LAW OF THE REPUBLIC OF KAZAKHSTAN

of December 28, 2018 No. 211-VI ZRK

About modification and amendments in some legal acts of the Republic of Kazakhstan concerning drug circulation and medical products

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

1. 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; No. 7, Art. 33; No. 10, Art. 50; No. 19-II, Art. 102; No. 20-IV, Art. 113; No. 20-VII, Art. 115; No. 22-І, Art. 143; No. 22-V, Art. 156; No. 23-II, Art. 170; 2016, No. 6, Art. 45; No. 8-II, Art. 67, 70; No. 23, Art. 119; 2017, No. 1-2, of Art. 3; No. 4, Art. 7; No. 9, Art. 22; No. 13, Art. 45; No. 22-III, Art. 109; No. 23-III, Art. 111; No. 24, Art. 115; 2018, No. 10, Art. 32; No. 14, Art. 42; No. 15, Art. 47; No. 19, Art. 62):

1) in table of contents:

to state heading of Chapter 5 in the following edition:

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

to state heading of Article 22 in the following edition:

"Article 22. The state control in the field of drug circulation and medical products";

to exclude heading of Article 22-1;

to state headings of Articles 63 and 63-1 in the following edition:

"Article 63. Examination of medicines and medical products

Article 63-1. Assessment of safety and quality of the medicines and medical products registered in the Republic of Kazakhstan";

add Chapter 12 with heading of Article 64-1 of the following content:

"Article 64-1. Assessment of technologies of health care";

to state heading of Section 4 in the following edition:

"Section 4. Pharmaceutical activities and drug circulation and medical products";

65, of 67, 68 and 69 to state headings of Articles in the following edition:

"Article 65. System of the sphere of drug circulation and medical products";

"Article 67. Production of medicines and medical products

Article 68. Production of medicines and medical products

Article 69. Wholesale and retail sale of medicines and medical products";

to state heading of Chapter 14 in the following edition:

"Chapter 14. Drug circulation and medical products";

70, of 71, of 72, of 73, 74 and 75 to state headings of Articles in the following edition:

"Article 70. Development of medicines and medical products

Article 71. State registration, re-registration and modification of the registration file of medicine or medical product

Article 72. Preclinical (not clinical) researches of medicines and research (testing) of assessment of biological effect of medical products

Article 73. Technical testing of medical products

Article 74. Clinical trials of medicines, medical products and clinical laboratory testing of medical products for diagnostics of in vitro

Article 75. Marking of medicines and medical products";

add with heading of Article 75-1 of the following content:

"Article 75-1. Pharmaceutical inspectorate on proper pharmaceutical practicians";

in Article 76 heading:

shall be replaced with words words of "products of medical appointment" "medical products";

add with words ", and medical care in system of compulsory social medical insurance";

add with heading of Article 77-1 of the following content:

"Article 77-1. Powers of the single operator";

78, of 79, of 80, 80-1, 80-2 and 81 to state headings of Articles in the following edition:

"Article 78. Storage and transportation of medicines and medical products

Article 79. Destruction of medicines and medical products

Article 80. Procedure for import of medicines and medical products on the territory of the Republic of Kazakhstan

Article 80-1. Persons to whom import of medicines and medical products to the territory of the Republic of Kazakhstan is resolved

Article 80-2. Import of medicines and medical products, and also biological material of preclinical (not clinical) and clinical trials, standard samples of pharmaceutical substances (active pharmaceutical substances) and their impurity on the territory of the Republic of Kazakhstan for personal use and other non-commercial purposes";

"Article 81. Procedure for export of medicines and medical products, and also biological material of preclinical (not clinical) and clinical trials, standard samples of pharmaceutical substances (active pharmaceutical substances) and their impurity from the territory of the Republic of Kazakhstan";

to state heading of Chapter 15 in the following edition:

"Chapter 15. General requirements of safety to medicines and medical products";

82, of 83, of 84, 84-1, 85 and 86 to state headings of Articles in the following edition:

"Article 82. Installation, repair, technical and metrological servicing of medical products

Article 83. Classification of safety and reclassification of safety of medical products depending on degree of potential risk of application

Article 84. Suspension, prohibition or retirement or restriction of use of medicines and medical products

Article 84-1. Counterfeited medicines and medical products

Article 85. Pharmakonadzor and monitoring of safety, quality and efficiency of medical products

Article 86. Information on medicines and medical products";

add Chapter 15 with heading of Article 86-1 of the following content:

"Article 86-1. State regulation of the prices of medicines or medical products";

add Chapter 15 with headings of Articles 86-2 and 86-3 of the following content:

"Article 86-2. Rational use of medicines

Article 86-3. Ethical promotion of medicines and medical products";

2) in Item 1 of Article 1:

add with subitems 13-1) and 13-2) of the following content:

