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How does Hong Kong’s poison schedule system work?

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.

Drug Office, Department of Health Chinese Medicines Board

Q3 · Category A: Licensing system and regulatory fundamentals (Q1–Q50)
Hong Kong’s Poisons List system is established under the Pharmacy and Poisons Regulations (Cap. 138A) and is central to the classification and management of medicines. The Poisons List appears in Schedule 10 to the Regulations, defines specified chemical substances or medicinal ingredients as poisons, and divides them into 2 main parts: Part I and Part II. Part I poisons carry higher potential risks, and their sale is strictly controlled. Part I poisons are further divided into 3 subdivisions: A, B and C. Subdivision A poisons, such as potent antibiotics and psychiatric medicines, may be sold only at a registered pharmacy under the supervision of a registered pharmacist and on a doctor’s prescription. Subdivision B poisons must also be sold at a pharmacy under a pharmacist’s supervision, but in some circumstances no prescription is required. Subdivision C poisons may be sold at pharmacies or licensed medicine shops (Listed Sellers of Poisons). Part II poisons carry relatively lower risks and can generally be sold at various retail shops, such as supermarkets, without pharmacist supervision. Through detailed classification, this system ensures that high-risk medicines are used under professional guidance while making commonly used medicines accessible to the public.

📘 Regulatory basis

Schedule 10 (Poisons List) to the Pharmacy and Poisons Regulations (Cap. 138A) is the direct legal basis for this system and sets out detailed lists and classifications of the different categories of poisons.

📗 Drew Tang's recommendations

If you plan to sell any products containing medicinal ingredients, your first task is to determine whether the ingredients are included in the Poisons List and, if so, which category they fall under. This will directly determine your sales channels and legal requirements. We can provide product ingredient assessment services.

📕 Risk notice

Incorrectly selling high-risk medicines at an unqualified shop, or selling prescription medicines without a prescription, is a serious offence. The Department of Health conducts “mystery shopper” operations, making it easy for offenders to be detected.

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