Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
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HONG KONG DRUG LICENSING

I am an overseas pharmaceutical company and want to set up an office in Hong Kong for marketing. Do I need to apply for a licence?

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

Q59 · Category B: Licence types and scope of application (Q51-Q100)
If your Hong Kong office serves only as a centre for liaison, coordination and market information gathering, and is not involved in any commercial transactions involving the actual storage, distribution, sale, import or export of medicines, it will generally not need to apply for any pharmaceutical licence issued by the Department of Health (such as a Wholesale Dealer Licence). However, all your promotional activities must comply with the law, and prescription medicines must not be promoted directly to the public. The actual import and distribution of medicines must be carried out by a local Hong Kong company holding a valid Wholesale Dealer Licence. This licensed wholesaler will act as your local agent and handle all compliance matters relating to the physical movement of medicines.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) principally regulates the “sale” and “possession for sale” of pharmaceutical products. If an office’s activities do not constitute either of these, they fall outside the scope of licensing regulation. However, legislation regulating the advertising of medicines still applies.

📗 Drew Tang's recommendations

To ensure that your business model is fully compliant, we recommend a detailed consultation on your business processes. We will help you clearly define the scope of the Hong Kong office’s functions and draft a service agreement with a local licensed wholesaler, setting out each party’s responsibilities and obligations to ensure every link in the commercial chain complies with Hong Kong regulations.

📕 Risk notice

The office must maintain strict boundaries and must never handle any medicine orders or samples privately. Any unauthorised sale or distribution, even on a small scale, if discovered, may be regarded as operating without a licence and seriously damage your company’s reputation in Hong Kong and internationally.

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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.

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