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HONG KONG DRUG LICENSING

Do I need to buy commercial insurance for my pharmaceutical business? What should it primarily cover?

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

Q285 · Category F: Fees, budgeting and financial planning (Q251–Q300)
Yes, purchasing comprehensive commercial insurance for your medicine business is an essential risk-management measure. You should focus on the following types of insurance: 1. “Public Liability Insurance”, which provides cover for compensation claims for third-party personal injury or property damage arising from your business activities (for example, a customer slipping in your shop). 2. “Product Liability Insurance”, which is of central importance and covers compensation claims for injury to users caused by defects in products you sell. 3. “Property All Risks Insurance”, which covers your assets, such as your shop, warehouse, equipment and inventory, against losses caused by events such as fire, theft and flooding. 4. “Employees' Compensation Insurance”, which is compulsory by law and is commonly known as employees' compensation insurance.

📘 Regulatory basis

The Employees' Compensation Ordinance (Cap. 282) requires all employers to take out employees' compensation insurance for their employees. Although other types of insurance are not compulsory, the Department of Health may consider whether a licence holder is “fit and proper” by taking account of the adequacy of its risk management measures. Taking out insurance is an important part of this.

📗 Drew Tang's recommendations

Insurance is fundamentally about transferring risk. We strongly recommend working with a professional insurance broker who can tailor a comprehensive insurance plan to your specific business (wholesale, retail or manufacturing) and product risks (high-risk biological products or low-risk health supplements). Premiums should be regarded as a key investment in business continuity.

📕 Risk notice

Trying to “save” on insurance is an extremely dangerous short-sighted approach. A serious product liability claim could amount to millions or even tens of millions of Hong Kong dollars, enough to bankrupt any uninsured SME instantly. You could lose not only your business, but potentially all your personal assets.

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