The Law of the Republic of Kazakhstan (hereinafter – the “RK”) dated April 6, 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

• 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].

Control and Supervision in the field of Medical Services, Sanitary and Epidemiological Control and Supervision, Control in the field of Circulation of Medicines and MD

The provisions regulating Control and Supervision over the provision of Medical Services, Sanitary and Epidemiological Control and Supervision, Control in the area of circulation of Medicines and MD have been amended, including:

• 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]:

1) Preventive Control with a visit to the subject (object) of Control and Supervision, Unscheduled Inspection in accordance with the Entrepreneurial Code of the RK;

2) Preventive Control without visiting the subject (object) of Control and Supervision in accordance with the Code, the Entrepreneurial Code of the RK and the Law of the RK “On Advertising”.

• 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]:

1) television and radio channels;

2) periodicals;

3) Internet resources and online publications;

4) outdoor (visual) advertising.

Carrying out monitoring of advertising consists of checking compliance with the requirements for the placement of advertising subject to State Sanitary and Epidemiological Control and Supervision of products (goods) as well as the availability of information about its state registration in the Unified Register of Certificates of State Registration of Products.

In case of violation of the requirements of the legislation of the RK in the field of advertising:

1) the advertiser and/or advertising distributor is sent a recommendation to eliminate the identified violations in accordance with Article 44 of the Code;

2) a rapid response measure is applied to the subject of Control and Supervision in the form of seizure and recall from sale of products (goods);

3) information about the violator is sent to the Authorized Body for Mass Media in the manner prescribed by the legislation of the RK.

Other

• 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].

The Law on Doing Business comes into force after 60 (sixty) calendar days from the day of its first official publication[12] (Published: “Kazakhstanskaya Pravda” dated April 8, 2024 No. 67-68 (30194-30195); IS “Standard Control Bank NLA RK in electronic form" April 11, 2024)[13]

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.