Medicine-related licences, such as wholesaler and manufacturer licences, are not valid indefinitely and must be renewed periodically. The renewal process is generally as follows: about 3–4 months before the licence expires, the Department of Health will send a renewal application form. You need to complete it, confirm that there have been no unapproved changes to the company’s registration details, key personnel or premises address, and return it to the Department of Health with the specified renewal fee. After receiving the application, the Department of Health may decide whether to conduct an on-site inspection before renewal, based on a risk assessment. If the company has a good compliance record and there have been no significant changes, renewal will generally proceed smoothly. Once approved, the Department of Health will issue a new licence. You should start preparing for renewal at least 3 months before expiry, allowing sufficient time to address any issues that may arise.
HONG KONG DRUG LICENSING
Our licence is about to expire. What is the renewal process, and how far in advance should we start preparing?
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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