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

Is it legal for Department of Health inspectors to conduct unannounced inspections?

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

Q446 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)
Yes, this is entirely lawful. In fact, unannounced inspections are a commonly used and important regulatory tool. The law gives Department of Health inspectors the power to enter licensed premises at any “reasonable time” for inspection, usually during normal business hours, without prior notice. The purpose of unannounced inspections is to observe the licence holder's real, day-to-day operations and ensure ongoing compliance with the regulations and codes of practice, rather than allowing them to make a “show” solely to prepare for a scheduled inspection.

📘 Regulatory basis

The powers of entry and inspection conferred by section 26 of the Pharmacy and Poisons Ordinance (Cap. 138) are not subject to a requirement for prior notice.

📗 Drew Tang's recommendations

The only way to deal with unannounced inspections is to make compliance part of your everyday routine. The compliance systems we design for clients aim to keep the company “inspection-ready” at all times. All documents, records and operating procedures should be well organised and readily available for inspection.

📕 Risk notice

If you refuse entry to an inspector conducting a surprise inspection, or attempt to conceal or destroy documents, this will be regarded as obstruction of enforcement. This is itself a criminal offence, and the consequences may be more serious than any breach discovered during the inspection.

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