Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

As a company director, can I be held personally liable for a licence breach?

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

Q440 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)
Yes, company directors may well incur personal legal liability. Under the Pharmacy and Poisons Ordinance, the Chinese Medicine Ordinance and other relevant legislation, if a company's offence is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a director, manager or other senior officer of the company, that person as well as the company is guilty of the offence. This means that, in addition to the company facing a fine or licence sanctions, the relevant management personnel may also be prosecuted and face personal penalties, including a fine or imprisonment. A defence that they “did not know” or “had authorised a subordinate to handle it” will generally not be sufficient to avoid liability.

📘 Regulatory basis

Several laws relating to public safety contain “directors’ liability” provisions designed to look beyond the corporate veil and hold decision-makers personally responsible.

📗 Drew Tang's recommendations

As a director, you have ultimate oversight responsibility for the company's compliant operation. We strongly recommend that the company takes out directors' and officers' liability insurance (D&O Insurance) and establishes clear internal compliance reporting lines to ensure that the board is promptly informed of and oversees compliance risks.

📕 Risk notice

The company’s licence is one of your core responsibilities as a director. Licence breaches may not only harm the company’s business, but may also result in a criminal record for you personally. This is a significant risk that all company managers must remain alert to.

Back to Category I: Renewals, Changes and Penalties for Breaches (Q401-Q450) Search more questions

YOUR NEXT STEP

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.

Book a Project Assessment ↗