A medicine approval number (approval document) issued to a Mainland OEM manufacturer cannot directly replace a Hong Kong Certificate of Drug/Product Registration. A Hong Kong medicine licence application must include a complete set of registration information in accordance with local regulations, including evidence of quality, safety and efficacy. Although Mainland documents may be used as reference material, the Drug Office, Department of Health must still conduct an independent review and grant approval. Applicants should prepare information that meets Hong Kong standards, including the product insert, GMP certificate and test reports, and ensure compliance with the Pharmacy and Poisons Ordinance (Cap. 138).
HONG KONG DRUG LICENSING
Can a medicine approval document provided by a Mainland OEM manufacturer be used directly for a Hong Kong medicine licence application?
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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