About Biomedical Cell Products
Original Language Title: О биомедицинских клеточных продуктах
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Russian Federation About biomedical cellular products Adopted by the State Duma on June 8, 2016 Approved by the Federation Council on June 15, 2016 Article 1. The subject of regulation of this Federal Law 1. This Federal Law regulates relations arising from the development, pre-clinical studies, clinical studies, expert examination, state registration, production, quality control, implementation, application, Storage, transportation, import into the Russian Federation, export from the Russian Federation, destruction of biomedical cellular products intended for the prevention, diagnosis and treatment of diseases or conditions of the patient, of the patient's pregnancy and medical rehabilitation (hereinafter referred to as "treatment") biomedical cellular products), as well as regulates relations arising from the donation of biological material for the production of biomedical cell products. 2. This Federal Act does not apply to relations arising in the development and production of medicines and medical products, organ donation and tissue donations for the purpose of transplantation, donation of blood, and of its components, with the use of human genitals for the use of assistive technologies, as well as the relationships that arise in the treatment of cells and tissues of the human being for scientific and educational purposes. Article 2: Basic concepts used in this Federal Law The following basic concepts are used in this Federal Law: 1) Biomedical Cellular Product-Complex, consisting of cell lines (cell lines) and auxiliary substances or cellular lines (cell lines) and auxiliary substances combined with the past state registration of medicinal products (Daley) Medicinal products) and (or) medical products; 2) implementation of biomedical cellular product-transfer of biomedical cell product on a reimbursable basis and (or) on a non-reimbursable basis; 3) autological biomedical cellular product-biomedical cell a product containing a cell line (cell lines) derived from a specific person's biological material, intended for use by the same person; 4) alloted biomedical cellular product- Biomedical cellular product, containing a cellular line (cellular lines) derived from the biological material of a certain person and intended for use by other people; 5) a combined biomedical cell product-biomedical cell product containing in its the composition of the cellular lines derived from the biological material of several people and designed for use by one; 6) the biomedical cellular product model, a biomedical cell product or part of it obtained from to examine its properties, including for the evaluation of the quality of biomedical cell product and its security; 7) cellular line-a standardized cell population of the same type with reproducible cell composition obtained by removing biological material from the human body, followed by cell cultivation outside the human body; 8) Subsubstances of inorganic or organic origin used in the development and production of biomedical cellular product; 9) biological material-biological fluids, tissues, cells, secrets and products human activity, physiological and pathological dislocations, swabs, scabies, flushing, biopsy material; 10) donor of biological material (hereinafter referred to as a donor), a person who has provided biological material in his lifetime, or the person whose biological material was obtained after his death, stated in the procedure established by the legislation of the Russian Federation; 11) the donation of biological material-the process of postmortem provision biological material (hereinafter referred to as posthumously donation) or The provision of biological material (hereinafter referred to as life donation); 12) normative documentation on biomedical cell product-produced by the producer of biomedical cell product, containing a list indicators of the quality of biomedical cellular product determined by the relevant expertise, and information on quality control methods for biomedical cellular product; 13) the quality of the biomedical cellular product- Biomedical cellular product compliance the biomedical cell product, the biomedical cellular product, based on a comparative analysis of its effectiveness, and the risk of harm to life and human health when applied; 15) the effectiveness of biomedical cellular product-the degree of positive influence of biomedical cellular product for duration, duration illness or condition or prevention, or preservation of the of pregnancy, medical rehabilitation of the patient; 16) protocol for clinical study of biomedical cell product-document defining the purposes of clinical study of biomedical cellular product, forms of it organization and methodology, statistical methods of processing research results and measures to ensure the safety of patients participating in the clinical study of biomedical cellular product; 17) patient flow-a document in which information is available in an accessible form Clinical study of the biomedical cellular product, its goals, plan and potential risks, the composition of the biomedical cellular product, and contains the patient's written voluntary consent to participate in the clinical trial Biomedical cellular product; 18) registration certificate for biomedical cellular product-a document confirming the registration of biomedical cellular product; 19) the manufacturer biomedical cellular product-an organization that implements Production of biomedical cell product at one stage, several or all stages of the process according to the license for the production of biomedical cellular products; 20) side effect-the reaction of the human body, associated with the use of biomedical cellular product according to the instructions for its application; 21) undesired reaction-adverse reaction of the human body that can Be bound by the biomedical cell product; 22) A serious undesired reaction is an adverse reaction of the human body, which is associated with the use of biomedical cellular product in accordance with the instructions for its use leading to death, congenital anomalies or defects development, which is a threat to human life, requiring hospitalization, or resulting in a temporary loss of work capacity or disability; 23) unanticipated undesired reaction-adverse reaction of the human body, which is related to the use of biomedical cellular products in the according to the protocol of the clinical study of the biomedical cellular product, the researcher's brochure or the instructions for its application and the essence, the severity and the outcome of which do not correspond to information about biomedical cellular product, contained in these documents; 24) falsified biomedical cell product-biomedical cellular product, deliberately accompanied by false information about its composition and (or) manufacturer; 25) malignant biomedical cellular product-biomedical cell A product that does not meet the requirements of the normative documentation for the biomedical cellular product; 26) counterfeit biomedical cellular product, a biomedical cell product in violation of a civilian Law; 27) pre-clinical study of biomedical cellular product-biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other studies of biomedical cellular product in order to identify a specific the mechanism of operation of such a product, obtaining evidence of its safety, quality and efficiency preceding the clinical study of the biomedical cellular product; 28) clinical study of biomedical cellular Study of prophylactic, diagnostic, curative, rehabilitative properties of biomedical cellular product in the process of applying it to a person for the purpose of obtaining evidence of its safety and efficiency, data on side effects of this product and the unwanted reactions associated with it application, as well as the effect of interaction of researched biomedical cell product with other biomedical cell products, medicinal products and (or) medical products, food products; 29) multicenter clinical study of biomedical cellular product-clinical study of biomedical cellular product, conducted in two and more medical organizations on a single protocol for biomedical research cellular product; 30) international multi-center Clinical study of biomedical cellular product-clinical study of biomedical cellular product, conducted in different countries under a single protocol of clinical research of biomedical cellular product; Post-patient clinical study of biomedical cellular product-clinical study of biomedical cell product, which is being treated in the Russian Federation after state registration, for purposes additional data collection on its safety and efficiency, To increase the evidence of this biomedical cellular product as well as to detect unwanted reactions to its use. Article 3. The principles of the implementation of the activities in the field of Biomedical cellular products , the Principles for the implementation of biomedical cellular products are: 1) voluntarism and The donation of biological material; (2) medical confidentiality and other secrecy laws; 3) impermissibility of biological material; 4) Inadmissibility of embryo creation (a) Human resources for the production of biomedical cell products; (5) The inadmissibility of the use for the development, production and use of biomedical cell products of biological material obtained by interrupting or disrupting the development of the embryo or fetus; 6) compliance with biosecome requirements to protect the health of biological material donors, workers in biomedical cell products, medical workers, patients and the environment. Article 4. Cellular line ready 1. The preparation of a cellular line for the production of biomedical cellular products includes the acquisition of biological material, its study, cell selection, cultivation and modification outside the human body, obtaining a standardized population of cells and assessing the consistency of the population of the sheet population with the biomedical cell product that contains the information set out in article 7 of this Federal Law. 2. For the purpose of making the cellular line, only human or human cells are used for which death is pronounced in accordance with the procedure established by the legislation of the Russian Federation. 3. Obtaining and using biomedical cell products for biomedical products of unidentified persons who, for reasons of health, age or other reasons, were unable to report their identity In the case of the Russian Federation, the State of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of the Russian Federation. Article 5. Development of biomedical cellular products 1. The development of biomedical cellular products is the process of creating a biomedical cellular product and its production technology. 2. The financial support for the development of biomedical cellular products can be provided by: 1) the budget allocation of the federal budget; 2) of the budget appropriations of the budgets of the constituent entities of the Russian Federation; 3) means for developers of biomedical cell products; 4) other sources not prohibited by the legislation of the Russian Federation. 3. The rights of the developer of a biomedical cellular product are protected under civil law. Article 6. The clinical study of biomedical cellular product 1. Clinical study of biomedical cell product is performed on the animals being modeled in the organism or outside the living organism pathological processes in humans and (or) pathological conditions of the person under which It is intended to use the biomedical cell product being developed, as well as on models that identify the specific mechanism of the operation of such a product, its effectiveness and safety. 2. According to the results of the pre-clinical study of biomedical cellular product, the organization that conducted the pre-clinical study reports on the pre-clinical study of biomedical cell product, which contains a description, the results and analysis of the results of the pre-clinical study, as well as the conclusion on the possibility of conducting a clinical study of biomedical cellular product. 3. Rules for the conduct of pre-clinical studies of biomedical cellular products, including requirements for qualification of specialists and material and technical basis of scientific organizations, educational institutions of higher education, and educational institutions. organizations of additional professional education, other organizations, are established by rules of good practice for working with biomedical cell products, approved by the federal executive body exercising functions for the formulation and implementation of public policies and Legal and regulatory framework in the area of health care (hereinafter referred to as the federal executive authority). 4. The financial provision of pre-clinical studies of biomedical cellular products can be provided by: 1) of the federal budget; 2) budget appropriations of the federal subjects of the Russian Federation The Russian Federation; 3) for developers of biomedical cell products; 4) other sources not prohibited by the legislation of the Russian Federation. Article 7. A specification for biomedical cellular product 1. Each biomedical cell product developed by the pre-clinical study, the developer of the biomedical cellular product or the manufacturer of a biomedical cell product, is a specification that represents A document containing information about type (autological, allogenic, combined) biomedical cellular product, its qualitative composition and quantity, biological and other characteristics of the cell line (cellular lines) and Biomedical cellular product. 2. The form of the specification for biomedical cell product is approved by the federal executive authority. Article 8. State registration of biomedical cellular products 1. Production, sale, use, storage, transport, import into the Russian Federation, export from the Russian Federation and destruction of biomedical cellular products are carried out if they are registered by an authorized federal authority The executive branch. 2. State registration is subject to: 1) all biomedical cellular products, first to be introduced in the Russian Federation; 2) biomedical cell products registered earlier, in case of change type (autological, allogenic, combined) biomedical cellular product, its qualitative composition and (or) size (excluding the composition of auxiliary substances), biological and other characteristics of the cellular line (cellular ) and the biomedical cellular product. 3. State registration of biomedical cellular products is carried out by: 1) biomedical expertise of biomedical cell product, including: (a) quality assessment of biomedical cell -products, including examination of the composition of samples of biomedical cell product and methods of quality control (hereinafter-examination of the quality of biomedical cellular product); b) examination of documents for obtaining a permit for clinical research on biomedical cell product; in) evaluation of the effectiveness of biomedical cellular product; g) expertise of the expected benefit to the possible risk of use of biomedical cell product; 2) ethical expertise The possibility of conducting a clinical study of biomedical cellular product (hereafter referred to as an ethical evaluation); 3) clinical studies of biomedical cellular product. 4. State registration of biomedical cell products is carried out by the authorized federal executive authority within a period not exceeding one hundred and fifty working days from the date of the application for State registration. a biomedical cellular product, or within a period not exceeding two hundred and fifty working days from the date of acceptance of the application for State registration of biomedical cell product, if approved by the authorized federal authority the decision to re-conduct the biomedical examination Biomedical cellular product and (or) ethical expertise pursuant to Article 19 of this Federal Law. The period of state registration of biomedical cellular product is calculated from the date of acceptance by the authorized federal executive authority of the application for state registration of biomedical cellular product with the application the necessary documents before the day of issue of the registration certificate for the biomedical cellular product. The time of clinical study of biomedical cellular product is not included in the calculation of the period of state registration of biomedical cellular product. 5. State registration: 1) of various biomedical cell products under the same trade name; (2) one biomedical cell product produced by the manufacturer under various Trade names and the State registration in the form of two or more biomedical cellular products. 