ESG Report 2020
Products Recall Requirements The Group strictly complies with the Administrative evaluate pharmaceuticals that may cause potential Measures for Drug Recalls issued and implemented safety risks, and recall pharmaceuticals with by the National Medical Products Administration, relevant problems. The Group implements strict and has established a drug recall system in safety supervision on the manufactured accordance with laws and regulations to pharmaceuticals to ensure the safety of medicines understand the safety of drugs, investigate or used by the public. Reporting of Adverse Drug Reactions According to the Measures for the Reporting and supervision information agency or the drug Monitoring of Adverse Drug Reactions issued by supervision and management department and the the Ministry of Health of the People s Republic of department of public health administration within China, the Group has set up relevant reports and the prescribed time according to the impact of the monitoring management systems to deal with event. If serious adverse drug reactions or group adverse reactions caused by different drugs to adverse events emerge, the Group will carry out individuals. The Quality Management Department drug recall, publish and submit a drug recall is responsible for handling adverse drug reaction summary report to the public to protect the safety events. The concerned processing personnel have and health of the general public. relevant expertise in medicine and statistics. They can scientifically analyse the adverse reactions of During the Year, the Group was not involved in any drugs, and undertake the Group's reporting and adverse reaction events due to drug quality monitoring of adverse drug reactions. As for defects. Therefore, the Group has not conducted adverse drug reaction events, the Group will any drug recall in the Year and did not need to record, analyse and handle them in detail, and submit adverse drug reaction reports or drug report to the national drug adverse reaction recall summary reports. ’ Product Recall Procedures Quality Assurance Department Collect information about product adverse reactions and product safety risks Provide a safety risk investigation and assessment report or a product recall notice Fill in the Product Recall Application form Person in Charge of Quality Approve Product Recall Application Decide whether to recall the product If he/she decides to recall the product, he/she must determine the type of recall and form a working group on recall Working Group on Recall Develop a recall plan Implement processing procedures according to the recall level Track the final processing results Fill in the Product Recall Record Evaluate the effect of recall and submit the recall summary report to the Drug Regulatory Department 43 Environmental, Social and Governance Report 2020 The United Laboratories International Holdings Limited
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