LAW OF THE REPUBLIC OF KAZAKHSTAN

of April 6, 2015 No. 299-V ZRK

About modification and amendments in some legal acts of the Republic of Kazakhstan concerning health care

Article 1. Make changes and additions to the following legal acts of the Republic of Kazakhstan:

1. In the Labor code of the Republic of Kazakhstan of May 15, 2007 (The sheet of Parliament of the Republic of Kazakhstan, 2007, No. 9, Art. 65; No. 19, Art. 147; No. 20, Art. 152; No. 24, Art. 178; 2008, No. 21, Art. 97; No. 23, Art. 114; 2009, No. 8, Art. 44; No. 9-10, of Art. 50; No. 17, Art. 82; No. 18, Art. 84; No. 24, Art. 122, 134; 2010, No. 5, Art. 23; No. 10, Art. 48; No. 24, Art. 146, 148; 2011, No. 1, Art. 2, 3; No. 11, Art. 102; No. 16, Art. 128; 2012, No. 3, Art. 26; No. 4, Art. 32; No. 5, Art. 41; No. 6, Art. 45; No. 13, Art. 91; No. 14, Art. 92; No. 15, Art. 97; No. 21-22, of Art. 123; 2013, No. 2, Art. 13; No. 3, Art. 15; No. 7, Art. 36; No. 9, Art. 51; No. 10-11, of Art. 56; No. 14, Art. 72, 75; No. 15, Art. 78, 81; No. 16, Art. 83; No. 23-24, of Art. 116; 2014, No. 2, Art. 10, No. 7, Art. 37; No. 8, Art. 44, 49; No. 11, Art. 67; No. 14, Art. 84; No. 16, Art. 90; No. 19-I, 19-II, Art. 96; No. 21, Art. 122; No. 23, Art. 143; 2015, No. 1, Art. 2):

in Article 151 of the word of "giving (donation)" to replace with the word "donations".

2. In the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (Sheets of Parliament of the Republic of Kazakhstan, 2009, No. 20-21, of Art. 89; 2010, No. 5, Art. 23; No. 7, Art. 32; No. 15, Art. 71; No. 24, Art. 149, 152; 2011, No. 1, Art. 2, 3; No. 2, Art. 21; No. 11, Art. 102; No. 12, Art. 111; No. 17, Art. 136; No. 21, Art. 161; 2012, No. 1, Art. 5; No. 3, Art. 26; No. 4, Art. 32; No. 8, Art. 64; No. 12, Art. 83; No. 14, Art. 92, 95; No. 15, Art. 97; No. 21-22, of Art. 124; 2013, No. 1, Art. 3; No. 5-6, of Art. 30; No. 7, Art. 36; No. 9, Art. 51; No. 12, Art. 57; No. 13, Art. 62; No. 14, Art. 72, 75; No. 16, Art. 83; 2014, No. 1, Art. 4; No. 7, Art. 37; No. 10, Art. 52; No. 11, Art. 65; No. 14, Art. 84, 86; No. 16, Art. 90; No. 19-I, 19-II, Art. 96; No. 21, Art. 122; No. 23, Art. 143; 2015, No. 1, Art. 2):

1) in all text changes in Kazakh are made, the text in Russian does not change;

2) in table of contents:

add with heading of Article 7-1 of the following content:

"Article 7-1. Competence of state body in the field of sanitary and epidemiologic wellbeing of the population";

to state heading of Article 15 in the following edition:

"Article 15. Certification on professional competence of specialists in the field of health care";

to state heading of Chapter 5 in the following edition:

"Chapter 5. The state control and supervision in the field of health care and pharmaceutical inspectorate in the field of drug circulation";

add with heading of Article 22-1 of the following content:

"Article 22-1. Pharmaceutical inspectorate in the field of drug circulation";

to state heading of Article 24 in the following edition:

"Article 24. Forms of financing of the subjects of health care rendering the guaranteed amount of free medical care";

add with heading of Article 66-1 of the following content:

"Article 66-1. State pharmacopeia of the Republic of Kazakhstan";

72, of 74, of 76, of 77, 80-2, 81 and 84 to state headings of Articles in the following edition:

