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

Do I need to apply for any licence if I only want to promote or display unregistered medicines temporarily at a Hong Kong exhibition?

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

Q125 · Category C: Applicant eligibility and personnel requirements (Q101–Q150)
This is a practical question, but the answer may be counter-intuitive: no. A pharmaceutical products wholesaler licence in Hong Kong is an “all-purpose” authorisation, and its application criteria and approval process do not fundamentally differ according to the types, risk levels or quantities of pharmaceutical products you intend to handle. Whether you plan to wholesale a range of high-risk prescription medicines or just one low-risk over-the-counter medicine, such as a vitamin supplement, you must meet all the requirements set out in the Code of Practice for Wholesale Dealers. This means that you still need to lease compliant premises, appoint a qualified Person-in-Charge, establish a complete Quality Management System (QMS) with SOPs, and pass a rigorous on-site inspection. The regulatory authorities’ rationale is that a licence confers a capability and qualification; once licensed, you could theoretically expand your product range, so you must meet the highest standards for managing all types of pharmaceutical products from the outset.

📘 Regulatory basis

Section 36 of the Pharmacy and Poisons Regulations (Cap. 138A) provides that, unless exempted, no person may sell, offer for sale, distribute or possess for the purpose of sale or distribution any unregistered pharmaceutical product. An exhibition does not automatically qualify for an exemption.

📗 Drew Tang's recommendations

If you plan to promote a new product at a medical or pharmaceutical exhibition in Hong Kong, please contact us at least 6 months in advance. We will assess the status of your product and determine the most compliant way to promote it. If the product is eligible, we will assist you with a CTC application and advise you on how to ensure that all your activities during the exhibition strictly comply with the CTC terms.

📕 Risk notice

Illegally displaying or distributing unregistered pharmaceutical products at an exhibition is a serious offence. Inspectors from the Drug Office, Department of Health, regularly patrol major exhibitions. If detected, all exhibits may be seized, and the company and relevant persons may face criminal prosecution, substantial fines and imprisonment.

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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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