6. by the Commissioner of the Federal Executive, in accordance with the procedure established by him, at the request of legal entities involved in the handling of biomedical cellular products (hereinafter referred to as biomedical cellular products), The provisions of the documentation relating to the State registration, as well as the pre-clinical and clinical studies of biomedical cellular products are provided in written or electronic form. Article 9. Submission of documents for state registration of biomedical cellular product 1. For state registration of biomedical cellular product, an organization with the rights to the results of pre-clinical studies of biomedical cellular product, clinical studies of biomedical cellular product and (or) on The technology for the production of biomedical cellular products, or the other legal person authorized by it (hereinafter referred to as the applicant), submits an application for the state registration of biomedical the cellular product and other documents from which the Registration dossier for biomedical cellular product. Form of application and procedure for the submission of these declarations and documents, including the stage of presentation (for biomedical cell products for which no clinical trials have been conducted in the territory of the Russian Federation), are established by the authorized federal executive authority. 2. The registration file for biomedical cell is formed from the following documents: 1) a statement on the state registration of biomedical cellular product; 2) a copy of the document in Russian, certified by The applicant's eligibility to apply for State registration of the biomedical cellular product (power of attorney); 3) specification for biomedical cellular product; 4) Normative documentation for biomedical cell product; 5) Primary packaging and secondary packaging design projects; 6) report on the pre-clinical study of the biomedical cellular product; 7) draft protocol -Clinical study of the biomedical cellular product; 8) draft regulations for the production of biomedical cell product; 9) a copy of the licence to produce biomedical cell product; 10) the patient's information sheet; 11) information on insurance payments to patients involved in the clinical study of the biomedical cellular product; 12) report on the results of international multi-centre clinical studies Biomedical cell product, part of which is held in the Russian Federation; 13), draft instruction on the application of biomedical cell product containing the following information: (a) the name of the biomedical cellular product; b) type of biomedical cell product (autological, allogenic, combined); in) qualitative and quantitative characteristics of the cell line (cell lines), the names and number of auxiliary substances in the biomedical cell products; g) names (international generic, or group, or chemical) and quantities of drugs in the biomedical cellular product; d) of the name of medical products; in the biomedical cell product; (e) Reading to use; (g) contraindication to application; h) mode and mode of use of biomedical cellular product, duration of treatment; and) Precautions in use Biomedical cellular product; c) specifying (if any) the behavior of the biomedical cellular product at first use; L) possible side effects in the biomedical cell product; m) compatibility with other treatments, including Interoperability with drugs and (or) medical products, other biomedical cell products and food products; n) shelf life and prohibition of the use of biomedical cellular products "Best before"; o) peculiarities of the use of children, pregnant women and women during breastfeeding; p) data on the stability of the biomedical cellular product; p) storage conditions (c) Biomedical cellular product; 14) documentation details, The payment of the State duty for the assessment of the effectiveness of the biomedical cellular product and the examination of the expected benefit to the possible risk of the use of the biomedical cell product for which International multi-centre clinical studies, some of which have been conducted in the Russian Federation; 15), are submitted in accordance with article 18, paragraph 2, of this Federal Act. 3. The applicant has the right to submit, on its own initiative, proof of payment of the State fee for carrying out the examination of the quality of the biomedical cellular product, the expert examination of the documents to obtain a permit to conduct Clinical study of biomedical cellular product and ethical expertise, expert examination of the effectiveness of biomedical cellular products and expertise of the expected benefit to the possible risk of biomedical cell product, in relations of which the international multi-centre Clinical research, some of which was conducted in the Russian Federation, when seeking state registration of biomedical cellular product. In case of non-submission of these documents, the authorized federal executive authority checks the payment of the state fee on the basis of the documents submitted by the applicant proving the payment of the payment, using Information on the payment of the State duty contained in the State Information System on State and Municipal Payments. 4. Information on the results of pre-clinical studies of biomedical cellular products and clinical studies of biomedical cell products presented by the applicant for public use is not permitted for commercial purposes. Registration of biomedical cellular product without its consent within six years from the date of the State registration of biomedical cellular product in the Russian Federation. Article 10. The decision to issue expert advice and advice on the ethics of the task of carrying out the expertise of the biomedical cellular product 1. Within five working days from the date of the adoption of the declaration of State registration of biomedical cellular product, the authorized federal executive authority checks the completeness and validity of the information contained in the the documents submitted by the applicant and the decision to issue a job for: 1) biomedical expertise of biomedical cellular product as part of the quality of the biomedical cellular product, expert examination of documents for authorization to conduct a clinical trial Biomedical cellular product and ethical expertise on the basis of the documents referred to in paragraphs 1-11, 13, paragraph 2, of this Federal Law; 2) biomedical expertise of biomedical cell product in part expert examination of the effectiveness of biomedical cellular products and the examination of the expected benefits of the possible use of biomedical cell product for which international multi-center clinical research has been conducted, Part of which took place in the Russian Federation on the basis of of the documents referred to in article 9, paragraphs 1 to 6, 8, 9, 12 and 13, of this Federal Act. 2. The Commissioner of the Federal Executive shall notify the applicant in writing of the decision taken and, in case of refusal to carry out the expert appraisal referred to in part 1 of this article, together with the reasons for the refusal. 3. In the event that the information contained in the documents submitted by the applicant is incomplete or unavailable, the authorized federal executive authority shall submit a request to the applicant for clarification of the information which may be transmitted to the applicant. The authorized representative of the applicant is personally under receipt, sent by post by registered mail or transmitted in electronic form via telecommunications channels. If the request is made by registered mail, it shall be deemed to have been received after six days from the date of the registered letter. 4. The applicant is required to submit a response to the request of the authorized federal executive body referred to in part 3 of this article within a period not exceeding ninety working days from the date of receipt. The period specified in part 1 of this article shall be suspended from the day the applicant has been requested by the authorized federal executive authority until the day of receipt of the corresponding reply. 5. The grounds for refusal of the organization of expertise provided for in Part 1 of this Article shall be the submission of the required documents in an incomplete amount, the failure of the applicant to submit a reply within the prescribed period of reply to the reply referred to in paragraph 3 of this article. The request of the Commissioner of the Federal Government or the absence of an exhaustive list of the necessary information in the documents submitted to be reflected in them, as well as the lack of information substantiating the payment of the payment. State fee for the quality assessment of biomedical cellular product, expert examination of documents for obtaining permission to conduct a clinical study of biomedical cellular product, ethical expertise, evaluation of the effectiveness of biomedical cellular product and the examination of the relationship Expected benefits of the possible use of biomedical cell product, for which international multi-centre clinical trials have been conducted, some of which have been conducted in the Russian Federation, in the case of the State Registration of the biomedical cellular product. Article 11. Federal State Budget Agency for biomedical expertise of biomedical cellular products 1. Biomedical examination of biomedical cellular products is carried out by the federal state budget institution, which is under the responsibility of the authorized federal executive authority and ensures that this is done The federal executive authority for issuing clinical studies on biomedical cellular products and (or) the State registration of biomedical cellular products (hereinafter referred to as an expert institution). 2. Expert advice is provided on issues related to pre-clinical studies of biomedical cellular products, clinical studies of biomedical cell products, biomedical expertise biomedical cellular products, state registration of biomedical cellular products, in the order approved by the authorized federal executive authority. Article 12. Organization of biomedical expertise of the biomedical cellular product 1. Biomedical examination of biomedical cellular product is carried out in two stages: 1) in the first stage review of the quality of biomedical cellular product and expert examination of documents for obtaining permission to conduct Clinical study of the biomedical cellular product, with the exception of the biomedical cellular product, for which international multidisciplinary clinical studies have been conducted, some of which have been conducted in the Russian Federation; 2) effectiveness evaluation is conducted in the second phase The use of biomedical cellular products and the examination of the expected benefit to the possible risk of biomedical cell product. These examinations are conducted on the basis of clinical studies of biomedical cellular product. 2. Biomedical examination of biomedical cell product is carried out by a commission of experts of the expert institution appointed by the head of this institution, on the basis of the task of the authorized federal executive authority to conduct biomedical expertise of biomedical cellular product. The head of the expert agency shall ensure the proper conduct of biomedical expertise of biomedical cellular product in accordance with the task of the authorized federal executive authority and organize the preparation of the synthesis The conclusions of the expert panel of experts. 3. The expert commission may, on the basis of the decision of the expert head of an expert institution, be included as experts on the basis of the expert's request, including those who do not work in this expert institution, if their expertise is necessary to carry out the expertise of a biomedical cellular product. 4. In the biomedical examination of a biomedical cellular product, the expert may not be dependent on the applicant, the person who nominated the biomedical examination, or other persons interested in the biomedical examination Biomedical cellular product. 5. When carrying out biomedical expertise of a biomedical cellular product, the expert is not entitled to claim the documents and/or the materials required for the examination. In case of insufficient documents and/or materials provided to the expert to give an opinion, the expert is entitled to raise the question of the provision of the necessary documents and/or materials to the head of the expert institution, who shall apply to the authorized federal executive body of the executive branch of the competent federal executive authority requesting a biomedical examination of biomedical cellular product. The Commissioner of the federal executive branch shall, within five working days of the request of the head of the expert institution, send a request in electronic or written form to the applicant for additional documents and (or) with a notice of receipt. The applicant is obliged, within a period not exceeding sixty working days from the date of receipt of the request of the authorized federal executive authority, to submit the requested documents and/or the material or to justify the impossibility of their submission. The response of the applicant to the request is not taken into account in the calculation of the period of state registration of the biomedical cellular product. 6. The results of each stage of biomedical assessment of biomedical cellular product are processed by expert commission's expert opinion. A commission of experts of the expert agency concludes with a list of studies, volume of studies carried out by each expert, the facts established by each expert and the conclusions drawn from the studies. The expert, whose opinion does not coincide with the decision of the expert commission of experts, is entitled to express his opinion in writing, which is attached to the conclusion of the expert commission. 7. The rules for biomedical assessment of biomedical cellular products and the form of expert commission's conclusions are established by an authorized federal executive body. 8. The expert institution is responsible for observing the rules of biomedical expertise of the biomedical cellular product and for the quality of its conduct. Article 13. Requirements for experts in biomedical expertise of biomedical cellular products, rights and obligations of experts 1. The expert on biomedical assessment of biomedical cellular products is a certified employee of an expert institution which has higher medical, pharmaceutical, veterinary, biological or chemical education, and Biomedical examination of biomedical cell products in the discharge of their duties. 2. The requirements for the training of experts and the length of service in the field of work, the procedure for qualification of experts, the procedure for the formation and functioning of qualification commissions are established by the authorized federal executive body. 3. The qualification commissions of the authorized federal executive body at least every five years are competent for the certification of experts on the right to conduct biomedical assessment of biomedical cellular products. 4. The expert in biomedical examination of biomedical cellular products is obliged: 1) to conduct a study of the research, documents and/or materials submitted to it, evaluate the proposed control methods the quality of the biomedical cellular product, to give an opinion on the issues before it, with the appropriate justification or conclusion that it is impossible for them to conduct biomedical expertise on biomedical cellular products, if they are supplied issues go beyond the expertise of the expert or If the objects of research, documents and (or) materials are not suitable or insufficient for conducting research and giving advice; 2), ensure that the studies, documents and/or materials submitted are properly stored. 5. The expert is not entitled: 1) to conduct biomedical expertise on biomedical cellular products by directly accessing legal or natural persons; 2) independently collect materials for the conduct Biomedical examination of biomedical cellular products; 3) conduct professional consultations outside the service; 4) to disclose information to which he is aware of the conduct biomedical expertise on biomedical cellular products, as well as information, State, commercial or other legally protected secret. 6. Each expert, who is a member of the commission of experts of the expert institution entrusted with biomedical expertise on biomedical cellular products independently and independently conducts research, evaluates the results obtained by them in person and other experts, and formulates conclusions on the issues raised within the limits of its expertise. Article 14. Ethical expertise 1. Ethical expertise is conducted by an ethics council established in accordance with the procedure established by the authorized federal executive authority to issue an opinion on the ethical grounds for conducting a clinical trial Biomedical cellular product. 