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HONG KONG DRUG LICENSING

What licence do I need to apply for to open a pharmacy in Hong Kong? What are the main steps?

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

Q11 · Category A: Pharmaceutical licensing regimes and regulatory fundamentals (Q1–Q50)
To open a retail pharmacy in Hong Kong, you need to apply for an “Authorised Seller of Poisons Licence”, commonly known as a “pharmacy licence”. This licence is issued by the Pharmacy and Poisons Board of Hong Kong (PPB). The main steps are as follows: first, you must establish a Hong Kong limited company and find retail premises that meet the requirements of the Code of Practice for Authorised Sellers of Poisons. Next, you must employ one or more registered pharmacists and ensure that a pharmacist is on duty throughout all business hours. You then need to prepare detailed application documents, including company information, a premises layout plan, the pharmacists’ registration certificates and employment contracts, and submit the application to the PPB Secretariat (operated by the Drug Office, Department of Health). After submission, the Drug Office will arrange a site inspection to check whether the layout, facilities, security system and medicine storage conditions comply with the requirements. Finally, if the inspection is passed and all documents are complete, the PPB’s Licensing Committee will consider your application. If successful, the licence will be issued.

📘 Regulatory basis

Section 7 of the Pharmacy and Poisons Ordinance (Cap. 138), the related regulations and the Code of Practice for Authorised Sellers of Poisons issued by the PPB are the principal legal and administrative bases for an application for a Pharmacy Licence.

📗 Drew Tang's recommendations

The choice of shop location and its fit-out are key to a successful application. Before signing a lease, it is best to have professional consultants such as us conduct a preliminary assessment of the shop layout plan to ensure it meets all complex regulatory requirements and avoid costly modifications later.

📕 Risk notice

Failure to ensure that a pharmacist “personally manages and controls” the pharmacy during all opening hours is one of the most common breaches by pharmacies. Even a brief absence by the pharmacist may have serious consequences, including revocation of the licence.

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