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Can I appeal if my pharmaceutical licence application is rejected by the Pharmacy and Poisons Board (PPB)?

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

Q24 · Category A: Pharmaceutical Licensing System and Regulatory Framework (Q1-Q50)
Yes, if you are dissatisfied with a decision of the Pharmacy and Poisons Board (PPB), such as refusing your licence application or deciding to suspend or revoke your existing licence, the law gives you a right of appeal. Under the Pharmacy and Poisons Ordinance, you may appeal to an independent appeal tribunal. The tribunal is chaired by a judge and includes members from the legal and medical professions. You must submit a notice of appeal within the specified period, usually 28 days after receiving the PPB's written decision. The appeal tribunal will rehear the entire case. You may submit evidence, call witnesses and make submissions. The tribunal may uphold, overturn or vary the PPB's original decision. Its decision is final. This appeal mechanism ensures that the PPB's powers are subject to checks and balances and safeguards procedural fairness for applicants and licence holders.

📘 Regulatory basis

Section 10 of the Pharmacy and Poisons Ordinance (Cap. 138) expressly establishes an appeal tribunal and sets out its composition and powers, providing a statutory appeal route for parties dissatisfied with a decision of the Board.

📗 Drew Tang's recommendations

An appeal is a serious, complex and costly legal process. Before proceeding, we recommend that you work with professional consultants such as us to carefully analyse the PPB's reasons for refusing the application and assess the prospects of success. In some cases, addressing the specific deficiencies in the application and then resubmitting it may be a more efficient and cost-effective option.

📕 Risk notice

Appeals are subject to strict time limits. If you miss the statutory deadline for filing a notice of appeal, you will permanently lose the right to appeal. Therefore, you must seek professional legal and compliance advice immediately upon receiving any adverse decision; do not delay.

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