Maintaining qualified key personnel is an ongoing responsibility of the licence holder. If the company’s RP or a registered pharmacist working in a pharmacy or medicines manufacturing premises leaves, the company must act immediately. Under the requirements, the licence holder must notify the Drug Office in writing within a reasonable time after the event (usually recommended within 24 hours). More importantly, the company must immediately seek and appoint a qualified replacement. Until a permanent replacement is found, the company may need to suspend some affected licensed activities. For example, a pharmacy cannot sell prescription medicines or regulated medicines when no pharmacist is on duty. The company must submit details of the newly appointed person to the Drug Office for approval within the specified period (usually within one month).
HONG KONG DRUG LICENSING
What legal obligations must a company fulfil if its Responsible Person (RP) or registered pharmacist leaves?
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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