2. The experts of the board may include representatives of medical organizations, scientific organizations, educational institutions of higher education, educational organizations of additional professional education, as well as representatives non-governmental organizations, religious organizations and the media. These experts shall not be subject to any dependency on the applicant and other persons interested in the results of the ethical review. 3. The fee for the services of the experts of the ethics board is based on a contract concluded between the Commissioner of the Federal Executive for which the Ethics Council is established, and the expert of the ethics council, from the budget appropriations, The authorized federal executive body, which established the ethics council, in the federal budget for the corresponding year to ensure its activity, in the amount determined by the Government of the Russian Federation. 4. The experts of the ethics board are responsible in accordance with the legislation of the Russian Federation. 5. Composition of the board of ethics, regulation of this council, its procedures, requirements for qualifications and experience in expert assessment of scientific, medical and ethical aspects of clinical studies of biomedical cell products To the experts of the board of ethics, organization and conduct of the ethical review, the form of the opinion of the board of ethics shall be established by the authorized federal executive body. The number of representatives of medical organizations and scientific organizations may not exceed half of the total number of experts of the board of ethics. 6. Information on the composition of the board of ethics, its plans of work and current activities is posted on the official website of the authorized federal executive authority in the Internet Information and Telecommunications Network (hereinafter referred to as the Internet) they are in the order they have installed. 7. Ethical expertise, advice on the ethics of opinions about the possibility or impossibility of conducting a clinical study of biomedical cellular product and sending these findings to the authorized federal executive body shall be carried out within a period not exceeding thirty working days from the date of receipt by the board of ethics of the task of the authorized federal executive authority and the necessary documents referred to in paragraphs 1 to 11, 13 (2) of article 9 of this Federal Act. of the law. 8. Documents contained in the registration file and submitted to the Ethics Council for an ethical review to obtain a permit to conduct a clinical study of the biomedical cellular product are to be returned to the The Commissioner of the Federal Executive. Article 15. Expertise of the quality of biomedical cellular product and expertise of documents to obtain permission to conduct a clinical trial Biomedical cellular product 1. Expertise of the quality of biomedical cell product, expert examination of documents for obtaining permission to conduct a clinical study of biomedical cellular product, expert commission of expert opinion formation evidence of the quality of the biomedical cellular product and the possibility of conducting a clinical trial or not confirming the quality of the biomedical cellular product and the impossibility of conducting a clinical trial to an authorized federal body The executive shall be executed within a period not exceeding one hundred working days from the date of receipt by an expert body of the task of the authorized federal executive authority with the application of the necessary documents referred to in paragraphs 1-11, 13 Article 9, paragraph 2, of this Federal Act. 2. Within sixty working days from the date of receipt by the applicant of the notification of receipt by the expert agency of the task of the authorized federal executive authority referred to in part 1 of this article, The applicant shall submit to an expert institution for the examination of the quality of the biomedical cellular product, samples of biomedical cellular product, cellular lines (cell lines), medical products, medicines, substances, in the biomedical cell product used in the when carrying out the quality assessment of biomedical cellular product by comparison with the biomedical cellular product in question, in the quantity needed to reproduce the quality control methods of the biomedical cellular product, The procedure established by the authorized federal executive authority. 3. In obtaining samples of the biomedical cellular product and other samples referred to in part 2 of this article, the expert institution shall issue to the applicant a document confirming receipt of these samples and for a period not exceeding three working days from " The day of receipt of these samples, shall notify the authorized federal executive body of this. 4. In the event that the declared retention period for biomedical cellular product is less than 15 days, the examination of the quality of biomedical cellular product is carried out in the order established by the authorized federal executive body The authorities, the expert commission of the expert agency at the site of production of biomedical cellular product using the equipment of the manufacturer, and the applicant within sixty working days from the date of receipt of the expert institution, as referred to in part 1 of this article, notifications of receipt by the The competent federal executive authority notifies the expert institution of the readiness to carry out expert examinations of the quality of the biomedical cellular product in the production site of the biomedical cellular product. 5. The period specified in paragraphs 2 and 3 of this article for the submission by the applicant of samples of biomedical cellular product and other samples and the period of notification by an expert agency to that authorized federal executive authority shall be included in the duration of the examinations provided for in Part 1 of this Article. 6. The collection of permanent storage of samples of standardized cell lines, formation of the samples of the cellular line, submitted for the examination of the quality of the biomedical cellular product is established by the expert agency. The use, storage, recording and destruction of which is carried out in accordance with the procedure established by the authorized federal executive authority. 7. Documents contained in the registration file and admitted to the expert institution for the purpose of obtaining permission to conduct a clinical study of the biomedical cellular product are to be returned to The Commissioner of the federal executive branch shall, at the same time, conclude with the results of these examinations. Article 16. { \cs6\f1\cf6\lang1024 } Receive and evaluate { \cs6\f1\cf6\lang1024 } { \cs6\f1\cf6\lang1024 } { \cs6\f1\cf6\lang1024 } { \b } { \b } { \b } { \b } { \b } Within a period not exceeding five working days from the date of receipt of the opinion of the expert commission of the expert institution referred to in article 15, paragraph 1, of this Federal Act, and the opinion of the Ethics Council referred to in article 14, part 7, of the present Federal Law The Federal Act, which is authorized by the federal executive authority, assesses the findings in order to determine their conformity with the relevant examinations and notifies the applicant in writing of the findings the results of the expert reports. 2. In obtaining the opinion of a commission of experts of an expert institution on the confirmation of the quality of the biomedical cellular product and the possibility of conducting a clinical trial and concluding an ethics council on the possibility of holding a clinical trial In the case of biomedical cell product research, the authorized federal executive authority suspends state registration of biomedical cell product before submitting the applicant to the authorized federal body the Government of the Republic of Korea Registration of biomedical cellular product. 3. In obtaining the opinion of a commission of experts of the expert institution on the non-confirmation of the quality of the biomedical cellular product and the impossibility of conducting its clinical study or advice on the ethics of impossibility of holding a clinical study of the biomedical cellular product, the authorized federal executive authority decides to terminate the state registration of biomedical cellular product and notifies in writing The complainant. Article 17. The decision to grant permission to conduct the clinical study of biomedical cellular product 1. In order to obtain a permit to conduct a clinical study of the biomedical cellular product, the applicant who has been notified of the results of the examination in accordance with article 16, paragraph 1, of this Federal Act Article 12, paragraph 1, of this Federal Law, the conclusion of a commission of experts of the expert institution on confirmation of the quality of the biomedical cellular product and the possibility of its clinical trial and advice on Ethics on the possibility of clinical research on biomedical a cellular product, representative to the authorized federal executive body: 1) an application for permission to conduct a clinical study of the biomedical cellular product; 2) Researcher, a synthesis of the results of the pre-clinical study of biomedical cellular product and clinical study of biomedical cellular product; 3) and their experience in clinical trials. of biomedical cellular products; 4) a copy of the contract of compulsory life insurance, the health of the patient participating in the clinical study of the biomedical cellular product (hereinafter referred to as the compulsory insurance), which is concluded in accordance with the model rules of compulsory life insurance, the health of the patient participating in the clinical study of the biomedical cellular product approved by the Government of the Russian Federation (hereinafter referred to as the "Model Regulations"). mandatory insurance), with details of the limit number of patients participating in the clinical study of biomedical cellular product; 5) information on medical organizations in which the biomedical cell clinical study is to be conducted Product (full and abbreviation, organizational and legal form, location, location, location, telephone, telefax, e-mail address, details of accreditation to the right to conduct clinical studies The biomedical cell products of each medical organization); 6) details of the proposed schedule for the biomedical cell product clinical study; 7) details of the document confirming the payment of the state fee for granting permission to conduct Clinical study of the biomedical cellular product. 2. Within a period not exceeding five working days from the date of adoption of the declaration and documents referred to in part 1 of this article, the authorized federal executive body: 1) shall verify the completeness and validity of the information; in the documents submitted by the applicant; 2) decides whether to grant permission to conduct a clinical study of the biomedical cellular product or to refuse the permission; 3) notifies the applicant in writing of the decision (if the decision is rejected) with the reasons for this refusal); 4) issues the authorization to conduct a clinical study of the biomedical cellular product in the manner prescribed by the authorized federal executive authority. 3. If the information contained in the documents submitted by the applicant is found to be incomplete or not, the authorized federal executive authority shall submit a request for clarification to the applicant. The request may be submitted to the authorized representative of the applicant personally under receipt, by mail by registered mail, or transmitted in electronic form via telecommunications channels. If the request is made by registered mail, it shall be deemed to have been received after six days from the date of the registered letter. 4. The applicant is required to submit a response to the request of the authorized federal executive body referred to in part 3 of this article within a period not exceeding ninety working days from the date of receipt of the request. The period specified in part 2 of this article shall be suspended from the day the applicant has been requested by the authorized federal executive authority until the day of receipt of the reply to the request. 5. The failure to grant a permit to conduct a clinical study of the biomedical cellular product is based on the failure to submit in full the documents referred to in paragraph 1 of this article, the failure of the applicant to submit it to the established The period of reply to the request of the authorized federal executive body referred to in part 3 of this article or the lack of conformity with the contents of the documents submitted by the applicant to the requirements of this Federal Act. Article 18. The evaluation of the efficacy of the biomedical cellular product and the examination of the expected benefits to potential risk of biomedical cellular product 1. Expertise in the effectiveness of the biomedical cellular product and the examination of the expected benefits of biomedical cell product risk, expert commission of expert opinions on their results, and These opinions shall be sent to the authorized federal executive body within a period not exceeding twenty-five working days from the date of receipt by an expert body of the relevant task of the authorized federal body with the documents referred to in paragraphs 1 to 5, 13 of Part 2 Article 9 of this Federal Law and the report on the clinical study of the biomedical cellular product. 2. In order to carry out the examinations specified in Part 1 of this article, the applicant shall submit to the authorized federal executive authority: 1) a declaration on the renewal of the State registration of the biomedical cellular product; and carrying out the tests specified in Part 1 of this article; (2) projects of primary packaging and secondary packaging for the biomedical cellular product, as required, resulting from the clinical trial conducted Biomedical cell product; 3) report on a clinical study of the biomedical cellular product; 4) a draft instruction on the use of biomedical cell product, as necessary, refined based on the results of the clinical trial Biomedical cellular product; 5) requisite documents to support payment of the state duty for carrying out an expert examination of the effectiveness of the biomedical cellular product and the examination of the ratio of expected benefits to possible risks the use of biomedical cellular products State registration of biomedical cellular product. The applicant has the right to submit the said documents on his own initiative. In the event of their failure, the authorized federal executive authority checks the payment of the State fee on the basis of the documents submitted by the applicant, confirming the payment of the fee, using the payment information. State duty contained in the State Information System on State and Municipal Payments. 3. In the period not exceeding five working days from the date of acceptance of the application for the resumption of the State registration of a biomedical cellular product with the documents referred to in Parts 1 and 2 of this Article, the authorized federal executive body Authorities: 1) checks the completeness and validity of the data contained in the applicant's report on the clinical study of the biomedical cellular product; 2) decides to resume State registration of the biomedical cellular product and The examination or refusal to renew the State registration of a biomedical cellular product and to carry out these examinations; 3) notifies the applicant in writing of the (a) Decision of the Conference of the Parties on the situation of human rights in the Democratic Republic of the 4. If the information contained in the documents submitted by the applicant is found to be incomplete or not, the authorized federal executive authority shall submit a request for clarification to the applicant. The request may be submitted to the authorized representative of the applicant personally under receipt, by mail by registered mail, or transmitted in electronic form via telecommunications channels. If the request is made by registered mail, it shall be deemed to have been received after six days from the date of the registered letter. 5. The applicant is obliged to submit a response to the request of the authorized federal executive body referred to in Part 4 of this Article within a period not exceeding ninety working days from the date of receipt of the request. The period specified in part 3 of this article shall be suspended from the day the applicant has been requested by the authorized federal executive authority until the day of receipt of the reply to the request. 