Cross-border pharmaceutical companies applying for Hong Kong pharmaceutical licences must be legally registered in Hong Kong or overseas, have a good business record and comply with the Pharmacy and Poisons Ordinance (Cap.138). They must appoint a local representative in Hong Kong (such as an agent) to liaise with the Drug Office, Department of Health, and ensure that information is complete and updated promptly. They must also have a robust pharmaceutical Quality Management System and post-market tracking mechanism to ensure the safe distribution of medicines.
HONG KONG DRUG LICENSING
What qualifications or conditions must cross-border pharmaceutical companies meet when applying for a pharmaceutical licence in 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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