ESG Report 2021

Products Recall Requirements The Group strictly complies with the Administrative pharmaceuticals that may cause potential safety Measures for Drug Recalls issued and implemented risks, and recall pharmaceuticals with relevant by the National Medical Products Administration, problems when necessary. The Group implements and has established a drug recall system in strict safety supervision on the manufactured accordance with laws and regulations to understand pharmaceuticals to ensure the drug safety of the the safety of drugs, investigate or evaluate public. Reporting of Adverse Drug Reactions According to the Measures for the Reporting and agency or the drug supervision and management Monitoring of Adverse Drug Reactions issued by the department and the department of public health Ministry of Health of the People's Republic of China, administration within the prescribed time according the Group has set up relevant reports and to the impact of the event. If serious adverse drug monitoring management systems to deal with reactions or group adverse events emerge, the adverse reactions caused by different drugs to Group will carry out drug recall, publish and submit individuals. The Quality Management Department is a drug recall summary report to the public to protect responsible for handling adverse drug reaction the safety and health of the general public. events. The concerned processing personnel have During the Year, the Group was not involved in any relevant expertise in medicine and statistics. They adverse reaction events due to drug quality defects. can scientifically analyse the adverse reactions of Therefore, the Group has not conducted any drug drugs, and undertake the Group's reporting and recall in the Year and did not need to submit monitoring of adverse drug reactions. As for adverse adverse drug reaction reports or drug recall drug reaction events, the Group will record, analyse summary reports. and handle them in detail, and report to the national drug adverse reaction supervision information Person in Charge of Quality Working Group on Recall Quality Assurance Department 50 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 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 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 Product Recall Procedures Environmental, Social and Governance Report 2021 The United Laboratories International Holdings Limited