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Home / Codes / Article 236. Preclinical (non-clinical) studies of medicines and studies (trials) evaluating the biological effect of medical products Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

Article 236. Preclinical (non-clinical) studies of medicines and studies (trials) evaluating the biological effect of medical products Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

АMANAT партиясы және Заң және Құқық адвокаттық кеңсесінің серіктестігі аясында елге тегін заң көмегі көрсетілді

Article 236. Preclinical (non-clinical) studies of medicines and studies (trials) evaluating the biological effect of medical products Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

     1. The purpose of preclinical (non-clinical) studies of medicinal products is to obtain evidence of their pharmacological activity and safety by scientific methods.

     Studies (trials) evaluating the biological effects of medical devices are conducted to determine the acceptability of any potential adverse biological response resulting from contact of medical device materials with the human body.

     2. The procedure for conducting preclinical (non-clinical) studies and the requirements for preclinical databases for assessing the biological effect of medical devices shall be determined by the authorized body.

     Preclinical (non-clinical) studies are carried out in accordance with the Good Laboratory Practice (GLP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union.

     Assessment of materials and compliance of preclinical (non-clinical) research conditions with the requirements of good laboratory practice (GLP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union is carried out within the framework of the pharmaceutical inspection in accordance with the procedure determined by the authorized body.

 

 

President    

Republic of Kazakhstan     

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