Chapter 5: Authorised Seller of Poisons (Pharmacy) Licence Explained
Hello, everyone. I am Drew Tang. In Hong Kong, anyone wishing to operate what is commonly known as a “pharmacy” or “dispensary” lawfully and sell prescription medicines must apply for an Authorised Seller of Poisons (ASP) licence. This is the most extensive and strictly regulated of the western medicine retail licences, as it directly concerns the safety of medicines used by the public. In this chapter, I will explain the various aspects of the ASP licence in detail and help you understand its core requirements and key operational considerations.
5.1 Legal basis and precise definition of “pharmacy”
First, let us clarify one point: “pharmacy licence” is not a legal term. The formal name is “Authorised Seller of Poisons licence”. This authorisation is issued under Chapter 138 of the Pharmacy and Poisons Ordinance of the Laws of Hong Kong. The Ordinance regulates the registration of pharmacists, the sale and purchase of pharmaceutical products, and the possession and sale of poisons.
Under the Ordinance, only an Authorised Seller of Poisons may use the designations “Pharmacy”, “Dispensary”, “Drugstore”, “Pharmacy” (in English) or the Chinese terms “藥房”, “藥行”, “藥坊” and “西藥房” at its registered address. This means that once you have successfully obtained an ASP licence, your shop may legally be called a “Pharmacy”. This is a key legal distinction between a professional pharmacy and an ordinary cosmetics shop or convenience store.
📘 Regulatory basis
Section 2 of the Pharmacy and Poisons Ordinance defines an “Authorised Seller of Poisons (ASP)”, and section 22 expressly provides that only registered premises of an ASP may use designations such as “pharmacy”. Any shop using such a designation without authorisation is acting unlawfully.
5.2 Authority, responsibilities and core requirements: registered pharmacist
The greatest benefit of an ASP licence lies in the scope of medicines that may be sold. Under the Pharmacy and Poisons Regulations (Cap. 138A), poisons are divided into Part I and Part II. An Authorised Seller of Poisons (pharmacy) is the only type of retailer legally permitted to sell all Part I and Part II poisons. Part I poisons generally refer to medicines that must be sold under the supervision of a registered pharmacist and on a doctor's prescription, such as antibiotics and medicines for lowering blood pressure.
This broad scope of authority also brings the core responsibility: A registered pharmacist must be present at the pharmacy at all times during business hours to supervise its operations. This is the point of greatest concern to the Drug Office, Department of Health, during approval and routine inspections. The pharmacist is responsible not only for supervising the dispensing of prescription medicines, but also for providing customers with professional advice on the use of medicines and ensuring they are used correctly and safely. If the pharmacist leaves temporarily, the pharmacy’s prescription medicine sales must stop immediately.
📕 Risk notice
Employing a stable, qualified registered pharmacist is the cornerstone of successfully operating a pharmacy. Many failed applications and licence revocations stem from an inability to meet the strict requirement for the pharmacist to provide continuous on-site supervision. When preparing a business plan, the pharmacist’s salary, recruitment and management costs must be considered core elements.
To make the differences in the permissions of the various licences clearer, I have prepared the following comparison table:
| Comparison item | Authorised Seller of Poisons (Pharmacy) | Listed Seller of Poisons (LSP, drug store) |
|---|---|---|
| Legal basis | Pharmacy and Poisons Ordinance (Cap. 138) | Pharmacy and Poisons Ordinance (Cap. 138) |
| Range of poisons that may be sold | Part I and Part II poisons | Part II poisons only |
| Can prescription medicines be sold? | Yes, a doctor's prescription is required and the medicine must be dispensed under the supervision of a pharmacist. | No |
| Personnel requirements | At least one registered pharmacist must be present during business hours. | Must have at least one “qualified person” present (having completed the relevant training course). |
| Shop name | May use terms such as “药房” or “Pharmacy” | Do not use titles such as “pharmacy”; the usual term is “medicine shop”. |
5.3 Premises standards and key points in the Code of Practice
In addition to personnel requirements, the Department of Health has strict standards for a pharmacy’s physical facilities (that is, its premises). A shop applying for an ASP licence must be independent, permanent and lockable; it cannot be a temporary stall or a premises operated in combination with another business. The premises must include a dedicated dispensary for storing and handling Part I poisons. The dispensary must be effectively separated from the public shopping area and kept clean and orderly.
In addition, all Authorised Sellers of Poisons must comply with the Code of Practice for Authorised Sellers of Poisons (2021 edition) issued by the Pharmacy and Poisons Board of Hong Kong. This Code provides detailed guidance for the day-to-day operation of pharmacies. I have summarised a few key points:
- Procurement and storage of medicines: Medicines must be purchased from licensed wholesalers and complete records must be kept. Medicines must be stored appropriately according to their nature, including whether they are dangerous drugs or require refrigeration.
- Dispensing process: Medicines must be dispensed strictly in accordance with the prescription, which must include information such as the patient's name, the doctor's signature and the date. After dispensing, the medicine label must clearly state key information, including the patient's name, directions for use, medicine name and dosage.
- Record-keeping: Sales of Part I poisons and dangerous drugs must be recorded in detail in the “Poisons Sales Register”, including the date, patient information, medicine name and quantity, and prescribing doctor. These records must be kept for at least two years for inspection.
- Professional conduct: Pharmacists and staff must not promote or induce the public to purchase unnecessary prescription medicines, and must always put public health first.
📗 Drew Tang's recommendations
Applying for an “Authorized Seller of Poisons” licence is a systematic undertaking, with closely interlinked stages ranging from site selection, fitting out and pharmacist recruitment to establishing a legally compliant set of SOPs (standard operating procedures). RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgments are to be verified and assumed by the respective responsible parties, and approval is decided independently by the competent authority. We have a deep understanding of the Department of Health's approval approach and inspection priorities. If you plan to open a pharmacy in Hong Kong, please feel free to contact me, Drew Tang. We can provide end-to-end compliance consulting services from the ground up to ensure that your application process is sound and efficient.