An application to renew a Wholesale Dealer Licence should be submitted within the 3 months before the licence expires, but no later than the expiry date. You must submit the designated renewal application form to the Drug Office, Department of Health, together with relevant documents, such as a copy of the company’s Business Registration Certificate, the company’s annual return and payment of the renewal fee. The Drug Office will review your application and may arrange an on-site inspection to ensure that your business operations, premises and facilities, and Quality Management System still meet licensing requirements. The renewal process usually takes several weeks. We recommend preparing early to avoid disruption to your business if the licence expires.
HONG KONG DRUG LICENSING
My Wholesale Dealer Licence for western medicines is about to expire. What is the renewal process?
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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