The Pharmacy and Poisons Ordinance (Cap. 138) is the principal legislation regulating Western medicines and poisons in Hong Kong. It has a broad scope and principally covers the following areas: first, it establishes the Pharmacy and Poisons Board (PPB), which is responsible for matters such as pharmacist registration, pharmacy licensing and disciplinary proceedings. Second, it sets out the application, issue and regulatory requirements for various pharmaceutical product licences, including manufacturer licences, wholesale dealer licences and Authorised Seller of Poisons licences. Third, it establishes a Poisons List system, classifying regulated “poisons” by toxicity, use and potential risk, and imposing different levels of control on the sale of different categories. Fourth, it sets out detailed requirements for the labelling, packaging, advertising and sale of pharmaceutical products to ensure accurate information and consumer safety. Fifth, it empowers Department of Health inspectors to enter licensed premises to conduct inspections, take samples and investigate, to ensure that licence holders comply with the law.
HONG KONG DRUG LICENSING
The Pharmacy and Poisons Ordinance (Cap. 138) is central to Hong Kong’s pharmaceutical licensing system. What are its main provisions?
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