News and developments
Amendments have been introduced into the Code of the Republic of Kazakhstan dated July 7, 2020 No. 360-VI “On the Health of the People and the Healthcare system”
2024 No. 71-VIII “On Introduction of Amendments and Additions to Certain Legislative Acts of the Republic of Kazakhstan on Matters of Doing Business” (hereinafter – the “Law on Doing Business”) amended the Code of the RK dated July 7, 2020 No. 360-VI “On the Health of the People and the Healthcare System” (hereinafter – the “Code”).
Price Regulation
Footnotes [1] sp. 34, clause 10 of the Law on Doing Business; [2] sp. 3, clause 10 of the Law on Doing Business; [3] sp. 4, clause 10 of the Law on Doing Business; [4] sp. 2, Art. 10 of the Code (with changes and additions as of 05/01/2024). [5] sp. 5, clause 10 of the Law on Doing Business; [6] sp. 22, clause 10 of the Law on Doing Business; [7] sp. 11, 15, 19 clause 10 of the Law on Doing Business; [8] sp. 13, clause 10 of the Law on Doing Business; [9] sp. 18, clause 10 of the Law on Doing Business; [10] sp. 18, clause 10 of the Law on Doing Business; [11] sp. 35, clause 10 of the Law on Doing Business; [12] clause 1, Art. 2 of the Law on Doing Business. [13] The Law on Doing Business.
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- Changes have been introduced to the following provisions of the Code on price regulation, namely, the terms medical devices (hereinafter – the “MD”) have been replaced with “Medical Products, MD for diagnostics outside a living organism (in vitro) produced in the territory of the RK under the long-term supply agreements concluded with the Single Distributor";
- In clause 5 of Art. 245 of the Code, after the words Maximum Retail price, the word “Medicine” was added: the Maximum Retail price of a Medicine cannot be approved without taking into account the total Wholesale and Retail markup to the Manufacturer’s Maximum Price[1].
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- The development and approval of the procedure for conducting an investigation in the field of provision of Medical Services (Assistance) was added to the competence of the State Body overseeing the provision of Medical Services[2];
- The competence of the State Body for Sanitary and Epidemiological Welfare of the Population has been expanded to include inter alia defining the list of requirements a violation of which entails taking rapid response measures and exercising state control over compliance with the requirements for placing advertising which is subject to the State Sanitary and Epidemiological Control and Supervision of products (goods) subject to state registration[3];
- Now the State Body in the field of Circulation of Medicines and MD carries out only State Control in the field of circulation of Medicines, MD as well as the circulation of narcotic Medicines, psychotropic substances and precursors in the field of health care (in the previous version – carried out State Control and Supervision[4]) [5];
- A rule has been added stating that Preventive Control in the area of circulation of Medicines and MD without visiting the subject (object) of control is carried out in relation to all Medicines and MD[6];
- The articles 34-1 “Investigation in the field of provision of Medical Services (Assistance)”, 42-1 “Rapid response measures and the procedure for their application in the field of Sanitary and Epidemiological Welfare of the Population”, 45-1 “Investigations in the field of Sanitary and Epidemiological Welfare of the Population” have been added[7];
- Rules have been added stating that State Control over compliance with the requirements for placement of advertising subject to State Sanitary and Epidemiological Control and Supervision of products (goods) subject to state registration is carried out in the form of[8]:
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- A rule stating that monitoring of advertising of products (goods) subject to State Sanitary and Epidemiological Control and Supervision is carried out in relation to products subject to state registration has been added[9].
- The provisions stipulating the objects of advertising monitoring have been added[10]:
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- A rule stating that entities in the field of circulation of Medicines and MD carrying out retail sales of Medicines are required to comply with the requirements of good pharmacy practice (GPP) has been introduced. This rule will come into effect from January 1, 2026 for pharmacies (this rule has come into effect retrospectively on January 1, 2023)[11].
Footnotes [1] sp. 34, clause 10 of the Law on Doing Business; [2] sp. 3, clause 10 of the Law on Doing Business; [3] sp. 4, clause 10 of the Law on Doing Business; [4] sp. 2, Art. 10 of the Code (with changes and additions as of 05/01/2024). [5] sp. 5, clause 10 of the Law on Doing Business; [6] sp. 22, clause 10 of the Law on Doing Business; [7] sp. 11, 15, 19 clause 10 of the Law on Doing Business; [8] sp. 13, clause 10 of the Law on Doing Business; [9] sp. 18, clause 10 of the Law on Doing Business; [10] sp. 18, clause 10 of the Law on Doing Business; [11] sp. 35, clause 10 of the Law on Doing Business; [12] clause 1, Art. 2 of the Law on Doing Business. [13] The Law on Doing Business.