48117_Amneal Code of Conduct-update 2023 R6.indd

35 November 2023 Pharmaceutical Laws Pharmaceutical laws afect virtually every aspect of Amneal’s operations—from regulatory approvals to product labeling, promotion and advertising. The purpose of these laws is to make sure our products are safe, efective, and promoted fairly and accurately. Regulated activities include: • Research and development • Distribution • Clinical trials • Product Quality • Regulatory approvals • Record keeping • Safety and eficacy • Marketing • Adverse event reporting • Advertising and Promotion • Labeling • Sales • Manufacturing • Reimbursement • Storage • Product Sampling Global regulation of the pharmaceutical industry is greatly influenced by government agencies such as the United States Food and Drug Administration and the European Union’s European Medicines Agency. While eforts are underway to harmonize regulations into consistent global standards, laws today may vary significantly depending on the specific country and market. Amneal requires all employees to comply at all times with applicable laws and regulations governing the pharmaceutical industry in those markets where the Company conducts its business and to comply with Amneal’s own policies and procedures. Failure to follow applicable laws can lead to severe penalties and sanctions against responsible colleagues and the Company, including large fines, product seizures, import restrictions, criminal prosecutions, product recalls, refusal to approve pending product applications, and the exclusion of individuals and the Company from participation in government programs. Violators may also be personally liable for prosecution, fines, and potentially even imprisonment. Violations of law or of Amneal policies may also lead to severe disciplinary action, up to and including termination of employment. Remember: It is your responsibility to understand the laws and regulations that apply to your work at the location where you are employed. Amneal requires employees to report suspected violations of applicable laws and regulations, and any suspected violations of Amneal policies and procedures, directly to a supervisor, Corporate Compliance, or Legal, or indirectly through the Amtegrity Line. Failure to report suspected noncompliance may lead to disciplinary action, up to and including termination of employment. Quality Amneal is committed to continuous quality improvement resulting in the development, production, and delivery of high-quality products for our customers and patients. We will comply with all applicable laws and regulations regarding our research, development, manufacturing and distribution activities, including Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) (collectively, “Good Operating Practices” or “GxP”), among other practices. We take quality-related complaints seriously, and will ensure that any complaints are properly investigated and reported, as required, to the appropriate regulatory authorities. If you have a quality-related concern you should immediately inform a supervisor, the Quality Department, a Corporate Compliance or Legal representative, or report your concern through the Amtegrity Line.