Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
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HONG KONG DRUG LICENSING

If my pharmaceutical licence application is unfortunately rejected by the PPB Committee, what options do I have afterwards?

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

Q215 · Category E: Application Process and Approval Procedures (Q201-Q250)
If your application is formally rejected by the PPB Committee, this is undoubtedly disappointing, but it is not the end of the world. You have a statutory right of appeal. Under the Pharmacy and Poisons Ordinance, an applicant dissatisfied with a PPB decision may appeal to the Administrative Appeals Board within the specified period after receiving written notification of the rejection (usually 28 days). The Administrative Appeals Board is an independent statutory body that will rehear your case and consider submissions from both you and the PPB. Alternatively, you may choose not to appeal, but instead thoroughly address the reasons given by the PPB in its rejection letter and submit a completely new application at an appropriate time (for example, after 6 months). The choice of route depends on the specific grounds for rejection and your assessment of your circumstances.

📘 Regulatory basis

Section 16 of the Pharmacy and Poisons Ordinance gives applicants the right to appeal to the Appeal Board. This safeguards fairness in administrative proceedings and gives applicants an opportunity for independent review of decisions made by the PPB.

📗 Drew Tang's recommendations

If you receive a refusal letter, we will convene an urgent meeting with you to analyse the underlying reasons for the refusal. If the refusal is based on a misunderstanding of the facts or a debatable interpretation of the law, we will advise and assist you in preparing an appeal, and our legal team will draft a strong statement of appeal. If the refusal is due to significant deficiencies on your part, we will advise you not to appeal, but instead to focus your resources on comprehensive remediation and develop a new, stronger strategy for your next application.

📕 Risk notice

An appeal is a time-consuming and costly process, and success is not guaranteed. Appealing without sound grounds and professional legal support is likely to waste time and money. On the other hand, hastily resubmitting an application without first addressing the issues is almost certain to result in another refusal and may damage your credibility with the regulatory authorities.

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