The labels and package inserts for medicines manufactured under cross-border contract manufacturing must comply with the requirements of Hong Kong’s Pharmacy and Poisons Ordinance (Cap.138), including the registration number, batch number, expiry date, ingredients, directions and dosage, and warning information. Labels should be in Chinese and English to ensure that consumers understand them. The licensee should verify that the label information provided by the OEM manufacturer is accurate and contains no misleading information. All labels and package inserts must be reviewed and approved by the Department of Health before use.
HONG KONG DRUG LICENSING
What compliance matters should be considered for labels and package inserts of medicines manufactured under cross-border contract manufacturing?
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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