Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

If my licence application is rejected, can the money already spent, such as fit-out and consultancy fees, be refunded?

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

Q267 · Category F: Fees, Budget and Financial Planning (Q251-Q300)
This is a very realistic and sobering question. If your licence application is formally refused by the regulator, most of the funds already invested cannot be recovered. Specifically: 1. “Government application fees” are expressly non-refundable. 2. “Premises rent and fitting-out costs” are governed by your commercial contracts with the landlord and contractor and are unrelated to the outcome of the licence application; the money spent is essentially a sunk cost. 3. “Equipment purchase costs”: equipment already purchased may be resold at a discount, but losses are inevitable. 4. “Professional consultancy fees” depend on the terms of your contract with the consultancy firm. Rengangyongsheng (Hong Kong) Limited’s contracts clearly set out service fees at each stage, but fees for services already completed are generally not refunded if an application fails.

📘 Regulatory basis

The Pharmacy and Poisons Regulations’ provision that application fees are non-refundable reflects the principle that the Government’s approval work must be cost-covered. The regulator’s role is to consider applications, not to guarantee their success.

📗 Drew Tang's recommendations

This is precisely why we repeatedly emphasise the importance of an "early-stage professional assessment". Before you invest substantial funds in fitting out premises and procurement, engaging a professional consultant to conduct a comprehensive and prudent feasibility analysis is the most critical step in controlling risk. Our goal is to maximise your chances of success and avoid the worst-case scenario of an application being rejected. RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority.

📕 Risk notice

The greatest consequence of an unsuccessful application is significant financial loss. This is why we do not recommend that clients attempt a “DIY” application based solely on enthusiasm, without adequate preparation and professional guidance. Every decision should be based on a thorough understanding of the regulations and a clear awareness of the risks. Even an apparently minor oversight could jeopardise the entire application.

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