Chapter 6. Performance of State Registration of Medicinal Products

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)

Article 13. State Registration of Medicinal Products

1. Medicinal products are put into civil circulation in the Russian Federation provided they have been registered with the relevant authorized federal executive body.

2. State registration is required for:

1) originator medicinal products;
2) generic medicinal products;
3) new combinations of previously registered medicinal products;
4) new dosage forms or new dosage rates of previously registered medicinal products.

3. State registration of medicinal products for medical use shall be carried out based on the results of expert examination of the medicines and ethical expert examination of the possibility of a clinical trial of the medicinal product for medical use (hereinafter – the “ethical expert examination”). State registration of medicinal products for veterinary use is carried out based on the results of expert examination of the medicines for veterinary use.

4. State registration of medicinal products shall be carried out by the relevant authorized federal executive body within the period not exceeding two hundred and ten business days upon filing an application for state registration of the medicinal product. The period specified above includes the time necessary to carry out repeated expert examination of the medicines and (or) repeated ethical expert examination in accordance with Article 25 hereof. The period of state registration of a medicinal product is calculated from the date of filing by the relevant authorized federal executive body of an application for state registration of the medicinal product together with required documents as enclosed to the date of issuance of the registration certificate for the medicinal product. The time spent on a clinical trial of the medicinal product is not considered when calculating the period of state registration.

5. No state registration is required for:

1) medicinal products compounded by pharmacy institutions, veterinary pharmacy institutions and individual entrepreneurs holding pharmaceutical licenses under medicinal product prescriptions and orders of medical institutions and veterinary institutions;
2) herbal medicinal raw materials;
3) medicinal products acquired by individuals outside the Russian Federation and intended for personal use;
4) medicinal products intended for export;
5) radiopharmaceutical medicinal products compounded directly in medical institutions in the manner prescribed by the authorized federal executive body.

6. State registration is forbidden for:

1) different medicinal products under the same trade name;
2) one and the same medicinal product manufactured by the manufacturer under different trade names and submitted for state registration as two or more medicinal products.

Article 14. Principles of Expert Examination of Medicines and Ethical Expert Examination

1. Expert examination of medicines and ethical expert examination are based on the principles of legality, observance of human and citizen rights and freedoms, legal entity rights, expert independence, objectiveness, comprehensiveness and completeness of the trials conducted using the latest achievements of science and technology, responsibility of the federal state-financed institution for carrying out expert examination of medicines and responsibility of experts for performance and quality of expert examination.

2. Expert examination of medicines is carried out on a staged basis:

1) first stage: expert examination of documents submitted to obtain a permit to conduct a clinical trial of a medicinal product, excluding:

a) medicinal products permitted for medical use in the Russian Federation for over twenty years, for which bioequivalence study can not be conducted;
b) medicinal products for medical use for which international multicentre clinical trials have been conducted, partially on the territory of the Russian Federation;

2) second stage: expert examination of proposed methods of a medicine quality control, expert examination of the quality of medicine samples submitted using those methods (hereinafter – the “expert examination of the quality of a medicine”), and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product carried out after its clinical trial has been conducted.

3. Expert examination of medicines for veterinary use is carried out on a one stage basis and involves expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product.

Article 15. Federal State-Financed Institution Carrying Out Expert Examination of Medicines

Expert examination of medicines shall be carried out by a federal state-financed institution of the relevant authorized federal executive body founded for the purpose of exercising the powers of that federal body on issuance of permits for the conduct of clinical trials of medicinal products and (or) on state registration of medicinal products (hereinafter – the “the expert institution”).

Article 16. Organization of Expert Examination of Medicines for State Registration Thereof

1. Expert examination of medicines is carried out by an expert commission under the expert institution appointed by the head thereof, under an assignment to conduct expert examination of a medicine issued by the authorized federal executive body. The head of the expert institution provides for proper performance of expert examination of medicines in compliance with the assignment issued by the authorized federal executive body, and makes arrangements for preparation of the commission’s summary conclusion. Under decision of the head of the expert institution persons not employed by that expert institution may be included on the commission as experts, if their special knowledge is necessary for performance of the expert examination, and if such experts are not available in that expert institution.

2. An expert appointed to carry our expert examination of medicines is a certified employee of an expert institution with higher medical, pharmaceutical, biological, veterinary or chemical education who carries out expert examination of medicines in the course of execution of his functions (hereinafter – the “the expert”).

3. When carrying out expert examination of medicines, the expert shall in no way depend upon the person who ordered the expert examination, the developer of the medicine or other persons interested in the results of the expert examination.

4. When carrying out an expert examination of medicines, it is not allowed to demand any materials necessary to carry out the expert examination from the applicant or other persons. In case of insufficiency of the materials submitted to an expert for him to make a conclusion, such expert is entitled to apply to the head of the expert institution for submission of necessary documents, which expert shall make a relevant request to the authorized federal executive body that issued the assignment to carry out expert examination of the medicine.

5. When carrying out expert examination of a medicine assigned to an expert by the head of the expert institution, such expert shall:

1) carry out a complete examination of the objects and materials submitted to him, issue a reasonable and objective conclusion as to the questions put to him, or a reasoned conclusion on impossibility of performance of expert examination of the medicine, should the questions put to him be beyond the expert’s competence, should the examination objects and the materials be inapplicable or not sufficient for carrying out the examination and issuance of a conclusion, or should the state-of-the-art of the science not allow responding to such questions;
2) not disclose information made available to him in connection with expert examination of a medicine, as well as information that constitutes state, trade or other secret protected by the law;
3) ensure safe keeping of examination objects and materials submitted.

6. The expert shall not be entitled to:

1) carry out expert examination of a medicine on application of any institutions or individuals directly to him;
2) independently collect materials to carry out expert examination of a medicine;
3) carry out expert examination of a medicine as a non-state expert.

