmacy means an organization, a business unit of a healthcare institution engaged in retail trade, storage, production and dispensing of medicinal drugs in accordance with requirements of this Federal Law;

36) Veterinary Pharmacy means an organization, a business unit of a veterinary organization engaged in retail trade, storage, production and dispensing of veterinary drugs in accordance with requirements of this Federal Law;

37) Fake Drug means a drug accompanied with untrue information on its composition and/or manufacturer;

38) Low-quality Drug means a drug that does not meet the Monograph requirements or Regulatory Documents or the Regulatory Document;

39) Counterfeited Drug means a drug circulated in violation of the civil law;

40) Drug Pre-Clinical Trial means biological, micro-biological, immunological, toxicological, pharmacological, physical, chemical and other trials aimed at obtaining, by application of scientific methods, of drug quality, efficacy and safety assessments and evidences;

41) Drug Clinical Trial means a study of diagnostic, therapeutic, preventive, pharmacological, properties of a drug when administered to a human being, an animal, including absorption, distribution, modification and clearance, aimed at obtaining, by application of scientific methods, of drug quality, efficacy and safety assessments and evidences, data on human or animal adverse responses to its administration and its interaction with other drugs and/or food (fodder);

42) Multicenter Medicinal Drug Trial means a medicinal drug clinical trial held by the drug developer in two and more healthcare institutions under the single drug clinical trial protocol;

43) International Multicenter Medicinal Drug Trial means a medicinal drug clinical trial held by the drug developer in various countries under the single drug clinical trial protocol;

44) Post-Registration Medicinal Drug Clinical Trial means a medicinal drug clinical trial held by the manufacturer of a drug brought in civil circulation after state registration for collection of additional data on its efficacy and safety, expansion of the drug indications and also identification of patients’ adverse responses to its effect;

45) Drug Bio-Equivalency Studies mean a type of clinical trials to determine the speed of absorption and clearance of the pharmaceutical substance and its quantity that reaches the systemic blood circulation, the findings of which enable to make a conclusion on bio-equivalence of any particular drug dosage and dose of a reproduced pharmaceutical to the respective original pharmaceutical;

46) Drug Therapeutic Equivalence Trial means a type of drug clinical trials, which is conducted for identification of the same drug parameters of a specific drug dosage, as well as of the same drug safety and efficacy parameters, if any, of the same clinical effects in their administration;

47) Drug Clinical Trial Protocol means a document that describes purposes of, arrangement for and methods of holding a clinical trial, statistical methods of processing of obtained results and measures to ensure safety of persons taking part in the drug clinical trial;

48) Investigator’s Booklet means consolidated statement of findings of held pre-clinical and clinical medicinal drug trial;

49) Patient’s Information Sheet means a document that contains, in intelligible form, information pertaining to the conducted drug clinical trial, with a documented patient’s voluntary informed consent to participation in a drug clinical trial which is given upon familiarization with all of the particular clinical trial features significant for decision-making;

50) Side Effect means an response of a body in connection with drug use in doses recommended in its leaflet for prevention, diagnosis, treatment of a disease or for recovery;

51) Severe Adverse Effect means an adverse response of a body in connection with drug use that resulted in death, congenital anomalies or developmental defects, or is life-threatening, requires admission to hospital or leads to permanent incapacity and/or disability;

52) Unexpected Adverse Effect means an adverse body response (including in connection with drug use in accordance with its leaftet), the essence and severity of which do not conform to the drug information contained in its leaflet;

53) Drug Prescription means a written drug prescription in the established format, which was issued by an authorized medical or veterinary worker for dispensing of the drug or for its production and dispensing;

54) Healthcare Institution, Veterinary Organization Requirement means a document in the established format, signed by a medical or veterinary worker with the respective right and containing a written instruction for a pharmacy to dispense a drug or to produce and dispense it for treatment purposes of the healthcare institution, veterinary organization.

 

Chapter 2. Powers of Federal Executive Authorities,

Executive Authorities of the Russian Federation Constituent Territories in the Field of Drug Circulation

 

Article 5. Powers of Federal Executive Authorities

in the Field of Drug Circulation

 

The powers of federal executive authorities in the field of drug circulation include:-

1) ensuring that the uniform governmental policy for provision of the population with drugs is implemented in the Russian Federation;

2) approval of General Monographs, Monographs and publication of the National Monograph;

3) exercise of governmental control and supervision;

4) licensing of drug manufacturing and pharmaceutical operations in accordance with the law of the Russian Federation;

5) arranging for drug review, ethical review in connection with medicinal drug clinical trials;

6) issue of authorizations for drug clinical trials and keeping of the Register of issued authorizations for drug clinical trials;

7) state registration of drugs and keeping of the State Register of drugs;

8) examination of drug manufacturing for conformity to the rules of drug manufacturing and quality control, issue of opinions on conformity of the drug manufacturer to the rules of drug manufacturing and quality control;

9) state registration of the maximum ex-works manufacturer prices for vital and essential drugs and keeping of the State Register of the maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

10) establishment of the procedure for drug import to/ export from the Russian Federation;

11) establishment of boards on drug circulation;

12) attestation and certification of specialists;

13) approval of educational programs for specialists’ training;

14) drug safety monitoring;

15) participation in international cooperation;

16) obtaining, at requests of a competent federal executive authority, of information on determination and application of drug prices and mark-ups thereon from executive authorities of the Russian Federation constituent territories and also from subjects of the medicinal drug circulation;

17) enforcement of measures for violation of the law of the Russian Federation.

Article 6. Powers of Executive Authorities

of the Russian Federation Constituent Territory

in the Field of Drug Circulation

 

The powers of executive authorities of the Russian Federation constituent territory in the field of drug circulation include:-

1) development and implementation of regional programs for provision of the population with drugs;

2) determination of the maximum wholesale and retail mark-ups on actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

3) exercise of control over application of prices for drugs included in the list of vital and essential drugs by wholesale operators, pharmacies and individual entrepreneurs holding a pharmaceutical license.

 

Chapter 3. National Monograph

 

Article 7. Development and Publication of

the National Monograph,

Placement of Data on It

 

1. The National Monograph is the code of General Monographs and Monographs.

2. Development of General Monographs and Monographs and inclusion thereof in the National Monograph are implemented in the manner established by the competent federal executive authority.

3. A Monograph for an original drug is developed and included in the National Monograph during the effective period of the original drug patent protection subject to consent of the drug developer.

4. The National Monograph is published by the competent federal executive authority using the federal budget funds and is subject to re-publication at least once in 5 years. In the period between publication dates of the National Monograph, appendices to the National Monograph, which contain General Monographs and/or Monographs approved of after publication/ re-publication of the National Monograph, are published.

5. The competent federal executive authority posts data on the National Monograph and appendices thereto on the official website in the manner established by the authority.

 

Chapter 4. State Control over Drug Circulation

 

Article 8. Licensing of Drug Manufacturing

and Pharmaceutical Operations

 

1. Drug manufacturing and pharmaceutical operations is licensed in accordance with the legislation of the Russian Federation.

2. Indication in the applicant’s application of the dosage forms and/or types of pharmaceutical substances the drug manufacturer is willing to manufacture is the statutory condition for issuing a drug manufacturing license.

3. If drug manufacturing is expanded by new dosage forms and types of pharmaceutical substances, the drug manufacturer should obtain a new license.

Article 9. State Control over Drug Circulation

 

1. All drugs manufactured in and imported to the Russian Federation are subject to state control.

2. State control is exercised by competent federal executive bodies and executive authorities of the Russian Federation constituent territories in accordance with their respective powers.

3. State control over drug circulation includes control over drug pre-clinical and clinical trials, quality, manufacturing, production, storage, transportation, import to the Russian Federation, advertising, dispensing, sales, destruction, and administration.

4. State control is exercised through:-

1) auditing of compliance by drug circulation subjects with laboratory and clinical practice in medicinal drug pre-clinical and clinical trials, rules for veterinary drug pre-clinical and clinical trials, drug manufacturing and quality control rules, wholesale drug trade rules, drug dispensing rules, drug production and dispensing rules, drug storage rules, drug destruction rules;

2) licensing of drug manufacturing and pharmaceutical operations, auditing of compliance with license requirements and conditions;

3) quality control over drugs in civil circulation:-

a) by way of sampling;

b) when conditions of drug manufacturing and quality control, drug wholesale trade, drug retail trade, drug production and drug storage are found to be in conflict with license requirements and conditions;

4) by issuing of authorizations for drug import to the Russian Federation;

5) by drug safety monitoring;

6) by receiving, upon requests from the competent federal executive authority, information on determination and use of prices and mark-ups thereon from executive authorities of the Russian Federation constituent territories, from subjects of the medicinal drug circulation.

5. State control over drug circulation is an expenditure responsibility of the Russian Federation or the Russian Federation constituent territories by control types related to, respectively, powers of federal executive bodies or executive authorities of the Russian Federation constituent territories.

 

Chapter 5. Drug Development, Pre-Clinical Trials

and Veterinary Drug Clinical Trials

 

Article 10. Drug Development

 

1. Drug development includes search for new pharmacologically active ingredients, subsequent study of their therapeutic properties, pre-clinical trials, development of the production technologies for pharmaceutical substances, development of the drug manufacturing compositions and technologies.

2. The drug development is funded from:-

1) the federal budget funds;

2) drug developers’ funds;

3) drug manufacturers’ funds as part of research and development implemented under a contract between the drug developer and the drug manufacturer;

4) any other sources not prohibited by the law of the Russian Federation.

3. Drug developer’s rights are protected by the civil law.

Article 11. Medicinal Drug Pre-Clinical Trial

 

1. A medicinal drug pre-clinical trial is aimed at obtaining, by applying scientific methods, of the drug quality, efficacy and safety assessments and evidences.

2. Medicinal drug pre-clinical trials are held in accordance with the laboratory practice rules approved of by a competent federal executive authority.

3. To arrange for and to hold a medicinal drug pre-clinical trial, drug developers may engage research organizations, educational institutions of higher professional education, having the necessary materials and equipment and specialists qualified in the appropriate field.

4. A medicinal drug pre-clinical trial is held in accordance with a plan approved of by the drug developer, with a protocol kept and a report drafted and containing findings of the drug pre-clinical trial and an opinion on the possibility to hold a clinical trial for the medicinal drug.

5. Compliance with the laboratory practice of and regulations on the use of animals in medicinal drug pre-clinical trials is audited by the competent federal executive authority.

6. Findings of a medicinal drug pre-clinical trial may be submitted to the competent federal executive authority in the established manner, to have the drug registered by state authorities.

Article 12. Veterinary Drug Pre-Clinical and Clinical Trials

 

1. A veterinary drug pre-clinical trial is aimed at obtaining, by applying scientific methods, of the drug quality, efficacy and safety assessments and evidences, including at determining of the period of its clearance from an animal body, to ensure safety of animal products upon application of the drug.

2. Veterinary drug pre-clinical and clinical trials and also drug bio-equivalence trials are held in accordance with the rules approved of by the competent federal executive authority.

3. Veterinary drug pre-clinical and clinical trials are held in accordance with a plan approved of by the drug developer, with the protocol kept and the report drafted and containing findings of the pre-clinical and clinical trials.

4. To arrange for and hold pre-clinical and clinical trials, the drug developer may engage organizations having the necessary materials and equipment and specialists qualified in the appropriate field of studies.

5. Drug clinical trials are held in veterinary institutions and organizations engaged in animal keeping, breeding and raising to:-

1) determine healthy animals’ tolerance thereto;

2) select the most appropriate doses and treatment course using a limited group of animals suffering from any particular disease;

3) establish drug efficacy and safety for animals suffering from any particular disease or prevention efficacy for healthy animals;

4) study possibilities to extend the indications and to identify earlier unknown side effects of the registered drug.

