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HONG KONG DRUG LICENSING

What specific penalties could I face if I am found operating a pharmacy without a 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.

Drug Office, Department of Health Chinese Medicines Board

Q406 · Category I: Renewals, changes and penalties for non-compliance (Q401–Q450)
In Hong Kong, operating a pharmacy without a licence (that is, selling Part I poisons without a licence) is an extremely serious offence. Under the Pharmacy and Poisons Ordinance, any unauthorised person who sells or possesses Part I poisons commits an offence. On summary conviction, the maximum penalty is a fine of HKD 100,000 and imprisonment for 2 years. In addition, enforcement officers of the Drug Office, Department of Health have the power to enter and search any premises suspected of unlicensed operation and seize all relevant medicines and documents as evidence. In sentencing, the court will consider not only fines and imprisonment but may also order forfeiture of all poisons seized.

📘 Regulatory basis

Section 28 of the Pharmacy and Poisons Ordinance (Cap. 138) expressly sets out the offences and penalties for the unlawful sale and possession of poisons.

📗 Drew Tang's recommendations

Do not take any chances. The regulator has a zero-tolerance policy towards unlicensed operations and often takes joint enforcement action with the police. If you intend to engage in retail sales of medicines, you must first apply for a Pharmacy licence through a professional organisation such as Rengangyongsheng (Hong Kong) Limited.

📕 Risk notice

In addition to statutory fines and imprisonment, a record of unlicensed operation will seriously affect your and your associated companies’ future applications for any type of licence in Hong Kong. It is a lasting “blemish”, and its commercial consequences go far beyond the fine itself.

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