For medicines manufactured in Mainland China and intended for private-label sale (OEM/ODM) in Hong Kong, first ensure that the manufacturer holds valid GMP certification and meets the relevant requirements for medicine registration under the Pharmacy and Poisons Ordinance (Cap. 138). Applicants must provide detailed product information, including manufacturing processes, quality control, test reports and stability data. The Hong Kong licence holder is also jointly liable for product quality and must ensure that imported medicines meet Hong Kong standards. A complete set of registration documents must be submitted, and the applicant must cooperate with the Drug Office’s review and on-site inspection.
HONG KONG DRUG LICENSING
How can medicines manufactured in mainland China be licensed in Hong Kong for private-label sales (OEM/ODM)?
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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