As a licensed wholesale dealer, what core compliance obligations must we fulfil each day?

As a licensed wholesale dealer, day-to-day compliance is the foundation for maintaining the validity of your licence. You must ensure that all procurement, storage, sale and distribution activities involving medicines strictly comply with Hong Kong law. Core obligations include: first, establishing and maintaining a robust Quality Management System (QMS) covering all operating procedures. Second, ensuring that all medicines are procured from qualified suppliers and keeping complete purchasing records. Third, storing medicines strictly in accordance with the label instructions, particularly those requiring specific temperature or humidity conditions, which must be monitored continuously and recorded. Fourth, keeping detailed sales and distribution records to ensure traceability; records must be retained for at least two years. Fifth, appointing one or more responsible persons to oversee day-to-day operations and ensuring all staff receive appropriate training and are familiar with their duties and relevant regulatory requirements.