ESG Report 2025

Person in Charge of Complaint 8.5.2 Product Recall Regulations The United Laboratories strictly complies with the “Measures for the Recall of Drugs” issued by the National Medical Products Administration (NMPA) and has established the “Product Recall Procedure” in accordance with the law. The Group investigates and assesses drugs that may have potential safety risks, and initiates a recall process when necessary. Depending on the severity of drug quality issues or other safety hazards, recalls are classified into three levels: Level 1, Level 2 and Level 3. The Quality Assurance Department, the Drug Safety Committee and the Recall Working Group collaborate according to their respective duties to manage the entire recall process. To ensure the effectiveness of the recall system, the Group conducts a mock recall for both finished products and bulk medicine active pharmaceutical ingredients (APIs) every two years. The mock recall covers the entire process, including recall application, plan formulation, notification issuance, process follow-up, effectiveness evaluation and product disposition, and is controlled in accordance with the time limit requirements for a Level 1 recall. All recall records and related investigation documents are archived for long-term preservation. During the Reporting Period, the Group did not experience any product recall incidents. The United Laboratories has always placed public drug safety as its highest priority, strictly complies with the “Good Practice for Pharmacovigilance” and other relevant regulatory requirements, and has established a sound pharmacovigilance management system to continuously monitor and evaluate the safety of drugs throughout their entire lifecycle. Through a systematic risk management mechanism, we are committed to ensuring that the benefits of drugs outweigh their risks, providing patients with safe and effective treatment options. 8.6 Pharmacovigilance 72 Complaint information Customer Collect information 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 Decide whether to recall If a recall is decided, the type of recall shall be determined and a Recall Working Group 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 regulatory authority Product Recall Procedure Quality Authorised Person Recall Working Group Contact, thoroughly understand and grasp the relevant information Identify the type of complaint Carry out internal and external investigations Sort out the investigation and suggest solutions Formulate corrective and preventive measures Approve suggested solutions/ corrective and preventive measures Reply to customers Track the results of compl int processing a Track the effectiveness of assessment and corrective and preventive measures File the complaint record The United Laboratories International Holdings Limited Relevant Department Person in Charge of Quality Person in Charge of Quality 2025 Environmental, Social and Governance Report