The “Person-in-Charge” is a key position at a licensed wholesaler or manufacturer, responsible for overseeing day-to-day operations to ensure compliance. Their departure has a significant impact on the licence, and you must act immediately. First, you should appoint a new, suitably qualified Person-in-Charge as soon as possible. They should have sufficient pharmaceutical knowledge, industry experience and understanding of the relevant legislation. Second, you must notify the Drug Office, Department of Health in writing within a reasonable time after the personnel change (usually recommended within 14 days), advising that the former Person-in-Charge has left and submitting the new appointee’s detailed CV and proof of qualifications. The Department of Health will assess whether the new appointee meets the requirements. Until a suitable replacement is found, senior management should appoint an interim acting person and ensure that all compliance activities continue without disruption.
HONG KONG DRUG LICENSING
Our “Responsible Person” has left the company. Will this affect the licence? What should we do?
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.
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