"Article 72. Preclinical (not clinical) researches of biologically active agents, pharmacological, medicines, products of medical appointment and medical equipment";

"Article 74. Clinical trials pharmacological, medicines, products of medical appointment and medical equipment";

"Article 76. Purchase of the medicines and products of medical appointment intended for rendering the guaranteed amount of free medical care

Article 77. Single distributor";

"Article 80-2. Import of medicines, products of medical appointment and medical equipment, and also biologically active agents, pharmacological means and biological material of preclinical (not clinical) and clinical trials, standard samples of medicinal substances and their impurity for personal use and other non-commercial purposes";

"Article 81. Procedure for export of medicines, products of medical appointment and medical equipment, and also biologically active agents, pharmacological means and biological material of preclinical (not clinical) and clinical trials, standard samples of medicinal substances and their impurity";

"Article 84. Prohibition, suspension or retirement or restriction of use of medicines, products of medical appointment and medical equipment";

add with heading of Article 84-1 of the following content:

"Article 84-1. Counterfeited medicines, products of medical appointment and medical equipment";

85, of 86, of 101, of 107, of 108, of 109, 110 and 111 to state headings of Articles in the following edition:

"Article 85. Pharmakonadzor of medicines and monitoring of side effects of medicines, products of medical appointment and medical equipment

Article 86. Information on medicines, products of medical appointment and medical equipment";

"Article 101. Donorship of gametes, tissues of reproductive organs";

"Article 107. The basis and procedure for the direction of citizens, TB patients, on forced treatment

Article 108. The rights of the TB patients who are on forced treatment

Article 109. Treatment and content of TB patients in the specialized antitubercular organizations

Article 110. Medical observation and treatment of TB patients after the end of forced treatment

Article 111. Public assistance to TB patients";

add with heading of Article 135-1 of the following content:

"Article 135-1. Delivery of health care to separate categories of government employees and citizens";

to state headings of Articles 146 and 148 in the following edition:

"Article 146. State registration of products making harmful effects on health of the person";

"Article 148. Sanitary and anti-epidemic and sanitary and preventive actions";

add with heading of Article 148-1 of the following content:

"Article 148-1. Radiation control in the field of sanitary and epidemiologic wellbeing of the population";

to state heading of Article 159 in the following edition:

"Article 159. Prevention and restriction of consumption of tobacco products and alcohol";

to state heading of Chapter 27 in the following edition:

"Chapter 27. Transplantation of fabrics (part of fabric) and (or) bodies (part of bodies)";

169, 170 and 176 to state headings of Articles in the following edition:

"Article 169. Transplantation of fabrics (part of fabric) and (or) bodies (part of bodies) and condition of their withdrawal

Article 170. Procedure for transplantation of fabrics (part of fabric) and (or) bodies (part of bodies)";

"Article 176. Certification of specialists in the field of health care";

add with heading of Article 176-1 of the following content:

"Article 176-1. Assignment and withdrawal of qualification categories";

3) in Item 1 of Article 1:

1) to state the subitem in the following edition:

"1) the authorized generic - the medicine identical to original medicine issued by the same producer, but differing in the trade name and the price;";

add with subitem 1-1) of the following content:

"1-1) habitats of the person (further - the habitat) - set of natural, anthropogenous and social factors, the environments (natural and artificial) determining conditions of life activity of the person;";

in the subitem 4) "(preventive)" shall be replaced with words the word "and sanitary and preventive";

add with subitems 15-1), 15-2), 15-3) and 15-4) of the following content:

"15-1) medicines of biological origin - the medicines containing biological substances (hormones, cytokines, the fibrillation factors, insulin, monoclonal antibodies, enzymes, colony stimulating factors, medicines created based on cells of fabrics, and other, received by means of biotechnological methods);

15-2) биосимиляр - biotechnological medicine, similar with (original) medicine made for the first time on quality, safety, efficiency and provided on registration after expiration of the patent of original medicine;

