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HONG KONG DRUG LICENSING

When applying for a pharmaceutical licence, must I submit the personal details of all employees for background checks?

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

Q135 · Category C: Eligibility and Personnel Requirements (Q101-Q150)
No. Regulatory background checks are targeted and focus mainly on people with key responsibilities for the company’s operations and compliance. You do not need to submit details of every employee. Those generally required to provide detailed personal information and undergo a “fit and proper person” assessment include: 1) all company directors; 2) the company’s ultimate beneficial owner (UBO); 3) nominated key personnel, such as the RP for a wholesaler or manufacturer, an Authorised Person (AP) and the person in charge of quality control; and 4) the pharmacist-in-charge of a pharmacy. Personal details of non-key staff, such as warehouse operators, sales representatives and general clerical staff, do not need to be submitted to the regulatory authority at the licence application stage.

📘 Regulatory basis

The PPB's assessment of whether a person is “fit and proper” mainly applies to individuals able to control or influence the licensed business. The scope of review is intended to cover the company's “directing mind and will”.

📗 Drew Tang's recommendations

We recommend that clients establish a clear organisational chart identifying which key positions must be declared to regulators. We will provide a detailed checklist to guide you in preparing the required personal information forms (Form 11) and supporting documents for these key personnel, ensuring that the application materials are accurate and complete.

📕 Risk notice

Although ordinary employees do not need to be declared, the licence holder is responsible for ensuring that all employees are of good character and have received appropriate training. If deliberate misconduct by an ordinary employee, such as stealing medicines, results in a breach during day-to-day operations, the company may still be held responsible for inadequate management.

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