When importing proprietary Chinese medicines into Hong Kong, a valid Hong Kong pharmaceutical licence must be held and the import licence requirements under the Pharmacy and Poisons Ordinance (Cap. 138) must be met. Product ingredients, formulae and pharmacological information must be submitted for review by the Drug Office to ensure that the ingredients are safe and the efficacy claims reasonable. Imports must be declared and undergo health inspection. Labels must state the ingredients, directions for use, contraindications and production batch number in both Chinese and English. Rengangyongsheng (Hong Kong) Limited assists clients in preparing complete documents and coordinating imports and pharmaceutical licence applications to help ensure compliant and prompt release.
HONG KONG DRUG LICENSING
What are the main compliance requirements when importing proprietary Chinese medicines into Hong Kong?
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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