6. A veterinary drug clinical trial is carried out using the drug developer’s funds.

7. Reports on findings of the veterinary drug pre-clinical and clinical trials are drafted by the drug developer, taking into account opinions of the organizations that took part in arranging for and holding of the these trials.

8. The competent federal executive authority performs control over drug pre-clinical and veterinary drug clinical trials.

 

Chapter 6. State Registration of Drugs

 

Article 13. State Registration of Drugs

 

1. Drugs enter into civil circulation in the Russian Federation, if they are registered by the competent federal executive authority.

2. Subject to state registration are:-

1) original drugs;

2) reproduced drugs;

3) new combinations of earlier registered drugs;

4) earlier registered drugs manufactured in other dosage forms, with new doses.

3. State registration of medicinal drugs is carried out based on findings of a drug review and an ethical review of the possibility of a medicinal drug clinical trial (hereinafter ‘the Ethical Review’). State registration of veterinary drugs is carried out based on findings of a veterinary drug review.

4. State registration of drugs is carried out by the competent federal executive authority within the period of time not exceeding two hundred and ten business days from the date the drug state registration application is accepted. This period of time includes the time required for a repeated drug review and/or ethical review in accordance with Article 25 of this Federal Law. The drug state registration period is calculated from the date the drug state registration application accompanied with all necessary documents is accepted by the competent federal executive authority to the date the drug registration certificate is issued. The drug clinical trial period is not accounted for in calculation of the drug state registration period.

5. Not subject to state registration are:-

1) drugs produced in pharmacies, veterinary pharmacies and by individual entrepreneurs holding a pharmaceutical license by drug prescriptions and at requests of medical, veterinary organizations;

2) medicinal plant raw materials;

3) drugs purchased by individuals outside the Russian Federation and intended for personal use;

4) drugs intended for export;

5) radioactive drugs produced in healthcare institutions in the manner established by the competent federal executive authority.

6. Prohibited is state registration:

1) of different drugs under the same trade name;

2) of one drug manufactured under different trade names and submitted for state registration as two and more drugs.

Article 14. Drug Review and Ethical Review Principles

 

1. Drug review and ethical review are based on principles of legality, observance of human and citizens’ rights and freedoms, legal entity rights and also of independence of an expert, neutrality, comprehensiveness and completeness of trials conducted using the most advanced scientific and technical achievements, of responsibility of a federal governmental budgetary drug review institution and experts for holding and quality of the review.

2. The medicinal drug review is conducted on a stage-by-stage basis:-

1) Stage One – review of documents for obtaining a clinical trial authorization for a drug, except for:

a) drugs authorized for medical use in the Russian Federation for over twenty years, with no possibility to hold a bio-equivalence trial in respect thereof;

b) medicinal drugs with global multicenter clinical trials held in respect thereof, including some held in the Russian Federation;

2) Stage Two – review of drug quality control methods proposed and of quality of provided drug samples using these methods (hereinafter ‘the Drug Quality Review’), as well as the review to assess the risk-benefit ratio for the drug, that are implemented after its clinical trial.

3. The veterinary drug review is carried out at one stage and includes the drug quality review and the review to assess the risk-benefit ratio for the drug.

Article 15. Federal Governmental Budgetary

Institution in Charge of Drug Review

 

Drug review is conducted by the federal governmental budgetary institution of the competent federal executive authority as established to ensure exercise of powers of this federal authority to issue authorizations for drug clinical trials and/or to register drugs by the state (hereinafter ‘the Expert Institution’).

Article 16. Drug Review Procedure for the Purpose of

Drug State Registration

 

1. Drug review is carried out by the Expert Institution’s Expert Commission appointed by the head of that institution, based on the drug review assignment issued by the competent federal executive authority. The head of the Expert Institution ensures the good quality of the drug review held in accordance with the assignment of the competent federal executive authority and arranges for drafting a consolidated opinion of the Commission. Persons not employed by the Expert Institution may be included into the Expert Commission as experts by resolution of the head of the Expert Institution, if their special knowledge is necessary for holding the review and there are no such experts in the Institution.

2. The expert in charge of drug review is a qualified employee of the Expert Institution with the higher medical, pharmaceutical, biological, veterinary or chemical education, holding the drug review in the course of his/her job duties (hereinafter ‘the Expert’).

3. In holding drug review, the Expert cannot be dependant in any way on the person who assigned the review, the drug developer or other persons interested in the review results.

4. During drug review it is not allowed to request from the applicant or any other sources any materials required for the review. In case of insufficient materials submitted to the expert for the expert opinion, the expert has the right to enquire submission of the necessary materials from the head of the Expert Institution, and the latter, in its turn, addresses the enquiry to the competent federal executive authority, that issued the drug review assignment.

5. The Expert is obliged, in conducting the drug review assigned to him/her by the head of the Expert Institution, to:-

1) carry out a comprehensive study of the objects and case materials provided to him/her, give a well-substantiated and unbiased opinion on questions posed to him/her or present a reasonable opinion on the impossibility for him/her to carry out the drug review, if the questions posed to him/her go beyond the scope of the expert’s special knowledge, if the study objects and case materials are unsuitable or insufficient for holding of the trials and giving the opinion or if the current scientific development level does not allow to answer the questions posed;

2) refrain from disclosing information, that became known to him/her in connection with the drug review and also information that constitutes public, business or other legally protected secret;

3) ensure preservation of the provided study objects and case materials.

6. The Expert is not entitled to:-

1) hold drug review upon approach by any organizations or individuals directly to him/her;

2) independently collect materials for drug review;

3) hold drug review as a non-governmental expert.

7. The Expert is free to petition the head of the Expert Institution for engagement of other experts in the drug review, if necessary.

8. Each Expert included into the Expert Commission in charge of drug review, independently and on its own, conducts trials, assesses the findings obtained by him/her personally and by other experts and formulates the conclusions on questions posed to them, to the extent of his/her special knowledge.

9. Drug review findings are formalized in the opinion of the Expert Commission. The opinion of the Expert Commission indicates what trials and to what extent were conducted by each expert, what facts were established by each expert and what conclusions were reached. The expert whose opinion differs from the resolution of the Expert Commission is free to draft his/her written opinion, that is attached to the opinion of the Expert Commission.

10. Experts included into the Commission are notified of their liability under the law of the Russian Federation for giving an opinion containing unsubstantiated or fabricated conclusions, and they swear in writing to that effect.

11. The expert qualification commissions determine the level of experts’ professional qualification and attest them as being qualified/not qualified to hold drug review in the manner established by the competent federal executive authority. The experts’ professional qualification level is subject to revision by these commissions at least once in five years.

12. The drug review procedure and the format of the Expert Commission’s opinion are established by the competent federal executive authority.

Article 17. Ethical Review

 

1. The ethical review is conducted to issue the opinion on the ethical feasibility of a medicinal drug clinical trial by the Ethics Board established in the manner established by the competent federal executive authority.

2. The Ethics Board experts may be representatives of medical, scientific, educational institutions of higher professional education, as well as representatives of public, religious associations and mass media. These experts shall not be dependant in any way on drug developers and other persons interested in the ethical review findings.

3. Remuneration is paid to the Board experts in accordance with the contract concluded between the competent federal executive authority that established the Ethics Board and the Ethics Board expert.

4. The Ethics Board experts are liable in accordance with the law of the Russian Federation.

5. Composition of the Ethics Board, the Regulations on the Board, its procedures, requirements to the Ethics Board experts’ qualification and experience in the field of expert assessment of scientific, medical and ethical dimensions of medicinal drug clinical trials, the ethical review arrangement and procedure, the format of the Ethics Board’s opinion are established by the competent federal executive authority. The number of representatives from healthcare institutions may not exceed half of the total number of the Ethics Board experts.

6. Information on the composition of the Ethics Board, its working plans and current activities is posted on the official website of the competent federal executive authority in the Internet in the manner established by the authority.

Article 18. Submission and Consideration of Applications

for State Registration оf Drugs and Presentation of

Necessary Documents

 

1. To ensure state registration of a drug, the drug developer or another legal entity authorized by the drug developer (hereinafter ‘the Applicant’) files an application for state registration of the drug with the competent federal executive authority in charge of state registration of drugs, as well as in the manner established by the latter, the necessary documents to form the drug registration file (hereinafter ‘the Registration File’).

2. The application for state registration of the drug indicates:-

1) name and address of the applicant and/or the drug manufacturer and the address of the drug manufacturing facilities;

2) the drug name (international non-proprietary or chemical and trade names);

3) a list of substances in the drug composition, with indication of quality for each of them;

4) the drug dosage, dose, administration and application method, shelf life;

5) description of pharmacological and pharmaco-dynamic or immunobiological properties of the drug;

6) the declared maximum ex-works manufacturer price in case of state registration of a drug included in the list of vital and essential drugs;

7) no need to hold a clinical trial, a bio-equivalence study for a drug authorized for medical use in the Russian Federation for over twenty years, with specification of normative legal acts evidencing the said period of use.

3. The following documents form the registration file:-

1) the mock-ups of primary and secondary (consumer) drug package;

2) a document translated in Russian, confirming that the manufacturer of the registered drug meets the drug production and quality control rules, issued by the competent authority of the registered drug manufacturer country and certified in the established manner;

3) draft regulatory documents or a draft regulatory document for the drug or indication of the appropriate Monograph;

4) the drug manufacturing process flow chart and its description and/or the pharmaceutical substance manufacturing process flow chart and its description;

5) a document translated in Russian, confirming that the manufacturer of the pharmaceutical substance meets the drug production and quality control rules, issued by the competent authority of the pharmaceutical substance manufacturer country, certified in the established manner, and containing:-

a) the pharmaceutical substance name (international non-proprietary or chemical and trade names);

b) name and address of the pharmaceutical substance manufacturer;

c) the pharmaceutical substance shelf life;

6) a document containing information on quality parameters of the pharmaceutical substance used in drug manufacturing;

7) regulatory documents or a regulatory document for the pharmaceutical substance or indication of the appropriate Monograph;

8) information on the drug storage and transportation conditions and other information;

9) a report on findings of the medicinal drug pre-clinical trial, that contains a description of the conducted drug pre-clinical trial, the findings of the pre-clinical trial and their statistical analysis;

10) a report on findings of the drug pre-clinical trial and the veterinary drug clinical trial;

11) the draft medicinal drug clinical trial protocol;

12) a booklet for an investigator;

13) the information sheet for a patient;

14) information on payments and compensations to patients/ healthy volunteers/ sick persons (hereinafter ‘the Patients’) involved in clinical trials of the medicinal drug, bio-equivalence and/or therapeutic equivalence studies;

15) a report on findings of the medicinal drug global multicenter clinical trials, including some held in the Russian Federation;

16) a draft drug leaflet that contains the following information:-

a) the drug name (international non-proprietary or chemical and trade names);

b) the drug dosage, with indication of names and quantities (activity) of the pharmaceutical substances and auxiliary substances;

c) the drug pharmaco-therapeutic group;

d) the indications;

e) the contraindications;

f) the dosage regimen, administration method; if necessary, the drug administration time, treatment duration (including in children younger and older than one);

g) the precautions at administration;

h) the overdosage sympthoms, assistance in case of overdosage;

i) the indication, if necessary, of the particular features of the drug effect at first administration or its cancellation;

j) the description, if necessary, of the physician’s/ his/her assistant’s/ veterinary specialist’s/ patient’s/ animal owner’s actions, if administration of one or more drug doses is omitted;

k) the possible side effects during drug administration;

l) the interaction with other drugs and/or food, fodder;

m) the indication of the possibility and particular features of medical use of the drug by pregnant women, breast-feeding women, minors and adults with chronic diseases;

n) the information on the possible medicinal drug effect on the ability to drive transportation vehicles, mechanisms;

o) the shelf life and the indication that the drug use is not allowed upon expiry of its shelf life;

p) the storage conditions;

q) the indication that the drug should be stored in locations inaccessible for children;

r) the indication, if necessary, of the special precautions at destruction of the unused drugs;

s) the time of possible use of animal products upon the veterinary drug administration to the animal;

t) the drug manufacturer name, address and the address of the drug manufacturing facilities;

17) a copy of the document, translated into Russian and certified in the established manner, which confirms the drug registration, if it is registered outside the Russian Federation;

18) the documents presented in accordance with Articles 19 to 23 of this Federal Law.