7. If necessary, an expert is entitled to petition the head of the expert institution to engage other experts to carry out expert examination of a medicine.

8. Each expert included in an expert commission which is assigned to carry out expert examination of a medicine shall carry out examination independently and solely, estimate the results obtained by him personally and by other experts, and draw inferences with respect to the questions put to the commission within his competence.

9. Results of expert examination of a medicine are documented in the conclusion of the expert commission. A conclusion of an expert commission shall include the list of examinations, the volume of examinations carried out by each expert, the facts determined by each expert and the inferences based on the examination results. An expert whose opinion does not meet the decision of the expert committee is entitled to express his opinion in writing, which opinion is enclosed with the conclusion of the expert commission.

10. Experts included in an expert commission shall be forewarned of responsibility stipulated by the legislation of the Russian Federation for issuance of a conclusion containing unreasonable or falsified inferences, which responsibility they acknowledge in writing.

11. Special expert and qualification commissions determine the professional level of the experts and certify the latter for carrying out expert examination of medicines in the manner prescribed by the authorized federal executive body. The professional level of experts is subject to review by such commissions at least every five years.

12. Rules for expert examination of medicines and a form of expert commission conclusion are established by the authorized federal executive body.

Article 17. Ethical Expert Examination

1. Ethical expert examination is carried out for the purpose of issuance of a conclusion on ethical feasibility to conduct a clinical trial of a medicinal product for medical use by the ethical council founded in the manner prescribed by the authorized federal executive body.

2. Representatives of medical, research and higher professional education institutions, as well as representatives of public and religious institutions and mass media may act as ethical council experts. Such experts shall in no way depend upon developers of medicinal products and other persons interested in the results of expert examination.

3. Remuneration to ethical council experts shall be paid under a contract concluded between the authorized federal executive body which founded the ethical council and an ethical council expert at the cost of budget allocations stipulated to authorized federal executive body, created ethical council, in the federal budget for corresponding year to ensure its activities in extent prescribed by the Government of the Russian Federation
(as amended by Federal Law of November 29, No. 313-FZ)

4. Ethical council experts bear responsibility in accordance with the legislation of the Russian Federation.

5. Ethical council composition, regulations on the council, requirements to qualification and experience of ethical council experts in expert assessment of scientific, medical and ethical aspects of clinical trials of medicinal products for medical use, procedures for arrangement and performance of ethical expert examination and a form of ethical council conclusion are established by the authorized federal executive body. The number of representatives of medicinal institutions shall not exceed a half of the total number of ethical council experts.

6. Information on ethical council composition, plan of operation and current activities shall be placed on the Internet official site of the authorized federal executive body in the manner prescribed by such body.

Article 18. Submission and Review of Applications for State Registration of Medicinal Products and Submission of Necessary Documents

1. For the purpose of state registration of a medicinal product, the developer of the medicinal product or any other legal entity authorized by such developer (hereinafter –the “applicant”) submits to the relevant authorized federal executive body carrying out state registration of medicinal products an application for state registration of the medicinal product, as well as necessary documents in the manner prescribed by the relevant authorized federal executive body, of which the registration dossier for the medicinal product is formed (hereinafter – the “registration dossier”).

2. An application for state registration of a medicinal product shall contain:

1) name and address of the applicant and (or) developer of the medicinal product and address of the place of manufacturing of the medicinal product;
2) name of the medicinal product (international nonproprietary name or chemical and trade names);
3) list of substances composing the medicinal product specifying the quantity of each;
4) dosage form, dosage rate, methods of administration and use and validity period of the medicinal product;
5) description of pharmacological and pharmacodynamic or immunobiological properties of the medicinal product;
6) maximum ex-works price for the medicinal product included in the list of vital and essential medicinal products as posted by the manufacturer, in case of state registration of such product;
7) statement on the lack of the need to conduct a clinical trial and bioequivalence study of the medicinal product permitted for medical use within the territory of the Russian Federation for over twenty years, specifying normative legal acts which prove such period of use.

3. The registration dossier shall comprise the following documents:

1) draft designs of primary packages and secondary (retail) packages for the medicinal product;
2) document certifying the compliance of the manufacturer of the medicinal product to be registered with the requirements of the good manufacturing practices, issued by a competent authority of the country of origin of the medicinal product to be registered and certified in the prescribed manner, as translated into the Russian language;
3) draft normative documentation or normative document for the medicinal product or reference to a relevant pharmacopeia monograph;
4) process flow diagram for manufacturing of the medicinal product and its description, and (or) process flow diagram for manufacturing of the pharmaceutical substance and its description;
5) document certifying the compliance of the manufacturer of the pharmaceutical substance with the requirements of the good manufacturing practices, issued by a competent authority of the country of origin of the pharmaceutical substance and certified in the prescribed manner, as translated into the Russian language, containing the following information:

a) name of the pharmaceutical substance (international nonproprietary name or chemical and trade names);
b) name and address of the manufacturer of the pharmaceutical substance;
c) pharmaceutical substance shelf-life;

