ESG Report 2022

6.4 Pharmacovigilance In order to ensure the safe, rational and effective channel for collecting information on adverse drug use of drugs by the public, the Group continues to reactions. enhance its pharmacovigilance management The Group has also set up a Pharmaceutical system. All of the Group's pharmaceutical Safety Committee, which consists of multi-level licensees have established independent d e p a r t me n t s r e s p o n s i b l e f o r ma j o r r i s k pharmacovigilance departments, which are mainly assessment, handling of major or emergency drug responsible for the collection, handling, and incidents, risk control decisions, and other major reporting of suspected adverse drug reaction issues related to pharmacovigilance. All information, drug risk identification, assessment departments maintain efficient long-term and control, post-marketing safety studies, cooperation and communication to monitor, pharmacovigilance education, training, and identify, evaluate, and control adverse drug preparation of relevant documents. The Group has reactions and other harmful reactions related to the established a series of pharmacovigilance system use of medicines. documents and an effective and unobstructed 6.4.1 Pharmacoviigilance Management 6.3.2 Products Recall Requirements The Group strictly complies with the Administrative manufactured pharmaceuticals to ensure the safety Me a s u r e s f o r D r u g Re c a l l s i s s u e d a n d of medicines used by the public. implemented by the National Medical Products During the Year, the Group was not involved in any Administration, and has established a drug recall adverse reactions incidents due to defects in the system in accordance with laws and regulations to quality of pharmaceutical products. Accordingly, the understand the safety of drugs, investigate or Group did not have any drug recalls during the Year evaluate pharmaceuticals that may cause potential and was not required to submit adverse drug safety risks, and recall pharmaceuticals with reaction reports or drug recall summary reports. relevant problems when necessary. The Group implements strict safety supervision on the Product Recall Procedures Quality Authorised Person Recall Task Force Quality Assurance Department Environmental, Social and Governance Report 2022 The United Laboratories International Holdings Limited 35 Collect informatoin on adverse product reactions and potential product safety hazards Provide safety hazard investigation and assessment report or recall notice letter Complete the "Product Recall Application" Review and approve "Product Recall Applications" Decide whether to recall If a recall is decided, the type of recall shall be determined and a recall task force shall be formed Develop a recall plan Implement procedures according to the severity of recall Follow up on the final outcome Complete the Product Recall Record Evaluate the effectiveness of the recall and submit a recall summary report to the drug regulartory authority