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

What specific requirements apply to my warehouse when applying for a “Wholesale Dealer Licence”, such as area and facilities?

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

Q54 · Category B: Licence types and scope of application (Q51-Q100)
The Hong Kong Department of Health has not specified a minimum area for a warehouse used for a “wholesale dealer licence” application. The key requirement is that the warehouse design and facilities must ensure the quality and safety of medicines. Specifically, the warehouse must have sufficient space for orderly storage and operations to avoid mix-ups and cross-contamination. It must also have effective temperature and humidity control and monitoring systems to ensure that storage conditions meet the requirements on medicine labels, particularly for medicines requiring refrigeration. Adequate security measures, such as burglar alarms and access controls, must be in place to prevent unauthorised access. Storage areas must be clearly separated from office, receiving and dispatch areas. Finally, appropriate facilities must be available to handle returned, expired or recalled medicines, with a dedicated quarantine area.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers sets out detailed requirements for storage management, covering premises, equipment, temperature control, security and hygiene procedures. Department of Health officers will inspect strictly in accordance with this code during on-site audits.

📗 Drew Tang's recommendations

We recommend that clients choose warehouse space that allows flexible zoning. Before fitting out the premises, it is best to submit the design drawings to us or consult the Department of Health directly for preliminary acceptance before proceeding with the works. Start-ups may consider using a qualified third-party logistics (3PL) provider, which can greatly reduce initial capital investment and management complexity.

📕 Risk notice

Inadequate warehouse conditions are one of the most common reasons for an application to be delayed or refused. This is particularly true of temperature and humidity control: if records are incomplete or equipment is unstable, the assessment cannot be passed. After a licence is granted, failure to maintain compliant storage conditions on an ongoing basis may also cause difficulties at renewal.

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