Yes, this is absolutely required. Under Hong Kong law, the definition of “manufacture” of pharmaceutical products is broad. It includes not only the process of synthesising or mixing raw materials into a finished dosage form, but also all forms of packaging, repackaging, labelling and relabelling. Even if you only subdivide unpackaged finished medicines (such as bulk tablets) or add localised Chinese labels to already packaged medicines, these activities are considered part of “manufacture”. You must therefore apply for and hold a valid Manufacturer of Pharmaceutical Products Licence, and your premises and processes must fully comply with GMP standards.
HONG KONG DRUG LICENSING
Do I need to apply for a manufacturer’s licence if I only package or label medicines?
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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