6) document containing data on qualitative indicators of the pharmaceutical substance used in manufacturing of the medicinal products;
7) normative documentation or normative document for the pharmaceutical substance, or reference to a relevant pharmacopoeia monograph;
8) information on conditions of storage and transportation of the medicinal product, and other information;
9) report on the results of preclinical testing of the medicine for medical use containing description, results and statistical analysis of the results of the preclinical testing;
10) report on the results of preclinical testing of the medicine and clinical trial of the medicinal product for veterinary use;
11) draft protocol of a clinical trial of the medicinal product for medical use;
12) investigator’s brochure;
13) patient information sheet;
14) information on remunerations and compensations paid to the patients (healthy volunteers and ill patients) (hereinafter – the “patients”) involved in clinical trials of the medicinal product for medical use, bioequivalence and (or) therapeutic equivalence studies;
15) report on the results of international multicentre clinical trials of the medicinal product for medical use, partially conducted in the Russian Federation;
16) draft instructions for use of the medicinal product containing the following information:

a) name of the medicine (international nonproprietary name or chemical and trade names);
b) dosage form indicating the names and quantitative level (activity) of the pharmaceutical substances and excipients;
c) pharmacotherapeutic group of the medicinal product;
d) indications for use;
e) counterindications for use;
f) dosage regimen, mode of administration, time of administration of the medicinal product, if necessary, and duration of treatment (including those for children under and over one year old);
g) safety precautions on use;
h) overdose symptoms; relief measures in case of overdose;
i) references, if necessary, to specific effects of the medicinal product at first use or withdrawal thereof;
j) description, if necessary, of actions to be undertaken by a physician (physician’s assistant), veterinary specialist, patient or animal’s owner in case of omission of one or several doses of the medicinal product;
k) possible side effects of the medicinal product;
l) interaction with other medicinal products and (or) food substances or animal food substances;
m) possibilities and specifics of medical use of the medicinal product in pregnant women, women in period of lactation, children or adults with chronic deceases;
n) information on possible effect of the medicinal product on the ability to drive and operate machinery;
o) validity period and indication not to use the medicinal product after its expiry;
р) storage conditions;
q) indication to keep the medicinal product away from children;
r) special safety precautions to be used when destructing unused medicinal products, if necessary;
s) terms of possible use of animal products after the animal has been administered the medicinal product for veterinary use;
t) name and address of the manufacturer of the medicinal product and address of the place of manufacturing of the medicinal product;
u) dispensing conditions;
(clause “u” introduced by Federal Law of November 29, No. 313-FZ)

17) copy of the document certifying registration of the medicinal product if it is registered outside the Russian Federation translated into the Russian language and certified in the prescribed manner;
18) documents submitted in accordance with articles 19 – 23 hereof.

4. At the applicant’s request, reports on the results of clinical trials, bioequivalence and (or) therapeutic bioequivalence studies of the medicinal product conducted in the applicant’s country and other countries (including epidemiological or episootological trials of immunobiological medicinal products designed for immunobiological prophylaxis and treatment of infectious diseases, including with children), containing descriptions of the trials of the medicinal product conducted, their results and statistical analysis of the results obtained may be submitted.

5. The following documents shall be enclosed with an application for state registration of a medicinal product:

1) document certifying payment of the state duty for performance of expert examination of the documents submitted to obtain permits to conduct clinical trials of the medicinal product for medical use and ethical expert examination when applying for state registration of the medicinal product;
2) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product permitted for use within the territory of the Russian Federation for over twenty years when applying for state registration of the medicinal product;
3) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for medical use when applying for state registration of the medicinal product, for which international multicentre clinical trials have been conducted, partially within the territory of the Russian Federation;
4) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for veterinary use when applying for state registration thereof.

6. The results of the nonclinical trials of medicinal products and clinical trials of medicinal products submitted by the applicant for state registration of the medicinal products shall not be obtained, disclosed, used for commercial purposes and for purposes of state registration without applicant's permission within six years from the date of the state registration of the medicinal product.

Violation of the prohibition specified by this Clause shall entail the responsibility in accordance with the legislation of the Russian Federation.

The circulation of medicines in the Russian Federation registered with violation of this Clause shall be prohibited.
(clause 6 introduced by Federal Law of October 11, 2010, No. 271-FZ)

Article 19. Procedure for Making Decision on Issuance of Assignment for Performance of Expert Examination of Medicines for Expert Institution and Ethical Council

1. Within five business days from on receipt of an application for state registration of a medicinal product, the authorized federal executive body shall review the data contained in the materials submitted by the applicant for completeness and reliability, and take decision on issuance of an assignment to carry out:

1) expert examination of the medicines, in particular expert examination of the documents submitted to obtain a permit for the conduct of a clinical trial of the medicinal product for medical use in accordance with the objectives specified in Article 38 hereof, and ethical expert examination with respect to the medicinal products, for which clinical trials have not been conducted within the territory of the Russian Federation, based on the documents specified in Sub-clauses 1 – 9, 11 – 14 and 17 of Clause 3 and Sub-clause 1 of Clause 5 of Article 18 hereof;
2) expert examination of the medicines, in particular expert examination of the quality of the medicines and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for medical use with respect to the medicinal products permitted for use within the territory of the Russian Federation for over twenty years, based on the documents specified in Sub-clauses 1 – 9 and 16 of Clause 3 and Sub-clause 2 of Clause 5 of Article 18 hereof, as well as the medicinal products, for which international multicentre clinical trials have been conducted, partially within the territory of the Russian Federation, based on the documents specified in Sub-clauses 1 – 9 and 15 - 17 of Clause 3 and Sub-clause 2 of Clause 5 of Article 18 hereof;
3) expert examination of the medicine with respect to the medicinal products for veterinary use, based on the documents specified in Sub-clauses 1 – 8, 10, Items a-e, g-l and o-t of Sub-clause 16 and Sub-clause 17 of Clause 3 and Sub-clause 4 of Clause 5 of Article 18 hereof.

2. The authorized federal executive body notifies the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal.

3. Failure to submit a complete set of the documents listed in Clauses 3 and 5 of Article 18 hereof necessary for performance of expert examinations, or submission of documents lacking a comprehensive list of necessary information is considered grounds for refusal to carry out expert examinations specified in Clause 1 of this Article.

