Q126 · Does a company applying for a drug licence…

Q126 · Category C: Applicant eligibility and personnel requirements (Q101–Q150)

Although the law does not require all types of pharmaceutical licence holders to purchase professional liability insurance, it is strongly recommended from a business risk management perspective. This is particularly true for medicine manufacturers and wholesalers, whose activities affect public health and safety and carry significant potential liability risks. Comprehensive Product Liability Insurance can provide financial protection against claims for personal injury or property damage caused to third parties by defective medicines. For pharmacies, purchasing Professional Indemnity Insurance for pharmacists is also standard practice, providing protection against claims arising from a pharmacist’s negligence or error when providing professional services such as dispensing or advice.

📘 Regulatory basis

Although the Pharmacy and Poisons Ordinance does not require insurance, a valid insurance policy can serve as positive evidence when assessing an applicant’s financial soundness and risk management capability, demonstrating that the company can deal with potential claims.

📗 Drew Tang's recommendations

We recommend that clients consult an insurance adviser before starting business and purchase adequate product liability or professional indemnity insurance based on the nature and scale of the business. Submitting an insurance proposal or a copy of the policy voluntarily with the licence application can demonstrate the company’s robust risk management framework to regulators.

📕 Risk notice

Not buying insurance is a dangerous form of “cost-cutting”. In the event of a serious product safety incident or professional negligence, the substantial compensation payable could cause an uninsured company to go bankrupt instantly. This financial vulnerability may also be a risk factor of particular concern to the regulatory authority when considering licence renewal.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Does a company applying for a drug licence need to take out specific professional indemnity insurance for its employees?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang