Yes, when applying for a Hong Kong medicine import/export licence, you must submit proof of medicine registration or evidence that the product may lawfully be sold in the importing country. Under section 20 of the Pharmacy and Poisons Ordinance (Cap. 138), the Drug Office, Department of Health requires confirmation that the medicine has a lawful source and meets quality standards. If the medicine is not yet registered in Hong Kong, relevant clinical or quality data must be provided in support of the application. Rengangyongsheng (Hong Kong) Limited recommends preparing a complete set of registration documents in advance to help ensure a smooth assessment.
HONG KONG DRUG LICENSING
When applying for an import/export licence, is proof of medicine registration required?
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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