6. The submission of documents referred to in parts 1 and 2 of this article is incomplete in the case of refusal to resume the State registration of the biomedical cellular product and to carry out the examinations referred to in part 1 of this article. amount, failure by the applicant to respond within a specified period of time to the request of the authorized federal executive body referred to in part 4 of this article, or the lack of an exhaustive list in the documents submitted information that should be reflected in them, as well as the lack of information, The payment of the state duty for the assessment of the effectiveness of the biomedical cellular product and the examination of the expected benefits of the use of biomedical cellular products at the state level. Registration of biomedical cellular product. 7. The evaluation of the effectiveness of the biomedical cellular product and the examination of the expected benefits of the possible use of biomedical cell product for which international multi-centre clinical research has been conducted, Part of which is carried out in the Russian Federation shall be carried out on the basis of the documents referred to in paragraphs 1 to 6, 8, 9, 12 and 13 of article 9, paragraph 2, of this Federal Act within the time limit specified in Part 1 of this article. Article 19. Re-conducting the biomedical expertise of the biomedical cell product and (or) ethic expertise 1. In case of a commission of experts of an expert institution or council on ethics of contradictory data, unreasonable and/or incomplete conclusions, falsification of conclusions of biomedical expertise of biomedical cellular product and (or) of an ethical review, concealment from the authorized federal executive body of the reasons for challenging the expert, as a result of his interest in the results of an expert examination, the existence of data on direct or indirect interference with The process of carrying out a relevant examination of the persons not involved in it, but The biomedical expertise of the biomedical cellular product and (or) reethical review of the biomedical examination is carried out by the authorized federal executive authority. The amount of re-examination is determined by the authorized federal executive authority. 2. Biomedical biomedical testing of biomedical cell product is carried out within the period established by the authorized federal executive authority and not exceeding one hundred working days from the date of receipt by the expert body of the task Biomedical biomedical testing of biomedical cell product, and reethical testing-within a period not exceeding fifteen working days from the date of receipt by the Ethics Council of the task of conducting a second ethical review. 3. Experts of the commission of experts and members of the board of ethics for which the circumstances referred to in Part 1 of this article are not allowed for re-examination. 4. The financial support for biomedical screening of biomedical cellular products is carried out with funds received by the expert agency from income-generating activities. Article 20. Decision on State registration of the Biomedical cellular product 1. At a time not exceeding five working days from the date of receipt of expert advice from an expert commission based on the results of an expert assessment of the effectiveness of the biomedical cellular product and the examination of the expected benefits of possible risk application of biomedical cell product, authorized by the federal executive authority: 1) assesses the findings of the findings of the reports in order to determine the conformity of these findings job for these examinations; 2) accepts Decision on State registration of biomedical cellular product or refusal of state registration of biomedical cellular product; 3) makes the decision on state registration of biomedical the cell product data on the registered biomedical cell product in the state register of biomedical cellular products and gives the applicant the registration certificate for the biomedical cellular product of which the form is approved by the Federal Executive Harmonized specifications for biomedical cell product, guidance on the use of biomedical cell product, normative documentation on biomedical cell product, or in the event of a decision to refuse The registration of a biomedical cellular product is notified in writing to the applicant, stating the reasons for the refusal. 2. The decision to refuse the registration of biomedical cell product is based on the results of the examinations specified in article 18, paragraph 1, of the decision on refusal to register a biomedical cell product. Federal law, expert committee's opinion that the effectiveness of the biomedical cell product recorded is not confirmed by the data obtained or the risk of harm to human health caused by the application biomedical cellular product exceeds its effectiveness application. Article 21. Registration certificate for biomedical cellular product 1. The registration certificate for biomedical cellular product for the first time registered in the Russian Federation biomedical cellular product is issued for a period of five years. 2. After the expiry of the period specified in part 1 of this article, the registration certificate for the biomedical cellular product is renewed every five years, subject to confirmation of the State registration. 3. In the case of an amendment to article 23 of this Federal Act, the records of the registered biomedical cell product, changes affecting the information recorded in the registration certificate Certificate of biomedical cellular product, the authorized federal executive authority issues a new registration certificate for the biomedical cellular product in the light of the changes. 4. The registration certificate for the biomedical cellular product is subject to a state duty in the amount and in accordance with the procedure established by the laws of the Russian Federation on taxes and charges. 5. The organization for which the registration certificate is issued for the biomedical cellular product is the holder of the biomedical cellular product registration certificate. 6. In case of loss of or damage to the biomedical cellular product registration certificate, upon written application of the holder of the biomedical cell product or its authorized person for the issuance of the duplicate Registration certificate of a biomedical cellular product, authorized by the federal executive authority for a period not exceeding ten working days from the date of receipt of such declaration shall issue a duplicate registration certificate Biomedical cellular product. A duplicate registration certificate for a biomedical cell product for loss of or damage to the registration card will be subject to a state fee in the amount and in accordance with the procedure established by law OF THE PRESIDENT OF THE RUSSIAN FEDERATION Article 22. The confirmation of state registration of the Biomedical cellular product 1. Confirmation of the State registration of biomedical cellular product is carried out on the issue of the registration certificate of biomedical cellular product in the case referred to in article 21, paragraph 2, of this Federal Law, on time, not exceeding ninety working days from the date of receipt by the authorized federal executive body of a declaration of confirmation of the State registration of a biomedical cellular product, indicating the details therein of the document confirming Payment of State fee for confirmation of the State Registration of biomedical cellular product. 2. Confirmation of the state registration of biomedical cellular product is carried out on the basis of the results of the examination of the ratio of the expected benefit to the possible risk of use of biomedical cell product carried out on the basis of data monitoring of the safety of biomedical cell product carried out by the holder of the biomedical cell product registration certificate and the federal executive authority exercising control and supervision functions in the sphere article 41 of the present Federal The law, as well as the expertise of the quality of biomedical cell product, is carried out in case of amendments to the normative documentation on biomedical cellular product. 3. A document containing the results of the monitoring of the biomedical cell product by the owner of the biomedical cellular product is attached to the statement on the confirmation of the registration of biomedical cellular products. Certificate of biomedical cell product, in the form prescribed by the authorized federal executive authority, and a copy of the license for the production of biomedical cell products. 4. Normative documentation for biomedical cell product, draft instruction on the use of biomedical cell product, draft primary packaging and secondary packaging for biomedical cellular product is attached to the statement of Confirmation of State registration of biomedical cellular product only if changes are made. 5. With a statement on the confirmation of state registration of biomedical cell product, the owner of the registration certificate of biomedical cellular product has the right to submit proof of payment on his own initiative. State duty for the confirmation of the State registration of biomedical cellular product. In the event of non-submission of the document, the authorized federal executive authority, on the basis of the registration certificate issued by the owner of the biomedical cellular product, verifies the facts of the document. Payment of state duties using information on payment of state duties in the State Information System on state and municipal payments. 6. Within ten working days from the date of acceptance of the declaration of confirmation of the State registration of the biomedical cellular product and the documents referred to in Part 3 of this Article, the authorized federal executive body: 1) checks the completeness and validity of the information contained in the documents submitted by the applicant; (2) directs the federal executive body exercising supervisory and oversight functions in the field of health care; request for results of security monitoring The biomedical cell product to be executed within five working days from the day of receipt; 3) decides whether or not to conduct an examination of the expected benefit to possible risk application of biomedical cellular product, as well as expertise on the quality of biomedical cellular products conducted in the event of changes to the regulatory documentation on biomedical cellular product; 4) notifies in in writing of the holder of the biomedical cellular A product of the decision (if a decision is taken to refuse to carry out the relevant expertise and the reasons for the refusal). 7. If the information contained in the documents submitted by the holder of the biomedical cell product is incomplete or not, the authorized body of the federal executive branch shall send the documents to the owner The registration certificate for the biomedical cellular product is a request for clarification of this information. The request may be transmitted to the authorized representative of the holder of the biomedical cellular product directly under the receipt, sent by mail by registered mail or transmitted in electronic form on telecommunications channels of communication. If the request is made by registered mail, it shall be deemed to have been received after six days from the date of the registered letter. 8. The holder of a registration certificate for a biomedical cellular product is required to submit a reply to the request of the authorized federal executive body referred to in Part 7 of this Article within a period not exceeding ninety working days from the date of receipt of this request. The period specified in part 6 of this article shall be suspended from the day the holder of the biomedical cell product is requested by the authorized federal executive authority until the day of receipt of the reply to the certificate. This request is not included in the calculation of the period of confirmation of the state registration of biomedical cellular product. 9. The basis for the refusal of the examination of the expected benefit to the possible risk of the biomedical cell product and (or) the quality assessment of biomedical cell product is the submission of documents specified in the Parts 1, 3 and 4 of this article are incomplete, failure to provide, within a specified period of time, a response to a request referred to in part 7 of this article by an authorized federal executive authority or an absence in the documents submitted the comprehensive information to be taken into account, as well as the lack of information confirming the payment of the State fee for the confirmation of the State registration of the biomedical cellular product. 10. The examination of the relationship of the expected benefit to the possible risk of the use of the biomedical cellular product and (or) the examination of the quality of biomedical cellular product is carried out on the basis of the documents in Parts 3, 4 and Part 6, paragraph 2 of this article, in accordance with the procedure set out in articles 15 and 18 of this Federal Law, taking into account the period specified in Part 1 of this Article. 11. The basis for the decision to refuse confirmation of the State registration of biomedical cell product is the expert's expert commission's opinion on the results of the examinations referred to in part 2 of this article. institutions that the quality and (or) effectiveness of biomedical cellular product is not supported by the data obtained and (or) the risk of harm to human health caused by the use of biomedical cellular product exceeds it efficiency. 12. At the time of the procedure for the confirmation of the State registration of biomedical cellular product, his application to the Russian Federation is continuing. Article 23. Changes to the documents in the registered file on the registered biomedical cellular product 1. In order to amend the documents in the registration file of the registered biomedical cell product, the holder of the biomedical cell product registration certificate shall be submitted to the authorized Federal The executive branch of the application for such changes in the form established by the authorized federal executive authority and the amendments attached thereto, as well as documents confirming the need for such changes. 2. Biomedical examination of biomedical cellular product as part of the quality assessment of biomedical cellular product, and (or) expertise of the effectiveness of biomedical cellular product, and (or) expertise in relation to expected benefits the possible risk of biomedical cell product being applied in the case of changes to the records of the registered biomedical cell product, with respect to: 1), referred to in the instructions for use of the biomedical cellular product and Article 9, paragraph 13 (13) (e), of this Federal Law; 2) where the biomedical cell product is produced; (3) quality indicators and (or) quality control methods Biomedical cellular product, contained in the normative documentation of the biomedical cellular product; 4) the life of the biomedical cellular product. 3. The holder of the registration certificate for the biomedical cellular product, together with the declaration and documents referred to in Part 1 of this article, shall submit the particulars of the payment of the State fee for the payment of the Documents contained in the register of registered biomedical cell product, changes requiring biomedical expertise for biomedical cellular product, or credentials of the document confirming the payment State duty for the incorporation of the Registration dossier on the registered biomedical cell product, changes that do not require biomedical expertise of biomedical cellular product, or has the right to submit these documents on their own initiative. In case the holder fails to submit the biomedical cell registration certificate, the authorized federal executive authority checks the fact of payment of the state duty on the basis of the details A document confirming its payment, using information on the payment of state duties in the State Information System on state and municipal payments. 4. Within five working days of the receipt of the declaration and documents referred to in part 1 of this article, the authorized federal executive authority: 1) shall verify the completeness and validity of the information contained in the The documents submitted by the holder of the biomedical cell product registration certificate; 2) decide to carry out the relevant examinations of the biomedical cellular product referred to in Part 2 of this article; or The Conference of the parties, The holder of the biomedical cell registration certificate of the decision (if a decision is taken to refuse to carry out an expert appraisal with the reasons for such refusal). 5. If the information contained in the documents submitted by the holder of the biomedical cell product is incomplete or not, the authorized body of the federal executive branch shall send the documents to the owner The registration certificate for the biomedical cellular product is a request for clarification of this information. The request may be transmitted to the authorized representative of the holder of the biomedical cellular product directly under the receipt, sent by mail by registered mail or transmitted in electronic form on telecommunications channels of communication. If the request is made by registered mail, it shall be deemed to have been received after six days from the date of the registered letter. 