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Legislation of the RK on pharmacovigilance

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1. Code of the Republic of Kazakhstan on the people's health and the health care system (with alterations and amendments as of 19.01.2011.):
   Article 84. Prohibition, suspension or withdrawal of medicinal products, medical devices and medical equipmentThe competent authority may prohibit or suspend the use, sale or manufacture of drugs, medical supplies and medical equipment, as well as the decision on retirement in cases of:

2. Inconsistencies of drugs, medical supplies and medical equipment with the technical regulations and normative documents for standardization;

3. Detection of adverse drug reactions that are dangerous to human health, not mentioned in the instructions for use of drug;

4. The findings in the application of medical devices or medical technology of defects in design, principle of operation, production performance, affecting safety of their application;

5. Violations of the approved process of production of drugs, medical supplies and medical equipment, affecting the quality, safety and efficiency of their application;

6. The available data about harming the patient's health or the consumer in connection with the use of drugs, medical supplies and medical equipment;

7. Obtaining data on lack of scientific and technological level of production technology and quality control, ensuring reduction of the safety of drugs, medical supplies and medical equipment.

8. The order of prohibition, suspension or retirement is being established by the authorized body.

9. Article 85. Monitoring of adverse drug reactions

10. Monitoring of adverse drug reactions is held in the medical and pharmaceutical organizations in the manner approved by the authorized body.

11. The subjects of healthcare are obliged to inform in writing the authorized body of the features of manifestations of drug interactions with other drugs and side effects, including those not listed in the instructions for use of drug.

12. RK MoH Order №647 dated 03.11.2010 «On approval of rules for monitoring adverse drug reactions in medical and pharmaceutical organizations»;

13. RK MoH Order №63 dated 6 of May 2005 «On the organization of monitoring adverse drug reactions» (RGP «NCED» - the authorized organization for the systematization, analysis and implementation of scientific assessment reports of the drug SE) ;

14. RK MoH Order №744 dated 19.11.2009 «On Approving the Rules for conducting clinical trials, and (or) the trials of pharmacological and medicinal products, medical devices and medical equipment»;

15. RK MoH Order №701 dated 12.11.2009 «On Approving the Rules for removal of the samples of drugs, medical supplies and medical equipment for the examination»