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HONG KONG DRUG LICENSING

I hold a Wholesale Dealer Licence. Can I import medicines directly from overseas into Hong Kong?

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

Q66 · Category B: Licence types and scope of application (Q51-Q100)
Holding a Wholesale Dealer Licence is necessary to conduct wholesale drug business in Hong Kong, but it does not in itself entitle you to import drugs directly from overseas. To bring pharmaceutical products into Hong Kong from outside Hong Kong, you must also apply to the Department of Health and the Trade and Industry Department for an “Import Licence” for each consignment of imported goods. When applying for an Import Licence, you will need to provide detailed information about the goods, including the drug name, quantity, batch number, manufacturer details and your Wholesale Dealer Licence number. Your goods can clear customs smoothly on arrival at the Hong Kong border only after the Import Licence has been approved.

📘 Regulatory basis

The Import and Export (General) Regulations under the Import and Export Ordinance (Cap. 60) classify pharmaceutical products and medicines as controlled articles whose import and export require a licence issued by the Director-General of Trade and Industry. The Department of Health reviews whether these applications meet the requirements of medicines regulation.

📗 Drew Tang's recommendations

We recommend that you familiarise yourself with the entire import licence application process before signing contracts with overseas suppliers and arranging shipment. Rengangyongsheng (Hong Kong) Limited provides comprehensive import and export licence application services. We can submit applications quickly and accurately through the Trade and Industry Department’s electronic system and liaise with the Department of Health to help ensure that your goods clear customs on time, avoiding unnecessary storage charges and delays.

📕 Risk notice

Bringing medicines into Hong Kong without a valid import licence is smuggling. The Customs and Excise Department conducts very strict checks for such conduct. If discovered, the goods will be detained and the persons concerned may face criminal prosecution. Even licensed wholesalers must strictly comply with the “one consignment, one licence” requirement.

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