Yes, this is necessary. Under the Companies Ordinance (Cap. 622), any overseas company wishing to carry on business in Hong Kong must register as a “registered non-Hong Kong company”. However, registration as a non-Hong Kong company alone is generally insufficient when applying for licences such as those for pharmaceutical wholesalers, manufacturers or pharmacies. The regulator (the Drug Office, Department of Health) requires the licence holder to be a legal entity incorporated in Hong Kong, namely a Hong Kong-incorporated limited company. This is because the regulator needs to oversee and enforce the law against an entity with a clear legal status and assets in Hong Kong. Accordingly, the standard approach is for the overseas company first to incorporate a wholly owned or joint venture local limited company in Hong Kong, and then submit the licence application in the name of that Hong Kong company.
HONG KONG DRUG LICENSING
I am an overseas pharmaceutical manufacturer and want to apply for a licence in Hong Kong. Must I establish a subsidiary in Hong Kong?
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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