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HONG KONG DRUG LICENSING

Is a fee payable for licence renewal? What are the renewal fees for Western medicine and Chinese medicine licences respectively?

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.

Drug Office, Department of Health Chinese Medicines Board

Q255 · Category F: Fees, Budget and Financial Planning (Q251-Q300)
Yes, all pharmaceutical and Chinese medicine licences are non-permanent and must be renewed periodically, with the applicable fees paid. For western medicine licences, such as a pharmaceutical product wholesaler licence, the annual renewal fee is 2,150 units, the same as the initial issue fee. An annual fee must also be paid each year for an Authorised Seller of Poisons (ASP) (pharmacy) licence. For Chinese medicine licences, such as a retail licence for Chinese herbal medicines, the annual renewal fee is 1,160 units. These renewal fees are necessary ongoing expenses for maintaining your lawful right to operate and must be paid on time.

📘 Regulatory basis

Renewal fees for Western medicine licences are specified in the Third Schedule to the Pharmacy and Poisons Regulations (Cap. 138A). Renewal fees for Chinese medicine licences are specified in the Chinese Medicine Regulation (subsidiary legislation under Cap. 549). The regulatory authorities review these fees periodically and may adjust them.

📗 Drew Tang's recommendations

We strongly recommend setting up a “compliance calendar” that clearly marks important dates, such as licence renewal dates and payment deadlines. The Drug Office or Chinese Medicines Board usually sends renewal notices in advance, but as the licence holder, you remain ultimately responsible for ensuring timely renewal. Include this annual expense as a fixed item in your annual financial budget.

📕 Risk notice

Failure to pay the renewal fee on time will cause the licence to expire automatically. Once the licence has expired, you must immediately stop all related pharmaceutical business activities; otherwise, your operations will be illegal. Reapplying for a licence is time-consuming and demanding, and may involve more stringent scrutiny. Any delay could therefore have a disastrous impact on your business.

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