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HONG KONG DRUG LICENSING

What licence do I need if I only intend to wholesale finished medicines and will not sell directly to the public?

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

Q53 · Category B: Licence types and scope of application (Q51-Q100)
If you plan to wholesale pharmaceutical products in Hong Kong, you must apply for a Wholesale Dealer Licence, whether or not the medicines are proprietary preparations (non-prescription medicines). This licence allows you to sell pharmaceutical products to other licensed wholesalers, licensed manufacturers, Authorised Sellers of Poisons (pharmacies), Listed Sellers of Poisons (drugstores), registered doctors, dentists and veterinary surgeons, as well as specified institutions such as hospitals and clinics. This licence does not allow you to retail any medicines directly to the general public. To apply, you need a business office address and storage facilities that meet the required standards, and must establish a comprehensive system for recording medicine procurement, storage, sales and recalls.

📘 Regulatory basis

Under the Pharmacy and Poisons Ordinance (Cap. 138), any business activity involving the sale of pharmaceutical products, other than retail sale, requires a valid wholesaler’s licence. The Code of Practice for Wholesale Dealers in Drugs published by the Department of Health provides licence holders with detailed operational guidance.

📗 Drew Tang's recommendations

Before applying, we strongly recommend establishing a Quality Management System (QMS) that complies with Good Distribution Practice (GDP). Although this is not currently mandatory in Hong Kong, GDP certification can greatly enhance your competitiveness and reputation in the industry, and is also a regulatory trend. We can provide comprehensive GDP compliance advice and document preparation services.

📕 Risk notice

Wholesale dealing in medicines without a licence is a serious offence. In addition, licensed wholesalers must rigorously check their customers' qualifications to ensure that medicines are supplied only to eligible organisations or individuals. If you sell medicines to unlicensed operators or members of the public, your licence may be suspended or even revoked.

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