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

How should a business prepare for a Department of Health site inspection to ensure it passes smoothly?

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

Q159 · Category D: Premises and Storage Requirements (Q151-Q200)
A premises inspection is one of the most critical steps in the licence assessment process, and thorough preparation is essential. First, all hardware and facilities must be in place and operational, including all functional areas, temperature and humidity monitoring systems, security systems and pest-control equipment. Second, all documents and records must be complete, organised and readily accessible. These include company registration documents; qualification evidence for the Person-in-Charge and key personnel; all Standard Operating Procedures (SOPs); temperature and humidity records; cleaning records; pest-control records; and staff training records. Third, provide pre-inspection training to all relevant staff to ensure that they understand their responsibilities, relevant SOPs and the premises layout, and can answer inspectors’ questions clearly and accurately. Finally, conduct a comprehensive internal self-inspection, simulating a Department of Health inspection to identify and correct all potential issues.

📘 Regulatory basis

The Department of Health’s inspections are based on all the requirements of the Pharmacy and Poisons Ordinance and Good Distribution Practice (GDP). Inspecting officers will comprehensively examine your premises, facilities, documentation system and personnel qualifications to assess your ability to operate a pharmaceutical wholesale business in ongoing compliance.

📗 Drew Tang's recommendations

We usually provide clients with a “Mock Inspection” before the formal inspection. Our consultants act as inspectors and conduct the inspection to the strictest standards, then provide a detailed report recommending corrective actions. This process can greatly help clients identify blind spots, familiarise themselves with the process and ease their anxiety, thereby significantly increasing the likelihood of passing the formal inspection on the first attempt.

📕 Risk notice

Do not assume that inspection officers will just “go through the motions”. They are experienced and pay close attention to detail. The absence of any key facility (such as an uncalibrated thermometer), gaps in important records (such as an interruption in temperature records lasting several days) or employees being unable to answer basic questions about procedures may lead to an unsuccessful inspection. An unsuccessful inspection not only delays opening but may also require an additional reinspection fee.

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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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