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

Can I refuse to answer inspectors’ questions or refuse them access to certain areas during a premises inspection?

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

Q200 · Category D: Premises and Storage Requirements (Q151-Q200)
Absolutely not. Under Hong Kong law, authorised Department of Health inspectors have statutory powers to enter and inspect any licensed premises or premises for which a licence application has been made while carrying out their duties. As a licence applicant or licensee, you are legally obliged to cooperate with inspections. Refusing to allow an officer to enter any part of the premises, refusing to answer questions about business operations, or refusing to provide documents requested for inspection constitutes “Obstruction”, a serious criminal offence. Your attitude towards cooperation is an important consideration during an inspection. A cooperative, transparent and professional attitude can support your application. Conversely, any form of obstruction, concealment or provision of false information will arouse the officers’ suspicions and may lead to the most serious legal consequences.

📘 Regulatory basis

Section 28 of the Pharmacy and Poisons Ordinance (Cap. 138) expressly confers on authorised officers the power to enter and inspect premises, inspect and copy documents, and take away samples. Section 29 of the Ordinance expressly provides that any person who “wilfully obstructs or impedes” an authorised officer in the execution of their duties commits an offence.

📗 Drew Tang's recommendations

We recommend that clients train all relevant employees before an inspection and tell them to fully cooperate with the inspectors. Appoint a senior manager (such as the quality manager or person responsible for the company) as the main escort and contact person to guide the inspection and answer questions. If unsure about an answer, staff may politely say that they need to check the information before responding, but must not refuse to answer outright. Open and honest communication is key.

📕 Risk notice

The consequences of obstructing enforcement are far more serious than being found to have a few “major deficiencies”. It will not only lead to the immediate refusal of your licence application or revocation of an existing licence, but will almost certainly result in criminal prosecution. A conviction will leave a criminal record and cause irreparable harm to the future prospects of the company and individuals. This is an absolute line that must not be crossed when dealing with the regulator.

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