Renewal of a pharmaceutical licence is an important procedure that must be completed on time to ensure the lawful continuity of your business. Usually, the Drug Office, Department of Health will mail the renewal application form to the registered address on its records about two to three months before your licence expires. You need to complete the form, update basic company information (such as any changes to directors or the Person-in-Charge), and return it by post or submit it in person to the Drug Office before the licence expires, together with a cheque for the specified renewal fee. The Department will review the application. For higher-risk licences, such as wholesaler or manufacturer licences, it may arrange a re-inspection before deciding on renewal. If all documents are complete, the fee has been paid and the company has a good compliance record, renewal will usually proceed smoothly. The new licence will be mailed to you.
HONG KONG DRUG LICENSING
If my pharmaceutical licence 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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