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HONG KONG DRUG LICENSING

For importing and exporting medicines, apart from holding a wholesale licence, is an import or export licence required for each consignment?

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

Q28 · Category A: Licensing system and regulatory fundamentals (Q1–Q50)
Yes, this is required in the vast majority of cases. A Wholesale Dealer Licence establishes your eligibility to conduct medicine import and export business, but for each individual consignment you must also apply to the Department of Health for the relevant import/export licence under the Import and Export Ordinance (Cap. 60). An import licence must be applied for and approved before the goods arrive in Hong Kong; an export licence must also be obtained before the goods leave Hong Kong. You will need to provide detailed information about the goods, including the medicine name, quantity, dosage form, manufacturer, batch number and details of the importing and exporting companies. By approving import/export licences for each consignment, the Department of Health monitors medicines entering and leaving Hong Kong in real time, tracks their movement and prevents unregistered or non-compliant medicines from entering the market. Small quantities of medicines for use as samples or in clinical trials may be exempt from registration requirements, but an import/export licence is usually still required.

📘 Regulatory basis

The Import and Export Ordinance (Cap. 60) and its subsidiary Import and Export (General) Regulations are the direct legal basis for requiring licences to import or export pharmaceutical products.

📗 Drew Tang's recommendations

Applying for and obtaining import and export licences takes time, so efficient logistics planning is essential. We recommend that clients establish a Standard Operating Procedure (SOP) making licence applications a required step before dispatch, and work closely with logistics companies to ensure that the documentation is complete and there is sufficient time.

📕 Risk notice

Bringing medicines into or out of Hong Kong without the relevant import or export licence is illegal. The goods may be detained by Customs, and the company and the persons responsible may be prosecuted. Never try to save time by “shipping first and obtaining the licence later”; that will not work.

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