4. Reports on findings of the drug clinical trials, biological equivalence and/or therapeutic equivalence trials (including epidemiological or epizootological trials of immunobiological drugs intended for immunological prevention and treatment of infectious diseases, including in children) held in the applicant’s country and in other countries, which contain a description of the conducted drug trials, the findings and their statistical analysis, may be provided at the option of the applicant.

5. To be attached to an application for state registration of a drug are:-

1) a document evidencing payment of the state duty for the review of the documents with a view to obtain authorizations to hold medicinal drug clinical trials and the ethical review, in case of application for the drug state registration;

2) a document evidencing payment of the state duty for the drug quality review and the review to assess the risk-benefit ratio for a drug authorized for medical use in the Russian Federation for over twenty years, in case of state registration of the drug;

3) a document evidencing payment of the state duty for the drug quality review and the review to assess the risk-benefit ratio for a medicinal drug, with global multicenter clinical trials held in respect thereof, including some held in the Russian Federation, in case of state registration of the drug;

4) a document evidencing payment of the state duty for the drug quality review and the review to assess the risk-benefit ratio for a veterinary drug, in case of state registration of the drug.

Article 19. Making Decisions on Issuance of

Drug Review Assignments to

the Expert Institution and the Ethics Board

 

1. The competent federal executive authority, within five business days from the date the application for state registration of a drug is accepted, verifies completeness and reliability of information contained in the case materials submitted by the applicant and makes a decision to issue an assignment for:

1) the drug review, in particular the review of the documents to obtain a medicinal drug clinical trial authorization in accordance with the purposes specified in Article 38 of this Federal Law, and the ethical review for drugs with no clinical trials held in respect thereof in the Russian Federation, based on the documents specified in subpara. 1 to 9, 11 to 14, 17, par. 3, and subpar. 1, par. 5, Article 18 of this Federal Law;

2) the drug review, in particular the drug quality review and the review to assess the risk-benefit ratio for a medicinal drug authorized for medical use in the Russian Federation for over twenty years, based on the documents specified in subpara. 1 to 9, 16, par. 3, and subpar. 2, par. 5, Article 18 of this Federal Law, as well as for drugs with global multicenter clinical trials held in respect thereof, including some held in the Russian Federation, based on the documents specified in subpara. 1 to 9, 15 to 17, par. 3, and subpar. 3, par. 5, Article 18 of this Federal Law;

3) the drug review for a veterinary drug, based on the documents specified in subpara. 1 to 8, 10, lines ‘a’ to ‘e’, ‘g’ to ‘l’, ‘o’ to ‘t’ of subpar. 16, subpar. 17, par. 3, and subpar. 4, par. 5, Article 18 of this Federal Law.

2. The competent federal executive authority notifies the applicant in writing of the decision made, and in case of a denial, giving reasons for the denial.

3. Partial submission of documents listed in para. 3 and 5 of Article 18 hereof or submission of documents not containing comprehensive information serve as a reason for the denial to arrange for the reviews specified in par. 1 of this Article.

Article 20. Review of the Documents to Obtain

a Medicinal Drug Clinical Trial

Authorization and Ethical Review

 

1. Review of the documents to obtain a medicinal drug clinical trial authorization in accordance with the purposes specified in Article 38 of this Federal Law, ethical review, drafting by the Expert Commission and the Ethics Board of the opinions on the possibility or impossibility of conducting such clinical trial and their submission to the competent federal executive authority are carried out within the period of time not exceeding thirty business days from receipt by the Expert Institution of the assignment from the competent federal executive authority, with all necessary documents listed in subpara. 9, 11 and 12, par. 3, Article 18, and documents specified in par. 4, Article 18 hereof and presented at the applicant’s option, and by the Ethics Board – of the assignment from the competent federal executive authority, with all necessary documents listed in subpara. 11 to 14, par. 3, Article 18, of this Federal Law.

2. The documents contained in the Registration File and received at the Expert Institution, the Ethics Board for their review for the purpose of obtaining a medicinal drug clinical trial authorization are to be returned to the competent federal executive authority simultaneously with the review opinions.

Article 21. Obtaining a Medicinal Drug

Clinical Trial Authorization

 

1. The competent federal executive authority, within five business days from receipt of the opinions specified in Article 20 of this Federal Law, assesses the said opinions to determine whether or not they comply with the assignments for the respective reviews and notifies the applicant in writing of the results of the conducted reviews and the possibility or impossibility to issue a medicinal drug clinical trial authorization to the applicant.

2. If a decision is made on the possibility to issue a medicinal drug clinical trial authorization, the competent federal executive authority suspends state registration of the drug until the applicant submits an application for the medicinal drug clinical trial authorization to the competent federal executive authority.

3. If a decision is made on the impossibility to issue a medicinal drug clinical trial authorization, the competent federal executive authority terminates the drug state registration procedure.

Article 22. Decision on a Medicinal

Drug Clinical Trial

 

1. For obtaining a medicinal drug clinical trial authorization, the applicant submits to the competent federal executive authority the following documents:-

1) the application for the drug clinical trial authorization;

2) information on the investigators’ professional experience and background in the field of clinical trials;

3) copies of life and health obligatory insurance agreements with the patients participating in the medicinal drug clinical trial.

2. The competent federal executive authority, within five business days from the date the application specified in par. 1 of this Article, with all of the necessary documents, is accepted:-

1) verifies completeness and reliability of information contained in the case materials submitted by the applicant;

2) makes a decision to issue the medicinal drug clinical trial authorization or to deny the same;

3) notifies the applicant in writing of the decision made, and in case of a denial, giving reasons for the denial;

4) issues the medicinal drug clinical trial authorization in the manner established by the competent federal executive authority.

3. Failure to provide documents specified in par. 1 of this Article or non-conformity of the content of the submitted documents to the requirements of this Federal Law serve as reasons for a denial to issue the medicinal drug clinical trial authorization.

Article 23. Drug Quality Review and

Risk-Benefit Ratio Assessment

for a Medicinal Drug

 

1. The drug quality review and the risk-benefit ratio assessment for a medicinal drug, drafting by Expert Commissions of opinions on the drug quality review findings and on the drug risk-benefit assessment and their submission to the competent federal executive authority are carried out within the period of time not exceeding one hundred and ten business days from receipt by the Expert Institution of the assignment from the competent federal executive authority with documents specified in subpara. 1 to 8, 15 to 17, par. 3, Article 18 of this Federal Law, and a report on the conducted medicinal drug clinical trial.

2. For holding the review and the assessment specified in par. 1 of this Article, the applicant submits to the competent federal executive authority the following documents:-

1) an application for resumption of the drug state registration and holding of the review and the assessment specified in par. 1 of this Article;

2) a report on the conducted medicinal drug clinical trial;

3) a document evidencing payment of the state duty for the drug quality review and the review to assess the risk-benefit ratio for the medicinal drug, in case of state registration of the drug.

3. The competent federal executive authority, within five business days from the date the application with documents specified in par. 1 and subpara. 2 and 3, par. 2 of this Article, is accepted:-

1) verifies completeness of the information contained in the medicinal drug clinical trial report submitted by the applicant;

2) makes a decision to resume the drug state registration and to hold the review and the assessment specified in par. 1 of this Article or to deny resumption of the medicinal drug state registration and holding of the said review and assessment;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

4. Partial submission of documents specified in par. 1 and subpara. 2 and 3, par. 2 of this Article of this Article or submission of the medicinal drug clinical trial report not containing the comprehensive information serve as reasons for the denial to resume the drug state registration and to hold the said review and assessment.

5. The applicant, within fifteen business days from receipt of the competent federal executive authority’s decision on resumption of the drug state registration and holding of the review and the assessment specified in par. 1 of this Article, submits samples of the medicinal drug manufactured in accordance with the pilot industrial and/or industrial regulations approved of by the head of the drug manufacturer, as well as a sample of the pharmaceutical substance in quantities required to reproduce the quality control methods, to the Expert Institution for the drug quality review.

6. The Expert Institution, upon receipt of the samples of the drug and the pharmaceutical substance, provides the applicant with the document evidencing acceptance of the said samples and, within three business days, notifies the competent federal executive authority in writing of the above.

7. The period for the applicant’s submission of samples of the drug and the pharmaceutical substance and the period for notification by the Expert Institution of the competent federal executive authority in writing of the above, as set forth in para. 5 and 6 of this Article, are not included into the period for the review and the assessment specified in par. 1 of this Article.

8. Documents received by the Expert Institution for the review and the assessment specified in par. 1 of this Article are to be returned to the competent federal executive authority simultaneously with opinions on findings of the said review and assessment.

Article 24. Drug Quality Review and

Risk-Benefit Ratio Assessment

for a Veterinary Drug

 

1. The drug quality review and risk-benefit ratio assessment for a veterinary drug, drafting by Expert Commissions of opinions on findings of the said review and assessment and their submission to the competent federal executive authority are carried out within the period of time not exceeding one hundred and ten business days from receipt by the Expert Institution of the assignment from the competent federal executive authority, with documents specified in subpara. 1 to 8, 10, lines ‘a’ to ‘e’, ‘g’ to ‘l’, ‘o’ to ‘t’ of subpar. 16 and subpar. 17, par. 3, Article 18 of this Federal Law.

2. The applicant, within fifteen business days from obtaining the decision of the competent federal executive authority on holding the review and the assessment specified in par. 1 of this Article, submits samples of the veterinary drug manufactured in accordance with the technological regulations approved of by the head of the drug manufacturer, as well as a sample of the pharmaceutical substance in the quantities required for reproduction of the quality control methods, to the Expert Institution for the drug quality review.

3. The Expert Institution, upon receipt of the samples of the drug and the pharmaceutical substance, provides the applicant with the document evidencing receipt of the said samples and, within three business days, notifies the competent federal executive authority in writing of the above.

4. The period for submission by the applicant of samples of the drug and the pharmaceutical substance and the period for notification by the Expert Institution of the competent federal executive authority in writing of the above, as specified in subpara. 2 and 3 of this Article, are not included into the period for the review and the assessment specified in par. 1 of this Article.

5. Documents received by the Expert Institution for holding the review and the assessment specified in par. 1 of this Article are to be returned to the competent federal executive authority simultaneously with the opinions on findings of the said review and assessment.

Article 25. Repeated Drug Review

and Ethical Review

 

1. If an opinion issued by the Expert Commission or the Ethics Board lacks substantiation or is incomplete, contains contradicting data, falsified conclusions on the drug review and/or the ethical review, if reasons for challenging an expert as being interested in the review findings are hidden from the competent federal executive authority, if there are data on direct or indirect intervention into the review by persons not involved in the review, which influenced the progress and findings thereof, then the competent federal executive authority assigns a repeated drug review and/or ethical review.

2. A repeated drug review is implemented within the period of time established by the competent federal executive authority and not exceeding forty business days from the date the repeated drug review assignment is received by the Expert Institution, and a repeated ethical review, within the period of time not exceeding fifteen business days from the date the repeated ethical review assignment is received by the Ethics Board.

3. The repeated drug review is not funded, and the funds transferred earlier for the review are to be returned to the federal budget.

Article 26. Accelerated Drug Review Procedure

 

1. The accelerated drug review procedure for the purposes of the drug state registration is applied with respect to reproduced drugs. In the course of the procedure, to be submitted is information obtained in drug clinical trials and published in specialized publications, as well as documents containing findings of the medicinal drug bio-equivalence and/or therapeutic equivalence studies or of the veterinary drug bio-equivalence study.