Article 20. Expert Examination of Documents Necessary to Obtain Permit for Conduct of Clinical Trial of Medicinal Product for Medical use and Ethical Expert Examination

1. Expert examination of documents necessary to obtain a permit to conduct a clinical trial of a medicinal product for medical use in accordance with the objectives specified in Article 38 hereof, ethical expert examination, generation of conclusions on possibility or non-possibility of the conduct of such clinical trial by the expert council and ethical council, and forwarding of such conclusions to the authorized federal executive body shall be exercised within the period not exceeding thirty business days from the date of receipt by the expert institution of the assignment issued by the authorized federal executive body together with necessary documents specified in Sub-clauses 9, 11, 12 of Clause 3 of Article 18 hereof, and documents specified in Clause 4 of Article 18 hereof as submitted at the request of the applicant, and from the date of receipt by the expert council of the assignment issued by the authorized federal executive body together with necessary documents specified in Sub-clauses 11 – 14 of Clause 3 of Article 18 hereof.

2. The documents contained in the registration dossier and submitted to the expert institution and expert council for performance of expert examination thereof for the purpose of obtaining a permit to conduct a clinical trial of the medicinal product for medical use are subject to return to the authorized federal executive body concurrently with the relevant expert examination conclusions.

Article 21. Procedure for Obtaining Permit to Conduct Clinical Trial of Medicinal Product for Medical use

1. Within the period not exceeding five business days from the date of receipt of the conclusions specified in Article 20 hereof, the authorized federal executive body shall evaluate the conclusions received to determine their compliance with the assignments for performance of the relevant expert examinations, and notify the applicant in writing of the results of the expert examinations which have been carried out and of the possibility or non-possibility of issuance of a permit to the applicant with respect to conduct a clinical trial of the medicinal product for medical use.

2. In case of a positive decision on the possibility of issuance of a permit to conduct a clinical trial of the medicinal product for medical use, the authorized federal executive body suspends performance of state registration of the medicinal product until the applicant has applied for a permit to conduct a clinical trial of the medicinal product for medical use to the authorized federal executive body.

3. In case of a negative decision on the possibility of issuance of a permit to conduct a clinical trial of the medicinal product for medical use, the authorized federal executive body stops the procedure of state registration of the medicinal product.

Article 22. Decision on Conducting of Clinical Trial of Medicinal Product for Medical use

1. To obtain a permit to conduct a clinical trial of a medicinal product for medical use, the applicant shall submit to the authorized federal executive body:

1) application for issuance of a permit to conduct such clinical trial;
2) information on the researchers’ experience in the relevant fields and in conducting clinical trials;
3) the copy of contract of compulsory insurance of the life and health of a patient involved in clinical trials of medicinal products for medical use (hereinafter “the contract of compulsory insurance”), made in accordance to the standard rules for compulsory life and health insurance of a patient involved in clinical trials of medicinal products for medical use approved by the Government of the Russian Federation (hereinafter “the standard rules for compulsory insurance”), with specifying the maximal number of patients involved in clinical trial of medicinal products for medical use ;
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
4) the details of medical organizations which are scheduled to conduct clinical trials of  medicinal product for medical use (full and brief names of medical institution, legal form of medical institution, the seat and business location of medical institution, telephone, telefax, email address);
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
5) estimated terms of the clinical trial of the medicinal product for medical use.
(sub-clause 5 introduced by Federal Law of October 11, 2010, No. 271-FZ)

2. Within the period not exceeding five business days from the date of receipt of the application specified in Clause 1 of this article together with necessary documents, the authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) take decision on issuance of a permit to conduct the clinical trial of the medicinal product for medical use, or on refusal to issue such permit;
3) notify the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal;
4) issue a permit to conduct the clinical trial of the medicinal product for medical use in the manner prescribed by the authorized federal executive body.

3. Failure to submit the documents specified in Clause 1 of this article, or non-compliance of the documents submitted with the requirements of this Federal Law, or the presence of the conclusion issued by the expert institution or the conclusion issued by the Ethical council on impossibility of conducting of clinical trial of a medicinal product for medical use on the base of results of performed expert examinations provided for in Article 20 of this Federal law is considered grounds for refusal to issue a permit to conduct the clinical trial of the medicinal product.
(as amended by Federal Law of October 11, 2010, No. 271-FZ)

Article 23. Expert Examination of Quality of a Medicine and Expert Examination of Correlation between Anticipated Benefit and Possible Risk from Use of Medicinal Product for Medical use

1. Expert examination of the quality of a medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of a medicinal product for medical use, generation of conclusions by the expert councils based on the results of clinical trials and forwarding of such conclusions to the authorized federal executive body shall be exercised within the period not exceeding one hundred and ten business days from the date of receipt by the expert institution of the relevant assignment issued by the authorized federal executive body together with the documents specified in Sub-clauses 1 – 8 and 15 - 17 of Clause 3 of Article 18 hereof and a report on the clinical trial of the medicinal product for medical use conducted.

2. For the purpose of expert examinations specified in Clause 1 of this article, the applicant shall submit to the authorized federal executive body:

1) application for renewal of state registration of the medicinal product and performance of the expert examinations specified in Clause 1 of this article;
2) report on the clinical trial of the medicinal product for medical use conducted;
3) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for medical use when applying for state registration.

3. Within the period not exceeding five business days from the date of receipt of the application together with the documents specified in Clause 1 and Sub-clauses 2 and 3 of Clause 2 of this article, the authorized body shall:

1) examine the data contained in the report on clinical trial of the medicinal product for medical use submitted by the applicant for completeness and reliability;
2) take decision on renewal of state registration of the medicinal product and performance of the expert examinations specified in Clause 1 of this article, or on refusal to renew state registration of the medicinal product and carry out such expert examinations;
3) notify the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal.

