ESG Report 2024

43 Product Recall Procedure Quality Assurance Department Quality Authorised Person 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 Working Group shall be formed Recall Working Group 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 Collect information on adverse product reactions and potential product safety hazards Provide safety hazard investigation and assessment report or recall notice latter Complete the Product Recall Application “ ” Pharmacovigilance quality management practices Pharmacovigilance Pharmacovigilance System Documentation, Records and Information Management Procedures The Group continues to improve its pharmacovigilance management system to ensure the safe, rational and effective use of medicines by the public. All of the Group's drug marketing licensees have set up independent pharmacovigilance departments, the main duties of which include: systematically collecting, processing and reporting information on suspected adverse drug reactions; identifying, evaluating and controlling potential risks of drugs; conducting post-marketing safety studies to ensure the safety of long-term use of drugs; and organising education and training related to pharmacovigilance while preparing relevant management documents to enhance overall management levels. All team members have backgrounds in medicine, pharmacy and other related disciplines to ensure professionalism and reliability. In addition, the Group has implemented a comprehensive set of pharmacovigilance system documents and opened up efficient and smooth channels for the collection of information on adverse reactions. The Group has also set up a Pharmaceutical Safety Committee, which is composed of multiple relevant departments and is primarily responsible for assessing major drug risks, addressing significant or urgent drug safety events, formulating risk control decisions, and deliberating on other important matters related to pharmacovigilance. All departments maintain efficient long-term cooperation and communication to monitor, identify, evaluate, and control adverse drug reactions and other harmful reactions related to the use of medicines. 7.4 Pharmacovigilance 7.4.1 Pharmacovigilance Management The Group has established effective information collection channels for doctors, pharmacists and patients, and proactively collects information on clinical applications, academic research and adverse drug reactions by means of interaction between sales employees and medical institutions or drug distributors, provision of contact telephone numbers and facsimiles in product literature, setting up of an email box for feedback on suspected adverse drug reactions on the Company's official website, dedicated staff to answer and handle feedback calls on adverse drug reactions, and regular searches of relevant academic literature. The Company actively collects information on clinical applications, academic research and adverse drug reactions from relevant websites or forums. In respect of risk identification and control, the Group conducts safety analyses on the monitoring of adverse reactions for each product each year and compiles corresponding analysis reports. In addition, the preparation and submission of periodic safety reports are completed within the prescribed timeframe in accordance with the internally formulated periodic safety report submission schedule and annual plan. For adverse drug reaction events, the Group conducts comprehensive recording, analysis and handling, and reports to the relevant national adverse drug reaction regulatory authorities, or drug supervision and management departments and health administration authorities within the prescribed timeframe, depending on the extent of the impact of the event. In the event of serious adverse drug reactions or mass incidents, the Group will activate the drug recall procedures and make public announcements to the community, followed by the submission of a final report on the drug recall to ensure public safety and health. 7.4.2 Reporting of Adverse Drug Reactions Environmental, Social and Governance Report 2024 The United Laboratories International Holdings Limited Aspects Relevant Laws, Regulations and Guidelines Internal Policies