2. The accelerated drug review procedure is not applied with respect to immunobiological drugs, insulin drugs and drugs first registered in the Russian Federation.

3. The accelerated drug review procedure is implemented by decision of the competent federal executive authority within the period of time not exceeding sixty business days. In this case, the review of the Registration File documents for obtaining the medicinal drug clinical trial authorization and the ethical review are conducted within the period of time not exceeding fifteen business days, and the drug quality review and the risk-benefit ratio assessment, within the period of time not exceeding forty five business days.

4. The accelerated drug review procedure is implemented in the manner established in Articles 17 to 20, 23 and 24 of this Federal Law and does not mean relaxation of the drug safety, quality and efficacy requirements.

Article 27. Decision on Drug State Registration

 

1. The competent federal executive authority, within five business days from the date opinions on findings of the drug quality review and the risk-benefit ratio assessment are received from the Expert Commission:-

1) assesses the opinions to determine whether or not they conform to the assignment for the said review and assessment;

2) makes a decision on the drug state registration or on a denial to hold the drug state registration;

3) if a decision is made to conduct the drug state registration, enters data on the registered drug, including on the pharmaceutical substance in its composition, into the State Register of drugs and issues the drug registration certificate, the format of which is approved of by the competent federal executive authority, as well as the approved regulatory documents, regulatory document, drug leaflet and mock-ups of primary and secondary (consumer) package with indication of the drug registration certificate number and its state registration date, to the applicant, or, if a decision is made to deny the drug state registration, notifies the applicant in writing of the above giving reasons for the denial.

2. The decision taken by the competent federal executive authority to the effect that the registered drug efficacy is not confirmed by the obtained data or to the effect that the risk of harm to human or animal health as a result of the drug administration exceeds its efficacy serves as the reason to deny state registration of the drug.

3. In case of state registration of a drug included in the list of vital and essential drugs, the necessary data is entered into the State Register of the maximum ex-works manufacturer prices for drugs included in the said list.

Article 28. Drug Registration Certificate

 

1. A drug registration certificate, with indication of the drug dosage forms and doses, is issued for an indefinite period of time, except for the registration certificates issued for five years for drugs first registered in the Russian Federation.

2. Upon expiry of the period of time specified in par. 1 of this Article, the perpetual registration certificate for a drug is issued, provided that the drug state registration is confirmed.

Article 29. Drug State Registration

Confirmation Procedure

 

1. State registration of a drug is confirmed when the perpetual registration certificate for the drug is issued in the case indicated in par. 2, Article 28 of this Federal Law, within the period of time not exceeding ninety business days from the date the competent federal executive authority receives an application for confirmation of the drug state registration, executed in accordance with in par. 2, Article 18 of this Federal Law.

2. The drug state registration is confirmed based on findings of the drug risk- benefit ratio assessment.

3. An application for confirmation of the drug state registration is accompanied with a document evidencing payment of the state duty for confirmation of the medicinal drug state registration or the veterinary drug state registration and a document containing findings of the drug safety monitoring held by the applicant, in the format established by the competent federal executive authority.

4. The competent federal executive authority, within ten business days from the date the application for the drug state registration confirmation with all of the necessary documents is accepted:-

1) verifies completeness and reliability of information contained in the case materials submitted by the applicant;

2) makes a decision to hold or to deny the risk-benefit ratio assessment;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

5. Partial submission of documents specified in para. 1 and 3 of this Article or lack of comprehensive information that should be included in the submitted documents serve as reasons to deny the risk-benefit ratio assessment.

6. The risk-benefit ratio assessment to confirm the drug state registration is held in the manner established in Articles 23 and 24 of this Federal Law.

7. During the state registration confirmation procedure the drug is in the civil circulation in the Russian Federation.

Article 30. Amendments to Documents

in the Registration File for

the Registered Medicinal Drug

 

1. For the purpose of amendments to documents contained in the Registration File for the registered medicinal drug, the applicant submits to the competent federal executive authority the application for such amendments, in the format established by the competent federal executive authority, with amendments to the said documents, as well as documents evidencing the need in such amendments. The decision to make such amendments or to deny the same is taken within the period of time not exceeding ninety business days from the date the competent federal executive authority accepts the application for such amendments.

2. If there is a need to amend the drug leaflet in respect of information specified in lines ‘e’ to ‘o’ of subpar. 16, par. 3, Article 18 of this Federal Law, the medicinal drug composition, then the drug review, in particular the drug quality review and/or the risk-benefit ratio assessment for the medicinal drug, is carried out. If there is a need to make other amendments to the said leaflet, the drug review for the purpose of amendments to information on the registered drug is not carried out.

3. In addition to documents specified in par. 1 of this Article, the application for amendments to the Registration File documents on the registered medicinal drug is accompanied with documents evidencing payment of the state duty for amendments to the medicinal drug leaflet, the state duty for amendments to the medicinal drug composition.

4. The competent federal executive authority, within ten business days from the date the application specified in par. 1 of this Article with all of the necessary documents is received:-

1) verifies completeness and reliability of information contained in the case materials submitted by the applicant;

2) makes a decision to hold the drug review and the assessment specified in par. 2 of this Article or to deny the same;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

5. Partial submission of documents specified in para. 1 and 3 of this Article or lack in the submitted documents of information confirming the need in amendments serve as reasons for the denial to hold the review and the assessment specified in par. 2 of this Article.

6. The review and the assessment specified in par. 2 of this Article are held in the manner established in Article 23 of this Federal Law.

7. The competent federal executive authority, within five business days from the date the Expert Commissions’ opinions on findings of the review and the assessment specified in par. 2 of this Article are received:-

1) makes a decision to amend the Registration File documents on the registered medicinal drug or to deny the same;

2) enters, by the decision on amendments to the Registration File documents on the registered medicinal drug, the required amendments into the State Register of drugs and returns the documents to the applicant.

8. The opinion of the competent federal executive authority on the possible drug quality deterioration, efficacy and safety reduction in case of amendments to the Registration File documents on the registered medicinal drug serves as a reason for the denial to make such amendments.

9. Medicinal drugs manufactured before the competent federal executive authority makes a decision to amend the Registration File documents on the said drugs or to deny the same are allowed in civil circulation.

Article 31. Amendments to Documents

in the Registration File

for the Registered Veterinary Drug

 

1. For the purpose of amendments to documents contained in the Registration File for the registered veterinary drug, the applicant submits to the competent federal executive authority the application for such amendments, in the format established by the competent federal executive authority, with amendments to the said documents, as well as documents evidencing the need in such amendments. The decision to make such amendments or to deny the same is taken within the period of time not exceeding ninety business days from the date the competent federal executive authority accepts the application for such amendments.

2. If there is a need to amend the veterinary drug leaflet in respect of changes to the doses, the deadlines for possible use of the animal products upon application of the veterinary drug, the veterinary drug review is carried out. If there is a need to make other amendments to the said leaflet, the veterinary drug review is not carried out.

3. In addition to documents specified in par. 1 of this Article, the application for amendments to the Registration File documents on the registered veterinary drug is accompanied with documents evidencing payment of the state duty for amendments to the veterinary drug leaflet.

4. The competent federal executive authority, within ten business days from the date the application specified in par. 1 of this Article, with all of the necessary documents, is received:-

1) verifies completeness and reliability of information contained in the documents submitted by the applicant;

2) makes a decision to hold the veterinary drug review or to deny the same;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

5. Partial submission of documents specified in para. 1 and 3 of this Article or lack in the submitted documents of information evidencing the need in amendments serve as reasons for the denial to hold the veterinary drug review.

6. The veterinary drug review for the purposes of amendments to the Registration File documents on the registered veterinary drug is held in the manner established in Article 24 of this Federal Law.

7. The opinion of the competent federal executive authority on the possible veterinary drug quality deterioration, efficacy and safety reduction in case of amendments to the Registration File documents on the registered veterinary drug serves as a reason for the denial to make amendments to the said documents.

8. Veterinary drugs manufactured before the competent federal executive authority makes a decision to amend the Registration File documents on the registered veterinary drug or to deny the same are allowed in civil circulation.

Article 32. Drug State Registration Cancellation

 

A decision to cancel the drug state registration and to exclude the drug from the State Register of drugs is made by the competent federal executive authority, if:-

1) the opinion on the risk or threat to life and health of a human being or an animal as a result of the drug administration, which exceeds the drug efficacy based on results of the drug safety monitoring carried out by the competent federal executive authority, is submitted;

2) the drug developer or its authorized legal entity submits the application for cancellation of the drug state registration;

3) the drug state registration is not confirmed upon expiry of the effective period of the registration certificate issued for five years;

4) the applicant fails to submit information that might entail the need in amendments to the Registration File documents on the registered drug within thirty business days from occurrence of these changes;

5) the drug is registered by the state under the trade name of a drug earlier registered under this trade name;

6) one and the same drug is registered by the state under different trade names;

7) a court makes a decision on violation of rights of the intellectual property rights holder in the field of drug circulation.

Article 33. State Register of Drugs

 

1. The State Register of drugs contains a list of drugs passed state registration, a list of pharmaceutical substances in the composition thereof and the following information:-

1) with respect to drugs:-

а) the drug name (international non-proprietary or chemical and trade names);

b) the drug dosage, with indication of the drug dose and its quantity per consumer package;

c) the drug developer name;

d) the drug manufacturer name and address;

e) the drug pharmaco-therapeutic group;

f) the drug indications and contraindications;

g) the drug side effects;

h) the drug shelf life;

i) the drug storage conditions;

j) the drug dispensing conditions;

k) the number of the Monograph or, if it does not exist, the number of regulatory documents or a regulatory document;

l) the drug state registration date and number;

2) with respect to pharmaceutical substances:-

а) the pharmaceutical substance name (international non-proprietary or chemical and trade names);

b) the pharmaceutical substance manufacturer name and address;

c) the pharmaceutical substance shelf life;

d) the pharmaceutical substance storage conditions;

e) the number of the Monograph or, if it does not exist, the number of the regulatory documents or a regulatory document.

2. The pharmaceutical substance not used in manufacturing of drugs may be entered into the State Register of drugs on the basis of the drug developer’s/ manufacturer’s or its authorized legal entity’s application, provided that the pharmaceutical substance quality review is held with respect to such pharmaceutical substance in the manner established in Article 34 of this Federal Law.

3. The procedures for keeping the State Register of medicinal drugs and the State Register of veterinary drugs are approved of by the competent federal executive authority.

Article 34. Review of Quality of

a Pharmaceutical Substance

Not Used in Drug Manufacturing

 

1. For a pharmaceutical substance not used in drug manufacturing be included into the State Register of drugs the review of its quality is conducted.

2. The review of quality of a pharmaceutical substance specified in par. 1 of this Article, drafting by the Expert Commission of opinions on the review findings and their submission to the competent federal executive authority are carried out within the period of time not exceeding sixty business days from receipt by the Expert Institution of the assignment from the competent federal executive authority with documents specified in subpara. 4 to 7, par. 3, Article 18 of this Federal Law.

3. For holding the review of quality of a pharmaceutical substance specified in par. 1 of this Article, the applicant submits to the competent federal executive authority the following documents:-

1) an application for inclusion of the pharmaceutical substance into the State Register of drugs;

2) a document evidencing payment of the state duty for inclusion of the pharmaceutical substance not used in drug manufacturing into the State Register of drugs;

3) documents specified in subpara. 4 to 7, par. 3, Article 18 of this Federal Law.

