Q67 · Do I also need to apply for a licence if I…

Q67 · Category B: Licence types and scope of application (Q51-Q100)

Yes, even if medicines are only trans-shipped through Hong Kong—that is, transported from one country to Hong Kong and then onward to another country, without entering the local Hong Kong market for distribution—you must still comply with Hong Kong's medicines control regulations. First, the Hong Kong company handling these medicines must hold a Wholesale Dealer Licence, because “possession for sale” of these medicines (even if the sale is to an overseas customer) falls within the scope of regulation. Secondly, you must apply for both an “import licence” and an “export licence” for the consignment. In the applications, you must clearly state that the goods are for trans-shipment and provide evidence of the final destination. The entire process must be carried out under Customs supervision to ensure that the goods do not enter the local market.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) and the Import and Export Ordinance (Cap. 60) also apply to the re-export of medicines. The Department of Health and Customs have specific regulatory procedures to ensure that Hong Kong’s status as a free port is not used for illegal trade in medicines.

📗 Drew Tang's recommendations

Hong Kong can serve as a hub for pharmaceutical product re-exports, offering efficient logistics and financial services. To ensure a smooth re-export process, the key is to prepare flawless documentation. We can help you establish operating procedures specifically for re-export business, including how to make the correct declarations to the Department of Health and the Trade and Industry Department, and how to coordinate with logistics companies to ensure goods are transferred seamlessly under regulatory control.

📕 Risk notice

The regulation of drug transhipment is also stringent. Document discrepancies, quantity mismatches or attempts to divert some of the goods unlawfully into the local market during operations will all be treated as serious non-compliance. This could not only cause the transaction in question to fail, but also affect your Wholesale Dealer Licence and future eligibility to apply for import and export licences.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

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.

Do I also need to apply for a licence if I only re-export medicines through Hong Kong and do not sell them in the Hong Kong market?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang