Article 261. Pharmacovigilance and monitoring of safety, quality and effectiveness of medical products Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. The authorized body ensures the functioning of the pharmacovigilance system and monitors the safety, quality and effectiveness of medical products in the territory of the Republic of Kazakhstan.
2. The State Expert Organization in the field of circulation of medicines and medical devices, in order to ensure the protection of public health and improve patient safety, conducts:
1) collection, analysis, evaluation and verification of reports on adverse reactions of a medicinal product, adverse events of a medical product received from healthcare entities and the sphere of circulation of medicines and medical products, consumers;
2) assessment of the benefit-risk ratio of medicines and medical devices based on data from pharmacovigilance and monitoring of the safety, quality and effectiveness of medical devices in the Republic of Kazakhstan, data provided by holders of registration certificates of medicines, manufacturers of medical devices, data obtained from other sources.
3. The procedure for conducting pharmacovigilance and monitoring the safety, quality and effectiveness of medical products is determined by the authorized body.
4. Pharmacovigilance and monitoring of the safety, quality and effectiveness of medical products are carried out by healthcare entities, entities in the field of circulation of medicines and medical products, as well as holders of registration certificates of medicines and manufacturers of medical products, organizations for the maintenance of medical products.
5. Healthcare entities are obliged to inform the authorized body in writing and in a timely manner about the facts of adverse reactions, including those not specified in the instructions for use of the medicinal product, about the specifics of the interaction of the medicinal product with other medicinal products, about overdose, drug dependence, abuse, the absence or low effectiveness of the medicinal product and about adverse events of medical products..
The holder of the registration certificate of the medicinal product and the manufacturer of the medical product are obliged to fully provide the authorized body with information on the safety of the medicinal product, as well as to promptly inform the authorized body of the facts of the manifestation of adverse reactions and (or) adverse events during the use of the medicinal product or medical product.
6. The authorized body takes into account data from pharmacovigilance and monitoring of the safety, quality and effectiveness of medical devices in other countries when making decisions on suspension, prohibition or withdrawal from circulation or restriction of the use of medicines and medical devices in the territory of the Republic of Kazakhstan.
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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