4. The competent federal executive authority, within five business days from the date the application for inclusion of the pharmaceutical substance specified in par. 1 of this Article into the State Register of drugs with documents specified in par. 1 and subpar. 2, par. 3 of this Article is accepted:-

1) verifies completeness of the information contained in the documents submitted by the applicant;

2) makes a decision to send to the Expert Institution of the assignment for the review of quality of the pharmaceutical substance specified in par. 1 of this Article or to deny the same;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

5. Failure to submit documents specified in par. 2 and subpar. 2, par. 3 of this Article, serves as a reason for the denial send to the Expert Institution of the assignment for the review of quality of the pharmaceutical substance specified in par. 1 of this Article.

6. The applicant, within fifteen business days from receipt of the competent federal executive authority’s decision on sending to the Expert Institution of the assignment for the review of quality of the pharmaceutical substance specified in par. 1 of this Article, submits samples of the pharmaceutical substance in quantities required to reproduce the quality control methods to the Expert Institution for the review. The Expert Institution, upon receipt of the samples of the pharmaceutical substance specified in par. 1 of this Article, provides the applicant with the document evidencing acceptance of the said samples and, within three business days, notifies the competent federal executive authority in writing of the above. These periods are not included into the review period.

7. Documents received by the Expert Institution for the review of quality of the pharmaceutical substance specified in par. 1 of this Article are to be returned to the competent federal executive authority simultaneously with opinions on findings of the said review.

8. The competent federal executive authority, within five business days from the date the opinion on findings of the review of quality of the pharmaceutical substance specified in par. 1 of this Article is received from the Expert Commission:-

1) assesses the opinion to determine whether or not it conforms to the assignment for the said review;

2) makes a decision on inclusion of the pharmaceutical substance specified in par. 1 of this Article into the State Register of drugs or to deny the same;

3) if a decision is made to include the pharmaceutical substance specified in par. 1 of this Article into the State Register of drugs, enters the information specified in subpar. 2, par. 1, Article 33 of this Federal Law and notifies the applicant in writing of the above.

Article 35. Repeated Submission of a Drug

Failed to Pass State Registration of Drugs

for State Registration of Drugs

 

Repeated submission to the competent federal executive authority of a drug, which did not pass state registration of drugs or the state registration of which was denied, and the composition of which was subsequently modified, is regarded as submission for state registration of a new drug, irrespective of keeping its original name.

Article 36. Appeal of a Decision to Deny Issuance of

a Drug Clinical Trial Authorization or

to Deny State Registration of a Drug

 

A decision of the competent federal executive authority to deny issuance of a drug clinical trial authorization or to deny state registration of a drug may be appealed in the manner established by the law of the Russian Federation.

Article 37. Information on State Registration of Drugs;

Information on Registered Drugs and Drugs

Excluded from the State Register of Drugs

 

1. The competent federal executive authority posts information pertaining to state registration of drugs, including information on drug reviews, registered drugs and drugs excluded from the State Register of drugs, on the official website in the Internet within five business days from the date of acceptance by the competent federal executive authority of an application for state registration of a drug.

2. The timing of and the procedure for posting information specified in par. 1 of this Article are established by the competent federal executive authority.

 

Chapter 7. Medicinal Drug Clinical Trials,

Agreements for their Conduct;

Rights of Patients Involved in these Trials

 

Article 38. Medicinal Drug Clinical Trials

 

1. Medicinal drug clinical trials, including global multicenter, multicenter and post-registration, are held for state registration of drugs and other purposes in one or more healthcare institutions in accordance with the clinical practice rules approved of by the competent federal executive authority in order to:-

1) determine drug safety for healthy volunteers and/or healthy volunteers’ tolerance thereto, except for such trials in respect of drugs manufactured outside the Russian Federation;

2) select the most appropriate doses and treatment course for patients suffering from any particular disease, the most appropriate doses and schemes for immunobiological drug administration in healthy volunteers;

3) establish drug safety and efficacy in patients suffering from any particular disease, preventive efficacy of immunobiological drugs in healthy patients;

4) study possibilities to extend the medical indications and to identify earlier unknown side effects of registered drugs.

2. As for reproduced medicinal drugs, bioequivalence and/or therapeutic equivalence are studied in the manner established by the competent federal executive authority.

3. Entitled to conduct medicinal drug clinical trials are:-

1) the drug developer or its authorized person;

2) the higher and/or additional professional education institutions;

3) R&D institutions.

4. Medicinal drug clinical trials are conducted in the manner established in Articles 20 to 22 of this Federal Law by virtue of the drug clinical trial authorization issued by the competent federal executive authority in accordance with purposes specified in par. 1 of this Article. The competent federal executive authority keeps the Register of issued drug clinical trial authorizations, with indication of their purpose or purposes, in the manner established by the authority.

5. In case of drug state registration, the state duty for the review of the documents with a view to obtain authorizations to hold medicinal drug clinical trials and for the ethical review, in case of drug state registration in accordance with the purpose or purposes specified in par. 1 of this Article, is paid once.

6. Legal entities of any legal form of incorporation may be engaged by the drug developer in holding of medicinal drug clinical trials, provided that these trials comply with this Federal Law.

7. Medicinal drug clinical trials are held in healthcare institutions accredited by the competent federal executive authority in the manner established by the Government of the Russian Federation.

8. The list of healthcare institutions entitled to hold medicinal drug clinical trials and the Register of issued drug clinical trial authorizations are published and posted by the competent federal executive authority on its official website in the Internet in the manner established by the authority.

Article 39. Medicinal Drug Global Multicenter

Clinical Trial or Medicinal Drug

Post-Registration Clinical Trial

 

1. A medicinal drug global multicenter clinical trial in the Russian Federation or a medicinal drug post-registration clinical trial are carried out on the basis of the drug clinical trial authorization issued by the competent federal executive authority based on findings of the review of documents required for obtaining an authorization to hold a drug global multicenter clinical trial or a drug post-registration clinical trial and the ethical review.

2. To obtain a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization, the applicant submits to the competent federal executive authority the following documents:-

1) the application for a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization;

2) a document evidencing payment of the state duty for a medicinal drug global multicenter clinical trial authorization or for a medicinal drug post-registration clinical trial authorization;

3) a report on drug pre-clinical trials and a report on earlier conducted medicinal drug clinical trials (if any);

4) the draft protocol of the medicinal drug clinical trial;

5) the draft investigator’s booklet;

6) the information sheet for the patient involved in medicinal drug clinical trials;

7) information on investigators’ professional experience and background in the field of clinical trials;

8) copies of life and health obligatory insurance agreements with the patients participating in medicinal drug clinical trials;

9) information on the drug composition with a view to obtain a medicinal drug global multicenter clinical trial authorization.

3. The competent federal executive authority, within five business days from the date the application specified in subpar. 1, par. 2 of this Article with all of the necessary documents is accepted:-

1) verifies completeness and reliability of information contained in the documents submitted by the applicant;

2) makes a decision to conduct the review of documents for obtaining a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization and the ethical review or to deny the same;

3) notifies the applicant in writing of the decision made and, in case of a denial, giving reasons for the denial.

4. Partial submission of documents specified in par. 2 of this Article or lack in the submitted documents of comprehensive information or data that should be included therein serve as reasons to deny the review of the documents for obtaining a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization and the ethical review.

5. The review of documents for obtaining a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization and the ethical review and issue of a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization are conducted in the manner established in Articles 20 to 22 of this Federal Law.

6. Decisions to deny the review of documents for obtaining a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization and the ethical review and the issue of a medicinal drug global multicenter clinical trial authorization or a medicinal drug post-registration clinical trial authorization may be appealed in the manner established by the law of the Russian Federation.

Article 40. Holding of a Medicinal Drug Clinical Trial

 

1. The head of a healthcare institution that conducts a medicinal drug clinical trial appoints an investigator responsible for holding the trial and having a medical specialization that corresponds to the conducted drug clinical trial, with at least five-year experience in drug clinical trials, and, at his/her proposal, appoints co-investigators out of the physicians of the healthcare institution.

2. The investigator selects patients who, by their medical indications, may be involved in the medicinal drug clinical trial.

3. The investigator and the co-investigators should be familiar with findings of the drug pre-clinical trial, which are contained in the investigator’s booklet, as well as with the draft medicinal drug clinical trial protocol developed by the drug developer or any other legal entity engaged in the medicinal drug clinical trial and with other materials of the trial.

4. If there is a need to amend the medicinal drug clinical trial protocol, institutions in charge of the medicinal drug clinical trial as specified in par. 3, Article 38 of this Federal Law, notify the competent federal executive authority, that issued the trial authorization, of the above.

5. The competent federal executive authority, within thirty business days from the date the notice specified in par. 4 of this Article is received, considers the notice in the manner established by the authority and makes a decision to amend the medicinal drug clinical trial protocol or to deny the same.

6. A medicinal drug clinical trial may be suspended or terminated, if a threat to life and health of patients is identified in holding thereof. If there is a threat to life and health of a patient who takes part in a medicinal drug clinical trial, the investigators are obliged to notify the head of the healthcare institution and the organization, that received the drug clinical trial authorization from the competent federal executive authority, of the above. The decision on suspension of the medicinal drug clinical trial is made by the head of the healthcare institution and/or the organization, that received the medicinal drug clinical trial authorization from the competent federal executive authority, and on termination of such trial, by the competent federal executive authority on the basis of a written notice from the head of the healthcare institution and/or the organization, that received the medicinal drug clinical trial authorization from the competent federal executive authority.

7. The institutions specified in par. 3, Article 38 of this Federal Law, within five business days from the date the medicinal drug clinical trial is completed, suspended or terminated, sends a notice of the above to the competent federal executive authority, in the format established by the authority.

8. The form of the notice on completion, suspension or termination of the medicinal drug clinical trial contains:-

1) information on the healthcare institution(s) that held the trial;

2) description of the trial;

3) investigator’s personal data (full name, place of employment, position, specialization, drug clinical trials he/she was involved in (periods of involvement) as investigator or co-investigator);

4) the trial result (completion, suspension or termination of the trial, with indication of reasons and their impact on assessment of the trial findings and the overall assessment of risk-benefit ratio for the studied drug, as well as further actions proposed).

9. The competent federal executive authority publishes and posts the notice of the medicinal drug clinical trial completion, suspension or termination on its official website in the Internet within the period of time not exceeding five business days from the date the notice is received.

10. The competent federal executive authority keeps the Register of investigators holding or having held medicinal drug clinical trials in accordance with rules approved of by the authority and posts the Register on its official website in the Internet in the manner established by the authority. The said Register contains information specified in subpar. 3, par. 8 of this Article.

11. A report on findings of the medicinal drug clinical trial is drafted by an institution specified in par. 3, Article 38 of this Federal Law, on the basis of opinions by medical institutions that held the trial and is submitted to the competent federal executive authority that issued the trial authorization, within three months from the date of completion, suspension or termination of the trial, in the manner established by the competent federal executive authority.

12. Violation of the clinical practice rules and falsification of findings of the medicinal drug clinical trial entail liability in accordance with the law of the Russian Federation.

13. In conducting a medicinal drug clinical trial, it is allowed to take patients’ biological materials (samples of biological liquids, tissues, secretions and waste products, physiological and pathological excretions, swabs, scrapes, lavages, microorganisms, biopsy material) for their study in and/or outside the Russian Federation.

14. The procedure for import to/ export from the Russian Federation of the biological materials obtained in a medicinal drug clinical trial is established by the Government of the Russian Federation.

Article 41. Agreement for a Medicinal Drug Clinical Trial

 

1. A medicinal drug clinical trial is held in accordance with an agreement for a medicinal drug clinical trial concluded between the organization that obtained the trial authorization from the competent federal executive authority and the healthcare institution that holds the trial.

2. The agreement for a medicinal drug clinical trial contains:-

1) the conditions and terms of the trial;

2) the overall cost of the trial program with indication of the amount intended for payments to investigators, co-investigators;

3) the form for submission of the trial findings to the competent federal executive authority.

