Chapter 3: Hong Kong Medicine Classification and Poisons Schedules
Hello to everyone aspiring to engage in the pharmaceutical business in Hong Kong! I am Drew Tang. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. I am well aware that the first priority in establishing a foothold in this highly regulated industry is to understand Hong Kong's drug classification system thoroughly. This is not only a legal requirement but also directly determines your business model, licence type and scope of operations. Many people find this system complicated, but rest assured: today I will explain it step by step and present it clearly.
Basic medicine classifications: regulatory distinctions between Chinese and Western medicines
In Hong Kong, the pharmaceutical regulatory system first draws a clear distinction between Chinese medicines and western medicines (also known as “pharmaceutical products”). These two categories are regulated by different offices under the Department of Health, under separate legislation—effectively, “two teams and two sets of regulations”, with a clear division between them. The first step for applicants is to identify which category of products they wish to handle, as this will determine an entirely different application route.
Chinese medicines are regulated mainly under the Chinese Medicine Ordinance (Cap. 549), implemented by the Chinese Medicine Regulatory Office (CMRO). Whether retailing or wholesaling Chinese herbal medicines, or manufacturing or wholesaling proprietary Chinese medicines, the relevant licence must be applied for from the Chinese Medicine Council of Hong Kong. Western medicines, defined as “pharmaceutical products” under the Pharmacy and Poisons Ordinance (Cap. 138), are regulated by the Drug Office under that Ordinance and its subsidiary regulations, with licences approved by the Pharmacy and Poisons Board (PPB). What is commonly referred to as a “pharmaceutical licence” usually means a licence relating to Western medicines.
📘 Regulatory basis
The Chinese Medicine Ordinance (Cap. 549) establishes a comprehensive regulatory framework for Chinese medicines in Hong Kong, including Chinese herbal medicines and proprietary Chinese medicines, covering registration, sale and manufacture. The Pharmacy and Poisons Ordinance (Cap. 138), by contrast, is the core legislation regulating Western medicines (pharmaceutical products); it has a longer history and a more complex framework.
The heart of western medicine: pharmaceutical products and the poison schedules explained
For western medicines, Hong Kong has established a detailed and stringent classification system centred on the “Poisons List” system. This system is derived from the Tenth Schedule to the Pharmacy and Poisons Regulations (Cap. 138A), known as the “Poisons List”. It classifies controlled chemical substances or medicinal ingredients into different parts according to their potential risks and side effects. Put simply, whether a medicine is included in the Poisons List, and which part it is listed under, directly determines how it may be sold and the level of regulation that applies.
Under the Pharmacy and Poisons Ordinance, pharmaceutical products can be divided into three main categories according to their ingredients and how they are sold:
- Prescription-only Medicines: These medicines may only be purchased from a registered pharmacy (an Authorised Seller of Poisons) under the supervision of a registered pharmacist and on the prescription of a registered medical practitioner. They generally fall under Division A of Part I of Schedule 1 to the Pharmacy and Poisons Regulations.
- Over-the-Counter (OTC) medicines: These medicines do not require a doctor's prescription, but must be sold in a registered pharmacy under the supervision of a registered pharmacist. They generally contain poisons listed in Division B of Part I or Part II.
- General Sale List (GSL) medicines: Also known as “doctor's list” medicines, these medicines have mild effects and a low safety risk. They may be sold freely in any shop, such as a supermarket or convenience store, without pharmacist supervision. They do not contain any ingredients listed in the Poisons List.
“Any substance specified in the Poisons List in the Tenth Schedule to the Pharmacy and Poisons Regulations is a poison for the purposes of this Ordinance.” — Definition in section 2 of the Pharmacy and Poisons Ordinance. This brief sentence forms the foundation of the entire system for classifying and regulating western medicines.
The far-reaching impact of the classification system on pharmaceutical business models
Once you understand the classifications above, you can see why they are so important to your business model. What kind of shop do you want to open? Who are your target customers? The answers to these questions lie in the classification of medicines. For example, if you plan to sell prescription antibiotics (regulated under the Antibiotics Ordinance, Cap.137, and also classified as Part I poisons), you must open a “Pharmacy” (Pharmacy / Dispensary) and apply for an Authorised Seller of Poisons (ASP) licence. You must also employ a full-time registered pharmacist to work at the pharmacy.
By contrast, if you only wish to sell common cold and flu medicines or painkillers, which may be Part II poisons, you may choose to open a Medicine Company and apply for a Listed Seller of Poisons Licence. No pharmacist is required, but sales staff are subject to specific requirements. If your business supplies pharmacies, medicine companies or healthcare institutions, you need a wholesale dealer licence. The table below clearly shows the sales restrictions for the different classifications.
| Medicine classification | Main sales premises | Key sales conditions | Core licences required |
|---|---|---|---|
| Part I poisons (Part I Poisons) | Pharmacy registration | Must be sold on a doctor’s prescription and under the supervision of a registered pharmacist. | Authorised Seller of Poisons (Authorised Seller of Poisons) |
| Part II poisons (Part II Poisons) | Pharmacy or Listed Seller of Poisons (LSP) registration | No prescription is required, but the medicine must be sold by a qualified person in a specified licensed shop. | Authorised Seller of Poisons or Listed Seller of Poisons |
| Non-poisons / General Sales List medicines (GSL) | Any retail outlet (e.g., supermarkets) | No special sales restrictions; may be sold freely. | No specific pharmaceutical licence required |
📗 Drew Tang's recommendations
I often advise clients new to the industry to start by dealing in GSL medicines or holding a Listed Seller of Poisons licence. The initial investment and compliance costs are relatively low, allowing you to gain industry experience while gradually familiarising yourself with the Department of Health’s regulatory culture and processes. When the time is right, you can consider upgrading to an Authorised Seller of Poisons licence or applying for a Wholesale Dealer Licence to expand your business.
📕 Risk notice
Please always remember that the illegal sale, possession or distribution of regulated pharmaceutical products is a serious criminal offence. Under the Pharmacy and Poisons Ordinance, the maximum penalty is a fine of HK$100,000 and imprisonment for 2 years. At Rengangyongsheng (Hong Kong) Limited, we have handled cases in which clients misunderstood the classification system and mistakenly sold Part I poisons as ordinary medicines. They ultimately had their licences revoked, faced prosecution and suffered substantial losses.