ESG Report 2019

19 PRODUCT RECALL REQUIREMENTS The Group strictly complies with the evaluate pharmaceuticals that may cause Administrative Measures for Drug Recalls p o t e n t i a l s a f e t y r i s k s , a n d r e c a l l issued and implemented by the National pharmaceuticals with relevant problems. The Medical Products Administration, and has Group implements strict safety supervision on established a drug recall system in the manufactured pharmaceuticals to ensure accordance with laws and regulations to the safety of medicines used by the public. understand the safety of drugs, investigate or REPORTING OF ADVERSE DRUG REACTIONS According to the Measures for the Reporting national drug adverse reaction supervision and Monitoring of Adverse Drug Reactions information agency or the drug supervision issued by the Ministry of Health of the and management department and the People's Republic of China, the Group has set department of public health administration u p r e l e v a n t r e p o r t s a n d mo n i t o r i n g within the prescribed time according to the management systems to deal with adverse impact of the event. If serious adverse drug reactions caused by different drugs to reactions or group adverse events emerge, individuals. The Quality Management the Group will carry out drug recall, publish Department are responsible for handling and submit a drug recall summary report to adverse drug reaction events. The concerned the public to protect the safety and health of processing personnel have relevant expertise the general public. in medicine and statistics. They can During the Year, the Group was not involved in scientifically analyze the adverse any adverse reaction events due to drug reactions, and undertake the Group's quality defects. Therefore, the Group has not reporting and monitoring of adverse drug conducted any drug recall in the Year and did reactions. As for adverse drug reaction not need to submit adverse drug reaction events, the Group will record, analyze and reports or drug recall summary reports. handle them in detail, and report to the drug 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 Environmental, Social and Governance Report 2019 The United Laboratories International Holdings Limited