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

What should I note if I plan to acquire a company that already holds a pharmaceutical licence? Will the licence automatically transfer to me?

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

Q96 · Category B: Licence types and scope of application (Q51-Q100)
Acquiring an already licensed company is an effective way to enter the market quickly, but the process requires great care. A pharmaceutical licence is granted to a specific company to operate at a specific address; it does not “automatically” transfer or remain valid when the company’s shares change hands. If the company’s ownership (shareholders) or control (directors) changes materially, you must formally notify the licensing authority. The authority will reassess the background and capabilities of the new shareholders and management to decide whether the licence may remain valid under the new ownership. This process may involve submitting extensive documentation and even undergoing a further on-site inspection.

📘 Regulatory basis

Although there is no such thing as a “licence transfer”, the Pharmacy and Poisons Regulations require changes of company directors or partners to be declared. The regulator is entitled to reassess the suitability of the licence in light of the new persons in control.

📗 Drew Tang's recommendations

Before signing any acquisition agreement, we strongly recommend commissioning us to conduct comprehensive compliance due diligence on the target company. We will thoroughly review its licence history, inspection reports, QMS documents, inventory and sales records to identify any potential undisclosed compliance risks or legacy issues. This can help you avoid discovering only after the acquisition that you have taken over a ‘mess’.

📕 Risk notice

The greatest risk is “hidden liabilities”. If the target company committed serious breaches before the acquisition that have not been discovered, you, as the new owner, may face the corresponding legal consequences if they come to light after you take over, including fines or even revocation of the licence. Due diligence is the only way to mitigate this risk.

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