ESG Report 2023

7.4 Pharmacovigilance Pharmacovigilance quality management practices Relevant Laws and Regulations and Guideline Pharmacovigilance Aspects 7.4.1 Pharmacovigilance Management In order to ensure the safe, rational and effective use of drugs by the public, the Group continues to enhance its pharmacovigilance management system. All of the Group's pharmaceutical licensees have established independent pharmacovigilance departments, which are mainly responsible for the collection, handling, and reporting of suspected adverse drug reaction information, drug risk identification, assessment and control, post-marketing safety studies, pharmacovigilance education, training, and preparation of relevant documents. The Group has established a series of pharmacovigilance system documents and an effective and unobstructed channel for collecting information on adverse drug reactions. The Group has also set up a Pharmaceutical Safety Committee, which consists of multi-level departments responsible for major risk assessment, handling of major or emergency drug incidents, risk control decisions, and other major issues 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. 7.4.2 Reporting of Adverse Drug Reactions The Group has established effective information collection channels for doctors, pharmacists and patients, and proactively collects information on clinical use, academic literature and holders of ADRs by means of sales personnel liaising with medical institutions or drug distributors, publishing contact telephone numbers and faxes in the Drug Formulary, establishing a feedback mailbox for suspected adverse drug reactions on the Company's official website, answering and handling feedback calls on adverse drug reactions by dedicated staff, and regularly retrieving academic literatures. Information on adverse drug reactions from relevant websites or forums is also collected. In terms of risk identification and control, safety analysis of adverse reactions of each variation are performed annually to generate analysis reports.The Periodic Safety Update Report is prepared and submitted within the prescribed time limit according to the internal Periodic Safety Update Report submission schedule and annual submission plan. As for adverse drug reaction events, the Group will record, analyse and handle them in detail, and report to the national drug adverse reaction supervision information agency or the drug supervision and management department and the department of public health administration within the prescribed time according to the impact of the event. If serious adverse drug reactions or group adverse events emerge, the Group will carry out drug recall, publish and submit a drug recall summary report to the public to protect the safety and health of the general public. 47 Product Recall Procedure Quality Assurance Department Quality Authorised Person Recall Task Force Recall Management Procedures Internal Policies Environmental, Social and Governance Report 2023 The United Laboratories International Holdings Limited 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 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 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”