Article 42. Funding of a Medicinal Drug Clinical Trial

 

A medicinal drug clinical trial is funded from:-

1) the federal budget;

2) funds of the organizations that obtained the trial authorizations, in accordance with terms and conditions of the agreement for the trial;

3) other sources not prohibited by the law of the Russian Federation.

Article 43. Rights of Patients Involved in

a Medicinal Drug Clinical Trial

 

1. Involvement of patients in a medicinal drug clinical trial is voluntary.

2. A patient or his/her legal representative is to be notified in writing of:-

1) the medicinal drug and the essence of the clinical trial for this drug;

2) the safety of the medicinal drug, its anticipated efficacy and the degree of risk to the patient;

3) the conditions of the patient’s participation in the medicinal drug clinical trial;

4) the purpose or purposes and duration of the medicinal drug clinical trial;

5) the actions to be taken by the patient in case of any unforeseeable effects of the medicinal drug on his/her health status;

6) the conditions of life and health obligatory insurance for the patient;

7) the guarantees of confidentiality of the patient’s involvement in the medicinal drug clinical trial.

3. A patient’s voluntary consent to participation in a medicinal drug clinical trial is confirmed by his/her signature or the signature of his/her legal representative on the information sheet for the patient.

4. A patient or his/her legal representative is free to withdraw from a medicinal drug clinical trial at any stage of such trial.

5. It is allowed to conduct a medicinal drug clinical trial in children as patients, always provided that their parents, adoptive parents give a written consent to the above. Children may be regarded as potential patients of the trial only when the trial is needed to promote children’s health or to prevent infectious diseases in minors or when the purpose of the trial is to obtain information on the most appropriate drug dose for treatment of minors. In these cases, the trial in minors should be preceded by the medicinal drug clinical trial in adults.

6. It is prohibited to hold a medicinal drug clinical trial with participation of the following persons as patients:-

1) orphans;

2) pregnant and breast-feeding women, except for cases when the studied drug is intended for the said women, when the necessary information may only be obtained in the appropriate clinical trials and when all the necessary efforts are taken to eliminate the risk of harm to a pregnant woman, a breastfeeding woman, a fetus or a baby;

3) military men, except for clinical trials of a drug specially intended for administration in hostilities, emergencies and also for prevention and treatment of diseases and conditions resulting from adverse factors of chemical, biological and radioactive nature. A clinical trial of such drug may be conducted with participation of military men as patients, except for draftees, in accordance with the requirements established by this Federal Law with respect to civilians;

4) employees of law enforcement authorities;

5) persons in prison and persons under arrest in pretrial detention centers.

8. It is allowed to conduct a clinical trial of a medicinal drug intended for treatment of mental diseases with participation of such patients as persons suffering from mental diseases, recognized as disabled in the manner established by the law of the Russian Federation. In this case, the drug clinical trial is conducted subject to a written consent of legal representatives of the said persons.

Article 44. Obligatory Insurance for Life

and Health of Patients Involved in

Medicinal Drug Clinical Trials

 

1. The organization that obtained a medicinal drug clinical trial authorization is obliged to insure, at its own expense as an insurer, life and health of the patient involved in the drug clinical trials by entering into an agreement for obligatory life and health insurance for the patient in case of any harm to life or health of the patient occurring as a result of the medicinal drug clinical trials (hereinafter in this Article ‘the Obligatory Insurance Agreement’).

2. The subject of the obligatory insurance is the property interest of the patient in connection with any harm to the patient’s life or health as a result of the medicinal drug clinical trials.

3. The event insured under the Obligatory Insurance Agreement is the patient’s death or impairment of health, including the invalidity established and entailed, as a result of involvement in the drug clinical trials, if there is any cause-effect relation between the events occurred and the drug administration.

4. Claims to compensate for harm to the patient’s life or health are satisfied within limitation periods established by the civil law.

5. The insurance compensation amount under the Obligatory Insurance Agreement is as follows:-

1) in case of the patient’s death, two million rubles per each patient involved in the drug clinical trials;

2) in case of impairment of the patient’s health:-

a) entailing the established Group I invalidity, one million five hundred thousand rubles per each patient involved in the drug clinical trials;

b) entailing the established Group II invalidity, one million rubles per each patient involved in the drug clinical trials;

c) entailing the established Group III invalidity, five hundred thousand rubles per each patient involved in the drug clinical trials;

d) not entailing the established invalidity, less than three hundred thousand rubles per each patient involved in the drug clinical trials.

6. The insurance compensation amount may be increased by a court decision.

7. The Obligatory Insurance Agreement term may not be less than the drug clinical trial period.

8. Insurance tariffs under the obligatory insurance for life and health of the patient involved in the drug clinical trials, the list of documents required for insurance compensation, the procedure for payment of insurance premium, the procedure for exercise of the parties’ rights and obligations under the Obligatory Insurance Agreement as established by this Federal Law and other federal laws are defined in standard rules of obligatory insurance for life and health of the patient involved in the drug clinical trials as approved of by the Government of the Russian Federation.

9. In case of any harm to life of the patient involved in the drug clinical trials, beneficiaries under the Obligatory Insurance Agreement are citizens having the right for compensation of harm in case of the supporter’s death in accordance with the civil law, and if such citizens do not exist, parents, spouse, children of the dead patient that was involved in the drug clinical trials; in case of death of the patient that was involved in the drug clinical trials and had no independent income, the citizens that supported him/her; in respect of compensation for expenses on a burial for the patient that was involved in the drug clinical trials, the person that incurred such expenses.

10. The insurance compensation amount to compensate for any harm to life of the patient that was involved in the drug clinical trials is distributed equally among beneficiaries in proportion to their number.

11. In case of an insured event, the patient that was involved in the drug clinical trials and the beneficiary are entitled to claim, directly from the assurer, the compensation for any harm incurred. The assurer pays the insurance compensation within thirty days from the date the required documents are submitted. The patient that was involved in the drug clinical trials or the beneficiary in accordance with the law of the Russian Federation on personal data is obliged to provide the assurer with his/her personal data defined in standard life and health insurance rules specified in par. 8 of this Article and required for payment of the insurance compensation.

12. Upon application of the patient that was involved in the drug clinical trials or the beneficiary, the assurer, before the compensation amount due for any harm is fully defined, is entitled to pay such amount of the insurance compensation that corresponds to the harm incurred and actually defined.

13. The insurance compensation under the Obligatory Insurance Agreement is paid regardless of payments due under insurance policies of other types.

14. The competent federal executive authority that issues drug clinical trial authorizations carries out control over implementation by the organization that obtained the drug clinical trial authorization of the obligation established by this Article in respect of obligatory insurance for life and health of the patient that was involved in drug clinical trials.

 

Chapter 8. Drug Manufacturing and Labeling

 

Article 45. Drug Manufacturing

 

1. Drug manufacturing should conform to the drug manufacturing and quality control rules approved of by the Government of the Russian Federation.

2. Drug manufacturing in the Russian Federation is carried out by drug manufacturers holding drug manufacturing licenses.

3. Drug manufacturing is carried out in compliance with requirements of industrial regulations, which are approved of by the head of the drug manufacturer and include the list of used pharmaceutical and auxiliary substances, with indication of quantity for each of them, data on equipment employed, description of the technological process and control methods at all drug manufacturing stages.

4. In drug manufacturing the pharmaceutical substances included in the State Register of drugs are used.

5. It is prohibited to manufacture:-

1) drugs not included in the State Register of drugs, except for drugs manufactured for clinical trials and export;

2) fake drugs;

3) drugs not covered by the drug manufacturing license;

4) drugs manufactured in violation of the drug manufacturing and quality control rules.

6. When drugs are brought into civil circulation the drug manufacturer’s authorized person confirms conformity of the drugs to the requirements set forth in their state registration and guarantees that the drugs are manufactured in accordance with the drug manufacturing and quality control rules.

7. The drug manufacturer’s authorized person is its employee with higher pharmaceutical, chemical or biological education or, in case of the veterinary drug manufacturing, veterinary education, with at least five-year experience in drug manufacturing and quality control, and qualified in the manner established by the competent federal executive authority.

8. Drug manufacturers may sell drugs or transfer them in the manner established by the law of the Russian Federation:-

1) to other drug manufacturers for drug manufacturing;

2) to drug wholesale operators;

3) to pharmacies, veterinary pharmacies and individual entrepreneurs holding pharmaceutical or medical licenses;

4) to research and development organizations for research and development;

5) to medical and veterinary organizations;

6) to animal breeding, raising and keeping organizations.

Article 46. Drug Labeling

 

1. Drugs, except for those produced in pharmacies, veterinary pharmacies or by individual entrepreneurs holding pharmaceutical licenses, should enter into circulation, if:-

1) the drug name (international non-proprietary or chemical and trade names), series number, date of manufacture (for immunobiological drugs), shelf life, dose and dosage form, quantity and the number of doses (for immunobiological drugs) are legibly indicated on the primary package in Russian;

2) the drug name (international non-proprietary or chemical and trade names), the drug manufacturer name, series number, date of manufacture (for immunobiological drugs), registration certificate number, shelf life, application method, dose and number of doses per package, dosage form, dispensing conditions, storage conditions, precautions in drug administration and warnings are legibly indicated on the secondary (consumer) package.

2. Pharmaceutical substances should enter into circulation, if the pharmaceutical substance name (international non-proprietary or chemical and trade names), the pharmaceutical substance manufacturer name, series number and date of manufacture, quantity per package and units of quantity, shelf life and storage conditions are legibly indicated on the primary package in Russian.

3. Serums should enter into circulation with indication of which animal blood, blood plasma, organs and tissues they are derived from. Vaccines should enter into circulation with indication of the culture medium used for re-production of viruses and bacteria.

4. Drugs derived from human blood, blood plasma, organs and tissues should bear on their secondary (consumer) package the inscription: ‘There are no HIV-1, HIV-2, hepatitis C virus antibodies and the hepatitis B virus surface antigen.’

5. Radioactive drugs should bear on their primary and secondary (consumer) packages the radiation danger sign.

6. Homeopathic drugs should bear on their secondary (consumer) package the inscription: ‘Homeopathic.’

7. Drugs from the plant raw materials should bear on their secondary (consumer) package the inscription: ‘The products passed radiation control.’

8. Drugs intended for clinical trials should bear on their primary and secondary (consumer) packages the inscription: ‘For clinical trials.’

9. Drugs intended for export only are labeled in accordance with requirements of the importer country.

10. The transport containers not intended for consumers, with drugs packed therein, should bear information on the drug name, series, date of manufacture, the number of drug secondary (consumer) packages, the drug manufacturer with indication of its name and location (address, including the country and/or place of drug manufacturing), the drug shelf life, storage and transportation conditions, as well as the necessary warning signs and handling marks.

11. Veterinary drugs should bear on their primary and secondary (consumer) packages the inscription: ‘For veterinary use.’

12. A drug secondary (consumer) package should bear a bar code.

Chapter 9. Drug Import to/ Export from

the Russian Federation

 

Article 47. Procedure for Drug Import to/

Export from the Russian Federation

 

1. Drugs are imported to the Russian Federation in the manner established by the Government of the Russian Federation in accordance with the law of the Russian Federation.

2. Drugs imported to the Russian Federation should be included in the State Register of drugs.

3. It is allowed to import to the Russian Federation any particular consignment of non-registered drugs intended for clinical trials, for drug review for the purposes of the drug state registration or for provision of healthcare according to individual indications with respect to a patient’s life by virtue of the authorization issued by the competent federal executive authority at the application of persons specified in Article 48 of this Federal Law. Consideration of the application and making of the decision to issue the authorization for import of any particular consignment of non-registered drugs intended for drug clinical trials, for drug review for the purposes of the drug state registration or for provision of healthcare according to individual indications with respect to a patient’s life, or to deny the issue of the said authorization, are carried out within the period of time not exceeding five business days. No payment is collected for issue of the said authorization.

