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FEDERAL LAW OF THE RUSSIAN FEDERATION

of June 23, 2016 No. 180-FZ

About biomedical cellular products

(as amended of the Federal Law of the Russian Federation of 03.08.2018 No. 323-FZ)

Accepted by the State Duma on June 8, 2016

Approved by the Federation Council on June 15, 2016

Article 1. Subject of regulation of this Federal Law

1. This Federal Law governs the relations arising in connection with development, preclinical researches, clinical trials, examination, state registration, production, quality control, realization, application, storage, transportation, import to the Russian Federation, export from the Russian Federation, destruction of the biomedical cellular products intended for prevention, diagnostics and treatment of diseases or conditions of the patient, preserving pregnancy and medical rehabilitation of the patient (further - the address of biomedical cellular products), and also governs the relations arising in connection with donorship of biological material for the purpose of production of biomedical cellular products.

2. Operation of this Federal Law does not extend to the relations arising in case of development and production of medicines and medical products, organ donation and tissues of the person for the purpose of their transplantation (change), donorship of blood and its components when using gametes of the person for the purpose of use of auxiliary reproductive technologies, and also to the relations arising in case of the address of cages and tissues of the person in the scientific and educational purposes.

Article 2. The basic concepts used in this Federal Law

In this Federal Law the following basic concepts are used:

1) biomedical cellular product - the complex consisting of the cellular line (cellular lines) and excipients or of the cellular line (cellular lines) and excipients in combination with the medicines which underwent state registration for medical application (further - medicines), and (or) the pharmaceutical substances included in the state register of medicines and (or) medical products;

2) realization of biomedical cellular product - transfer of biomedical cellular product on paid basis and (or) on a grant basis;

3) autologichny biomedical cellular product - the biomedical cellular product containing the cellular line (cellular lines) received from biological material of certain person in the structure, and intended for application to the same person;

4) allogenny biomedical cellular product - the biomedical cellular product containing the cellular line (cellular lines) received from biological material of certain person in the structure, and intended for application to other people;

5) the combined biomedical cellular product - the biomedical cellular product containing the cellular lines received from biological material of several people in the structure, and intended for application to one of them;

6) sample of biomedical cellular product - the biomedical cellular product or its part received for the purpose of studying of its properties including for quality evaluation of biomedical cellular product and its safety;

7) the cellular line - the standardized population of cages of one type with the reproduced cellular structure received by way of withdrawal from human body of biological material with the subsequent cultivation of cages out of human body;

8) excipients - the substances of inorganic or organic origin used in case of development and production of biomedical cellular product;

9) biological material - biological liquids, fabrics, cages, secrets and waste products of the person, physiological and pathological allocations, dabs, scrapes, washouts, biopsiyny material;

10) the donor of biological material (further also - the donor) - the person who provided biological material during lifetime, or the person at whom biological material is received after his death verified according to the procedure, established by the legislation of the Russian Federation;

11) donorship of biological material - process of posthumous provision of biological material (further - posthumous donorship) or lifetime provision of biological material (further - lifetime donorship);

12) the regulating documentation on biomedical cellular product - the document developed by the producer of biomedical cellular product containing list of the indicators of quality of biomedical cellular product determined by results of the corresponding examinations and information on methods of quality control of biomedical cellular product;

13) quality of biomedical cellular product - compliance of biomedical cellular product to requirements of the regulating documentation of biomedical cellular product;

14) safety of biomedical cellular product - the characteristic of biomedical cellular product based on the comparative analysis of its efficiency and risk of damnification of life and to health of the person in case of its application;

15) efficiency of biomedical cellular product - the characteristic of extent of positive influence of biomedical cellular product on current, duration of disease or condition or on their prevention, on preserving pregnancy, on medical rehabilitation of the patient;

16) the protocol of clinical trial of biomedical cellular product - the document determining the purposes of clinical trial of biomedical cellular product, form of its organization and methodology of carrying out, statistical techniques of processing of results of research and measure for safety of the patients participating in clinical trial of biomedical cellular product;

17) the information leaflet of the patient - the document in which in available form information on clinical trial of biomedical cellular product, its purposes, the plan of carrying out and possible risks, structure of biomedical cellular product is stated and contains written voluntary consent of the patient to participation in clinical trial of biomedical cellular product;

18) the registration certificate of biomedical cellular product - the document confirming the fact of state registration of biomedical cellular product;

19) the producer of biomedical cellular product - the organization performing production of biomedical cellular product at one stage, several or all stages of engineering procedure according to license for activities on production of biomedical cellular products;

20) side effect - the reaction of human body connected using biomedical cellular product according to the instruction for its application;

21) undesirable reaction - adverse reaction of human body which can be connected using biomedical cellular product;

22) serious undesirable reaction - adverse reaction of human body which is connected using biomedical cellular product according to the instruction for its application, led to death, congenital anomalies or malformations or representing threat of human life, requiring hospitalization or led to temporary disability or to disability;