4. Failure to submit a complete set of the documents listed in Clause 1 and Sub-clauses 2 and 3 of Clause 2 of this article, or submission of the report on the clinical trial of the medicinal product for medical use lacking a comprehensive list of necessary information is considered grounds for refusal to renew state registration and carry out expert examinations specified in Clause 1 of this article.

5. Within fifteen business days from the date of receipt of the decision on renewal of state registration of the medicinal product and performance of expert examinations specified in Clause 1 of this article, issued by the authorized federal executive body, the applicant shall submit samples of the medicine product for medical use manufactured in compliance with the requirements of the experimental industrial regulations and (or) industrial regulations approved by the head of the medicines manufacturing company, as well as, in appropriate cases, sample of the pharmaceutical substance, test strain of microorganisms, cultured cells, samples of substances used for quality control of a medicinal product be means of comparison of a medicinal drug to them, in the quantities necessary to reproduce the quality control methods, for the purpose of expert examination of the quality of the medicinal product.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

6. On receipt of samples of a medicinal product and pharmaceutical substance the expert institution shall provide the applicant with a document certifying the receipt of such samples, and notify the authorized executive body thereof in writing within the period not exceeding three business days.

7. The period of submission of samples of a medicinal product and pharmaceutical substance by the applicant and the period of a written notification thereof of the authorized federal executive body by the expert institution specified in Clauses 5 and 6 of this article are not included in the period of performance of expert examinations specified in Clause 1 of this article.

8. The documents submitted to the expert institution for performance of expert examinations specified in Clause 1 of this article are subject to return to the authorized federal executive body concurrently with the conclusions based on the results of such expert examinations.

Article 24.  Expert Examination of Quality of a Medicine and Expert Examination of Correlation between Anticipated Benefit and Possible Risk from Use of Medicinal Product for Veterinary Use

1. Expert examination of the quality of a medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of a medicinal product for veterinary use, generation of conclusions based on the results of expert examinations by expert councils and forwarding of such conclusions to the authorized federal executive body shall be exercised within the period not exceeding one hundred and ten business days from the date of receipt by the expert institution of the relevant assignment issued by the authorized federal executive body together with the documents specified in Sub-clauses 1 – 8, 10, Items a-e, g-l and o-t of Sub-clause 16 and Sub-clause17 of Clause 3 of Article 18 hereof.

2. Within fifteen business days from the date of receipt of the decision on performance of the expert examinations specified in Clause 1 of this article issued by the authorized federal executive body, the applicant shall submit samples of the medicinal product for veterinary use manufactured in compliance with the requirements of the technological regulations approved by the head of the medicines manufacturing company, as well as sample of the pharmaceutical substance in the quantities necessary to reproduce the quality control methods, for the purpose of expert examination of the quality of the medicinal product.

3. On receipt of samples of the medicinal product and pharmaceutical substance the expert institution shall provide the applicant with a document certifying the receipt of such samples, and notify the authorized executive body thereof in writing within the period not exceeding three business days.

4. The period of submission of samples of the medicinal product and pharmaceutical substance by the applicant and the period of a written notification thereof of the authorized federal executive body by the expert institution specified in Clauses 2 and 3 of this article are not included in the period of performance of expert examinations specified in Clause 1 of this article.

5. The documents submitted to the expert institution for performance of expert examinations specified in Clause 1 of this article are subject to return to the authorized federal executive body concurrently with the conclusions based on the results of such expert examinations.

Article 25. Repeated Expert Examination of Medicines and Repeated Ethical Expert Examination

1. In case of insufficient feasibility or incompleteness of the conclusion issued by the expert institution or ethical council, presence of controversial data in such conclusion, falsification of the inferences based on the results of expert examination of a medicine and (or) ethical expert examination, concealment from the authorized federal executive body of any grounds for rejection of an expert due to his being interested in the results of the relevant expert examination, availability of data on direct or indirect interference in the expert examination procedure of any persons not participating in the performance thereof, however having influenced the procedure and the results thereof, the authorized federal executive body shall schedule repeated expert examination of the medicine and (or) repeated ethical examination.

2. Repeated expert examination of a medicine shall be carried out within the period prescribed by the authorized federal executive body, not exceeding forty business days from the date of receipt by the expert institution of an assignment to carry out repeated expert examination of the medicine; repeated ethical expert examination shall be carried out within the period not exceeding fifteen business days from the date of receipt by the ethical council of an assignment to perform repeated ethical expert examination.

3. Financing of repeated expert examination of a medicine is not provided, and the funds transferred for the performance of such expert examination earlier are subject to return to the federal budget.

Article 26. Accelerated Procedure for Expert Examination of Medicines

1. Accelerated procedure for expert examination of medicines for the purpose of state registration of medicinal products shall be applied to generic medicinal products. For the purpose of such expert examination information obtained in clinical trials of the medicinal products and published in specialized editions, as well as documents containing the results of bioequivalence and (or) therapeutic equivalence studies of the medicinal product for medical use or the results of bioequivalence studies of the medicinal product for veterinary use are submitted.

2. Accelerated procedure for expert examination of medicines shall not be applied to immunobiological medicinal products, insulin products and medicinal products to be registered in the Russian Federation for the first time.

3. Accelerated procedure for expert examination of medicines shall be performed under decision of the relevant authorized federal executive body within the period not exceeding sixty business days. In this case expert examination of the documents contained in the registration dossier for the purpose of obtaining a permit to conduct a clinical trial of a medicinal product for medical use and ethical expert examination shall be performed within the period not exceeding fifteen business days, and expert examination of the quality of a medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of a medicinal product shall be performed within the period not exceeding five business days.