6. The holder of a registration certificate for a biomedical cellular product is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of receipt of the request. The period specified in part 4 of this article shall be suspended from the day the holder of the biomedical cellular product is requested by the authorized federal executive authority until the day of receipt of the reply to them. This request is not taken into account when calculating the time limit for making changes to the documents in the registration file of the registered biomedical cellular product. 7. The examinations referred to in part 2 of this article shall be conducted in accordance with the procedure established by articles 15 and 18 of this Federal Law, taking into account the period specified in part 10 of this article. 8. Within a period not exceeding five working days from the date of the receipt of the opinions of the expert commission of experts on the results of the expert assessment referred to in part 2 of this article with regard to the proposed amendments, The executive branch: 1) assesses the findings of the expert commission's expert committee to determine their compliance with the relevant expertise; (2) makes a decision on how to make changes to documents in the registration file of the registered Biomedical cellular product, or refusal to make such changes; 3) enters the public register of biomedical cellular products based on the decision to amend the documents in the registration file a registered biomedical cell product, necessary changes; 4) issues a new registration certificate for the biomedical cellular product if the information contained therein is changed, previously issued The registration certificate shall be revoked. 9. The decision of the authorized federal authority to refuse to amend the documents contained in the registration file on the registered biomedical cell product is based on the results of expert examinations, In accordance with article 2, paragraph 1, of the Convention, the Committee is of the opinion that: injury to human health resulting from the use of biomedical of the cellular product over its effectiveness. 10. If the documents contained in the registration file of the registered biomedical cell product are submitted, the modifications specified in Part 2 of this Article shall be decided upon (including the appropriate modifications). changes to the public register of biomedical cell products) or their refusal to be made within a period not exceeding ninety working days from the date of acceptance by the authorized federal executive body of the application such changes. 11. Decision to amend (including appropriate changes to the public register of biomedical cellular products) or to deny them the documents contained in the registration file Biomedical cell product, in respect of information not requiring the carrying out of the expertise referred to in Part 2 of this Article, shall be carried out within a period not exceeding thirty working days from the date of acceptance by the designated federal executive authority. The authorities of the application for such changes. 12. Conversion of biomedical cell product up to the date of adoption by the authorized federal executive authority of the decision to amend the documents contained in the register file on the registered biomedical The cellular product, as well as produced within a hundred and eighty calendar days after the date of acceptance by the authorized federal executive authority of the said decision, is permitted until its expiration date is reached. Article 24. Abolition of State registration of biomedical cellular product Decision to cancel state registration of biomedical cellular product and exclude biomedical cellular product from state The register of biomedical cell products is accepted by the federal executive authority in the case of: 1) by the federal executive body exercising control and supervision functions in the sphere Health, risk assessment, or health, life and health of a biomedical cellular product that exceeds its effectiveness by the results of its monitoring of the safety of biomedical cell product; 2) by the holder of the registration certificate Biomedical cellular product declaration of the withdrawal of the State registration of biomedical cell product; 3) by the authorized federal executive authority to refuse confirmation of the State registration of the biomedical cellular product The expiry of the registration certificate for the biomedical cellular product; 4) failure to provide the applicant with information that may lead to the registration of a registered person. the biomedical cellular product of the changes referred to in article 23, paragraph 2, of this Federal Act, within thirty working days of the day of such changes; 5) by the court, results of intellectual activity in biomedical cellular products. Article 25. The State register of biomedical cellular products 1. The State register of biomedical cellular products is maintained by the federal executive authority. 2. The State register of biomedical cellular products contains a list of biomedical cell products that have been registered and the following information: 1) the name of the biomedical cellular product; 2) type of biomedical cell product (autological, allogenic, combined); 3) the name of the owner of the biomedical cell product registration certificate; 4) the name and address of the manufacturer Biomedical cellular product; 5) cell line denomination (cell line), which is part of the biomedical cell product; 6) names (international generic, or group, or chemical) of drugs included in the Biomedical cellular product, standard documentation number; 7) name of medical items included in the biomedical cellular product, name and number of regulatory documentation; 8) biomedical cell product; 9) Storage of biomedical cellular product; 10) evidence and contraindications to biomedical cellular product; 11) byproduct of biomedical cellular product; 12) date of the state registration of biomedical cellular product and its registration number; 13) date of replacement of the biomedical cellular product registration certificate, date of certification of the State registration of biomedical cell product, date of withdrawal of State registration Biomedical cellular product. 3. The procedure for maintaining the public register of biomedical cellular products is approved by the authorized federal executive authority. Article 26. Appeal against the decision not to issue a permit to conduct a clinical trial on the biomedical cellular product or the decision to refuse state registration biomedical cellular product Decision of the authorized federal executive body to refuse permission to conduct a clinical study of the biomedical cellular product or the decision to refuse registration of biomedical cellular product, commission conclusion Experts of the expert institution or opinion of the ethics council may be appealed in accordance with the procedure established by the legislation of the Russian Federation. Article 27. Information related to the implementation of State registration of biomedical cell product, information about registered biomedical cellular products and biomedical cell products, excluded from the public registry biomedical cellular products 1. The Commissioner of the federal executive authority has posted on its official website on the Internet information related to the implementation of the State registration of biomedical cellular products, including biomedical for biomedical cell products and ethical expertise, information on registered biomedical cellular products and biomedical cell products excluded from the public register of biomedical cell products, not later than five working days from the date of receipt The competent federal authority of the executive branch of the state registration of biomedical cellular product. 2. The procedure for the placement of the information referred to in part 1 of this article shall be established by the authorized federal executive authority. Article 28. Organization of clinical studies Biomedical cellular products 1. The organization of clinical studies of biomedical cellular products has the right to carry out an organization with the rights to the results of pre-clinical studies of biomedical cellular product, clinical studies of biomedical the cellular product and/or the technology for the production of biomedical cell product, or the legal entity authorized by it, the educational organization of higher education, the educational organization of additional professional education, a scientific organization. 2. Organizations referred to in part 1 of this article may involve in the organization of clinical studies of biomedical cell products other legal entities, irrespective of their legal form and form of ownership. 3. The financial support for the clinical study of the biomedical cellular product is implemented by: 1) of the federal budget; 2) of the budget appropriations of the federal subjects of the Russian Federation The Federation; 3) of the organizations authorized to conduct a clinical study of the biomedical cellular product; 4) other sources not prohibited by the legislation of the Russian Federation. 4. Clinical studies of biomedical cellular products are carried out on the basis of authorization to conduct a clinical study of the biomedical cellular product issued by the authorized federal executive body in the order, Articles 16 and 17 of this Federal Law, and are aimed at: 1) establishing the security and (or) portability of biomedical cellular products, including the detection of side effects in their application; (2) Establishment of the safety and efficiency of biomedical cell products, including the selection of optimal biomedical adhesive products and treatment courses, for patients with certain diseases; 3) discovering the interaction of biomedical cellular products with Medical supplies, medical products, food products, other biomedical cellular products; 4) study the possibility of expanding the evidence for the use of registered biomedical cellular products. 5. The authorized body of the federal executive branch shall conduct in the prescribed procedure a register of issued permits for the conduct of clinical studies of biomedical cellular products. 6. In case a clinical study of biomedical cellular product is conducted for the state registration of the product, the state fee for carrying out the examination of the quality of biomedical cell product, expert examination of documents In order to obtain a permit for the clinical study of biomedical cellular product and ethical expertise, the payment is made on one time for the registration of biomedical cellular product. 7. The clinical study of biomedical cellular product is conducted in one or more medical organizations accredited by the federal executive authority in accordance with the procedure established by the Government of the Russian Federation. The Federation, pursuant to a treaty on the clinical study of biomedical cell product, concluded between an organization authorized by the authorized federal executive authority to conduct such a study the study, and the medical organization. 8. The contract for the clinical study of biomedical cell product should contain: 1) the name of the contract parties; 2) the terms and date of the clinical trial; 3) the definition of general the cost of a clinical trial program with an indication of the amount to be paid to researchers and co-researchers appointed under Part 1 of Article 29 of this Federal Law; 4) the definition of the form and order Presentation of the results of the clinical trial. 9. A list of medical organizations entitled to conduct clinical studies of biomedical cell products and a register of clinical studies of biomedical cell products shall be placed by the Commissioner. The federal executive branch, in accordance with the procedure established by it, on its official website on the Internet. 10. The production of biomedical cellular products to conduct its clinical trial is carried out using the technology described in the biomedical cell product registration file. 11. Clinical studies of biomedical cellular products are conducted in accordance with the rules of good clinical practice of biomedical cellular products approved by the authorized federal executive authority. 12. In the Russian Federation, in accordance with international treaties of the Russian Federation, and in the absence of an international treaty of the Russian Federation, the results of biomedical research are recognized on the basis of the principle of reciprocity. of cell products held outside the Russian Federation. Article 29. Clinical study Biomedical cellular product 1. The head of the medical organization in which a clinical study of biomedical cellular product is conducted, appoints a researcher who is responsible for carrying out the study with a medical specialty appropriate to the profile of the disease or condition for which the biomedical cellular product is designed for which the clinical study is conducted, with the experience of clinical research programmes for at least five years (hereinafter referred to as the researcher) and on his proposal appoints co-doctors of this Medical organization (hereinafter referred to as co-researchers). 2. The researcher selects patients who may be involved in the clinical study of the biomedical cellular product. 3. Researcher and co-researcher should be familiarized with the results of the pre-clinical study of biomedical cell product contained in the biomedical cell product specification and the researcher's booklet, clinical protocol research on biomedical cell product developed by the organization for the organization of clinical studies of biomedical cell products, or other legal entity involved in the organization of clinical trials research on the biomedical cellular product, and others the materials of such a study. 4. The head of the medical organization in which a clinical study of biomedical cellular product is conducted, within a period not exceeding three working days from the start of the clinical study of the biomedical cellular product, The beginning of the clinical study of biomedical cellular product to the authorized federal executive body, which gave permission to conduct a clinical trial, according to its form. 5. Organizations organizing a clinical study of biomedical cellular product, if necessary to amend the clinical trial protocol of biomedical cell product, report it in The authorized body of the executive branch of the executive branch, who has given the permission to conduct the clinical trial, in accordance with the prescribed form. 6. Within a period not exceeding thirty working days from the date of receipt of the communication referred to in part 5 of this article, the authorized federal executive authority shall examine the communication in the manner prescribed by it and decide on the application. Changes to the protocol of clinical research of biomedical cellular product or refusal to make such changes with reasons for refusal. The basis for the decision not to amend the clinical trial of biomedical cellular product is to present the information provided for in Part 5 of this Article, incomplete and (or) the existence of a risk Causing harm to the health of a patient participating in a clinical trial, as a result of changes in the conditions of the patient's conduct. 7. The clinical study of the biomedical cell product may be suspended or terminated if the life and health of patients are in danger. In the event of danger to life, the health of the patient participating in the clinical study of the biomedical cellular product, the researcher and (or) co-researchers are obliged to inform the head of the medical organization, which is a clinical study of the biomedical cellular product, and (or) an organization authorized to conduct a clinical study of biomedical cellular product. The decision to suspend the clinical study of biomedical cellular product is taken by the head of the medical organization in which the clinical study of biomedical cellular product is conducted. The decision to terminate the study is made by the authorized federal executive authority on the basis of a written communication by the head of the medical organization in which the biomedical research is conducted. a cellular product, or an organization authorized to conduct a clinical study of the biomedical cellular product. 