Q397 · When importing or exporting medicines, what…

Q397 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)

When importing or exporting medicines, in addition to obtaining import/export licences issued by the Department of Health in advance, you must comply with Hong Kong Customs clearance requirements. For every consignment entering or leaving Hong Kong, an accurate and complete import/export declaration must be submitted to Hong Kong Customs within 14 days after the goods arrive in or depart from Hong Kong. For medicines, you must declare the correct Harmonized System (HS) code and state the Department of Health licence number. Hong Kong Customs is entitled to inspect goods entering or leaving Hong Kong to ensure that the declaration matches the goods and to verify the relevant licences. If your medicines contain ingredients controlled under the Dangerous Drugs Ordinance, you must also comply with more stringent licensing and secure transport requirements.

📘 Regulatory basis

The Import and Export Ordinance (Cap. 60) sets out the declaration requirements for all imports and exports. The Hong Kong Customs and Excise Department enforces this Ordinance and the provisions on cargo control in other relevant laws, including the Dangerous Drugs Ordinance (Cap. 134).

📗 Drew Tang's recommendations

We recommend that clients engage an experienced customs broker to handle import and export customs declarations to ensure accuracy and timeliness. Before goods are shipped, provide the broker with the full set of documents (including the invoice, packing list, bill of lading and Department of Health licences). Keeping all customs declaration documents and records of correspondence with Customs is part of day-to-day compliance management.

📕 Risk notice

Failure to submit customs declarations on time or accurately may result in fines from Customs. More seriously, if the declared medicine information does not match the actual goods, or you cannot provide a valid Department of Health licence, the goods will be detained and may be treated as smuggling, leading to a criminal investigation. This will not only cause substantial financial losses but also put the company’s licence and reputation at serious risk.

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.

When importing or exporting medicines, what Hong Kong Customs requirements should we note in addition to the Department of Health licences?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang