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

Can a company hold several types of pharmaceutical licence at the same time, for example, both a wholesaler’s licence and a manufacturer’s 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

Q141 · Category C: Eligibility and Personnel Requirements (Q101-Q150)
Yes. A company may apply for and hold more than one pharmaceutical licence, depending on its business needs. For example, a company that manufactures medicines and also sells them to other wholesalers, hospitals or pharmacies must hold both a manufacturer’s licence and a wholesaler’s licence. Similarly, a company may hold licences for both wholesale of proprietary Chinese medicines and wholesale of Western medicines. The key is that the company must meet the relevant statutory requirements for every licensed activity. This means that if it holds two types of licence, its facilities, personnel, Quality Management System and operating procedures must meet the regulatory standards for both licences, and it must be able to clearly demonstrate compliant operations under each licence during inspections.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance regulates by “activity”. Each regulated activity (such as manufacture, wholesale or retail) requires a separate licence. The law does not prohibit the same legal entity from holding multiple licences, provided it can meet the conditions of each licence.

📗 Drew Tang's recommendations

For clients planning to diversify their business, we recommend identifying all the licensed activities involved at the outset of business planning. We can assist with a comprehensive compliance gap analysis to ensure that your premises layout, staffing and SOP documents meet the requirements for all applications together, enabling the most efficient application process.

📕 Risk notice

Holding multiple licences entails multiple compliance responsibilities. The company must ensure that different business activities are clearly separated and managed; for example, materials in the production area must not be confused with finished goods in the wholesale area. A serious violation under any one licence may affect the standing and validity of the company’s other licences.

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