Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
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HONG KONG DRUG LICENSING

Do I need a licence if I only want to run an online shop offering medicines sourced overseas on behalf of Hong Kong customers?

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

Q98 · Category B: Licence types and scope of application (Q51-Q100)
Yes, you absolutely need a licence, and under the current regulations this business model is almost impossible to operate lawfully. First, your personal shopping service—where you take orders and payment from customers and then purchase and deliver medicines for them—constitutes “sale”, so you need the relevant retail licence (a pharmacy or dispensary). Secondly, purchasing medicines from overseas for customers constitutes “import”, which requires an import licence for each consignment and, in turn, a Wholesale Dealer Licence. More importantly, as noted above, Hong Kong does not permit the sale of regulated medicines solely online. A purely online medicine personal-shopping platform would therefore breach several requirements, including those relating to unlicensed sales, unlicensed imports and unlawful online sales, and would be strictly illegal.

📘 Regulatory basis

Your business model breaches both the licensing requirements for the sale and possession of medicines under the Pharmacy and Poisons Ordinance and the licensing requirements for importing medicines under the Import and Export Ordinance. This is a typical case involving multiple offences.

📗 Drew Tang's recommendations

We never recommend that anyone try this business model. If you are interested in cross-border pharmaceutical e-commerce, the lawful route is much more complex. It may involve establishing a fully compliant physical pharmacy and licensed wholesale business in Hong Kong, and reaching customers through an O2O model (online display, offline transactions). We would be pleased to discuss these lawful and sustainable business models with you.

📕 Risk notice

Operating a website for the illegal procurement of medicines is a key enforcement target for the Department of Health and the Customs and Excise Department. As transaction records are online, evidence is easy to obtain. If the offence is established, operators may face very severe criminal prosecution. In addition, the overseas medicines you procure may be of unknown origin and unassured quality. If they cause harm to consumers’ health, you may face unlimited civil liability for damages.

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