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

Do I need to notify the Department of Health if my company's address or person in charge changes?

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

Q69 · Category B: Licence types and scope of application (Q51-Q100)
Yes, you must notify the relevant authority immediately. You are legally responsible for notifying the relevant licensing authority (the Drug Office, Department of Health, or the Chinese Medicine Regulatory Office) in writing within the specified period, usually within 28 days of the change, of any change to key information recorded on the licence. This includes, but is not limited to, the company name, business address, warehouse address, changes of directors or partners, and changes to key personnel (such as the supervising pharmacist at a pharmacy, the qualified person at a Chinese medicine shop, or the Authorised Person at a wholesaler or manufacturer). A change of address in particular usually requires a fresh review and an on-site inspection by the Department of Health. Approval can be granted only after the new address has been confirmed as meeting all regulatory requirements.

📘 Regulatory basis

Both the Pharmacy and Poisons Regulations and the Chinese Medicines Regulations contain provisions on notifying changes to licence-holder information. Failure to notify on time is itself a breach and may result in a fine.

📗 Drew Tang's recommendations

Before planning any major change, particularly a change of address, please consult us. We will explain the application process, documents and possible review time required for the change, helping you plan a smooth transition and avoid disruption to operations caused by administrative approval processes. We can also help you identify and assess the qualifications of successors when key personnel change.

📕 Risk notice

After moving to a new address, you must not conduct any regulated pharmaceutical business there until formal approval has been obtained from the Department of Health. This would be regarded as operating from unapproved premises and would amount to operating without a licence. Following a change of Person-in-Charge, the new Person-in-Charge must assume all legal responsibilities, so ensure that the handover is clear.

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