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HONG KONG DRUG LICENSING

I hold a drug store licence. Can I sell products that look like medicines in their packaging but are described as “health supplements”?

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

Q83 · Category B: Licence types and scope of application (Q51-Q100)
This is a grey area that requires very careful handling. The key is how the product is classified. If a product, despite having packaging (such as capsules or tablets) and marketing similar to those of medicines, is legally classified as a “food” or “health food” because of its ingredients and claimed effects, you may in theory sell it in a pharmacy because it is not regulated by the Pharmacy and Poisons Ordinance. However, if the product contains controlled Western medicine or Chinese medicine ingredients, or its label or advertising expressly or implicitly claims to treat, diagnose or prevent disease, it is highly likely to be classified by the Department of Health or the Chinese medicine regulatory office as a “pharmaceutical product” or “proprietary Chinese medicine”. In that case, selling it without the relevant licence, such as a Pharmacy licence or a proprietary Chinese medicine retailer licence, would be unlawful.

📘 Regulatory basis

The final status of a product is determined jointly under the Pharmacy and Poisons Ordinance, the Chinese Medicine Ordinance and the Public Health and Municipal Services Ordinance. The Department of Health’s “Guidance Notes on the Differentiation between Pharmaceutical Products and Non-pharmaceutical Products” set out specific criteria.

📗 Drew Tang's recommendations

Before introducing any new “health food” product, we strongly recommend asking the supplier for an official product classification certificate issued by the Hong Kong Department of Health confirming that the product is not classified as a pharmaceutical product. If you do not have this document, you should provide us with the product information so that we can make an enquiry with the Department of Health on your behalf. Do not put a product on sale based solely on the supplier’s assurances.

📕 Risk notice

Selling ‘borderline products’ whose regulatory status has not been determined is one of the greatest risks facing pharmacies. Many overseas health supplements may be regarded in Hong Kong as ‘unregistered medicines’ because of their ingredients or claims. If detected, you may face prosecution; claiming ‘I did not know’ is generally not accepted as a valid defence.

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