Hong Kong’s pharmaceutical licensing system is a comprehensive and stringent legal framework governing the manufacture, sale, distribution and possession of pharmaceutical products (that is, western medicines) and Chinese medicines. Its principal legal bases are the Pharmacy and Poisons Ordinance (Cap. 138) and the Chinese Medicine Ordinance (Cap. 549). The main parties it regulates include manufacturers, wholesalers and retailers of western medicines, such as pharmacies and medicine companies, as well as manufacturers, wholesalers and retailers of Chinese medicines. Any company or individual wishing to conduct these activities in Hong Kong must apply for the relevant licence from the Drug Office, Department of Health, or the Chinese Medicine Regulatory Office, as appropriate to the nature of the business. For example, a wholesale dealer licence is required to conduct wholesale business in western medicines, while an Authorised Seller of Poisons Licence is required to operate a community pharmacy. The system aims to ensure that medicines on the market are safe, effective and of good quality, thereby protecting public health.
HONG KONG DRUG LICENSING
What is Hong Kong’s pharmaceutical licensing system, and whom does it mainly regulate?
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.
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