When medicines manufactured under cross-border contract manufacturing are imported into Hong Kong, they must comply with the relevant requirements of the Pharmacy and Poisons Ordinance (Cap.138) and the Import and Export Ordinance (Cap.60). The importer must hold a valid pharmaceutical licence and ensure that the imported medicines are registered, and provide complete import declaration documents and test reports. Imported medicines must meet Hong Kong quality standards, and complete import records must be retained for inspection by the Department of Health. In addition, imported medicines may be subject to sampling tests or on-site inspections to ensure their safety and compliance.
HONG KONG DRUG LICENSING
What compliance requirements apply when importing medicines manufactured under cross-border contract manufacturing 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.
Back to Category J: Cross-border Medicines and Industry Practice (Q451-Q500) Search more questions