4. The drugs, the quality of which is certified by the drug manufacturer’s certificate confirming that the imported drugs meet the requirements of Monographs or, in their absence, of regulatory documents or the regulatory document may be imported to the Russian Federation.

5. It is prohibited to import fake, low-quality and counterfeited drugs to the Russian Federation.

6. Fake and low-quality drugs are subject to withdrawal and subsequent destruction or removal from the Russian Federation, and counterfeited drugs, to withdrawal and subsequent destruction. Destruction or removal from the Russian Federation of fake, low-quality and counterfeited drugs is carried out at the expense of the importing person. The procedure for destruction of withdrawn fake, low-quality and counterfeited drugs is established by the Government of the Russian Federation.

7. Persons importing fake, low-quality and counterfeited drugs to the Russian Federation are liable in accordance with the law of the Russian Federation.

8. Drugs are exported from the Russian Federation without any limitations established by the law of the Russian Federation on state regulation of foreign trade. Drugs intended for humanitarian (support) purposes or emergency purposes are exported from the Russian Federation by virtue of the resolution of the Government of the Russian Federation or of governmental authorities of the Russian Federation constituent territories on provision of assistance to a foreign country.

Article 48. Legal Entities Entitled to Import

Drugs to the Russian Federation

 

The following persons may import drugs to the Russian Federation:-

1) drug manufacturers, for their own manufacturing purposes;

2) foreign drug developers and manufacturers or other legal entities at the assignment of the drug developer, for drug clinical trials, state registration, entering a pharmaceutical substance into the State Register of drugs, drug quality control, provided that there is an authorization issued by the competent federal executive authority for import of any particular drug consignment;

3) drug wholesale operators;

4) R&D organizations, educational institutions of higher professional education, drug manufacturers, for drug development, trials, safety/quality/efficacy control, provided that there is an authorization issued by the competent federal executive authority;

5) healthcare institutions, as well as other institutions specified in para. 1 to 4 of this Article, for provision of healthcare according to individual indications with respect to a patient’s life, provided that there is an authorization issued by the competent federal executive authority for import of any particular drug consignment, in the established manner, in the format of an electronic document with a digital signature.

Article 49. Documents Submitted to Customs Authorities

of the Russian Federation at Drug Import

to the Russian Federation

 

1. At drug import to the Russian Federation, in addition to documents, submission of which is envisaged by the law of the Russian Federation, the following documents are submitted to the customs authorities of the Russian Federation:-

1) the drug manufacturer’s certificate confirming that the imported drug conforms to the requirements of the Monograph or, in case of its absence, regulatory documents or the regulatory document;

2) the authorization issued by the competent federal executive authority for import of any particular drug consignment, in cases set forth in par. 3, Article 47 of this Federal Law.

2. Documents specified in subpara. 1 and 2, par. 1 of this Article, are submitted to the customs authorities of the Russian Federation upon delivery of drugs to the Russian Federation.

Article 50. Import of Drugs to the Russian Federation

for Personal Use and Other

Non-Commercial Purposes

 

1. Drugs may be imported to the Russian Federation without taking into account the requirements envisaged in para. 1 to 4 of Article 47, Articles 48 and 49 of this Federal Law, if they are intended for:-

1) personal use by individuals arrived to the Russian Federation;

2) use by employees of diplomatic corps or representatives of international organizations accredited in the Russian Federation;

3) treatment of passengers and crews of vehicles, train crews and vehicle drivers arrived to the Russian Federation;

4) treatment of participants in international cultural and sports events and expeditions;

5) treatment of any particular animals in zoos and also animals imported to the Russian Federation for participation in sports and entertainment.

2. In cases envisaged in par. 1 of this Article, it is allowed to import drugs not registered in the Russian Federation to the Russian Federation.

3. Drugs intended for humanitarian (support) purposes or emergency purposes are imported to the Russian Federation in the manner established by the Government of the Russian Federation. It is prohibited to import non-registered drugs intended for humanitarian (support) purposes or emergency purposes to the Russian Federation.

Article 51. Cooperation between the Federal

Executive Customs Authority

and Other Competent Federal

Executive Authorities

 

1. The competent federal executive authorities make available to the federal executive customs authority the State Register of drugs and also information on the issued authorizations for import of any particular drug consignment, in cases set forth in par. 3, Article 47 of this Federal Law.

2. The federal executive customs authority notifies the competent federal executive authorities specified in par. 1 of this Article of drug import/ export to/ from the Russian Federation in the format and the manner established by the Government of the Russian Federation.

 

Chapter 10. Pharmaceutical Operations

 

Article 52. Pharmaceutical Operations

 

1. Pharmaceutical operations are carried out by drug wholesale operators, pharmacies, veterinary pharmacies, individual entrepreneurs holding pharmaceutical licenses, healthcare institutions holding pharmaceutical licenses and by their separate business units (outpatient departments, feldsher’s and feldsher’s/maternity stations, centers/divisions of general healthcare / family practice) located in rural settlements where there are no pharmacies, and also by veterinary organizations holding pharmaceutical licenses.

2. Individuals may carry out any particular pharmaceutical operations, provided that they have higher or secondary pharmaceutical education, or higher or secondary veterinary education, and a professional certificate.

Article 53. Drug Sales and Transfer

by Drug Wholesale Operators

 

Drug wholesale operators may sell drugs or transfer them in the manner established by the law of the Russian Federation to:-

1) other drug wholesale operators;

2) drug manufacturers for manufacturing purposes;

3) pharmacies and veterinary pharmacies;

4) research and development organizations for research and development;

5) individual entrepreneurs holding pharmaceutical or medical licenses;

6) healthcare and veterinary organizations;

7) animal breeding, raising and keeping organizations.

Article 54. Drug Wholesale Rules

 

Drug wholesale trade is carried out by drug manufacturers and drug wholesale operators in accordance with rules approved of by the competent federal executive authorities.

Article 55. Drug Retail Rules

 

1. Drug retail trade in the quantities required for fulfillment of physician’s/ feldsher’s prescriptions or prescriptions by veterinary professionals is carried out by pharmacies, veterinary pharmacies, individual entrepreneurs holding pharmaceutical licenses, healthcare institutions holding pharmaceutical licenses and by their separate business units (outpatient departments, feldsher’s and feldsher’s/maternity stations, centers/divisions of general healthcare / family practice) located in rural settlements where there are no pharmacies, and also by veterinary organizations holding pharmaceutical licenses. Retail trade in drugs registered in the Russian Federation or produced in pharmacies, veterinary pharmacies or by individual entrepreneurs holding pharmaceutical licenses only is allowed.

2. The types of pharmacies and the medicinal drug dispensing rules for pharmacies and individual entrepreneurs holding pharmaceutical licenses and also the medicinal drug dispensing rules for healthcare institutions holding pharmaceutical licenses and their separate business units (outpatient departments, feldsher’s and feldsher’s/maternity stations, centers/divisions of general healthcare / family practice) located in rural settlements where there are no pharmacies is approved of by the competent federal executive authority.

3. The dispensing rules for narcotic drugs and mood-altering drugs registered as drugs and also drugs containing narcotic substances and mood-altering substances is approved of by the competent federal executive authority upon agreement with the federal executive authority in charge of the governmental policy, normative and legal regulation, control over and supervision of circulation of narcotic drugs, mood-altering drugs and their precursors and also of combating their illegal circulation.

4. Veterinary drugs are to be dispensed through veterinary pharmacies, veterinary organizations and by individual entrepreneurs holding pharmaceutical licenses. The veterinary drug dispensing rules are approved of by the competent federal executive authority.

5. The list of healthcare institutions holding pharmaceutical licenses and their separate business units (outpatient departments, feldsher’s and feldsher’s/maternity stations, centers/divisions of general healthcare / family practice) located in rural settlements where there are no pharmacies and also the list of drugs (except for narcotic drugs and mood-altering drugs) that are allowed for sales by the said organizations and their separate business units veterinary organizations are established by executive authorities of the Russian Federation constituent territories.

6. Pharmacies and individual entrepreneurs holding pharmaceutical licenses are obliged to procure the minimum drug range required for health care and established by the competent federal executive authority.

7. Pharmacies and individual entrepreneurs holding pharmaceutical licenses have rights to purchase and sell, in addition to drugs, medicinal products, disinfectants, personal hygiene items and means, medicinal dishes, items and means for nursing, taking care of newborns and children younger than three, spectacles and spectacles care items, mineral waters, therapeutic, child and dietetic products, biologically active food supplements, therapeutic perfumery and cosmetic products, medical and sanitary education publications for healthy lifestyle promotion.

8. Operations of pharmacies in the Armed Forces of the Russian Federation, other troops, military units and authorities where the law of the Russian Federation envisages military or law enforcement services are governed by this Federal Law and the provisions approved of by the competent federal executive authorities. Control over compliance with the provisions of this Federal Law by the said pharmacies is implemented by the competent federal executive authorities.

Article 56. Drug Production and Dispensing

 

1. Drug production and dispensing in pharmacies, veterinary pharmacies and by individual entrepreneurs holding pharmaceutical licenses is carried out at physician’s prescriptions and at requests of healthcare and veterinary organizations in accordance with the drug production and dispensing rules approved of by the competent federal executive authority.

2. In production of drugs by pharmacies, veterinary pharmacies and individual entrepreneurs holding pharmaceutical licenses, the pharmaceutical substances included in the State Register of medicinal drugs and the State Register of veterinary drugs, respectively, in the established manner are used. It is not allowed to produce drugs registered in the Russian Federation in pharmacies, veterinary pharmacies and by individual entrepreneurs holding pharmaceutical licenses.

3. Labeling and packaging of drugs produced by pharmacies, veterinary pharmacies and individual entrepreneurs holding pharmaceutical licenses should meet the requirements specified in par. 1 of this Article.

4. Pharmacies, veterinary pharmacies and individual entrepreneurs holding pharmaceutical licenses are liable for non-compliance with the drug production and dispensing rules in accordance with the law of the Russian Federation.

Article 57. Prohibition on Sales of Fake,

Low-Quality and Counterfeited Drugs

 

It is prohibited to sell fake drugs, low-quality drugs and counterfeited drugs.

Article 58. Drug Storage

 

1. Drugs are stored by drug manufacturers, drug wholesaler operators, pharmacies, veterinary pharmacies, individual entrepreneurs holding pharmaceutical or medical licenses, healthcare, veterinary and other organizations involved in drug circulation.

2. The drug storage rules are approved of by the competent federal executive authority.

3. Narcotic drugs, mood-altering drugs and radioactive drugs are stored in accordance with the law of the Russian Federation.

 

Chapter 11. Drug Destruction

 

Article 59. Grounds and Procedure

for Drug Destruction

 

1. Low-quality and fake drugs are subject to withdrawal from civil circulation and destruction in the manner established by the Government of the Russian Federation. The decision by the drug owner or by the competent federal executive authority or by a court serves as grounds for drug destruction.

2. Counterfeited drugs are subject to withdrawal from civil circulation and destruction by a court judgment. The counterfeited drug destruction procedure is established by the Government of the Russian Federation.

3. Counterfeited, low-quality and fake drug destruction costs are indemnified for by the owner thereof.

4. The drug owner provides the competent federal executive authority with a document evidencing drug destruction or its copy certified in the established manner.

5. The competent federal executive authority that resolved to destroy drugs performs control over their destruction.

6. Drugs are destroyed by organizations holding appropriate licenses, on/in specially equipped grounds, sites and premises, in compliance with environment protection requirements and in accordance with the law of the Russian Federation.

7. Narcotic drugs, mood-altering drugs and radioactive drugs are destroyed in accordance with the law of the Russian Federation.

