Article 55-1. Investigation into the circulation of medicines and medical devices Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. Investigations are conducted on the grounds provided for in subparagraphs 1) and 3) of paragraph 3 of Article 144-4 of the Entrepreneurial Code of the Republic of Kazakhstan.
2. Investigations are conducted by officials provided for in paragraph 1 of Article 53 of this Code, in accordance with this Code, the Business Code of the Republic of Kazakhstan and the procedure for conducting investigations in the field of circulation of medicines and medical devices.
3. Subjects (objects) of control and supervision in the framework of the investigation are obliged to ensure:
1) providing officials, experts and specialists with special clothing and personal protective equipment, the requirement for the availability of which is provided for by internal documents of the subject (object) of control and supervision;
2) submission of documents and (or) materials, including archival, explanations on paper and (or) in electronic form, related to the case of the investigation, as well as providing access to automated databases (digital systems);
3) an unhindered opportunity to conduct an inspection of the facility, take samples of medicines and medical products, raw materials, components;
4) unhindered access to officials, members of the commission, experts and specialists involved in the territory of the facility related to the subject of the investigation (residential and administrative buildings, buildings, facilities, premises and other facilities).
4. As part of the investigation, samples of medicines and medical devices, raw materials, and components may be taken for laboratory testing.
5. In the course of the investigation, the reasons for the violation of the requirements of the legislation of the Republic of Kazakhstan are established, the subjects (objects) of control and supervision are identified who committed violations of the requirements of the legislation of the Republic of Kazakhstan, which became the basis for the investigation.
6. Based on the results of the investigation, an act on the results of the investigation is drawn up, which, among other things, reflects the identified violations, instructions for their elimination, and deadlines for eliminating the identified violations.
The time limits for the elimination of identified violations are determined taking into account the circumstances affecting the actual possibility of its execution, but not less than ten calendar days from the date of delivery of the act on the results of the investigation.
7. If additional time and (or) financial costs are required to eliminate the identified violations, the subject (object) of control and supervision has the right to apply to the state body in the field of circulation of medicines and medical devices, which conducted the investigation, no later than three working days from the date of delivery of the act on the results of the investigation, with an application for an extension of the period for eliminating the identified violations..
8. Appealing against the results of the investigation does not suspend the execution of the act on the results of the investigation.
9. If a subject (object) of control and supervision is identified as having violated the requirements of the legislation of the Republic of Kazakhstan, measures are taken to bring persons to justice in accordance with the procedure established by the laws of the Republic of Kazakhstan.
10. In case of early elimination of the identified violations specified in the act on the results of the investigation, or within the time limits specified in the act on the results of the investigation, the subject (object) of control and supervision is obliged to provide information on the elimination of the identified violations to the state body in the field of circulation of medicines and medical devices that conducted the investigation.
The subject (object) of control and supervision shall attach materials proving the fact of elimination of violations to the information provided on the elimination of identified violations.
In cases of providing information on the elimination of identified violations, as well as failure to provide it within the time limits specified in the act on the results of the investigation, an unscheduled inspection is carried out.
11. Non-compliance with the provisions of this article and the rules for conducting investigations in the field of circulation of medicines and medical devices is the basis for invalidating acts on prescribing, extending the terms and results of an investigation and (or) canceling them.
12. The results of the investigation, with the exception of information constituting state secrets or other secrets protected by the laws of the Republic of Kazakhstan, are published within ten working days after the end of the investigation on the Internet resource of the state body in the field of circulation of medicines and medical devices that conducted the investigation.
Code of the Republic of Kazakhstan "on Public Health and the healthcare system" dated July 7, 2020
The article was amended and supplemented by the Law of the Republic of Kazakhstan dated July 7, 2026, No. 334-VIII SAM.
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