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HONG KONG DRUG LICENSING

Do I also need a pharmaceutical licence if I only want to sell health products online?

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

Q15 · Category A: Pharmaceutical Licensing System and Regulatory Framework (Q1-Q50)
This is a key question, and the answer depends on how your “health product” is classified under Hong Kong law. Hong Kong law does not have a statutory category of “health products”. A product is classified as a “pharmaceutical product” or a “non-pharmaceutical product” according to its ingredients and claimed effects, regardless of its market positioning or common name. If your product contains any Western medicine ingredient listed in the Poisons List under the Pharmacy and Poisons Ordinance, or its claimed effects meet the definition of a “pharmaceutical product” (that is, it is intended to diagnose, treat or prevent disease), it will be regarded as a pharmaceutical product. Once classified as a pharmaceutical product, it must first be registered in Hong Kong before it can be sold, whether in a physical shop or online, and the seller must hold the relevant pharmaceutical licence, such as a wholesaler licence. If your product contains no Western medicine ingredients and makes no therapeutic claims in its promotion, it may be regarded as an ordinary food and may not require a pharmaceutical licence. However, classification can be complex and requires case-by-case analysis.

📘 Regulatory basis

The definition of “pharmaceutical product” in section 2 of the Pharmacy and Poisons Ordinance is key to making this determination. The Drug Office’s Guidelines on Classification of Products as “Pharmaceutical Products” under the Pharmacy and Poisons Ordinance (Cap. 138) provide detailed criteria.

📗 Drew Tang's recommendations

Before introducing any ‘health product’ to the Hong Kong market, the safest approach is to submit its ingredient list, labels, instructions and all marketing materials to us for a professional compliance assessment. Based on the law and past cases, we can assess the risk of the product being classified as a ‘medicine’ rather than a ‘food’.

📕 Risk notice

Incorrectly selling products containing medicinal ingredients online as ordinary food is an extremely serious offence. It amounts to unlicensed sale and the sale of unregistered medicines, and may carry a custodial sentence. This is one of the easiest traps for cross-border e-commerce businesses to fall into.

Back to Category A: Licence System and Regulatory Basics (Q1-Q50) Search more questions

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Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

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