8. In a period not exceeding five working days from the day of completion, suspension or termination of the clinical study of the biomedical cellular product, this shall be reported by medical organizations in which the clinical trial is conducted. a study of the biomedical cellular product, to the authorized federal executive body by its prescribed form. 9. The Commissioner of the federal executive branch posts on his official website "Internet" a communication about the completion, suspension or termination of a clinical study of biomedical cellular product up to a term not exceeding 5 working days from the date of receipt, in accordance with the procedure established by them. 10. The Commissioner of the federal executive authority, in accordance with the procedure approved by him, carries out the maintenance of the State Register of Researchers, which is to be placed on the official website of the authorized federal authority Executive power on the Internet and contains data about the researcher (surname, name, patronymic, place of work, speciality, length of work in clinical research programmes, list of clinical studies (including clinical studies) biomedical cellular products) in which he participated as a a researcher or researcher, and periods of his/her participation). 11. The report on the clinical study of the biomedical cellular product is prepared by the organization conducting the clinical study of the biomedical cellular product, and is submitted to the Commissioner A federal executive authority that issued a permit to conduct the study within a period not exceeding three months from the date of its completion, suspension or termination, in accordance with the procedure established by the authorized federal authority The executive branch. 12. The procedure for the removal from the Russian Federation of biological material obtained during the clinical study of the biomedical cellular product is determined by the Government for the purposes of this clinical study of the Russian Federation. Article 30. An international multi-centre clinical study of biomedical cellular product, post-registry clinical study Biomedical cellular product 1. The International Multi-Centre Clinical Research of Biomedical Cellular Product in the Russian Federation or Post-Registration Clinical Study of Biomedical Cellular Product is based on permission to conduct a clinical study of biomedical cellular product, issued by the authorized federal executive body on the results of the examination of the quality of the biomedical cellular product, expert examination of documents for obtaining a permit for international multi-centre clinical trial Research on biomedical cellular product or post-registration clinical study of biomedical cellular product and ethical expertise. 2. In order to obtain permission to conduct an international multi-centre clinical study of biomedical cellular product or post-registration clinical study of biomedical cellular product, the organization implementing The organization of a clinical study of the biomedical cellular product (hereinafter referred to as the applicant), submits the following documents and information to the federal executive authority: 1) Authorization to conduct an international multi-centre Clinical study of biomedical cellular product or post-registration clinical study of biomedical cellular product; 2) details of the document confirming the payment of the state fee for extradition Authorization to conduct an international multi-centre clinical study of biomedical cellular product or for granting a post-registration clinical study of the biomedical cellular product or this A document (on its own initiative). In the event of non-submission of the document, the authorized federal executive authority, on the basis of the applicant's details, verifies the payment of the State fee using the payment information. State duties contained in the State Information System on State and Municipal Payments; 3) a report on pre-clinical studies of the biomedical cellular product and a report on previous clinical trials Research on biomedical cellular product (if any); (4) Draft protocol for an international multi-centre clinical study on biomedical cellular product or post clinical study of biomedical cellular product; 5) a researcher's brochure; 6) patient's information sheet; 7) information about the experience of researchers in relevant specialties and their experience in conducting clinical studies of biomedical cellular products; 8) Medical organizations in which clinical study of biomedical cellular product (full and abbreviation, organizational and legal form, location and location of activity, telephone, telefax, email address, details of -accreditation for the right to conduct clinical research on biomedical cellular products of each medical organization); 9) the expected date for the clinical study of the biomedical cellular product; 10) copy of the contract of compulsory insurance entered into In accordance with the model rules of compulsory insurance, with the limit of the number of patients participating in the biomedical cellular product study; 11) information on the composition of biomedical cell product; 12) a document produced by the manufacturer of the biomedical cell product providing information on the quality, quantity and other characteristics of the biomedical cell product produced for Clinical research. 3. Within a period not exceeding five working days from the date of submission of documents and information referred to in part 2 of this article, the authorized federal executive authority: 1) shall verify the completeness and validity of the information; in the documents submitted by the applicant; (2) decides whether to conduct an expert examination of the biomedical cellular product, to review the documents to obtain permission to conduct an international multi-center Clinical study of the biomedical cellular product or Post-patient clinical research on biomedical cellular product and ethical review or refusal to conduct these examinations; 3) notifies the applicant in writing of the decision (if adopted) The decision to refuse an examination indicates the reasons for the refusal. 4. If the information contained in the material submitted by the applicant is found to be incomplete or unavailable, the authorized federal executive authority shall submit a request for clarification to the applicant. The request may be submitted to the authorized representative of the applicant personally under receipt, by mail by registered mail, or transmitted in electronic form via telecommunications channels. If the request is made by registered mail, it shall be deemed to have been received after six days from the date of the registered letter. 5. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of receipt of the request. The period specified in part 3 of this article shall be suspended from the day the applicant specified in Part 4 of this article is requested by the authorized federal executive authority until the day of receipt of the reply to the request and not is taken into account in the calculation of the period of adoption by the authorized federal executive authority of a decision to conduct an expert examination of the quality of the biomedical cellular product, to review the documents for authorization of the conduct of the international multi-centre clinical study of biomedical cellular product or post-registration clinical trial of biomedical cellular product. 6. Grounds for refusal to perform the quality assessment of biomedical cellular product, expert examination of documents for obtaining permission to conduct an international multi-centre clinical study of biomedical cellular product, or Post-patient clinical study of biomedical cellular product and ethical expertise is the submission of documents provided for in part 2 of this article, in incomplete terms, failure to submit a response to the prescribed deadline. of the present article The federal executive branch, or the lack of information in the documents submitted, which must be reflected in them, and the lack of information confirming the payment of the State fee for issuing the permit. An international multi-centre clinical study of biomedical cellular product or authorization to conduct a post-registration clinical study of biomedical cellular product. 7. Quality assessment of biomedical cellular product, expert examination of documents for obtaining permission to conduct an international multi-centre clinical study of biomedical cellular product or post-registration clinical study of biomedical cellular product and ethical expertise and authorization to conduct an international multi-centre clinical study of biomedical cellular product or post-registration clinical Research on biomedical cellular products is carried out in in accordance with articles 14 to 17 of this Federal Act. 8. The decision not to perform the quality assessment of the biomedical cellular product, to review the documents in order to obtain permission to conduct an international multi-centre clinical study of the biomedical cellular product or Post-patient clinical research on biomedical cellular products and ethical expertise and in issuing a permit for the conduct of an international multi-centre clinical study of the biomedical cellular product or Post-patient clinical research on biomedical cellular The products may be appealed in accordance with the procedure established by the legislation of the Russian Federation. Article 31. The rights of a patient participating in a clinical study of biomedical cellular product 1. The patient's participation in the clinical study of the biomedical cellular product is voluntary and confirmed by his signature or by the signature of his legal representative on the patient's information sheet. 2. The patient or his legal representative must be informed in writing: 1) on biomedical cell product; 2) on the purpose and duration of the clinical study of the biomedical cellular product; 3) on guarantees of confidentiality of participation in the biomedical cellular product study; 4) on conditions for participation in the biomedical cellular product study; 5) on the expected the effectiveness of the biomedical cellular product as well as the degree of risk, who may be subject to a patient in a clinical study of the biomedical cellular product; 6) of the patient's actions in the event of the unexpected effects of the biomedical cell product on his condition Health; 7) on the conditions of compulsory life insurance and the patient's health. 3. The patient or his legal representative has the right to refuse to participate in the clinical study of the biomedical cellular product at any stage of the study. 4. The clinical study of biomedical cellular product with participation as children of children is permitted only with the written consent of their parents. Children may be treated as patients if they are required to treat the disease in the child. In such cases, the study could be carried out on the basis of a decision of a physician established under the Federal Act of 21 November In 2011, No. 323-FZ "On the foundations of public health in the Russian Federation", on the possibility of child participation in the biomedical cell study, and provided that the study was preceded by a study adult biomedical cell product Citizens, except in cases of clinical research of the biomedical cellular product intended for the treatment of diseases exclusively in children. 5. A clinical study of a biomedical cellular product with the participation as a patient of a person who is legally recognized as incompetent or limited to legal capacity may be conducted, with the written consent of the patient the legal representative. The decision on the possibility of the person's participation in such a clinical trial shall be taken by a doctor, who is made up of specialists in the case of the patient's disease. 6. It is prohibited to conduct a clinical study of biomedical cellular product as patients: 1) orphan children and children deprived of parental care; 2) women during pregnancy, childbirth, women in Breastfeeding period, except where appropriate treatment is intended for these patients and provided that all necessary measures are taken to eliminate the risk of harm to a woman during pregnancy, childbirth, and woman Breastfeeding period, foetus or child; 3) Military personnel, except in cases of clinical research of biomedical cellular product specially designed for use in conditions of war, emergency situations, prevention and treatment of diseases and losses, from adverse chemical, biological and radiological factors. The clinical study of this biomedical cell product may be conducted with the participation of military personnel, with the exception of military conscripts, subject to the requirements of the present Federal law on civilians; 4) law enforcement officers; 5) persons serving sentences in places of deprivation of liberty, as well as persons in pretrial detention. Article 32. Mandatory life insurance, patient's health, participating in the clinical trial Biomedical cellular product 1. The organization, which has been granted permission to conduct a clinical study of biomedical cellular product, is obliged to insure the risk of harm to life, to the patient's health as a result of clinical trial The study of biomedical cellular products at its own expense, through the conclusion of a compulsory insurance contract. 2. The subject of compulsory insurance is the patient's property interest in the infliction of damage to life and health of the patient as a result of clinical research of biomedical cellular product. 3. The insurance contract of the compulsory insurance is the death of the patient or the impairment of his/her health, including the establishment of a disability, if there is a causal link between the occurrence of the event and the participation a patient in a clinical study of biomedical cellular product. 4. Claims for compensation for harm caused to a patient's life or health shall be made within the time limits prescribed by civil law. 5. The amount of the insurance amount under the compulsory insurance agreement is 2 million rubles. 6. The insurance premium under the compulsory insurance contract is: 1) in case of death of the patient two million rubles per patient who participated in the clinical study of biomedical cellular product; 2) If the patient's health is deteriorating: (a) disability I group, one million five hundred thousand roubles for each patient who participated in the clinical study of the biomedical cellular product; b) with the establishment of a group II disability, 1 million Each patient who participated in the clinical study of the biomedical cellular product; in) resulted in the establishment of disability of the group III, five hundred thousand roubles for each patient who participated in the clinical trial The study of biomedical cellular product; g) does not result in the establishment of disability or increase the degree of limitation of the activity of the disabled person without changing the disability group, no more than 300 thousand rubles for every patient who participated in the clinical trial biomedical cell product, based on regulations that reflect the nature and degree of injury to the health, as well as the patient's actual costs of causing harm to health, medical care, acquisition Medicinal drugs and medical products. 7. The compulsory insurance contract is for a period covering the period of clinical study of biomedical cellular product, and not less than one year after the completion of the biomedical study cellular product. 8. The terms of the compulsory insurance contract, including insurance rates for compulsory insurance, the list of necessary documents for the implementation of the insurance payment, the order of the holder of the individual identification code The patient is informed by the Insurer's Insurer about the biomedical clinical product biomedical research of patients, the order of payment of the insurance premium, the procedure for the implementation of certain true federal law and others by federal laws of the rights and obligations of the parties, The nature and extent of damage to health under the compulsory insurance contract shall be established by the model rules of compulsory insurance. 9. In case of harm to the life of the patient who participated in the clinical study of biomedical cellular product, the beneficiaries of the compulsory insurance contract are citizens entitled to compensation of harm in the event of death The breadwinner, in accordance with the civil law, in the absence of the parents, the spouse, the children of the deceased patient who participated in the clinical study of the biomedical cellular product, in the event of the patient's death, in the clinical study of the biomedical cellular product and In the case of a person who was dependent on his or her own income, the person who was involved in the clinical study of the biomedical cellular product was responsible for the cost of the burial of the patient. 10. The insurance payment for damages caused to the patient's life, who participated in the clinical study of the biomedical cellular product, is distributed among the beneficiaries in proportion to their number in equal shares. 