Article 259. Suspension, prohibition or withdrawal from circulation or restriction of the use of medicines and medical Devices Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. The authorized body may suspend or prohibit the use, sale or manufacture of medicines and medical devices, as well as decide on withdrawal from circulation or restriction of use in the following cases::
1) non-compliance of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare;
2) identification of adverse reactions of drugs dangerous to human health that are not specified in the instructions for medical use of the drug, or an increase in the frequency of detection of cases of serious adverse reactions specified in the instructions, or low therapeutic efficacy (lack of therapeutic effect), or information about the suspension and (or) withdrawal of it from the market of others countries in connection with the identification of serious adverse reactions with an unfavorable benefit-risk ratio;
3) detection of defects in the design, principle of operation, and manufacturing design during the use of medical devices that affect the safety of their use;
4) violations of the approved manufacturing process of medicines and medical devices affecting the safety, quality and effectiveness of their use;
5) the availability of data on harm to the health of the patient or consumer in connection with the use of medicines and medical devices;
6) obtaining data on the insufficiency of the scientific and technical level of production technology and quality control, ensuring a decrease in the level of safety of the use of medicines and medical devices;
7) requests from the holder of the registration certificate for suspension, revocation of the registration certificate, or withdrawal from circulation or restriction of the use of a medicinal product and medical device;
8) non-compliance of medicines with the requirements of good pharmaceutical practices of the Republic of Kazakhstan and (or) the Eurasian Economic Union, identified by the results of the pharmaceutical inspection;
9) failure to fulfill obligations under pharmacovigilance by the holder of the registration certificate of the medicinal product and the manufacturer of the medical product to monitor the safety, quality and effectiveness of medical products.
2. The rules for suspension, prohibition or withdrawal from circulation or restriction of the use of medicines and medical devices are approved by the authorized body.
President
Republic of Kazakhstan
© 2012. RSE na PHB "Institute of Legislation and Legal Information of the Republic of Kazakhstan" of the Ministry of Justice of the Republic of Kazakhstan
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