If a company holding a pharmaceutical licence is convicted by a court of a criminal offence relating to medicines, public health or commercial integrity, this poses a serious threat to its licence. Even if the offence does not directly breach the Pharmacy and Poisons Ordinance, after learning of the conviction the regulator (such as the PPB or CMRO) will reassess whether the company remains a “fit and proper” licence holder. The regulator has the power to convene a disciplinary hearing and, having regard to the nature and seriousness of the offence, decide whether action against the licence is warranted, including suspension or revocation.
HONG KONG DRUG LICENSING
What effect will a criminal conviction against my licensed company have on its licence?
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.
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