Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

We are a licensed wholesaler. If we need to import or export medicines from overseas, do we need to apply for additional permits?

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

Q358 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
Yes, holding a Wholesale Dealer Licence does not automatically grant the right to import or export medicines. The import and export of medicines are strictly controlled under Hong Kong law. You must apply to the Department of Health for an import or export licence for each consignment of pharmaceutical products or substances registered in Hong Kong, whether importing or exporting. You will need to provide detailed information about the goods, including the medicine name, ingredients, quantity and manufacturer details, as well as relevant supporting documents from the place of origin or destination country. The Department of Health will assess each application to ensure that the import or export activities comply with local regulations and international standards. Unregistered medicines are in principle not permitted to be imported or exported unless a special exemption is granted (for example, for clinical trials or a specific patient).

📘 Regulatory basis

Under the Import and Export Ordinance (Cap. 60) and the Import and Export (General) Regulations made under it, pharmaceutical products and substances are controlled articles. Their import or export requires a valid licence issued by the Department of Health under the authority of the Director-General of Trade and Industry.

📗 Drew Tang's recommendations

We recommend that clients fully understand and plan the import and export licence application process before signing contracts with overseas suppliers or customers. As approval takes time, prepare all required documents in advance and allow sufficient time for the application to avoid delaying shipments. For frequent, small-volume imports and exports, you can discuss with the Department of Health whether a simplified application procedure is available. Rengangyongsheng (Hong Kong) Limited has extensive experience handling import and export licence applications and can manage the paperwork to help ensure a smooth process.

📕 Risk notice

Any unauthorised import or export of medicines constitutes smuggling and is a serious criminal offence. Upon conviction, the company and the Person-in-Charge may face substantial fines and imprisonment, and the company’s Wholesale Dealer Licence is also highly likely to be revoked. Do not break the law to save time or costs; the consequences could be disastrous.

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