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HONG KONG DRUG LICENSING

What rights do I have if my licence application is refused? Can I appeal?

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

Q93 · Category B: Licence types and scope of application (Q51-Q100)
Yes, if your application for a pharmaceutical licence is refused by the Pharmacy and Poisons Board (PPB) or the Chinese Medicine Council of Hong Kong (CMCC), you have a right of appeal. When the licensing authority refuses an application, it will usually notify you in writing and state the reasons for refusal. After receiving the refusal notice, you may appeal to an independent appeal board within the specified period (for example, 28 days). The appeal board's members are usually appointed by the Government and include professionals from the legal, medical, pharmaceutical and other fields. They will reconsider your application and whether the licensing authority's decision was reasonable.

📘 Regulatory basis

Both the Pharmacy and Poisons Ordinance and the Chinese Medicine Ordinance provide appeal mechanisms to ensure the fairness and transparency of administrative decisions and safeguard applicants’ procedural rights. The ordinances set out the appeal procedures and time limits in detail.

📗 Drew Tang's recommendations

After receiving a refusal letter, the first priority is to analyse the reasons for refusal calmly. In many cases, a refusal results from incomplete documents or a misunderstanding of certain requirements. Before deciding whether to appeal, we recommend assessing with us whether the issue can be resolved by providing supplementary information or communicating further with the licensing authority. If an appeal is indeed necessary, we will help prepare strong appeal submissions and evidence to demonstrate to the Board that your application meets all statutory requirements.

📕 Risk notice

An appeal is a serious, time-consuming and costly legal process. Without adequate grounds and evidence, a blind appeal is unlikely to succeed. More importantly, if any concealment or misrepresentation is discovered during the appeal, it will cause lasting damage to your credibility and affect any future related licence applications.

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