11. When an insured event occurs, the patient who participated in the clinical study of the biomedical cellular product, the beneficiary of the compulsory insurance contract has the right to present to the insurer the claim for compensation of harm caused. The insurance payment is carried out by the insurer within thirty days from the date of submission of the necessary documents. The patient who participated in the clinical study of the biomedical cellular product or the beneficiary of the compulsory insurance contract is required to inform the insurer of the insurance payment of the individual identification code A patient established by the policyholder in accordance with the model rules of compulsory insurance. 12. Prior to the full determination of the amount of damages to be compensated, upon application of the patient who participated in the clinical study of the biomedical cellular product, or the application of the beneficiary, the beneficiary is entitled to make part of the insurance payment, the corresponding actual part of the damage caused. 13. Insurance payments under the compulsory insurance contract shall be made irrespective of the payments due under other types of insurance. 14. The patient is not allowed to participate in the clinical study of biomedical cellular product in the absence of a contract of compulsory insurance. 15. Control of the performance of an organization authorized to conduct a clinical study of the biomedical cellular product established by this article of responsibility for life insurance, the health of the patient participating in the clinical trial The study of the biomedical cellular product is carried out by the authorized federal executive authority, which issued permission to conduct a clinical study of the biomedical cellular product. Article 33. Obtaining biological material 1. Obtaining biological material from the donor of biological material for the production of biomedical cellular products, including for pre-clinical studies and (or) clinical studies, and a medical examination of the donor The biological material for the purpose of detecting contraindications for the receipt of biological material is carried out in organizations licensed to medical activities on the basis of a contract between such an organization and the manufacturer Biomedical cellular products at the manufacturer's expense. 2. The rules for obtaining biological material for the production of biomedical cell products and for transferring it to the manufacturer of biomedical cellular products are established by the authorized federal executive authority. 3. Obtaining biological material for the production of biomedical cell products at the time of life donation is permitted if expressed in written form and contributed to the donor's medical documentation: 1) Voluntary consent of a person who has reached the age of majority, or a minor who has been declared in full legal capacity by a medical examination, free of charge for his or her biological family material for the production of biomedical cellular product, in the number, in order to conduct preclinical studies and (or) clinical studies; 2) informed consent of one of the parents or other legal representative of a minor (except in case of a minor referred to in paragraph 1 of this Part), as well as a person declared legally incompetent or of limited capacity, to provide the biological material of the person to be made available free of charge. biomedical cellular product, including for the purpose of pre-clinical studies and (or) clinical studies. Obtaining biological material from persons referred to in this paragraph is permitted only in cases where the biomedical cellular product is intended solely for use by these persons or their relatives-biological parents, children of birth, to brothers and sisters. 4. A person referred to in paragraph 1 of part 3 of this article may, in writing, certified by the head of a medical organization or notary, express his or her consent to consent or dissent on the postmortem provision of his or her biological material for the production of biomedical cellular product. 5. In the absence of express expression of will of the person referred to in paragraph 1 of part 3 of this article, in respect of postmortem donation, after his death a biological material for the production of a biomedical cellular product is allowed with the written consent of the spouse of the deceased, and at his/her absence one of the relatives (children, parents, adoptive parents, adoptive parents, siblings, grandchildren, grandfathers and grandmothers) certified by the leader by a medical organization or by a person authorized by him or by a notary. 6. Information on the expression of the will of the person referred to in part 4 of this article shall be entered in the donor's medical records in the case provided for in paragraph 5 of this article. 7. Obtaining biological material with posthumency is not allowed: 1) if the person referred to in paragraph 1 of part 3 of this article in life expressed orally in the presence of witnesses his or her expression of dissent The posthumously provision of biological material for the production of a biomedical cellular product and the data is included in the medical documentation of the person in accordance with the procedure established by the authorized federal executive authority; (2) of the deceased minor, except where specified in Part 3, paragraph 1, of this article, or an individual declared legally incompetent; 3) in the absence of the express consent of the person referred to in paragraph 1 of part 3 of this article on consent The provision of biological material for the production of a biomedical cellular product and the consent of his wife (s), and at the time of his/her absence, one of the relatives referred to in Part 5 of this article. 8. Form of informed voluntary consent of the biological material donor or one of the parents or other legal representative of the person referred to in paragraph 2 of part 3 of this article for the donation of biological material for the production of biomedical cellular products, including for the purposes of pre-clinical studies and (or) clinical studies, the form of the written consent of the spouse or of one of the relatives referred to in Part 5 of this article, of a deceased person to the posthumant provision of biological material for The production of biomedical cellular products, including pre-clinical studies and (or) clinical studies, is approved by the authorized federal executive body. Article 34. The rights and obligations of the donor of biological material, parents and other legal representatives 1. The donor of biological blood donation (one of his parents or other legal representative) has the right: 1) to protect the rights and health of the donor; 2) to become familiar with the results of the medical examination a donor survey; 3) to obtain, in an accessible form, information on the biomedical cell product for which biological material is provided, on how to obtain and use biological material, Possible effects of the recovery of biological material on donor health; (4) To receive medical care under the state guarantee scheme to provide free medical assistance to citizens in the event of a donor's reaction and complications related to the donation; 5) to refuse at any time from the provision of biological material. 2. The donor of biological material (one of his parents or other legal representative) is obliged to report to: 1) information about known cases transmitted by the donor and (or) available to the donor; (2) Information on the use of narcotic drugs, psychotropic substances, medicines; 3) other information relevant to the safe donation of biological material, the list of which approved by the authorized federal executive branch. 3. The donor of biological material is required to undergo a medical examination. The medical examination is free of charge to the donor. The procedure for medical examination of the donor and the list of contraindications (absolute and relative) for obtaining biological material shall be approved by the authorized federal executive authority. 4. The donor of biological material (one of his parents or other legal representative), while donating or distorting known information about the donor's health condition in his or her life blood donation of biological material, which caused harm to the life, health of the patient, medical workers and other persons, is liable under the legislation of the Russian Federation. Article 35. Production and implementation of biomedical cellular products 1. The production of biomedical cellular products is carried out in compliance with the requirements of its production regulations, which is approved by the manufacturer of the biomedical cellular product and includes: 1) the list of used cell lines, drugs, medical products and auxiliary substances, including the number of each; 2) data on the equipment used, a description of the technological process and methods of control in all stages Production of biomedical cellular product. 2. The rules for the production of biomedical cellular products are established by the rules of good practice for working with biomedical cell products approved by the authorized federal executive body. 3. Production of biomedical cellular products not registered in the Russian Federation, except for the production of biomedical cellular products for pre-clinical studies of biomedical cellular products and clinical products Research on biomedical cellular products is not allowed. 4. A registered biomedical cell product of a certain type (autological, allogenic, combined) can be produced using cell lines prepared from biological material from various donors. If the requirements of the biomedical cellular product registration are complied with, no re-registration of such biomedical cell product is required. 5. It is prohibited to manufacture: 1) falsified biomedical cellular products; 2) biomedical cellular products, in violation of the rules of good practice for handling biomedical cell products. 6. Certification of the compliance of a biomedical cell product with the requirements established upon its state registration and the conformity of its production process with the requirements of good practice for biomedical cell The products are carried out by the authorized person of the manufacturer of the biomedical cellular product, with the exception of biomedical cellular products produced for pre-clinical research and clinical studies of biomedical cellular products. The requirements for the level of education and qualification, the procedure for certification of the authorized person of the manufacturer of biomedical cellular product and its authority to ensure the quality of biomedical cell product being issued shall be established. The Commissioner of the Federal Executive. 7. Biomedical cellular products manufacturers can implement biomedical cellular products: 1) other producers of biomedical cellular products for the production of biomedical cell products; 2) scientific organizations, educational organizations for scientific research; 3) organizations conducting medical activities. 8. The rules for the implementation of biomedical cellular products are established by the Government of the Russian Federation. Article 36. Marking of biomedical cellular products 1. The list of particulars of the primary packaging, the secondary packaging of biomedical cellular products and the transport packaging in which the biomedical cell product is placed is established by the federal executive authority. 2. Primary packaging and secondary packaging for autological biomedical cellular products and mixed biomedical cellular products are marked with the use of radio frequency identification methods for this biomedical a cellular product to a particular patient in the manner prescribed by the authorized federal executive authority. 3. The primary packaging and secondary packaging of biomedical cellular products for pre-clinical research or clinical studies bear the inscription: "For pre-clinical research" or "For clinical trials". Article 37. Transportation and storage of biological material, cells for the preparation of cellular lines lines, cell lines designed for production of biomedical cellular products, biomedical cellular products 1. Biological material, cells for the preparation of cellular lines, cell lines intended for the production of biomedical cellular products, biomedical cell products must be transported with compliance The authorised federal executive authority for the transport rules. 2. Biological material, cells for the preparation of cellular lines, cell lines intended for the production of biomedical cellular products, biomedical cellular products must be stored in conditions of biobanks that conserve them of the biological properties and the prevention of their infection and pollution. 3. Requirements for the organization and operation of biobanks, as well as the rules of storage of biological material, cells for the preparation of cellular lines, cell lines for the production of biomedical cellular products, biomedical cell The competent federal organ of the executive branch shall determine the products. Article 38. Destruction of unclaimed biological material, unclaimed cells for preparation of cell lines, untapped cellular lines for the production of biomedical cellular products that are not in need of biomedical cellular products 1. Unclaimed biological material, unclaimed cells for the preparation of cell lines, unclaimed cellular lines, intended for the production of biomedical cellular products, unclaimed biomedical cellular products To be destroyed in accordance with the procedure established by law in the field of health care. 2. Falsified biomedical cellular products or malignant biomedical cellular products are to be removed from circulation by decision of the federal executive authority exercising control and supervision functions in the sphere Health care. The subsequent destruction of falsified biomedical products or malignant biomedical cellular products is carried out on the basis of the decision of the owner of the biomedical cellular product and (or) the decision of the federal authority The executive branch, which is responsible for monitoring and supervising the health sector, or the court's decision. 3. Counterfeit biomedical cellular products are subject to removal and destruction by court decision. 4. The procedure for the destruction of falsified biomedical cellular products, defective biomedical cellular products and counterfeit biomedical cellular products is established by the Government of the Russian Federation. 5. The costs of destroying falsified biomedical cell products, defective biomedical cellular products and counterfeit biomedical cellular products are reimbursed by their owners. 6. The owner of a biomedical cellular product must submit to the federal executive body exercising control and oversight functions in the field of health, a document confirming the destruction of biomedical cell a copy of the product or a certified copy thereof. 7. The federal executive body exercising control and supervision in the sphere of public health, which has taken a decision on the destruction of the biomedical cellular product, supervises the execution of this decision. Article 39. Characteristics of medical assistance with use of biomedical cellular products 1. Medical care with biomedical cell products can be provided by medical personnel trained in the additional professional programme (advanced training programme) on biomedical cell applications. products. The additional professional programmes (advanced training programmes) on the use of biomedical cell products are approved by the federal executive authority. 2. The patient's use of biomedical cellular products is not permitted. 3. Biomedical cell products, which include cell lines derived from the biological material of the donor of biological material with contraindications included in the list of contraindications (absolute and relative) for the obtaining biological material for the production of biomedical cellular products can be used to treat only the donor of this biological material (autological application). Article 40. Information on biomedical cellular products 1. Information on biomedical cellular products should be available only in specialized publications, including monographs, handbooks, scientific articles, congresses, conferences, symposiums, scientific councils, specialized publications Internet sites, as well as instructions for the use of biomedical cell products and other information materials for medical personnel. 2. Any material media that can be used to store, transmit and use information about biomedical cellular products without distortion is permitted. Article 41. Monitoring the security of biomedical cellular products 1. Biomedical cell products in circulation in the Russian Federation are subject to security monitoring to determine the possible negative consequences of their application, which is carried out by the federal executive branch, The functions of monitoring and supervision in the field of health shall be carried out in accordance with the procedures established in accordance with the communications provided for in Parts 2 and 3 of this Article. 