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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 3, 2020 No. KR DSM-177/2020

About approval of rules of issue of the conclusions (allowing documents) for import to the territory of the Republic of Kazakhstan from the states which are not members of the Eurasian Economic Union and export from the territory of the Republic of Kazakhstan to these states of samples of biological materials of the person, haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos

(as amended of the Order of the Minister of Health of the Republic of Kazakhstan of 07.12.2021 No. KR DSM-126)

According to the subitem 13) of article 8 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" and the subitem 1) of article 10 of the Law of the Republic of Kazakhstan of April 15, 2013 "About the state services" I ORDER:

1. Approve the enclosed rules of issue of the conclusions (allowing documents) for import to the territory of the Republic of Kazakhstan from the states which are not members of the Eurasian Economic Union and export from the territory of the Republic of Kazakhstan to these states of samples of biological materials of the person, haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos.

2. Recognize invalid some orders of the Ministry of Health of the Republic of Kazakhstan according to appendix to this order.

3. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) placement of this order on official Internet resource of the Ministry of Health of the Republic of Kazakhstan;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

5. This order becomes effective after ten calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Tsoi

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of November 3, 2020, No. KR DSM-177/2020

Rules of issue of the conclusions (allowing documents) for import to the territory of the Republic of Kazakhstan from the states which are not members of the Eurasian Economic Union and export from the territory of the Republic of Kazakhstan to these states of samples of biological materials of the person, haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos

Chapter 1. General provisions

1. These rules of issue of the conclusions (allowing documents) for import to the territory of the Republic of Kazakhstan from the states which are not members of the Eurasian Economic Union and export from the territory of the Republic of Kazakhstan to these states of samples of biological materials of the person, haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos (further – Rules) are developed according to the subitem 13) of article 8 of the Code of the Republic of Kazakhstan "About health of the people and health care system" and the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services" (further – the Law of the Republic of Kazakhstan) and determine procedure for issue of the conclusions (allowing documents) for import to the territory of the Republic of Kazakhstan from the states which are not members of the Eurasian Economic Union and export from the territory of the Republic of Kazakhstan to these states of samples of biological materials of the person, haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos.

2. In these rules the following basic concepts are used:

1) waste products of the person – the biological substances emitted by the person on internal environment of organism or external environment;

2) biological materials – samples of physiological and pathological liquids, fabrics, secrets and waste products of the person which treat: amniotic liquid, pus, blood, lymph, phlegm, colostrum, urine, prostate gland secret, slime of mucous membranes, synovial liquid, sperm, cerebrospinal fluid, fabric liquid, pleural liquid, nasal slime, sweat, transudate, ear sulfur, exudate, biopsionny material, histologic cuts, dabs, scrapings, washouts, pathological allocations, scraping, secret, physiological allocations, washout, fabric, and also samples of deoxyribonucleic acid (further - DNA);

3) haematopoietic stem cells – the haematogenic cells of marrow of the person having polipotentnost and being in process of life in marrow, peripheral blood and umbilical blood;

4) the donor – the person, corpse of the person, animal from which are made donor blood sampling, its components, other donor material (including sperm, ova, tissues of reproductive organs, gametes, embryos), and also removal of organs (part of body) and (or) fabrics (part of fabric) for transplantation to the recipient;

5) cage – the main structurally functional unit of human body having own metabolism capable to independent existence, self-reproduction and development;

6) consultation – research of person for the purpose of establishment of the diagnosis, determination of tactics of treatment and the forecast of disease with participation at least three doctors;

7) the recipient – the patient to whom transfusion of donor blood or the components and (or) medicines allocated from it, introduction of men's or women's donor material (sperm, ovum, embryos) or organ transplantation (part of body) and (or) fabrics (part of fabric) from the donor, and also artificial organs (part of bodies) is carried out;

8) marrow – the fabric performing blood formation, located in internal part of bones and including haematopoietic stem cells, stroma and other components of microenvironment;

9) the informed consent – the procedure of written voluntary confirmation by person of the consent to receipt of medical care and (or) participation in specific research after receipt of information on all significant for adoption of the decision by it aspects of medical care and (or) research. The informed written consent is drawn up in the form approved by authorized body.

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