Article 55-2. Rapid response measures and the procedure for their application in the field of circulation of medicines and medical devices Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. During the implementation and (or) based on the results of state control and supervision by the state body in the field of circulation of medicines and medical devices and its territorial divisions, rapid response measures are applied if medicines and medical devices that pose an immediate threat to constitutional rights, freedoms and legitimate interests are identified in the activities of the subject (object) of control and supervision. individuals and legal entities, human life and health, environment, national security of the Republic of Kazakhstan.
2. Rapid response measures are the methods of influencing subjects (objects) of control and supervision provided for in this article, applied during the implementation and (or) based on the results of an inspection or investigation.
In case of detection of violations of the requirements that are the basis for the application of rapid response measures, during the implementation and (or) based on the results of the audit, investigation, rapid response measures are applied without initiating administrative proceedings.
3. Rapid response measures include the following types::
1) suspension of the activity of the subject (object) of control and supervision over the production and sale of medicines and medical devices;
2) suspension, recall and withdrawal from circulation of medicines and medical devices that do not comply with the requirements of the legislation of the Republic of Kazakhstan and (or) acts of the Eurasian Economic Union.
4. The grounds for the application of rapid response measures are violations of the requirements established by the legislation of the Republic of Kazakhstan, which are the subject of state control and supervision in accordance with Article 52 of this Code.
5. The state body in the field of circulation of medicines and medical devices, in the course of carrying out and (or) following the results of an inspection or investigation, if a violation of the requirements is found, which is the basis for the application of rapid response measures, draws up an act of supervision in the form of a resolution provided for in subparagraph 3) paragraph 2 of Article 54 of this Code.
6. In case of refusal to accept the act of supervision, upon its delivery, a corresponding entry is deliberately made in it and a video recording is made recording the fact of refusal to accept the act. The act of supervision is sent to the legal address, location or actual address of the subject (object) of control and supervision by registered mail with a notification of its delivery.
7. Refusal to receive an act of supervision is not a reason for its non-fulfillment.
8. Violations of the requirements identified during the implementation and (or) as a result of the audit and investigation, which are the basis for the application of rapid response measures, are reflected in the act on the results of the audit and investigation, as well as in the instruction on the elimination of identified violations of the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare.
9. The subject (object) of control and supervision is obliged to eliminate the identified violations, which are the basis for the application of rapid response measures, within the time limits specified in the act on the results of the audit, the instruction on the elimination of identified violations of the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare.
10. Before the expiration of the time limits stipulated by the regulation on the elimination of identified violations, acts on the results of verification, investigation, the subject (object) of control and supervision is obliged to provide information on the elimination of identified violations with the attachment of materials proving the fact of elimination of violations.
11. If information is provided on the elimination of identified violations that are the basis for the application of rapid response measures, in accordance with paragraph 10 of this article or after the expiration of the time limits for the elimination of violations identified during the implementation and (or) based on the results of an inspection or investigation, an unscheduled inspection is conducted to monitor their elimination.
12. In case of failure to eliminate the identified violations that are the basis for the application of rapid response measures, based on the results of an unscheduled inspection or investigation, measures are taken to bring the perpetrators to justice in accordance with the procedure established by the laws of the Republic of Kazakhstan.
13. The subject (object) of control and supervision, in case of disagreement with the results of the audit or investigation, which led to the application of rapid response measures, may file a complaint about the invalidation of the act of supervision and its cancellation.
A complaint is filed with a higher state body in accordance with the procedure provided for in Article 29 of this Code, or with a court in accordance with the procedure established by the legislation of the Republic of Kazakhstan.
Filing a complaint does not suspend the execution of the act of supervision.
14. The grounds for the recognition of acts of supervision by a higher authority or official as invalid and their cancellation are:
1) the lack of grounds for the application of rapid response measures;
2) the application of rapid response measures on grounds that do not correspond to this measure;
3) the use by control and supervisory authorities in the field of circulation of medicines and medical devices of rapid response measures on issues outside their competence;
4) failure to comply with the procedure for coordinating and taking prompt response measures established by Article 153 of the Entrepreneurial Code of the Republic of Kazakhstan.
15. Information on the application of rapid response measures is sent to the state body that carries out activities in the field of state legal statistics and special accounting within its competence, in accordance with the procedure determined by the Prosecutor General's Office of the Republic of Kazakhstan.
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.
President
Republic of Kazakhstan
Constitution Law Code Standard Decree Order Decision Resolution Lawyer Almaty Lawyer Legal service Legal advice Civil Criminal Administrative cases Disputes Defense Arbitration Law Company Kazakhstan Law Firm Court Cases Declaration Decree Order Resolution Decision Report Conclusion Statement Conclusion Convention Contract Memorandum Methodology Norms Note Rules Program Charter Charter Article Commentary Resolution Regulations Protocol Draft Program Rules Messages
