Q416 · What statutory powers do Department of…

Q416 · Category I: Renewals, changes and penalties for non-compliance (Q401–Q450)

Under the law, inspectors of the Drug Office, Department of Health are granted extensive powers to carry out their regulatory duties. When inspecting licensed premises, they may enter at any reasonable time; inspect and search the premises; require the production of and inspect any books, records or documents relating to the business; question any person on the premises; and take samples of any medicine or substance for testing. As a licence holder, you are legally obliged to cooperate with inspectors. You should appoint a senior staff member to accompany them throughout the inspection and promptly and accurately provide the documents and information requested.

📘 Regulatory basis

Section 26 of the Pharmacy and Poisons Ordinance (Cap. 138) confers detailed powers on inspectors to enter, search, take samples and seize documents.

📗 Drew Tang's recommendations

An inspection is not only a check but also an opportunity for communication. We recommend that clients approach inspections with a professional, open and cooperative attitude. Clear document management and record-keeping: RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority. Thorough preparation in everyday work naturally allows you to remain composed during inspections.

📕 Risk notice

Any deliberate act that obstructs or hinders an inspector in the performance of their duties, such as refusing to open the door, concealing documents or providing false information, is itself a criminal offence and may, upon conviction, result in a fine and imprisonment.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

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.

What statutory powers do Department of Health inspectors have during routine inspections, and how should I cooperate?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang