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HONG KONG DRUG LICENSING

Do Hong Kong sellers need to apply for an additional online sales licence when selling medicines through cross-border e-commerce?

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

Q489 · Category J: Cross-border pharmaceuticals and industry practice (Q451-Q500)
Hong Kong legislation does not currently establish a separate licence specifically for online medicine sales. However, under the Pharmacy and Poisons Ordinance (Cap.138), any medicine sales activity must be covered by a valid pharmacy licence and the relevant import and export licences. Online sales are subject to the same regulatory requirements as other sales channels. Rengangyongsheng advises sellers to ensure their existing licences cover all sales channels before undertaking cross-border e-commerce, and to monitor the latest Department of Health policies.

📘 Regulatory basis

Section 18 of the Pharmacy and Poisons Ordinance (Cap.138); Department of Health guidance on online sales

📗 Drew Tang's recommendations

Confirm that the existing licence covers online sales, monitor policy changes closely and avoid compliance blind spots.

📕 Risk notice

Failure to cover online sales channels may result in non-compliant operations and risk of penalties

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