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How does Hong Kong law distinguish between “Part I poisons” and “Part II poisons”? What does this mean for my choice of licence?

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

Q81 · Category B: Licence types and scope of application (Q51-Q100)
In Hong Kong, the Pharmacy and Poisons Regulations divide regulated Western medicines (i.e. “poisons”) into two main categories. Part I poisons (Part 1 Poisons) are the most strictly regulated category and generally include all prescription medicines (such as antibiotics and antihypertensive medicines), as well as certain medicines that must be sold under the supervision of a pharmacist (such as cough mixtures containing codeine). These medicines may only be sold by an Authorised Seller of Poisons (ASP) (a pharmacy) with a registered pharmacist on the premises, on a doctor's prescription or under a pharmacist's supervision. Part II poisons (Part 2 Poisons) are less strictly regulated non-prescription medicines, commonly known as “over-the-counter medicines”, such as most cold and flu medicines and pain relief tablets. These medicines may be sold by a pharmacy or by a Listed Seller of Poisons (LSP) (a medicine shop) with only a “qualified person” on the premises. This classification therefore directly determines your choice of retail licence: if you wish to sell Part I poisons, you must operate a pharmacy; if you sell only Part II poisons, a medicine shop is sufficient.

📘 Regulatory basis

Schedules 1 and 3 to the Pharmacy and Poisons Regulations (Cap. 138A) set out detailed lists of Part I and Part II poisons. Schedule 10 prescribes the licence requirements for selling different categories of poisons.

📗 Drew Tang's recommendations

When planning your retail business, first define your product range. If you want to provide a comprehensive range of pharmaceutical services, including dispensing prescriptions, the aim should be to apply for a Pharmacy licence. If you are positioning the business as a community convenience outlet selling commonly used medicines, an LSP licence is a more practical choice. We will develop the most suitable licence application strategy based on your market positioning.

📕 Risk notice

A “medicine shop” must never sell any medicine that is a Part I poison. This is one of the most common breaches. If discovered, the medicines may be confiscated, and the shop may face prosecution and fines or even have its licence revoked. You must have a clear understanding of the legal classification of the medicines you sell.

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