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

We have a batch of expired medicines in our warehouse. How should we handle them? Can we simply throw them away as rubbish?

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

Q420 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)
Absolutely not. Expired medicines must not be discarded as ordinary rubbish. They are subject to strict disposal requirements to prevent them from re-entering the market or polluting the environment. As a licensed wholesaler or manufacturer, you must establish a formal medicine destruction procedure. First, isolate the expired medicines and label them clearly. Then engage a qualified chemical waste collector to handle them. Detailed records of the entire destruction process must be kept, including the medicine name, batch number, quantity, destruction date and method. At least two staff members, one of whom should be a manager, must jointly supervise and sign to confirm the process. These records must be available for inspection, and the Department of Health may request them during an inspection.

📘 Regulatory basis

Both the Good Distribution Practice (GDP) for Wholesale Dealers in Medicines and the Waste Disposal (Chemical Waste) (General) Regulation set out clear requirements for handling expired medicines and retaining records.

📗 Drew Tang's recommendations

We recommend that clients include the medicines destruction procedure in the company’s Standard Operating Procedures (SOPs) and review it regularly. It is essential to choose a reputable chemical waste disposal company holding the appropriate licence. Keep all destruction contracts and records for inspection.

📕 Risk notice

Improper handling of expired medicines, such as casually discarding or reselling them, is a serious violation. If discovered, this not only breaches medicines management regulations but may also contravene environmental legislation, resulting in penalties under both. If the medicines ultimately endanger public health, the consequences could be severe.

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