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HONG KONG DRUG LICENSING

I want to open a pharmacy in Hong Kong specialising in prescription medicines and medicines for sale under supervision. Which licence should I apply for?

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

Q51 · Category B: Licence types and scope of application (Q51-Q100)
If you plan to operate a retail pharmacy in Hong Kong that dispenses prescriptions and sells various Western medicines (including prescription medicines, medicines for sale under supervision and over-the-counter medicines), you must apply for an Authorised Seller of Poisons licence, commonly known as a “pharmacy licence” or “pharmacist licence”. This is the only licence under Hong Kong law that permits retail sale of all categories of pharmaceutical products (Part I and Part II poisons). The key requirement is that you employ a registered pharmacist to manage and supervise the shop full-time during business hours. The shop layout, facilities, security system and medicine storage conditions must also meet the stringent standards set by the Pharmacy and Poisons Board (PPB) to ensure the safety and quality of medicines.

📘 Regulatory basis

Under section 17 of the Pharmacy and Poisons Ordinance (Cap. 138), only an Authorised Seller of Poisons may retail poisons at its registered address. The Pharmacy and Poisons Regulations also set out in detail the registration standards for pharmacies, management requirements and the duties of pharmacists.

📗 Drew Tang's recommendations

At the site-selection stage, you should consider whether the premises meet the Department of Health’s requirements for setting up a pharmacy, such as the shop area and the provision of dispensing and storage areas. We recommend that you engage us to carry out a preliminary assessment of the proposed address before signing a lease. This can help avoid unnecessary financial losses if the application is refused because the premises do not meet the requirements.

📕 Risk notice

Do not sell prescription medicines or operate under the name “pharmacy” without first obtaining a Pharmacy / Authorised Seller of Poisons (ASP) licence. This is a criminal offence and, upon conviction, may result in a substantial fine and imprisonment. A pharmacy must also not sell regulated medicines unless a pharmacist is present to supervise.

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