In Hong Kong, all pharmaceutical products must be registered with the Pharmacy and Poisons Board (PPB) and obtain a Hong Kong registration number (HK-XXXXX) before they may be sold on the market. If you plan to import and wholesale a medicine that is not yet registered in Hong Kong, you must first act as the product’s local agent and submit a “pharmaceutical product registration application” to the Drug Office, Department of Health. This is a complex process requiring extensive technical documentation, including chemistry, manufacturing and controls (CMC) information, preclinical and clinical study data, and stability study reports, to demonstrate the medicine’s safety, efficacy and quality. You may lawfully import and sell the product only after obtaining a Certificate of Drug Registration and using it together with your wholesale dealer licence.
HONG KONG DRUG LICENSING
I plan to import and wholesale a pharmaceutical product that is not yet registered in Hong Kong. What additional procedures are required?
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 B: Licence Types and Scope of Application (Q51-Q100) Search more questions