Under section 20 of the Pharmacy and Poisons Ordinance (Cap. 138), applicants for an import or export licence must hold a valid pharmaceutical licence and ensure that imported or exported medicines comply with Hong Kong’s quality and safety standards. Applicants must submit detailed information about the goods, the import or export destination and intended use, and must also have appropriate storage and transport conditions. The Drug Office, Department of Health will rigorously review the application documents to ensure compliance with the requirements for the regulation of medicines. Rengangyongsheng (Hong Kong) Limited recommends preparing all supporting documents in advance to avoid approval delays due to incomplete information.
HONG KONG DRUG LICENSING
What are the main requirements for applying for a Hong Kong pharmaceutical import/export 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.
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