15-3) biotechnological medicine - the biological medicine made by bioengineering procedures using technology of recombinant deoxyribonucleic acid, method of controlled expression of the genes coding development of biologically active proteins, method of hybrid and monoclonal antibodies, and also gene and therapeutic and somatotherapeutical medicines of genetically engineered modification;

15-4) certificate on assignment of qualification category - the document of the established sample confirming assignment of the corresponding qualification category;";

16) and 16-1) to state subitems in the following edition:

"16) original medicine - the medicine representing or containing new active agents which efficiency and safety are confirmed with results of preclinical and clinical trials, and registered based on the complete file;

16-1) single distributor - the legal entity performing within the guaranteed amount of free medical care purchase of medicines, products of medical appointment, services in storage and transportation of medicines, products of medical appointment and the conclusion of agreements, long-term agreements, and also the organization of purchase of medical equipment;";

add with subitems 16-2) and 16-3) of the following content:

"16-2) haematopoietic stem cells - the part of fabric of the internal circle of organism, cells of marrow of the person having polipotentnost which are in process of life in marrow, peripheral blood (after stimulation) and umbilical blood;

16-3) homeopathic medicines - the medicines containing substances of natural origin in small doses and made on special technology;";

18) to state the subitem in the following edition:

"18) medicine - the means representing or containing pharmacological the active agents coming into contact with human body or getting into its bodies and fabrics intended for prevention, diagnostics and treatment of diseases, and also change of condition and functions of organism: medicinal substance, medicinal raw materials, balk-products of medicines, medicines;";

add with subitems 18-1) and 18-2) of the following content:

"18-1) long-term agreement of supply of medicines, products of medical appointment - the civil agreement signed by the single distributor with the legal entity - the resident of the Republic of Kazakhstan on supply of medicines, the products of medical appointment made according to requirements of proper production practice (GMP) for medicines and requirements of the international standard for products of medical appointment having the certificate of origin for the internal address according to the legislation of the Republic of Kazakhstan or with the legal entity having intention on creation of production of medicines, products of medical appointment according to requirements of proper production practice (GMP) for medicines and requirements of the international standard for products of medical appointment;

18-2) long-term agreement on storage and transportation of medicines, products of medical appointment - the civil agreement of rendering services signed by the single distributor with the legal entity - the resident of the Republic of Kazakhstan according to requirements of proper distributor practice (GDP);";

19) to exclude the subitem;

add with subitems 20-1), 21-1), 21-2) and 21-3) of the following content:

"20-1) contract manufacturing of medicines, products of medical appointment and medical equipment - production of medicines, products of medical appointment and medical equipment to order on production capacities of the producer which provides full compliance with requirements of proper production practice (GMP) for medicines and requirements of the international standard for products of medical appointment and medical equipment;";

"21-1) proper pharmaceutical practicians in the field of drug circulation (further - proper pharmaceutical practicians) - the standards in the field of health care extending to all stages of lifecycle of medicines: proper laboratory practice (GLP), proper clinical practice (GCP), proper production practice (GMP), proper distributor practice (GDP), proper pharmaceutical practice (GPP), proper practice of pharmakonadzor (GVP) and other proper pharmaceutical practicians;

21-2) pharmaceutical inspectorates in the field of drug circulation - the structural division of authorized body performing pharmaceutical inspection;

21-3) regulating documents on control of quality and safety of medicines, products of medical appointment - the document establishing complex of the quality requirements of medicine, to products of medical appointment, and also techniques of its determination providing their identical parameters of safety and qualities;";

23) to state the subitem in the following edition:

"23) objects in the field of drug circulation, products of medical appointment and medical equipment - drugstore, pharmaceutical Item in the organizations of health care rendering primary medical and sanitary and (or) consulting and diagnostic help, the mobile pharmaceutical unit for the remote rural zones organized from drugstore, pharmaceutical warehouse, warehouse of temporary storage of medicines, products of medical appointment and medical equipment, shop of optics, shop of medical equipment and products of medical appointment, the warehouse of medical equipment and products of medical appointment, the organization for production of medicines, products of medical appointment and medical equipment functioning according to the standard provisions approved by authorized body in the field of health care;";

add with subitems 24-1), 24-2), 25-1) and 25-2) of the following content:

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