Article 10. The competence of the state body in the field of circulation of medicines and medical devices is the Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

Home / RLA / Article 10. The competence of the state body in the field of circulation of medicines and medical devices is the Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

Article 10. The competence of the state body in the field of circulation of medicines and medical devices is the Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

The state body in the sphere of circulation of medicines and medical devices:

1) implements the state policy in the field of circulation of medicines and medical devices;

2) carries out state control in the sphere of circulation of medicines, medical devices, as well as over the turnover of narcotic drugs, psychotropic substances and precursors in the field of healthcare;

3) approves, within its competence, legal acts and forms of accounting and accounting documentation in the field of circulation of medicines and medical devices;

4) excluded by the Law of the Republic of Kazakhstan dated 04/25/2025 No. 185-VIII (effective ten calendar days after the date of its first official publication).

5) carries out licensing of the types of pharmaceutical activities specified in the sub-paragraphs 1), 2), 3), 4), 5) and 7) Articles 230 of this Code, as well as types of activities related to trafficking in narcotic drugs, psychotropic substances and precursors in the field of healthcare;

6) coordinates the activities of healthcare organizations in the field of circulation of medicines and medical devices;

7) carries out state registration, re-registration and modification of the registration dossier, revocation of the decision on state registration of medicines and medical devices, maintains the State Register of Medicines and Medical Devices;

8) coordinates the import (export) of medicines and medical products registered and not registered in the Republic of Kazakhstan;

9) approves standards of good pharmaceutical practices;

10) receives notifications on the commencement or termination of the activities specified in subitems 4), 5) and 6) of paragraph 1 of Article 24 of this Code, in accordance with the procedure established by the Law of the Republic of Kazakhstan "On Permits and Notifications", and also maintains the state electronic register of permits and notifications;

11) issues a certificate for a pharmaceutical product (CPP);

12) issues a permit for conducting an interventional clinical trial of a medicinal product or medical device;

13) decides on the suspension of the medical use of a medicinal product or medical product by suspending the validity of the registration certificate of a medicinal product or medical product, as well as the prohibition of medical use and on the withdrawal from circulation or suspension of the medical use of a series (batch) of medicinal products and medical products;

14) carries out the accreditation of testing laboratories engaged in monopoly activities for the examination and assessment of the safety and quality of medicines and medical devices;

15) approves the rules for the wholesale and retail sale of medicines and medical devices;

16) approves checklists, risk assessment criteria and semi-annual schedules for conducting inspections in the regulated area in accordance with the Business Code of the Republic of Kazakhstan;

17) approves the rules for conducting inspections in the field of circulation of medicines and medical devices;

18) carries out pharmaceutical inspections;

19) approves the rules for the formation of the pharmaceutical inspectorate, maintaining the register of pharmaceutical inspectors of the Republic of Kazakhstan;

20) approves the rules for the selection of medicines and medical devices from the market, including in medical organizations, subject to quality control, taking into account a risk-based approach;

21) participates in determining the procedure for labeling goods and the procedure for monitoring the turnover of goods subject to labeling;

22) performs other functions stipulated by this Code, other laws of the Republic of Kazakhstan, acts of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan.

President

Republic of Kazakhstan

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