Under a cross-border contract manufacturing arrangement, the Hong Kong licence holder bears ultimate responsibility for the quality, safety and compliance of the medicines it sells. The licence holder must ensure that the contract manufacturer complies with the relevant GMP standards and maintain complete production and testing records. Under the Pharmacy and Poisons Ordinance (Cap. 138), the licence holder is legally liable for any incident resulting from a medicine quality issue, including administrative penalties and civil compensation. The licence holder should therefore rigorously audit the supply chain and ensure that every step complies with regulatory requirements.
HONG KONG DRUG LICENSING
What legal responsibilities do Hong Kong licensees have when medicines are manufactured under cross-border contract manufacturing?
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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