4. Accelerated procedure for expert examination of medicines shall be performed in the manner prescribed in Articles 17 -20, 23 and 24 hereof, and it does not mean downgrading of requirements for safety, quality and efficacy of medicinal products.

Article 27. Decision on State Registration of a Medicinal Product

1. Within the period not exceeding five business days from the date of receipt of the conclusions issued by the expert commission based on the results of expert examination of the quality of a medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product the relative authorized federal executive body shall:

1) evaluate such conclusions in order to determine compliance thereof with the assignment for performance of such expert examinations;
2) take a decision on whether to approve state registration of the medicinal product or to refuse approving state registration of the medicinal product;
3) in case of a positive decision on state registration of the medicinal product, enter the data on the registered medicinal product, including, but not limited to the data on the pharmaceutical substance contained in the medicinal product, into the state register of medicines and issue to the applicant a registration certificate, the form of which is to be approved by the authorized federal executive body, approved normative documentation, the normative document, Package Leaflet for the medicinal product and designs of the primary and secondary (retail) packages bearing the number of the registration certificate for the medicinal product and the date of state registration thereof or, in case of refusal of state registration of the medicinal product, notify the applicant in writing of the grounds for such refusal;

2. Decision of the relevant authorized federal executive body stating that the data obtained do not confirm quality and(or) efficacy of the medicinal product to be registered, or possible health hazard to human beings and animals taking the medical product exceeds the efficacy thereof is considered grounds for refusal of state registration of the medicinal product.
(as amended by Federal Law of October 11, 2010, No. 271-FZ)

3. When registering a medicinal product included in the list of vital and essential medicinal products, necessary data shall be entered into the state register of maximum ex-works manufacturers’ prices for the medicinal products included in such list.

Article 28. Registration Certificate for a Medicinal Product

1. A registration certificate for a medicinal product indicating dosage forms and dosage rates shall be issued for an unlimited period, except for registration certificates with a validity period of five years issued for the medicinal products to be registered in the Russian Federation for the first time.

2. Upon expiration of the period specified in Clause 1 of this article, a permanent registration certificate for the medicinal product shall be issued subject to confirmation of the state registration thereof.

Article 29. Confirmation of State Registration of a Medicinal Product

1. Confirmation of state registration of a medicinal product shall be carried out when issuing a permanent registration certificate for the medicinal product in the case specified in Clause 2 of Article 28 hereof, within the period not exceeding ninety business days from the date of receipt of an application for confirmation of state registration of the medicinal product executed in accordance with Clause 2 of Article 18 hereof.

2. Confirmation of state registration of a medicinal product is carried out based on the results of expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product as well as expert examination of the quality of the medicine, carried out in the case of amendments to normative documentation or normative document.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

3. The document certifying payment of the state duty for confirmation of state registration of the medicinal product for medical use or the medicinal product for veterinary use, and the document containing the results of safety monitoring of the medicinal product conducted by the applicant, executed as prescribed by the relevant authorized federal executive body, shall be enclosed with the application for confirmation of state registration of the medicinal product. Normative documentation or normative document, draft instructions for use of the medicinal product, draft designs of primary packages and secondary (retail) packages for the medicinal product shall be enclosed with the application for confirmation of state registration of the medicinal product again only in the case of amendments to them.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

4. Within ten business days upon the date of receipt of an application for confirmation of state registration of a medicinal product and necessary documents, the relevant authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) make a decision on whether to carry out or refuse carrying out expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product as well as expert examination of the quality of the medicine, carried out in the case of amendments to normative documentation or normative document;
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
3) notify the applicant in writing of the positive decision or, in case of refusal to carry out expert examination, of the grounds for such refusal.

5. Failure to submit a complete set of the documents listed in Clauses 1 and 3 of this article, or submission of the documents lacking comprehensive information which shall be reflected therein is considered grounds for refusal to carry out expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product and (or) expert examination of the quality of the medicinal drug.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

6. Expert examination of the quality of the medicine and (or) expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for the purpose of confirmation of state registration of a medicinal product shall be carried out based on the documents specified in Clause 3 of this Article, in the manner prescribed in Clauses 5 - 8 of Articles 23 and 24 hereof.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

7. While the procedure of confirmation of state registration of a medicinal product is on, civil circulation thereof is conducted within the territory of the Russian Federation.

Article 30. Amendments to Documents Contained in Registration Dossier for Registered Medicinal Product for Medical Use

1. To enter amendments to the documents contained in the registration dossier for a registered medicinal product for medical use, the applicant shall submit to the authorized federal executive body an application for such amendments in the form prescribed by the authorized federal executive body, together with the amendments to such documents as enclosed, as well as documents certifying the necessity of such amendments. Approval of such amendments, or refusal to enter such amendments shall be given within the period not exceeding ninety business days from the date of receipt by the authorized federal executive body of an application for such amendments.

2. In case of amendments to the Package Leaflet for a medicinal product with respect to the data specified in Items d-o,u of Sub-clause 16 of Clause 3 of Article 18 hereof or changes in the composition of a medicinal product for medical use, changing the place of production of medicinal product for medical use, changing the qualitative indicators of the medicinal product for medical use and (or) the methods of quality control of the medicinal product for medical use, changing the expiry date of the medicinal product for medical use, expert examination of the medicines, in particular expert examination of the quality of the medicine and (or) expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product shall be carried out. In case of necessity to enter other amendments to such directions, no expert examination of the medicine for the purpose of such amendments to the data on such registered medicinal product shall be carried out.
(as amended by Federal Laws of October 11, 2010, of November 29, 2010, No. 313-FZ)

3. Together with an application for amendments to the documents contained in the registration dossier for a registered medicinal product for medical use, besides the documents specified in Clause 1 of this article, the documents certifying payment of the state duty for amendments to the Package Leaflet for the medicinal product for medical use or the documents certifying payment of the state duty for change in the composition of the medicinal product for medical use shall be enclosed.