23) unforeseen undesirable reaction - adverse reaction of human body which is connected using biomedical cellular product according to the protocol of clinical trial of biomedical cellular product, the brochure of the researcher or the instruction for its application and essence, weight and which outcome do not correspond to information on biomedical cellular product containing in the specified documents;

24) counterfeited biomedical cellular product - the biomedical cellular product which is purposely accompanied with false information about its structure and (or) the producer;

25) poor-quality biomedical cellular product - the biomedical cellular product which is not conforming to requirements of the regulating documentation of biomedical cellular product;

26) counterfeit biomedical cellular product - the biomedical cellular product which is in circulation with violation of the civil legislation;

27) preclinical research of biomedical cellular product - the biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other researches of biomedical cellular product for the purpose of identification of the specific mechanism of action of such product, receipt of proofs of its safety, quality and efficiency preceding clinical trial of biomedical cellular product;

28) clinical trial of biomedical cellular product - studying of preventive, diagnostic, medicinal, rehabilitation properties of biomedical cellular product in the course of its application to the person for the purpose of receipt of proofs of its safety and efficiency, data on side effects of such product and the undesirable reactions connected with its application and also about effect of interaction of the researched biomedical cellular product with other biomedical cellular products, medicines and (or) medical products, foodstuff;

29) multicenter clinical trial of biomedical cellular product - the clinical trial of biomedical cellular product conducted in two and more medical organizations for the single protocol of clinical trial of biomedical cellular product;

30) the international multicenter clinical trial of biomedical cellular product - the clinical trial of biomedical cellular product conducted in various countries under the single protocol of clinical trial of biomedical cellular product;

31) post-registration clinical trial of biomedical cellular product - clinical trial of biomedical cellular product which address in the Russian Federation is performed after state registration, for the purpose of the additional charge of data on its safety and efficiency, extension of indications to application of such biomedical cellular product, and also identification of undesirable reactions to its application.

Article 3. The principles of implementation of activities in the sphere of the address of biomedical cellular products

The principles of implementation of activities in the sphere of the address of biomedical cellular products are:

1) voluntariness and gratuitousness of donorship of biological material;

2) observance of medical secret and other secret protected by the law;

3) inadmissibility of purchase and sale of biological material;

4) inadmissibility of creation of embryo of the person for the purpose of production of biomedical cellular products;

5) inadmissibility of use for development, production and application of biomedical cellular products of the biological material received by interruption of development of embryo or fruit of the person or violation of such process;

6) observance of requirements of biological safety for the purpose of protection of health of donors of biological material, the workers occupied on production of biomedical cellular products, health workers, patients and the environment.

Article 4. Preparation of the cellular line

1. Preparation of the cellular line intended for production of biomedical cellular products includes receipt of biological material, its research, allocation from it of cages, their cultivation and modification out of human body, receipt of the standardized population of cages and assessment of conformity of population of cages of the specification on biomedical cellular product containing data, stipulated in Clause the 7th this Federal Law.

2. For preparation of the cellular line cells of the person or the person concerning whom death according to the procedure is verified, established by the legislation of the Russian Federation are used only.

3. Obtaining and use for production of biomedical cellular products of biological material of unidentified persons who for health reasons, could not report to age or other reasons data on the personality concerning which death according to the procedure is verified subsequently, established by the legislation of the Russian Federation and at the time of receipt of biological material data about which personality are not established, are not allowed.

Article 5. Development of biomedical cellular products

1. Development of biomedical cellular products represents process of creation of biomedical cellular product and technology of its production.

2. Financial provision of development of biomedical cellular products can be performed for the account:

1) budgetary appropriations of the federal budget;

2) budgetary appropriations of budgets of subjects of the Russian Federation;

3) means of developers of biomedical cellular products;

4) other sources which are not forbidden by the legislation of the Russian Federation.

3. The rights of developer of biomedical cellular product are protected according to the civil legislation.

Article 6. Preclinical research of biomedical cellular product

1. The preclinical research of biomedical cellular product is conducted on the animals modelled in organism or out of live organism the pathological processes proceeding in human body, and (or) pathological conditions of the person in case of which it is supposed to apply the developed biomedical cellular product, and also on the models allowing to reveal the specific mechanism of action of such product, its efficiency and safety.

2. By results of the conducted preclinical research of biomedical cellular product the organization which conducted preclinical research constitutes the report on preclinical research of biomedical cellular product containing the description, results and the analysis of results of preclinical research, and also the conclusion about possibility of performing clinical trial of biomedical cellular product.

3. Rules of carrying out preclinical researches of biomedical cellular products, including requirements to qualification of specialists and material and technical resources of the scientific organizations, the educational organizations of the higher education, the educational organizations of additional professional education, other organizations, are established by rules of proper practice on work with the biomedical cellular products approved by the federal executive body performing functions on development and realization of state policy and normative legal regulation in health sector (further - authorized federal executive body).

4. Financial provision of preclinical researches of biomedical cellular products can be performed for the account:

1) budgetary appropriations of the federal budget;

2) budgetary appropriations of budgets of subjects of the Russian Federation;

3) means of developers of biomedical cellular products;

4) other sources which are not forbidden by the legislation of the Russian Federation.

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