 

Chapter 12. State Regulation of Prices for

Medicinal Drugs

 

Article 60. State Regulation of Prices for

Medicinal Drugs

 

State regulation of prices for medicinal drugs is carried out through:-

1) approval of the list of vital and essential drugs (included in the list under international non-proprietary or chemical names) meeting the following criteria:-

a) use of any particular drug for diagnosis, prevention or treatment of diseases, including those prevailing in the incidence pattern among the population of the Russian Federation;

b) an advantage of any particular drug in comparison to other drugs used to treat any particular disease, symptom or clinical condition;

c) the therapeutic equivalence of any particular drug to drugs with a similar mechanism of the pharmacological action;

2) approval of the procedure for determination of maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

3) the state registration of maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

4) keeping of the State Register of maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

5) approval of the procedure for determination by executive authorities of the Russian Federation constituent territories of the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

6) setting out of the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs;

7) approval of the rules for giving to executive authorities of the Russian Federation constituent territories of instructions on bringing to conformity with the law of the Russian Federation of decisions on determination of the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs, if they are adopted in contravention of the law of the Russian Federation, in the manner established by the Government of the Russian Federation;

8) sending by the competent federal executive authority to executive authorities of the Russian Federation constituent territories of instructions on bringing to conformity with the law of the Russian Federation of decisions on determination of the maximum wholesale and retail mark-ups on prices for drugs included in the list of vital and essential drugs, if they are adopted in contravention of the law of the Russian Federation;

9) performance of state control over application of prices for drugs;

10) enforcement of measures provided for by the law of the Russian Federation for violation of the pricing procedure for vital and essential drugs.

Article 61. State Registration of the Maximum Ex-works

Manufacturer Prices for Vital and

Essential Drugs and Sales Thereof

 

1. The maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs are subject to state registration.

2. The maximum ex-works manufacturer price for a vital and essential drug included in the list of vital and essential drugs is subject to state registration, if it does not exceed the price rate for this drug as calculated in accordance with the Procedure for determination of maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs as approved of in the manner established by the Government of the Russian Federation.

3. Sales of drugs included in the list of vital and essential drugs with no maximum ex-works manufacturer prices registered for the same is not allowed.

Article 62. State Register of the Maximum Ex-Works

Manufacturer Prices for Drugs

Included in the List of Vital

and Essential Drugs

 

1. The registered maximum ex-works prices for drugs included in the list of vital and essential drugs are subject to entering into the State Register of the maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs.

2. The State Register of the maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs contains the following information:-

1) the drug manufacturer name;

2) the drug name (international non-proprietary or chemical and trade names);

3) the drug registration certificate number;

4) the dosage form with an indication of the drug dose and its quantity per secondary (consumer) package;

5) the registered maximum ex-works price in rubles;

6) the date of state registration of the maximum ex-works price for drugs included in the list of vital and essential drugs.

3. State registration of the maximum ex-works prices for drugs included in the list of vital and essential drugs and keeping of the State Register of the maximum ex-works manufacturer prices for drugs included in the list of vital and essential drugs are carried out in the manner established by the Government of the Russian Federation.

Article 63. Determination by Executive Authorities

of the Russian Federation Constituent Territories

of the Maximum Wholesale and Retail Mark-ups

on the Actual Ex-works Manufacturer Prices

for Medicinal Drugs

 

1. Executive authorities of the Russian Federation constituent territories determine the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs in accordance with the Procedure for determination by executive authorities of the Russian Federation constituent territories of the maximum wholesale and retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs as approved of in the manner established by the Government of the Russian Federation.

2. Sales by wholesale operators and/or pharmacies, individual entrepreneurs holding pharmaceutical licenses of drugs included in the list of vital and essential drugs is carried out at prices not exceeding the sum of the actual ex-works manufacturer price that does not exceed the registered maximum ex-works price and of the wholesale and/or retail mark-ups that do not exceed the maximum wholesale and/or retail mark-ups, respectively, set out in the Russian Federation constituent territory.

3. Executive authorities of the Russian Federation constituent territories place in the Internet or publish information on the registered maximum ex-works price for drugs included in the list of vital and essential drugs, on the maximum wholesale and/or retail mark-ups on the actual ex-works manufacturer prices for drugs included in the list of vital and essential drugs as established in the Russian Federation constituent territory and on the sum specified in par. 2 of this Article. The information envisaged in this paragraph is to be placed in pharmacies in the format available for all the persons concerned and is to be updated as it is published.

4. Decisions on determination of the maximum wholesale and retail mark-ups on the registered maximum ex-works prices for drugs included in the list of vital and essential drugs as made by executive authorities of the Russian Federation constituent territory in contravention of the law of the Russian Federation are subject to cancellation at court.

 

Chapter 13. Safety Monitoring for Drugs

in Circulation in the Russian Federation

 

Article 64. Drug Safety Monitoring

 

1. Drugs circulating in the Russian Federation are subject to safety monitoring in order to identify any possible adverse effects of drug administration, to warn and protect patients from use of such drugs.

2. Drug safety is monitored at all stages of their circulation in the Russian Federation by the competent federal executive authority.

3. The drug circulation subjects are obliged to notify, in the manner established by the competent federal executive authority, of all cases of side effects not included in the drug leaflets, of severe adverse effects, of unexpected adverse effects in drug administration and of the particular features of the drug interaction with other drugs as identified in clinical trials and in drug administration.

4. For failure to provide or for hiding of information envisaged in par. 3 of this Article the persons to whom such information became available in the course of their professional activities are liable in accordance with the law of the Russian Federation.

5. The procedure for monitoring of drug safety, for registration of side effects, severe adverse effects and unexpected adverse effects in drug administration, including for provision of information on the same, is established by the competent federal executive authority.

Article 65. Drug Use Suspension

 

If information on side effects not specified in the drug leaflet, on severe adverse effects, unexpected adverse effects in drug administration and on the particular features of its interaction with other drugs that may pose threat to patient’s life and health and also information not corresponding to the drug information contained in its leaflet is obtained, the competent federal executive authority considers suspension of the drug use in the manner established by the competent federal executive authority.

Article 66. Information on Findings of

Drug Safety Monitoring

 

Following findings of the monitoring, the competent federal executive authority that monitors drug safety posts on its official website in the Internet information on the decisions made to amend the drug leaflets, to suspend the drug use, to withdraw the drug from circulation or to resume the drug use.

 

Chapter 14. Drug Information

 

Article 67. Drug Information

 

1. Information on drugs dispensed at the physician’s prescription (prescription drugs) should only be available in specialized publications intended for medical, pharmaceutical and veterinary workers. Information on drugs for specialists in the field of drug circulation may be available as monographs, reference books, scientific articles, reports at congresses, conferences, symposiums, scientific boards and also as drug leaflets.

2. Information on drugs dispensed without the physician's prescription (over-the-counter drugs) may be available in mass media publications and announcements, specialized and general publications, drug leaflets, other publications of the drug circulation subjects. The advertising materials on an over-the-counter drug should correspond to its leaflet.

3. It is allowed to use any tangible media enabling storage, transmission and use of drug information without distortion.

 

Chapter 15. Liability for Violation of the Russian Federation Law on Drug Circulation and Indemnification for Harm to Health of Citizens as a Result of Drug Administration

 

Article 68. Liability for Violation

of the Russian Federation Law

On Drug Circulation

 

Violation of the Russian Federation law on drug circulation entails liability in accordance with the law of the Russian Federation.

Article 69. Indemnification for Harm to

Health of Citizens as a Result of

Drug Administration

 

1. The drug manufacturer is obliged to indemnify for harm to health of citizens as a result of the drug administration, if it is proven that:-

1) the drug was administered in accordance with its indications and the drug leaflet and the harm was caused by bringing a low-quality drug in civil circulation;

2) harm to health was due to the untrustworthy information contained in the drug leaflet published by the drug manufacturer.

2. If harm to health of citizens is caused by administration of a drug that became unfit because of violation of the drug storage rules, the drug wholesale trade rules, the drug dispensing rules, and the drug production and dispensing rules, the harm is indemnified for by the drug wholesale operator, the pharmacy, the individual entrepreneur holding a pharmaceutical or a medical license, the healthcare institution holding a pharmaceutical license (its separate business unit – an outpatient department, feldsher’s and feldsher’s/maternity stations, a center/division of general healthcare / family practice) located in a rural settlement where there are no pharmacies), respectively, that is at fault for selling or dispensing of the drug.

3. Indemnification for harm to health of citizens as a result of the drug administration or illegal actions of the drug circulation subjects is performed in accordance with the law of the Russian Federation.

 

 

Chapter 16. Final Provisions

 

Article 70. On Invalidation of Separate Laws

(Provisions of Laws)

of the Russian Federation

 

To invalidate:-

1) Federal Law of June 22, 1998, No. 86-FZ, On Drugs (Collection of Laws of the Russian Federation, 1998, No. 26, Art. 3006);

2) Federal Law of January 2, 2000, No. 5-FZ, On Amendments and Supplements to the Federal Law On Drugs (Collection of Laws of the Russian Federation, 2000, No. 2, Art. 126);

3) Article 40, Federal Law of January 10, 2003, No. 15-FZ, On Amendments and Supplements to Certain Laws of the Russian Federation in Connection with Adoption of the Federal Law On Licensing Individual Business Activities (Collection of Laws of the Russian Federation, 2003, No. 2, Art. 167);

4) Article 31, Federal Law of June 30, 2003, No. 86-FZ, On Amendments and Supplements to Certain Laws of the Russian Federation, Invalidation of Separate Laws of the Russian Federation, Provision of Certain Guarantees to Employees of Interior Departments, Narcotic and Mood-Altering Drug Circulation Supervision Departments and the Abolished Federal Tax Police in Connection with State Administration Improvement Efforts (Collection of Laws of the Russian Federation, 2003, No. 27, Art. 2700);

5) Article 101, Federal Law of August 22, 2004, No. 122-FZ, On Amendments to Laws of the Russian Federation and on Invalidation of Certain Laws of the Russian Federation in Connection with Adoption of Federal Laws On Amendments and Supplements to the Federal Law ‘On General Principles of Establishment of Legislative/Representative and Executive Authorities of the Russian Federation Constituent Territories’ and ‘On General Principles of Establishment of Local Self-Governments in the Russian Federation’ (Collection of Laws of the Russian Federation, 2004, No. 35, Art. 3607);

6) Article 28, Federal Law of December 18, 2006, No. 231-FZ, On Enforcement of Part IV, Civil Code of the Russian Federation (Collection of Laws of the Russian Federation, 2006, No. 52, Art. 5497).

Article 71. Enactment of this Federal Law

 

1. This Federal Law inures from September 1, 2010.

2. Drugs registered before this Federal Law takes effect are subject to entering into the state registers of drugs, with inclusion of information on these drugs as specified in par. 1, Article 33 of this Federal Law, without the need to pass the drug state registration procedure once again.

3. State registration of drugs submitted for the said registration before this Federal Law takes effect is carried out in accordance with this Federal Law on the basis of the documents and information submitted before this Federal Law takes effect.

4. It is allowed to conduct drug review by experts of the Expert Institution before they pass attestation in the manner established by the federal executive authority during the period from enactment of this Federal Law to April 30, 2011, inclusively.

5. The complete transfer to drug manufacturing in accordance with drug manufacturing and quality control rules specified in par. 1, Article 45 of this Federal Law, is carried out during the period from enactment of this Federal Law to December 31, 2013, inclusively. The periods for transfer to drug manufacturing in accordance with specific requirements of these rules, including the periods for attestation of authorized persons specified in para. 6 and 7, Article 45 of this Federal Law, are established by the Government of the Russian Federation.

6. Drugs manufacturing licenses issued prior to January 1, 2014, are effective after January 1, 2014, until their expiration, provided that the licensee complies with drug manufacturing and quality control rules specified in par. 1, Article 45 of this Federal Law.

 

          President of

the Russian Federation                                                                     D. Medvedev