2. Actors of biomedical cellular products are required to report by-action, unwanted reactions, serious undesired reactions, unexpected unwanted reactions in the use of biomedical cellular products, personal intolerance, lack of effectiveness of biomedical cellular products, the peculiarities of their interaction with drugs, medical products, food products, other biomedical cell products, and Other facts and circumstances presenting a threat The life or health of a person in the use of biomedical cell products and identified at all stages of biomedical cellular products in the Russian Federation. 3. Organizations providing medical care to pregnant women, women giving birth, relatives and newborns are obliged to report on all cases of children born with congenital abnormalities or developmental defects in the case of one of the parents In the past, biomedical cell products were used in medical intervention. 4. Owners of registration certificates of biomedical cellular products, legal entities authorized to conduct clinical studies of biomedical cell products or other legal entities authorized by them in the The framework for ensuring the safety of biomedical cell products in the manner prescribed by the federal executive authority exercising control and supervision in the health sector is obliged to carry out the reception, processing, Analysing and storing incoming referrals from entities Biomedical cellular products and public authorities about the side effects, unwanted reactions, serious undesired reactions, unexpected unwanted reactions in the use of biomedical cellular products, peculiarities of their interaction with medicines, medical products, food products, other biomedical cell products, individual intolerance, as well as other facts and circumstances that pose a threat person's life or health or affect the changing relationship Expected benefits of possible use of biomedical cell products. 5. In identifying information provided for in Part 4 of this article, owners of biomedical cellular products, legal entities authorized to conduct biomedical research or other legal entities authorized by them to take measures to eliminate the negative effects of such biomedical cell products, prevent harm to life or health, Protecting patients from biomedical cell biomedical In addition to collecting data on the effectiveness and safety of such biomedical cellular products. Article 42. Suspension of biomedical cellular product 1. The federal executive body exercising supervisory and oversight functions in the field of public health shall decide on the suspension of the application, in accordance with the procedure established by the federal executive authority. Biomedical cellular product: 1) when receiving information on side effects not specified in the instructions on the use of biomedical cell product, serious unwanted reactions and unanticipated unwanted reactions, interactions of the biomedical cellular product with medicinal products, medical products, food products, other biomedical cell products that may pose a threat to human life or health, as well as the lack of data on the effectiveness of biomedical the cell product and the safety of biomedical cell product data contained in the instructions for its application; 2) in default or improper performance by the owners of biomedical cell registration cards products, legal entities whose names have been issued for conducting clinical studies of biomedical cell products, or by other legal persons authorized by them, of the duties established in article 41, paragraphs 4 and 5, of this Federal Law; 3) in the case of an opinion on the lack of credibility of the clinical study of the biomedical cell product, which is based on the findings of a medical organization that conducted the clinical trial in violation of the rules of good practice with biomedical cell products or in the case of Failure to comply with the requirements of the selective quality control of the biomedical cellular product. 2. The federal executive body exercising control and oversight functions in the field of health care, as a result of the monitoring of the safety of biomedical cell products, places information on its official website on the Internet The decision to suspend the use of the biomedical cellular product and the related decision on the possible renewal of the biomedical cellular product. Article 43. The procedure for importing and exporting from the Russian Federation of biomedical cellular products 1. The import into the Russian Federation of biomedical cellular products is carried out in accordance with the procedure established by the Government of the Russian Federation, in accordance with international treaties and acts constituting the law of the Eurasian Economic Union The right of the EEU), and (or) the legislation of the Russian Federation on customs affairs. 2. Biomedical biomedical cellular products imported into the Russian Federation should be included in the public register of biomedical cell products. 3. The Russian Federation accepts the import of biomedical cell products, the quality of which is confirmed by the certificate of the manufacturer of the biomedical cellular product, attesting to the conformity of imported biomedical cell products with the requirements Normative documentation for the biomedical cellular product. 4. Importation into the Russian Federation of a particular consignment of unregistered biomedical cellular products intended for its state registration (including biomedical expertise, pre-clinical studies and clinical trials). or to provide medical assistance to a specific patient on the basis of his or her life's testimony, may be subject to the authorization of the competent federal executive authority, on the application of the persons referred to in article 44 of this Federal Act. of the law. The application and the decision to issue a permit for the import of biomedical cell products or for refusal of the said permit shall be made on the basis of the application of the biomedical cell A product within a period not exceeding ten working days from the date of acceptance by the designated federal executive authority of such a declaration. No charges are levied for the issuance of the authorization. 5. The Russian Federation imported biomedical cell products to the Russian Federation, along with documents provided for in the right of the Eurasian Economic Union (EEU) and (or) the customs legislation of the Russian Federation, The following documents are submitted: 1) a certificate of the manufacturer of a biomedical cellular product, verifying compliance of imported biomedical cellular products with the biomedical cell requirements product; 2) Biomedical cell specification product; (3) authorization of the authorized federal executive authority to import a specific batch of biomedical cell product in the cases referred to in Part 4 of this Article. 6. The importation into the Russian Federation of falsified biomedical cellular products, defective biomedical cellular products, counterfeit biomedical cellular products is prohibited. 7. The import of biomedical cell products from the Russian Federation is carried out without the application of the restrictions established by the right of the EEU and (or) legislation of the Russian Federation on foreign trade activities, unless otherwise established by international law. of the Russian Federation 8. The importation of biomedical cell products for humanitarian assistance (assistance) or emergency assistance from the Russian Federation is carried out in accordance with the procedure established by the Government of the Russian Federation. Article 44. Legal persons who are permitted to import biomedical cellular products Biomedical cellular products can import the following legal entities into the Russian Federation: 1) biomedical manufacturer cellular product for its own production of biomedical cellular product; 2) an organization with the rights to the results of pre-clinical studies of biomedical cellular product, clinical research (b) Biomedical cell product and/or production technology Biomedical cellular product, or the legal person authorized by it to carry out State registration of biomedical cellular product; 3) educational organizations of higher education and (or) organization Additional professional education involved in the organization of pre-clinical studies and (or) clinical studies of biomedical cellular products or conducting such research, as well as other organizations that Participate in the organization of pre-clinical studies and (or) Clinical research on biomedical cell products or in which such research is conducted; 4) medical organizations referred to in paragraphs 1 to 3 of this article of the organization to provide medical assistance to a specific patient On the basis of the authorization of the competent federal executive authority, issued in accordance with the procedure established by the federal executive authority, in the form of an electronic document, signed reinforced by the a qualified electronic signature. Article 45. Interaction of the federal body of the executive power in the field of the customs case and the authorized federal of the executive branch 1. The Commissioner of the federal executive authority provides the federal executive authority with a register of biomedical cell products, as well as information on the state register of biomedical products. issued permits for the import of a specific batch of biomedical cell products in the cases referred to in article 43, paragraph 4, of this Federal Act. 2. The federal executive body, which is authorized in the field of customs affairs, informs the authorized federal executive body about the importation of biomedical cell products into the Russian Federation and the export of biomedical cell OF THE PRESIDENT OF THE RUSSIAN FEDERATION Article 46. State control in the field of treatment of biomedical cellular products 1. State control over biomedical cell products is carried out by the federal executive body exercising control and supervision in the field of health care, and includes licensing control in the sphere of health care. Production of biomedical cellular products, state control over activities in the field of biomedical cellular products, selective control of the quality of biomedical cell products. 2. Licensing controls in the production of biomedical cell products are carried out in accordance with the Federal Act No. 99-FZ "Licensing of Certain Activities". 3. State control over the management of biomedical cellular products is carried out in accordance with the Federal Law of 26 December 2008, No. 294-FZ "On the protection of the rights of legal persons and individual entrepreneurs in the exercise of State control (supervision) and municipal control", taking into account the characteristics set out in this article and in the order, by the Government of the Russian Federation. 4. State control over activities in the field of biomedical cellular products includes: 1) organizing and conducting inspections of compliance with biomedical cell products that are established by the present by the Federal Act and other regulatory legal acts of the Russian Federation, the requirements for pre-clinical research, clinical research, production, sale, storage, transportation, importation into the Russian Federation OF THE PRESIDENT OF THE RUSSIAN FEDERATION Biomedical cellular products; (2) organization and conduct of checks on biomedical cellular products in circulation, quality indicators established by normative documentation on biomedical cell Product: 3) the application, in accordance with the law of the Russian Federation, of measures to address the detected violations of the requirements of this Federal Law and (or) to address the consequences of such violations, including acceptance Decisions to suspend the application of biomedical cell The Convention on the Rights of the child; 5. Preliminary agreement with the Prosecutor's Office on the timing of unscheduled inspections of biomedical cell products, as well as prior notification of legal entities and individual entrepreneurs to start the implementation No such verification is required. The procuratorial authorities are informed of the unscheduled inspections of biomedical cellular products by sending the relevant documents within three working days of the end of the check. 6. Selective control of the quality of biomedical cellular products is carried out in the order established by the authorized federal executive authority and includes: 1) processing of information, mandatory biomedical cell products, series, biomedical cellular products coming into circulation in the Russian Federation; (2) screening biomedical samples of biomedical products from actors Biomedical cell product applications for testing compliance with the requirements of the biomedical cell product documentation; 3) the decision on further treatment of the relevant biomedical cellular product; 4) The adoption by the federal executive body exercising supervisory and oversight functions in the field of health, the decision to transfer biomedical cell product to serial quality control in the event of re-discovery Biomedical cellular product quality requirements of the normative documentation for biomedical cellular product and, if necessary, to verify the subject of biomedical cellular products. The cost of serial sampling quality control of the biomedical cellular product is paid by the manufacturer of the biomedical cell product or by the owner of the biomedical cell registration certificate product. 7. Officials of the federal executive body exercising control and supervision in the sphere of public health, in accordance with the procedure established by the legislation of the Russian Federation: 1) on the basis of reasoned written Requests received from the subject of biomedical cell products information necessary for decision-making on matters within the competence of the State control authority; 2) without any interference with the production of a service and copies of the order (s) for the appointment of the verification Visit the use of biomedical cell products, premises, facilities and facilities used by the agents to carry out monitoring activities; 3) select samples of biomedical cellular products, In order to implement and implement biomedical cellular products, to verify their quality, conduct research, test according to the sampling rules established by the Federal Commissioner for Human Rights the executive branch; 4) issued to the subjects of treatment Biomedical cell products are ordered to stop violations of the requirements of this Federal Act and to eliminate the detected breaches of these requirements. Article 47. Liability for violation of the legislation of the Russian Federation on the treatment of biomedical cellular products Violation of the Russian Federation's legislation on the application of biomedical cellular products OF THE PRESIDENT OF THE RUSSIAN FEDERATION Article 48. Reparation for the harm caused to the life and health of the citizens by the use of biomedical cellular products 1. The manufacturer of the biomedical cellular product is obliged to compensate for the damage caused to life and to the health of citizens through the use of a biomedical cellular product, if one of the following circumstances is proved: 1) Biomedical cell product was used according to the instructions on the use of biomedical cell product and the cause of harm to life, the health of citizens was the use of a poor biomedical cellular product; 2) the cause of damage to life and the health of citizens The information contained in the instructions on the use of the biomedical cellular product is not reliable. 2. The organization, in which the biomedical cellular product is used, is obliged to compensate for the damage caused to life and to the health of citizens due to the use of biomedical cellular product, if it is proved that the cause of life is harmful to the health of the citizens Use of biomedical cellular product in violation of the instructions for its application. 3. Reparation for harm caused to life and health of citizens by the use of biomedical cellular product is carried out in accordance with the legislation of the Russian Federation. Article 49. The procedure for the entry into force of this Federal Law 1. This Federal Act shall enter into force on 1 January 2017, with the exception of provisions for which this article sets a different time limit for their entry into force. 2. Part 2 and article 35, paragraph 2, of this Federal Act shall enter into force on 1 January 2018. President of the Russian Federation Vladimir Putin President of the Russian Federation, the Kremlin 23 June 2016 No. 180-FZ
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