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HONG KONG DRUG LICENSING

Should my financial budget include provision for a possible product recall event?

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

Q279 · Category F: Fees, budgeting and financial planning (Q251–Q300)
Yes, your financial budget and risk-management plan must make provision for resources in the event of a product recall. Although you do not necessarily need to set aside a specific “recall fund”, you must ensure that your financial position is sufficiently flexible to cope with one. A product recall can give rise to a range of direct and indirect costs: 1. “Logistics and reverse logistics costs”, namely the costs of retrieving and transporting affected products. 2. “Disposal costs”, for the safe destruction of recalled products. 3. “Replacement or refund costs”, for providing replacement products or refunds to customers. 4. “Communication costs”, for issuing notices to the public, customers and regulatory authorities. 5. “Loss of goodwill”, which is the most difficult cost to quantify but may be the most serious.

📘 Regulatory basis

The Department of Health requires all licensed pharmaceutical wholesalers and manufacturers to establish an effective product recall procedure. After receiving an instruction or identifying a problem, you must be able to initiate the recall within the specified time (usually within 24-48 hours) and notify all affected downstream customers.

📗 Drew Tang's recommendations

The best financial protection against recall risks is product liability insurance or product recall insurance. This type of insurance can cover most direct financial losses arising from a recall. We strongly recommend that all pharmaceutical businesses, particularly manufacturers and wholesalers, seriously consider purchasing this insurance as part of their standard operating costs.

📕 Risk notice

A serious product recall, if mishandled or unsupported by sufficient financial resources, could put a company out of business. This is not only a financial blow but also a devastating blow to brand reputation. Failing to prepare is effectively placing the company’s future at the mercy of uncontrollable risks.

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