4. Within ten business days upon the date of receipt of the application specified in Clause 1of this article and necessary documents, the authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) take a decision on whether to carry out or refuse carrying out expert examinations of the medicine specified in Clause 2 of this article;
3) notify the applicant in writing of the positive decision or, in case of refusal to carry out a relevant expert examination of the medicine, or the grounds for such refusal.

5. Failure to submit a complete set of the documents listed in Clauses 1 and 3 of this article, or submission of the documents lacking comprehensive data confirming the necessity of such amendments is considered grounds for refusal to carry out expert examinations specified in Clause 2 of this article.

6. Expert examinations specified in Clause 2 of this article shall be carried out in the manner prescribed in Article 23 hereof.

7. Within the period not exceeding five business days from the date of receipt of the conclusions issued by the expert commission based on the results of expert examinations specified in Clause 2 of this article, the authorized federal executive body shall:

1) take a decision on whether to approve or refuse approving amendments to the documents contained in the registration dossier of the registered medicinal product for medical use;
2) make necessary changes in the state register of medicines based on the decision on amendments to the documents contained in the registration dossier for the registered medicinal product for medical use, and return them to the applicant.

8. Conclusion of the authorized federal executive body on possible downgrading of safety, quality and efficacy of the medicine in case of such amendments is considered grounds for refusal to approve amendments to the documents contained in the registration dossier for the registered medicinal product for medical use.

9. Civil circulation of medicinal products for medical use manufactured earlier than a decision on approval of or refusal to approve amendments to the documents contained in the registration dossier for such medicinal products has been taken by the authorized federal executive body shall be allowed.

Article 31.  Amendments to Documents Contained in Registration Dossier for Registered Medicinal Product for Veterinary Use

1. To enter amendments to the documents contained in the registration dossier for a registered medicinal product for veterinary use, the applicant shall submit to the authorized federal executive body an application for such amendments in the form prescribed by the authorized federal executive body, together with the amendments to such documents as enclosed, as well as documents certifying the necessity of such amendments. Approval of or refusal to approve such amendments shall be given within the period not exceeding ninety business days from the date of receipt by the authorized federal executive body of an application for such amendments.

2. In case of amendments to the Package Leaflet for a medicinal product for veterinary use with respect to any data related to changes in the dosage rates or terms of possible use of animal products after the animal has been administered the medicine for veterinary use, expert examination of the medicine for veterinary use shall be carried out. In case of necessity to make other amendments to such a Package Leaflet, expert examination of the medicine for veterinary use shall not be carried out.

3. Together with an application for amendments to the documents contained in the registration dossier for a registered medicinal product for veterinary use, besides the documents specified in Clause 1 of this article, the documents certifying payment of the state duty for amendments to the Package Leaflet for a medicinal product for veterinary use shall be enclosed.

4. Within the period not exceeding ten business days upon the date of receipt of the application specified in Clause 1of this article and necessary documents, the authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) take a decision on whether to carry out or refuse carrying out expert examination of the medicine for veterinary use;
3) notify the applicant in writing of a positive decision or, in case of refusal to carry out expert examination of the medicine for veterinary use, of the grounds for such refusal.

5. Failure to submit a complete set of the documents listed in Clauses 1 and 3 of this article, or submission of the documents lacking comprehensive data confirming the necessity of such amendments is considered grounds for refusal to carry out expert examination of the medicine for veterinary use.

6. Expert examination of a medicine for veterinary use for the purpose of entering amendments to the documents contained in the registration dossier for the registered medicinal product for veterinary use shall be carried out in the manner prescribed in Article 24 hereof.

7. Conclusion of the authorized federal executive body on possible downgrading of safety, quality and efficacy of the medicinal product for veterinary use in case of such amendments to the documents is considered grounds for refusal to approve amendments to the documents contained in the registration dossier for the registered medicinal product for veterinary use.

8. Civil circulation of medicinal products for veterinary use manufactured earlier than a decision on approval of or refusal to approve the amendments to the documents contained in the registration dossier for such medicinal products for veterinary use has been taken by the authorized federal executive body shall be allowed.

Article 32. Cancellation of State Registration of a Medicinal Product

Decision on cancellation of state registration of a medicinal product and removal of such medicinal product from the state register of medicines shall be made by the authorized federal executive body in the following cases:

1) The relevant authorized federal executive body advances an opinion on existence of a risk or threat to the health and life of people or animals taking that medicinal product, which risk or threat exceeds the efficacy thereof based on the results of safety monitoring of the medicinal product performed by the said authorized federal executive body;
2) The developer of the medicine or any person authorized by the developer, or any other legal entity has filed an application for cancellation of the state registration of the medicinal product;
3) The state registration of the medicinal product failed to be confirmed upon expiration of the registration certificate issued for five years;
4) The applicant failed to provide information that can involve the need for amending the documents as part of the registration dossier for the registered medicinal product within 30 calendar days of the effective date of such amendments;
5) The medicinal product underwent state registration under the trade name of a medicinal product which was earlier registered under this trade name;
6) The same medicinal product was registered under different trade names by the applicant;
7) Legal judgment was passed on violation of rights of a possessor of intellectual property rights in the area of medicines.

