Obtaining a pharmaceutical licence is the beginning, not the end, of compliant business operations. The Drug Office, Department of Health conducts routine inspections of all licensed premises to ensure that licence holders continue to comply with relevant laws and codes of practice. Inspection frequency depends on the licence type and risk level. Higher-risk licence holders, such as medicine manufacturers and wholesalers, are generally inspected more frequently; for example, a comprehensive GDP or GMP re-inspection may take place every 1 to 2 years. Routine inspections of retail pharmacies and dispensaries may be less frequent, but the Department of Health also conducts unannounced ‘mystery shopper’-style inspections to check for breaches such as the illegal sale of prescription medicines. During inspections, officers will examine your premises, records (such as purchasing, sales and temperature records), staff qualifications and operating procedures. After the inspection, you will receive a report identifying any deficiencies and requiring you to correct them within a specified period.
HONG KONG DRUG LICENSING
After successfully obtaining a drug licence, what routine inspections will the Department of Health conduct, and how often?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
Back to Category A: Licence System and Regulatory Basics (Q1-Q50) Search more questions