Whether a breach in the course of dealing in medicines will lead to criminal prosecution depends mainly on its nature and seriousness. Serious offences involving public health and safety, or conduct with an obvious fraudulent intent, are highly likely to result in criminal prosecution. Examples include operating any type of medicine business without a licence; selling or possessing unregistered pharmaceutical products (“counterfeit medicines”); selling proprietary Chinese medicines containing undeclared Western medicine ingredients; illegally selling antibiotics or dangerous drugs; and adulterating medicines with harmful substances. Such cases are usually investigated jointly by the Department of Health and the Commercial Crime Bureau of the Hong Kong Police Force, with the Department of Justice deciding whether to prosecute.
HONG KONG DRUG LICENSING
Under what circumstances can unlawful pharmaceutical operations escalate from administrative penalties to criminal prosecution?
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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