Article 33. State Register of Medicines

1. The state register of medicines contains the list of medicinal products which passed state registration, the list of pharmaceutical substances included in the composition of medicinal products and the following information:

1) with respect to medicinal products:

a) name of the medicinal product (international nonproprietary or chemical name of and trade name);
b) dosage form with indication of dosage rate of the medicinal product and its quantity in consumer package;
c) name of developer of the medicinal product;
d) name and addresses of the manufacturer of the medicinal product;
e) pharmacotherapeutic group of the medicinal product;
f) indications and contraindications for use of the medicinal product;
g) side effects of the medicinal product;
h) shelf life of the medicinal product;
i) storage conditions for the medicinal product;
j) dispensing conditions for the medicinal product;
k) number of pharmacopoeia monograph and, failing the latter, of normative documentation or normative document;
l) date of state registration of the medicinal product and registration number thereof and;

2) with respect to pharmaceutical substances:

a) name of the pharmaceutical substance (nonproprietary or chemical name of and trade name);
b) name and address of the manufacturer of the pharmaceutical substance;
c) shelf life of the pharmaceutical substance;
d) storage conditions for the pharmaceutical substance;
e) number of the pharmacopoeia monograph and, failing the latter, of normative documentation or normative document.

2. A pharmaceutical substance not used in the manufacturing of medicinal products may be included in the state register of medicines on the basis of the developer’s application, or manufacturer of the medicine, or a legal entity authorized by any of them, provided that the pharmaceutical substance was duly evaluated for quality as prescribed in article 34 of this Federal Law.

3. The procedure for maintenance of the state register of medicines intended for medical use and the procedure for maintenance of the state register of medicines intended for veterinary use shall be approved by the relevant authorized federal executive body.

Article 34. Quality Evaluation of Pharmaceutical Substance not used in Manufacturing of Medicinal Products

1. Any pharmaceutical substance not used in manufacturing of medicinal products requires quality evaluation before it is included in the state register of medicines.

2. Quality evaluation of the pharmaceutical substance referred to in Clause 1 of this Article shall be carried out, expert opinion based on the evaluation findings shall be prepared and submitted to the authorized federal executive body within sixty business days of receipt by the expert institution of the relevant assignment issued by the authorized federal executive body and the documents specified in sub-clauses 4 – 7 of Clause 3 of Article 18 of this Federal Law.

3. For the purpose of quality evaluation of the pharmaceutical substance referred to in Clause 1 of this Article, the applicant shall submit to the authorized federal executive body:

1) an application for including medicines of this pharmaceutical substance into the state register;
2) a document to confirm payment of state duty for the inclusion of the pharmaceutical substance not used in manufacturing of medicinal products in the state register of medicines;
3) documents specified in Sub-clauses 4 - 7 of Clause 3 of Article 18 of this Federal Law.

4. Within five business days upon filing the application for including the pharmaceutical substance referred to in Clause 1 of this Article in the state register of medicines and documents enlisted in Part 1 and Item 2 of Part 3 of this article, the authorized federal executive body shall:

1) make sure that the data contained in the documents submitted by the applicant is complete;
2) decide to assign a task to the expert institution to carry out quality evaluation of the pharmaceutical substance referred to in Clause 1 of this Article or reject such assignment;
3) notify the applicant in writing of a positive decision or, in the event of a negative decision, give the reasons of such rejection.

5. Failure to provide any of the documents listed in Clause 2 and Sub-clause 2 of Clause 3 of this Article will be a reason for rejection of quality evaluation of the pharmaceutical substance specified in Clause 1 of this Article by the expert institution.

6. Within fifteen business days of receipt of the decision made by the authorized federal executive body to assign quality evaluation of the pharmaceutical substance specified in Clause 1 of this Article to the expert institution, the applicant shall provide the expert institution with samples of the pharmaceutical substance in the quantity as may be necessary for realization of quality control methods. On receipt of samples of the pharmaceutical substance referred to in Clause 1 of this Article, the expert institution shall issue to the applicant a documentary proof of receipt of the samples and notify the authorized federal executive body in writing within three business days. This term is not included in the term for the quality evaluation.

7. The documents submitted to the expert institution for quality evaluation of the pharmaceutical substance referred to in Clause 1 of this Article shall be returned to the authorized federal executive body together with the expert opinion.

8. Within five business days of receipt of the expert opinion on the pharmaceutical substance referred to in Clause 1 of this Article, the authorized federal executive body shall:

1) study this expert opinion to make sure that it complies with the expert assignment;
2) decide on including the pharmaceutical substance referred to in Clause 1 of this Article in the state register of medicines or reject such inclusion;
3) if it is decided to include the pharmaceutical substance referred to in Clause 1 of this Article in the state register of medicines as specified in Sub-clause 2 of Clause 1 of Article 33 hereof, add the necessary information and notify the applicant in writing.

Article 35. Repeated Presentation of a Medicinal Product, which Failed State Registration of Medicinal Products for State Registration of Medicinal Products

Repeated presentation to the relevant authorized federal executive body of a medicinal product that failed state expert registration of medicinal products or was rejected for such registration, the composition of which medicinal product was changed, shall be considered as presentation of a new medicinal product for state registration regardless of whether its initial name was preserved or not.

Article 36. Appeal of Decision on Refusal to Issue Permit for Clinical Trials of Medicinal Product, or Refusal to Perform State Registration of a Medicinal Product

Decision of the relevant authorized federal executive body on refusal to issue a permit for clinical trial of a medicinal product, or refusal to perform state registration of a medicinal product may be appealed in the manner established by the legislation of the Russian Federation.

Article 37. Information Relating to State Registration of Medicinal Products, Information about Registered Medicinal Products, and Medicinal Products Removed from the Sate Register of Medicines

1. The relevant authorized federal executive body shall place on its official web-site the information relating the process of state registration of medicinal products, including expert examination of medicines, and information about medicinal products and medicinal products removed from the state register of medicines not later than within five business days of receipt by the authorized federal executive body of an application for state registration of the medicinal product.

2. The term and procedure of placing information referred to in Clause 1 of this Article shall be established by the authorized federal executive body.

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)