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

When applying for a pharmaceutical licence, does the background check on company shareholders extend to the ultimate beneficial owner (UBO)?

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

Q130 · Category C: Eligibility and Personnel Requirements (Q101-Q150)
Yes, the regulatory authority conducts a comprehensive and in-depth background review of applicant companies, going beyond the level of immediate shareholders. This is particularly relevant where the corporate structure is complex (for example, where several offshore companies hold shares through multiple tiers). The Drug Office, Department of Health, and the Pharmacy and Poisons Board (PPB) may require the applicant to disclose its full shareholding structure and identify the Ultimate Beneficial Owner (UBO). The regulatory authority will then carry out the same “fit and proper person” assessment of those UBOs, including reviewing their identity, financial position, business reputation and any criminal record. This is intended to prevent people from using complex corporate structures to conceal disqualifying status and circumvent regulation.

📘 Regulatory basis

Hong Kong has implemented the Anti-Money Laundering and Counter-Terrorist Financing Ordinance (Cap. 615), which requires companies to keep a Significant Controllers Register (SCR). In practice, the pharmaceutical licensing regulators also adopt this ‘look-through’ review principle to establish who ultimately controls the licensed business.

📗 Drew Tang's recommendations

We recommend that clients prepare a clear shareholding structure chart and all ownership documents from the outset. For every individual holding more than a specified percentage of the interests (for example, 10% or 25%), prepare proof of identity and background information. Proactive and transparent disclosure of the ultimate beneficial owner information when applying can significantly speed up the approval process.

📕 Risk notice

Any attempt to conceal or obscure the identity of the ultimate beneficial owner will be regarded by the regulator as a serious integrity issue. If the UBO is found not to meet the “fit and proper” standard, or if the company is unable or refuses to provide clear UBO information when requested, the licence application is almost certain to be rejected.

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