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HONG KONG DRUG LICENSING

How should I handle a complaint about a product my company plans to sell if we receive one during the application period?

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

Q242 · Category E: Application Process and Approval Procedures (Q201-Q250)

📘 Regulatory basis

The Code of Practice for Wholesale Dealers requires licence holders to have written procedures for handling product complaints. Although you are not yet a licence holder during the application period, establishing this procedure in advance is important evidence that you are capable of becoming a qualified licence holder.

📗 Drew Tang's recommendations

We will draft a world-class complaint-handling SOP for you. If such a situation arises, we will guide you on how to initiate the process, communicate with the supplier and document the entire handling process to create a complete “case file”. This file will be a powerful demonstration of your professionalism when communicating with inspectors.

📕 Risk notice

The risk lies in disregarding potential complaints. If you assume “I have not started operating yet, so it has nothing to do with me” and ignore a complaint, this sends a dangerous signal. If the product later develops a genuine quality issue and the regulator discovers that you had an opportunity to raise the alarm but took no action, your credibility will be seriously damaged.

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