"13-1) list of medicines and medical products for free and (or) preferential out-patient ensuring separate categories of citizens with certain diseases (conditions) - the list of medicines, medical products and the specialized medical products bought at the expense of budgetary funds and assets of fund of social medical insurance within the guaranteed amount of free medical care and in system of compulsory social medical insurance for rendering the out-patient and polyclinic help, including names and characteristics of medicines, medical products and specialized medical products by separate categories of citizens with certain diseases (conditions);

13-2) biosimilar medicine (bioanalogue, biosimilar medicine, биосимиляр) - biological medicine which contains the version of active ingredient of the registered biological original medicine or reference medicine and on which similarity (similarity) on the basis of comparative researches on indicators of quality, biological activity, safety and efficiency is shown;";

subitems 15), 15-1) and 15-2) to state in the following edition:

"15) dietary supplements - natural and (or) identical natural biologically active agents, and also the pro-biotic microorganisms intended for the use along with food or introductions in structure of food products;

15-1) biological medicine - medicine which active ingredient is made or emitted from biological source and the description of properties and which quality control requires combination of biological and physical and chemical methods of the analysis to assessment of production process and methods of its control;

15-2) biotechnological medicine - the medicine made by means of bioengineering procedures and application of methods with use of technology of recombinant deoxyribonucleic acid, controlled expression of the genes coding development of biologically active proteins, gibridomny technologies, monoclonal antibodies or other bioengineering procedures;";

exclude subitem 15-3);

state subitem 15-4) in the following edition:

"15-4) ceiling price for the trade name of medicine for retail sale - the price of the trade name of medicine above which its retail sale cannot be enabled;";

add with subitems 15-5) and 15-6) of the following content:

"15-5) certificate on assignment of qualification category - the document of the established sample confirming assignment of the corresponding qualification category;

15-6) original medicine - medicine with new active ingredient which was registered and placed by the first in the world pharmaceutical market based on the file containing results of the complete preclinical (not clinical) and clinical trials confirming its safety, quality and efficiency;";

16) to exclude the subitem;

subitems 16-3), 18), 18-1) and 18-2) to state in the following edition:

"16-3) homeopathic medicine - the medicine made on homeopathic technology with use of homeopathic raw materials according to requirements of pharmacopeias of the Republic of Kazakhstan and (or) the Eurasian Economic Union or in case of their absence according to requirements of homeopathic pharmacopeias;";

"18) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

18-1) long-term agreement of supply of medicines and medical products - the civil agreement signed by the single distributor for up to ten years with producers of medicines, medical products of the Republic of Kazakhstan or the customer of the contract manufacturing of medicines and medical products located in the territory of the Republic of Kazakhstan on supply of the medicines and medical products made according to requirements of proper production practice (GMP) for medicines and requirements of the international standard of quality management system (ISO 13485) for medical products, except for medical products of class of safety of potential risk of application 1 and 2a (except sterile); or with the subject in the field of drug circulation and medical products having intention to create and modernize production of medicines and medical products or contract manufacturing of medicines and medical products with the producer of medicines located in the territory of the Republic of Kazakhstan, according to requirements of proper production practice (GMP) for medicines, and for medical products according to requirements of the international standard of quality management system (ISO 13485), except for medical products of class of safety of potential risk of application 1 and 2a (except sterile), according to the procedure, established by the legislation of the Republic of Kazakhstan;

18-2) long-term agreement on storage and transportation of medicines and medical products - the civil agreement of rendering services signed by the single distributor with the subject in the field of drug circulation and medical products - resident of the Republic of Kazakhstan, to relevant requirements of proper distributor practice (GDP);";

add with subitem 18-3) of the following content:

"18-3) ceiling price for medicine - the price above which the realization of medicine cannot be enabled;";

add with subitems 18-4), 18-5), 18-6), 18-7) and 18-8) of the following content:

"18-4) producer of medicines - the organization which is performing activities for production of medicines and having the license for production of medicines;

18-5) register of authorized persons of producers of medicines - the information resource of authorized body in the field of health care containing data on authorized persons of producers of medicines;

18-6) rational use of medicines - the drug treatment corresponding to clinical indications in the doses meeting individual needs of the patient during the sufficient period of time and in case of the smallest costs;

18-7) web portal of purchase of medicines and medical products - the information system providing single point of access to electronic services of purchase of medicines and medical products within the guaranteed amount of free medical care and in system of compulsory social medical insurance;

18-8) single operator in the field of purchases of medicines and medical products (further - the single operator) - the legal entity determined by authorized body in the field of health care in coordination with authorized body in the field of public procurements;";

subitems 20), 20-1) and 21) to state in the following edition:

"20) retail sale of medicines and medical products - the pharmaceutical activities connected with acquisition (except import), storage, distribution, realization (except export) to the final consumer, destruction of medicines and medical products, performed according to the rules approved by authorized body in the field of health care;

20-1) contract manufacturing of medicines and medical products (further - contract manufacturing) - production of medicines and medical products on contractual basis on production capacities of producers of the medicines and medical products located in the territory of the Republic of Kazakhstan which provide full compliance with requirements of proper production practice (GMP) for medicines;

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