Chapter 6: Listed Seller of Poisons Licence Explained
Hello, everyone. I am Drew Tang. In Hong Kong, besides the familiar “pharmacy” or “dispensary” (that is, an Authorised Seller of Poisons (ASP)), there is another common type of retail medicine shop known as a “medicine shop”. These shops hold a Listed Seller of Poisons Licence. Although they cannot sell prescription medicines, they play an indispensable role in community health services. In this chapter, I will explain the application, requirements and operational details of this licence.
Legal definition and scope of business of a Listed Seller of Poisons
First, we need to understand clearly what a “Listed Seller of Poisons” is. Under the Pharmacy and Poisons Ordinance (Chapter 138) of the Laws of Hong Kong, a Listed Seller of Poisons is a person whose name appears on a dedicated “register of sellers” and who is authorised to sell Part II poisons at specified premises. Such shops often display the term “dispensary” or a similar name outside, but must never use the words “pharmacy”, “dispensary pharmacy” or “Pharmacy” in English. This is strictly prohibited by law to prevent misleading the public.
The core business of an LSP is selling medicines listed in Part II of the Poisons List in Schedule 10 to the Pharmacy and Poisons Regulations (Cap. 138A). These are generally lower-risk proprietary medicines used to treat minor ailments, such as certain painkillers, cold and flu medicines, fever remedies and topical skin preparations. Unlike a Pharmacy, an LSP must not sell any Part I poisons (that is, prescription medicines and medicines that may only be sold under the supervision of a pharmacist), and must not sell antibiotics or dangerous drugs. This is the most fundamental distinction between an LSP and a Pharmacy.
📘 Regulatory basis
Under section 21 of the Pharmacy and Poisons Ordinance, any person who, while not an Authorised Seller of Poisons, or without a licence as a wholesaler, or whose name is not entered in the register of Listed Sellers of Poisons, sells any poison in the course of any business commits an offence. This clarifies the lawful status and business boundaries of Listed Sellers of Poisons.
Application requirements, premises standards and display requirements
To qualify as a Listed Seller of Poisons (LSP), applicants must meet a series of strict conditions. First, the applicant must be a “fit and proper person”. The Drug Office will review the applicant’s background to ensure good character and business reputation. Second, the applicant must have fixed business premises that meet the required standards. The premises must be independent, well-lit and well-ventilated, with sufficient space to store and display medicines.
The Drug Office has clear guidance on specific premises requirements. For example, medicines must be stored where customers cannot access them themselves, usually behind the counter or in locked glass cabinets. The premises must be kept clean and hygienic, with appropriate temperature and humidity controls to ensure medicine quality. In addition, all Part II poisons must be clearly segregated from other non-medicinal goods, such as food and groceries. These requirements are intended to protect public safety and prevent the misuse or abuse of medicines.
📕 Risk notice
The physical condition of the premises is critical to the licence application and subsequent inspections. I, Drew Tang, have handled many cases where non-compliant shop layouts, drugs mixed with miscellaneous items, or inadequate security measures led to required remedial work and delayed opening. Therefore, when renovating and fitting out your shop, strictly follow the Department of Health’s Code of Practice for Listed Sellers of Poisons.
Key points in the code of practice and key distinctions between Pharmacy licences
The Code of Practice for Listed Sellers of Poisons, updated in 2021, is a fundamental code that all practitioners must follow. It emphasises several key operational requirements. For example, when selling Part II poisons, the medicine must be handed to the customer personally by the proprietor or an employee; customers must not be allowed to collect it themselves. During the sale, basic information on the medicine’s uses, dosage and side effects should also be offered proactively. The Code also provides specific guidance on the procurement, storage, labelling and record-keeping of medicines, requiring all medicines to be purchased from licensed wholesalers and relevant documents to be retained for at least two years.
To make the key differences clearer, I have summarised them in a table comparing a Listed Seller of Poisons Licence with a Pharmacy (Authorised Seller of Poisons) Licence. This is essential when deciding which licence to apply for.
📗 Drew Tang's recommendations
For those planning to enter pharmaceutical retail but without access to a pharmacist, applying for a Listed Seller of Poisons (LSP) licence is an ideal starting point. The threshold is relatively low and the investment is manageable, while the business can meet community demand for commonly used over-the-counter medicines. Building a good reputation and customer trust is key to success. I, Drew Tang (Tang Shangyong), can assist you with one-stop compliance consultancy services, from site selection and renovation to preparing application documents and staff training.
Listed Seller of Poisons application process and estimated timeline
| Stage | Main responsibilities | Estimated time | Key points to note |
|---|---|---|---|
| 1. Assessment and preparation | Determine the business model, find suitable premises, assess the applicant’s qualifications and prepare an initial business plan. | 1–2 weeks | The shop premises must meet the physical standards set out in the Code of Practice. This is the first step to success. |
| 2. Submit the application | Complete the application form (Form 8) and submit it to the Drug Office, Department of Health, together with the Business Registration Certificate, company incorporation documents, premises layout plan and other documents. | 2–4 weeks | The application fee is HKD 455 (this is the current standard and may change). All documents must be accurate. |
| 3. Premises inspection | The Drug Office will send inspectors to examine on site whether the premises’ layout, facilities, security system and medicine storage comply with requirements. | 4–8 weeks | This is the most critical stage of the entire application process. You must ensure that all preparations are complete before the inspection. |
| 4. Formal approval | After the inspection has been passed, the Pharmacy and Poisons Board (PPB) will make its final decision. Once approved, the applicant's name will be entered in the register and a licence will be issued. | 8–12 weeks | The total time from submission of the application to final approval is generally between 3 and 6 months, depending on the complexity of the case. |
“Overall, although the scope of business of a Listed Seller of Poisons is limited, it plays an important ‘triage’ role in Hong Kong’s healthcare system by meeting much of the public’s demand for self-medication. As long as the regulations are strictly observed and the business is run diligently, a ‘medicine shop’ remains a business worth investing in.” – Drew Tang (Tang Shangyong)